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X-WR-CALNAME:dia2026globalannualmeeting
X-WR-CALDESC:Event Calendar
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PRODID:-//Sched.com DIA 2026 Global Annual Meeting//EN
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BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260608T170000Z
DTEND:20260608T200000Z
SUMMARY:12P : Real-World Evidence for Regulatory Decision-Making: Guidance\, Methods\, and Case Studies
DESCRIPTION:Component Type: TutorialCE: ACPE 2.75 Knowledge UAN: 0286-0000-26-501-L04-P\; IACET 2.75Pre-Registration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.This Short Course will be offered virtually – Join from anywhere!This short course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is transforming the regulatory landscape for drugs and biologics. The course begins with an overview of global regulatory trends\, highlighting the increasing acceptance and integration of RWE alongside randomized controlled trials to inform approvals\, label expansions\, and clinical development planning. Participants will learn to identify and assess diverse sources of real-world data (RWD)\, applying practical frameworks to determine when data are “fit for purpose” for regulatory use. Through case studies and recent regulatory guidance\, the course illustrates the evolution of RWE from safety evaluation to supporting efficacy\, label extensions\, and population bridging\, underscoring the importance of methodological rigor and early engagement with regulators. The curriculum emphasizes structured approaches and frameworks\, for designing transparent and valid real-world studies\, including the use of external control arms. Participants will learn that RWE generation for regulatory decision-making requires thoughtful study design and use of transparent frameworks to ensure data fitness and validity. The course will be interactive with the use of polling questions and participants are encouraged to raise scenarios they encounter for open discussion.Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart. Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course\, but are interested in the content? Register anyway and you will receive access to the recording!
CATEGORIES:07: REGCMC-PRODUCT QUALITY\,10: STATS-EVIDENCEGENERATION-RWE\,17: SHORT-COURSES
LOCATION:TBD\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/9e54f52dbf226762dd52c62763548e31
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DTSTAMP:20260517T134759Z
DTSTART:20260615T120000Z
DTEND:20260615T140000Z
SUMMARY:#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures
DESCRIPTION:Component Type: SessionLevel: IntermediateThis opening plenary explores how patient driven science\, AI enabled discovery\, and regulatory innovation can uncover “hidden cures” in the medicines and data we already have. Through a keynote from David Fajgenbaum and a panel on AI in biopharma\, the session asks how we can find\, trust\, and deliver tomorrow’s cures from today’s science.Learning Objectives Describe the latent potential of existing medicines and data\, and how patient driven science can uncover new uses for known therapies\; Explain how AI and advanced analytics can de risk drug discovery and trial design\, surfacing overlooked opportunities and improving investment decisions\; Identify system level levers: collaboration\, regulation\, and capital\, that can help translate today’s science into tomorrow’s cures more quickly\, safely\, and equitably.Chair Maria Vassileva\, PHDSpeaker PanelistLawrence TallonPanelistDavid PfeifferPanelistGreg SarafinPanelistRahul Gupta\, MD\, MBA\, MPHPanelistDavid FajgenbaumPanelistAudrey Greenberg\, CPA\, MBA
CATEGORIES:03: DATA-TECH-AI\,05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,00: PLENARY
LOCATION:Ballroom AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/5ebbab77a0a00f56e525c04ea40a8f1e
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DTSTAMP:20260517T134759Z
DTSTART:20260615T140000Z
DTEND:20260615T150000Z
SUMMARY:#401 SCC: Student Case Competition
DESCRIPTION:Component Type: SessionEach year\, DIA hosts a Student Case Competition at our Global Annual Meeting that provides students the opportunity to respond and propose viable solutions to current challenges faced throughout the drug development lifecycle. The competition will be judged by a committee of DIA Fellows and Esteemed Volunteers\, who include our most experienced and engaged members that encompass a broad range of expertise.Chair Sorcha McCrohan\, MS
CATEGORIES:15: NETWORKING-OPPORTUNITIES
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/c9c5508f7bee0ab5f18c02ab05c69b3e
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DTSTAMP:20260517T134759Z
DTSTART:20260615T141500Z
DTEND:20260615T144500Z
SUMMARY:#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready
DESCRIPTION:Component Type: SessionBiopharma organizations have spent decades generating clinical content. Trial master files\, investigator documents\, safety narratives\, and regulatory submissions sit largely unclassified and functionally invisible across content repositories. Content was generated across every study\, processed once\, and never revisited — leaving every insight locked inside the document itself\, blind to the AI systems now being built on top of it. Join us to hear from Industry leaders\, in a candid conversation about transforming years of digital debt into an AI-ready content foundation. You will hear real-world perspectives on what metadata maturity looks like in practice and what becomes possible when intelligent content workflows finally reach regulated clinical data.Chair Box\, Inc.Speaker SpeakerManu VohraSpeakerAli ShamounSpeakerBoris Braylyan\, MBA
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 3\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/447fa6812df9cca24fef849ff3fcb74d
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DTSTAMP:20260517T134759Z
DTSTART:20260615T141500Z
DTEND:20260615T144500Z
SUMMARY:#401.2 IT: Deep Intelligent Pharma K.K. Innovation Theater: Accelerate Deep Tech Impact - Mentor Japanese MD/PhDs with Agentic AI from Startup Launch to Physician-Led Trials
DESCRIPTION:Component Type: SessionJapanese MDs and PhDs possess deep tacit knowledge and clinical insights that could transform patient care\, yet turning these into successful deep tech startups and physician-led clinical trials remains extremely challenging due to fragmented support systems\, regulatory complexity\, and limited entrepreneurial resources. This session introduces a powerful new approach that combines structured mentoring with Agentic AI to guide Japanese physician-scientists from idea validation and company founding through to efficient\, physician-led clinical development. Participants will discover practical frameworks and real-world examples of how Agentic AI accelerates critical steps—including protocol design\, regulatory navigation\, and evidence generation—while experienced mentors help bridge the gap between academic excellence and market impact. Attendees will leave with actionable strategies to unlock societal value from university and hospital tacit knowledge and build more successful\, clinician-driven innovation pipelines in Japan and beyond.Chair DEEP INTELLIGENT PHARMA (SG) PRIVATE LIMITEDSpeaker SpeakerShinya Yamamoto\, PHD\, MS
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/c7f4109f98e1aeae8f6764ba27ab28a5
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DTSTAMP:20260517T134759Z
DTSTART:20260615T141500Z
DTEND:20260615T144500Z
SUMMARY:#401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation
DESCRIPTION:Component Type: SessionChair IQVIASpeaker SpeakerRaja Shankar\, MS
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/8629105babd9928757509a22e2a5709c
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P\; CME 1.25\; RN 1.25This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care. Learning Objectives Describe the changes in availability and use of different data sources for safety surveillance across the healthcare landscape in the future\; Identify the challenges for data collection\, monitoring and assessment of safety data from evolving real world use of healthcare products\; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.Chair Alison CaveSpeaker PanelistPhil TregunnoPanelistAngela Radcliff
CATEGORIES:01: CLINSAFETY-PV-RM\,03: DATA-TECH-AI
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/5bbe8f3829cb1310a9bf8c53f04fac3a
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DTSTAMP:20260517T134759Z
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SUMMARY:#404: Evidence-Based Insights Informing Participant Compensation Strategies
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-512-L04-P\; CME 1.25\; RN 1.25This session presents findings from a DIA–Tufts CSDD study examining how participant compensation strategies vary across trial phases and therapeutic areas and their impact on recruitment\, retention\, and enrollment outcomes\, with implications for protocol design and trial executionLearning Objectives Describe how participant compensation strategies vary by trial phase and therapeutic area\; Assess evidence linking compensation practices to recruitment\, retention\, and enrollment outcomes\; Apply study insights to support consistent\, ethical\, and effective compensation decisions in protocol design and trial execution.Chair Kenneth Getz\, MBASpeaker PanelistLindsay McNair\, MD\, MPH\, MSPanelistSabina KineenPanelistBrittany NilandPanelistElizabeth Smith Morris
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/75a531e79434a31b34095e75bdcea740
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#403: Clinical Operations in Transition: Leadership Perspectives on AI\, the Workforce\, and the Future of Trial Execution
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P\; CME 1.25\; RN 1.25Clinical Operations leaders today are navigating one of the most dynamic periods in recent history. From managing AI-driven transformation to rethinking global outsourcing models and rebuilding teams in a post-layoff landscape\, the challenges facing clinical operations executives are unprecedented — and so are the opportunities. This session brings together senior leaders from large\, mid-size\, and emerging biopharma companies for an unscripted fireside conversation exploring how the role of Clinical Operations has evolved over the past decade and where it’s heading next. Panelists will share candid insights on leading change\, balancing innovation with execution\, and maintaining resilience in the face of shifting talent models and regulatory expectations.Learning Objectives Discuss current trends\, pressures\, and innovations shaping Clinical Operations directly from industry leaders\; Recognize operational strategies using benchmark data through real-world examples of how organizations are adapting their models\, technologies\, and teams\; Identify emerging roles\, skill requirements\, and leadership priorities within the evolving ClinOps landscape to guide personal career planning and organizational development.Chair Joseph DustinSpeaker PanelistJennifer Sheller\, MPHPanelistNikki Amaratunge\, MA\, PMPPanelistRosalie FilingPanelistEmily Walker\, MBA
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/da3a62f1632c0e0cf6f277ef1ec1f8e9
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-514-L04-P\; CME 1.25\; RN 1.25AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities\, risks\, regulatory oversight\, and the role of reference datasets for tool validation.Learning Objectives Describe the current landscape and practical applications of AI-based diagnostic tools\; Examine potential regulatory frameworks and strategies to ensure oversight and reliability of AI-based diagnostics\; Identify key considerations in developing reference datasets to support validation of AI tools.Chair Hillary Andrews\, PHDSpeaker Industry PerspectiveAlain Silk\, PHDPatient Advocate PerspectiveJason Binder\, MAIndustry PerspectiveMike Montalto\, PHD
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/4334018e8a5339efd66d76b9f2c97527
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#406: Enhancing Regulatory Collaboration through Cloud Technologies
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P\; CME 1.25\; RN 1.25The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers\, regulatory agencies\, and industry representativesLearning Objectives Explain the value of regulatory collaboration and describe recent technological advancements that enable it\; Identify key challenges and opportunities associated with integrating cloud technologies into regulatory processes\; Examine perspectives from technology providers\, regulators\, and industry on the future of regulatory collaboration and outline ways to participate in these efforts. Chair Dominique Lagrave\, PHARMDSpeaker PanelistMarko EricPanelistJulie Lepin\, MAPanelistAna Carolina Moreira Marino AraujoPanelistVada Perkins\, MS
CATEGORIES:03: DATA-TECH-AI\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/a661b923225cdda75c24229c1fb34803
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#407: The Great Debate: Using AI in Patient-Facing Materials
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-515-L04-P\; CME 1.25\; RN 1.25Artificial intelligence is influencing how pharmaceutical companies plan to develop patient-facing materials (promising faster production\, improved readability\, and more personalized education) —while also raising questions about accountability\, empathy\, trust\, bias\, and accuracy. In this “Great Debate” session\, two industry presenters will offer contrasting perspectives on whether AI should directly generate or refine patient communications and will share practical examples of technologies being used today. A patient advocate will ground the discussion in real-world needs and expectations\, helping participants leave with actionable guardrails for adopting AI responsibly and keeping patients at the center.Learning Objectives Discuss the role of AI in patient-facing materials and practical guardrails\; Identify key benefits and limitations of AI-enabled communication workflows in the pharmaceutical industry\; Assess ethical and trust considerations for AI-influenced patient communications—such as transparency\, bias\, inclusivity\, empathy\, and the potential for misinformation—through both industry and patient-advocate lenses.Chair Regina Lynn PreciadoSpeaker The Great Debate: Using AI in Patient-Facing MaterialsChristine Marie Von RaesfeldThe Great Debate: Using AI in Patient-Facing MaterialsKimbra Edwards\, PHDThe Great Debate: Using AI in Patient-Facing MaterialsIrene Kuhlman\, MS
CATEGORIES:04: MEDAFFAIRS-SCICOMM\,03: DATA-TECH-AI
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/b265f39f98502804fe2a3aeb93dd051b
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P\; CME 1.25\; RN 1.25In this session\, we will address the challenges of conducting clinical research in Europe under IVDR and CTR\, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.Learning Objectives Explain the key principles involved in biomarker-driven approvals\; Describe the role of in vitro diagnostics\; Identify the types of detailed information required in applications to meet regulatory expectations for biomarker-guided medicinal products.Chair Ana Trullas\, PHARMD\, MSCSpeaker Building Bridges\, Not Silos: Lilly's IVDR-Driven TransformationLauren Tobe\, JDtbd. In vitro biomarker tests for patient selection for efficacyMartin MengelCompanion Diagnostics and Medicinal Products: A notified Body perspective on Co-development under IVDRRolf Thermann\, PHDCombined studies in the EU- overview and considerations for industryJoshua D Levin\, MA
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/577e5825c9a26bfcc3675a403143e62f
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DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
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SUMMARY:#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-517-L04-P\; CME 1.25\; PDU 1.25 PMI 216647VJP8\; RN 1.25What if every investment were assessed for impact - before committing resources? As portfolio decisions in R&D and Medical Affairs are becoming increasingly complex\, leadership teams often struggle to link individual projects to overall portfolio performance. This makes it difficult to clearly articulate portfolio potential\, compare alternative portfolio configurations\, or understand the portfolio-level impact of adding\, re-prioritizing\, or stopping initiatives. This interactive workshop explores whether and how an impact-driven portfolio approach\, using the efficient frontier as a practical example\, can help bridge this gap and support more effective management decision-making. Through hands-on exercises and facilitated discussion\, participants will work with realistic portfolio scenarios to visualize portfolio performance and examine how individual initiatives contribute to overall portfolio value. Participants will test different portfolio scenarios\, discuss trade-offs\, and explore how project-level decisions shift portfolio-level performance. Rather than optimizing projects in isolation\, the workshop focuses on using the efficient frontier to enable management-ready conversations that explicitly connect project choices to portfolio impact\, risk\, and strategic alignment. The workshop also examines the evolving role of project and portfolio managers as strategic impact managers\, supporting leadership teams by creating portfolio transparency\, enabling informed trade-offs\, and driving value realization across R&D and Medical portfolios. The session is designed for Medical and R&D leaders seeking to strengthen strategic decision-making\, improve transparency\, and elevate portfolio management to impact stewardship.Learning Objectives Explain how the efficient frontier clarifies portfolio performance and supports leadership discussions portfolio-level impact and value\; Analyze how individual initiatives change portfolio performance by using the efficient frontier to simulate adding\, re-prioritizing\, or stopping projects and assessing each decision by its portfolio-level effect\; Discuss ways portfolio managers are evolving into strategic impact leaders.Chair Robin Boss\, MSSpeaker PanelistJill Orosz
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/543fb2afd2016da1553a5f62cf696f9a
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DTSTAMP:20260517T134759Z
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SUMMARY:#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P\; CME 1.25\; PDU 1.25 PMI 216641I1NS\; RN 1.25In this session\, we will focus on the evolving role of the quality assurance professional\, show you how to manage your professional development as a project\, and build skills to deliver measurable outcomes in the age of AI.Learning Objectives Recognize the evolving role of the quality assurance professional in the age of AI and how to align with emerging expectation\; Apply project management principles to strategically plan and execute your personal upskilling journey in AI\; Discuss how to build a personalized career roadmap using practical tools and frameworks to stay relevant\, resilient\, and future-ready.Chair Michael Pelosi\, MA\, MBASpeaker Smarter Roles\, Stronger Skills: AI in Workforce EvolutionHaleh Valian\, PHDCompliance to Competence: How AI and New Regulations Are Reshaping the Quality ProfessionalJeremy Jones\, MSQuality in the Age of Agents: A Look Back From the AI-Driven FutureRoshan D'Souza
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,09: RD-QUALITY-COMPLIANCE
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/602596cb312795744db909d57c4266d2
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SUMMARY:#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-519-L04-P\; CME 1.25\; RN 1.25The recent focus by the US government to increase US-based pharmaceutical manufacturing has created opportunities to revisit the regulations and guidelines that lead to the lengthy time that it takes to construct or expand a manufacturing facility.Learning Objectives Discuss critical path items that lead to extended construction and regulatory approval timelines\; Describe how FDA's innovative regulatory concepts address these challenges\; Identify the similarities and differences between bolstering domestic manufacturing by onshoring manufacturing to established facilities versus new or expanded US based facilities.Chair Joseph Kutza\, PHDSpeaker Modernizing Oversight: Enabling the Future of U.S.-Based Pharmaceutical ManufacturingLisa Wright\, MSInnovative Regulatory Approaches to Increasing US-based Pharmaceutical ManufacturingCecilia Tami\, PHDBuilding U.S. Biopharmaceutical Manufacturing Workforce Capacity: Challenges\, Opportunities\, and InnovationsJohn Balchunas\, MSC
CATEGORIES:07: REGCMC-PRODUCT QUALITY
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f20875933f3dca696c188a9b5bb4849f
URL:http://dia2026globalannualmeeting.sched.com/event/f20875933f3dca696c188a9b5bb4849f
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DTSTAMP:20260517T134759Z
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SUMMARY:#415: Regulatory Cooperation Between the United States and Japan
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-522-L04-P\; CME 1.25\; RN 1.25This session provides an update on the current regulatory affairs between FDA and PMDA. Both agencies will highlight significant regulatory collaboration in two areas\, oncology and drug safety and discuss future regulatory activities in their region.Learning Objectives Describe the latest regulatory collaboration between the United States and Japan\; Identify new key areas for further regulatory collaboration between FDA and PMDA.Chair Sema Hashemi\, MSSpeaker PanelistMark AbdooPanelistNaoyuki Yasuda\, MSCPanelistGerald Dal Pan\, MD\, MHSPanelistMiki Ota\, MPHARMPanelistAkihiro Ishiguro\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f587b2e2b4ff7ade6bcb8d8ed03211fb
URL:http://dia2026globalannualmeeting.sched.com/event/f587b2e2b4ff7ade6bcb8d8ed03211fb
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SUMMARY:#416.1: International Regulatory Cooperation with the African Medicines Agency
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-608-L04-P\; CME 1.25\; RN 1.25A 60-minute session with AMA\, FDA\, and partners will review successes in collaboration\, explore future opportunities to enhance oversight and access\, and conclude with interactive Q&A on advancing harmonized regulatory systems in Africa.Learning Objectives Discuss the FDA priorities in regulatory alignment\, supply chain resilience\, and collaboration in Africa\; Recognize how regulators work across regions to improve access\, using approaches such as reliance\, convergence\, and joint inspections to reduce duplication\, strengthen resilience\, and advance public health.Chair Meisha Sampson\, MSSpeaker International Regulatory Cooperation with the African Medicines AgencyEmile BienvenuPanelistAissatou SOUGOUInternational Regulatory Cooperation with the African Medicines AgencyDelese Mimi Darko\, MBA\, RACInternational Regulatory Cooperation with the African Medicines AgencyAhmed MohamedInternational Regulatory Cooperation with the African Medicines AgencyHeran Gerba\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:110A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
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URL:http://dia2026globalannualmeeting.sched.com/event/284909c652815c499b36f8517ba6d7a6
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SUMMARY:#416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-524-L04-P\; CME 1.25\; RN 1.25This session presents insights from the Women’s Health Innovation Radar\, highlighting global evidence gaps and emerging research priorities. It explores strategic and policy implications to accelerate scientific and clinical progress in women’s health.Learning Objectives Identify key global evidence gaps and emerging areas of activity in women’s health R&D\; Recognize how patterns in scientific evidence and clinical research can guide strategic and policy priorities in women’s health\; Outline actionable levers\, scientific\, clinical\, and policy-related\, that can accelerate progress in women’s health innovation.Chair Martin Hodosi\, MSSpeaker -Victoria DiBiaso\, BSN\, MPH\, RN-Katherine Senter\, MPH-Sanj Singh\, MBA
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e0fa7d13a6c2019ef4e2154652f1d90c
URL:http://dia2026globalannualmeeting.sched.com/event/e0fa7d13a6c2019ef4e2154652f1d90c
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DTEND:20260615T161500Z
SUMMARY:#413: Health Canada Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P\; CME 1.25\; RN 1.25In this session\, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.Learning Objectives Describe Health Canada’s regulatory initiatives and strategic priorities\; Identify opportunities for engagement with the Canadian regulator.Chair Alysha Croker\, PHDSpeaker PanelistSophie Sommerer
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d3c1fcce11386ae5923f932641329107
URL:http://dia2026globalannualmeeting.sched.com/event/d3c1fcce11386ae5923f932641329107
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P\; CME 1.25\; RN 1.25As FDA–industry negotiators finalize future performance goals\, Congress will shape the next user-fee statute. This session examines how budget politics\, workforce shifts\, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.Learning Objectives Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals\; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability\; Assess how leadership priorities to accelerate innovation—including review vouchers\, AI\, and MAHA initiatives—could influence policy riders and oversight.Chair Jeffrey Francer\, JD\, MPASpeaker How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the AgencyClare PaolettaHow the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the AgencyBarrett Tenbarge\, JD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:162832db602d01ad7ac540a9a243f632
URL:http://dia2026globalannualmeeting.sched.com/event/162832db602d01ad7ac540a9a243f632
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#412: FDA Public Posting of Complete Response Letters: A Year in Review\, Trends\, and Impact Analysis
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P\; CME 1.25\; RN 1.25This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data\, identify emerging trends\, and assess the implications of this transparency initiative. Learning Objectives Discuss FDA's process for issuing and publicly posting Complete Response Letters (CRLs)\; Analyze trends in CRLs over the past year\, including common reasons for issuance\; Evaluate the benefits and potential drawbacks of public CRL disclosure.Chair Lina AlJuburi\, PHARMD\, MSCSpeaker PanelistEva Temkin\, LLMPanelistAmanda ContiPanelistEric Gascho
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:df0e392146ed2263d398e42efb8ca408
URL:http://dia2026globalannualmeeting.sched.com/event/df0e392146ed2263d398e42efb8ca408
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T150000Z
DTEND:20260615T161500Z
SUMMARY:#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P\; CME 1.25\; RN 1.25This session will provide a practical\, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically\, centered on Critical to Quality (CtQ) factors\, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.Learning Objectives Recognize CtQ factors using integrated QbD and RBQM in a collaborative\, cross-functional setting\; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle\; Discuss regulatory expectations and industry best practices for a unified quality strategy\; List practical strategies for implementing this approach within organizations.Chair Paula Walker\, MASpeaker PanelistMandy Kaur Budwal-Jagait\, MSCPanelistPaula Walker\, MAPanelistSumitra SachidanandanPanelistCheryl Grandinetti
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8da7b7ff4d032879b940782bd7b154de
URL:http://dia2026globalannualmeeting.sched.com/event/8da7b7ff4d032879b940782bd7b154de
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T161500Z
DTEND:20260615T181500Z
SUMMARY:#418 POS: Student Poster Session I
DESCRIPTION:Component Type: SessionStudent Posters provide an opportunity for methodology (“how to”)\, case study\, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery\, development\, and lifecycle management of pharmaceuticals\, biotechnology\, medical devices\, and healthcare-related products.
CATEGORIES:14: POSTERS
LOCATION:Exchange\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:29bfb402345ba643928243717e9d4517
URL:http://dia2026globalannualmeeting.sched.com/event/29bfb402345ba643928243717e9d4517
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T162500Z
DTEND:20260615T165500Z
SUMMARY:#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos
DESCRIPTION:Component Type: SessionThis session explores practical\, systematic approaches to AI-orchestrated authoring and quality control across the end-to-end R&D document lifecycle. We examine high-value use cases spanning clinical (Protocol\, CSR\, M2.5\, M2.7)\, CMC\, and nonclinical documentation to demonstrate how AI can drastically accelerate IND\, NDA\, and BLA filing timelines by shortening the draft-to-submission window. Attendees will see AI tool demonstrations showing how regulatory writing teams leverage AI within familiar environments\, specifically a Microsoft Word add-in integrated with Veeva RIM. This approach ensures evidence-anchored content generation and orchestration across eCTD documents\, utilizing content linkage for change intelligence. Finally\, we introduce a document-network model that identifies propagation paths for automated updates across a tightly linked network of documents. This framework enables cross-document consistency and scalable QC for both initial submissions and subsequent amendments\, empowering professionals to produce high-quality\, compliant filings with greater efficiency and confidence.Chair AlphaLife SciencesSpeaker SpeakerWilliam Chen SpeakerSharon Chen
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d6bd84d662bc3629c24021941f0a3d56
URL:http://dia2026globalannualmeeting.sched.com/event/d6bd84d662bc3629c24021941f0a3d56
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T162500Z
DTEND:20260615T165500Z
SUMMARY:#420 IT: CGS Immersive Innovation Theater: From 12 Weeks to 6 - How AI Transformed Compliance Training
DESCRIPTION:Component Type: SessionThe biggest barrier in regulated training isn’t delivery — it’s the painstaking process of development. In this live session\, see how Cicero Learn\, an AI engine built for compliance-driven organizations\, automatically transforms SOPs\, protocols\, and SME interviews into fully structured\, audit-ready training — no templates or instructional designers needed. You’ll also discover how a major blood services organization used this approach to cut new-hire certification time nearly in half while maintaining safety and compliance across thousands of learners. Walk away with a proven framework for piloting next-generation AI learning in your own regulated environment.Chair CGS ImmersiveSpeaker SpeakerMicah White
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 3\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7dfe878912e99aff50d05147e27165da
URL:http://dia2026globalannualmeeting.sched.com/event/7dfe878912e99aff50d05147e27165da
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T165000Z
DTEND:20260615T172000Z
SUMMARY:#421 CH: From Siloed Data to AI Ready Insights: How HL7 FHIR Enables Health Authority Ready Interoperability
DESCRIPTION:Component Type: WorkshopLevel: IntermediateThis session explores how to prepare data for AI and regulatory expectations through interoperable architectures with HL7 FHIR. Attendees will discuss how to make their own data reusable\, trustworthy\, and ready for tomorrow’s regulatory requirements.Learning Objectives • Show how the life sciences industry is using modern technology and HL7 FHIR to break down data silos. • Demonstrate how interoperable data becomes “AI ready” and “Health Authority ready.” • Engage participants in discussing practical steps for improving data quality\, structure\, and trust.
CATEGORIES:12: CONTENT-HUBS
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:bf4a6c4576d9fb44364e7f7fe140469e
URL:http://dia2026globalannualmeeting.sched.com/event/bf4a6c4576d9fb44364e7f7fe140469e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T170000Z
DTEND:20260615T180000Z
SUMMARY:#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Regulatory Affairs Community for a follow up round table discussion tied to session: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts (Monday\, June 15 | 1:00pm - 2:00pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Jude Nwokike\, MPH\, MSC\, RPH\, RAC
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:11418f01231ebe227785754f9e19fe49
URL:http://dia2026globalannualmeeting.sched.com/event/11418f01231ebe227785754f9e19fe49
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T170000Z
DTEND:20260615T180000Z
SUMMARY:#423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the AI in Healthcare Community for a follow up round table discussion tied to session: Enhancing Regulatory Collaboration through Cloud Technologies (Monday\, June 15 | 1:00pm - 2:00pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Khushboo Sharma\, MBA
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8671b51747aed1163c8c8c64a3d25678
URL:http://dia2026globalannualmeeting.sched.com/event/8671b51747aed1163c8c8c64a3d25678
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T170500Z
DTEND:20260615T173500Z
SUMMARY:#424 IT: Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days
DESCRIPTION:Component Type: SessionQuality improvement rarely starts with a blank slate — but what happens when it does? When CRISPR Therapeutics faced a contract deadline and an overly complex QMS\, they chose disruption over incremental fixes\, rebuilding their Quality processes from the ground up in just 52 days. In this session\, CRISPR's Executive Director of Quality and Pharmacovigilance Operations\, Kate Ellmer\, and Kivo's VP of Services\, Chris Xistris\, share how stripping away the bells and whistles revealed a simpler\, more effective path forward. Walk away with a practical framework for right-sizing your QMS\, evaluating vendors under pressure\, and turning operational constraints into a catalyst for real change.Learning Objectives How to think about Quality Management Systems from an entrepreneurial perspective\; What “right-sizing” a Quality system means for smaller / scaling organizations\; Concrete examples of simplified processes\; What to look for when exploring a new system.Chair Kivo\, Inc.Speaker SpeakerKate Ellmer\, MPHSpeakerChris Xistris
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ef2dbc28b08e8f1d83425db42770ca80
URL:http://dia2026globalannualmeeting.sched.com/event/ef2dbc28b08e8f1d83425db42770ca80
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T170500Z
DTEND:20260615T173500Z
SUMMARY:#425 IT: Parexel Innovation Theater: The Connected Submission - How AI\, Automation\, and Intelligence are Changing the Regulatory Ecosystem
DESCRIPTION:Component Type: SessionExplore how AI enabled authoring is transforming regulatory content development\, delivering measurable improvements in speed\, consistency\, and quality across submissions. Discuss how process standardization serves as the critical enabler for automation\, supporting faster\, more scalable submission execution. Understand how connecting authoring\, standardization\, and automation enables regulatory intelligence\, unlocking insights from submission content to support proactive planning and decision making.Learning Objectives Explain how AI-enabled authoring\, process standardization\, and automation connect to create a modern regulatory submission ecosystem\; Demonstrate practical steps and frameworks organizations can use to implement across the regulatory ecosystem\; Discuss how integrated submission processes generate regulatory intelligence that supports proactive decision making.Chair ParexelSpeaker SpeakerKatie Connelly
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:908be0f8583c62e7abb8308bab9f2b05
URL:http://dia2026globalannualmeeting.sched.com/event/908be0f8583c62e7abb8308bab9f2b05
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T170500Z
DTEND:20260615T173500Z
SUMMARY:Google Cloud Innovation Theater: Accelerating Discovery: The Shift to Agentic Research Workflows with Google’s Co-Scientist
DESCRIPTION:Component Type: SessionIn a secure Gemini Enterprise environment\, Google’s Co-Scientist uses multi-agent systems to accelerate breakthroughs by bridging digital data and biological insights\, enabling high-velocity "Design-Test-Refine" cycles.Learning Objectives In a secure Gemini Enterprise environment\, Co-Scientist provides frictionless enablement of scientific processes via a "Scientist-in-the-Loop" architecture. This allows researchers to offload routine data orchestration\, focusing expertise on high-level heuristic decision-making as "Mission Commanders" who retain final authority over all critical scientific breakthroughs.Speaker SpeakerDavid Henderson\, PHDSpeakerVolker Eyrich\, PHD
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 3\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8e2f30e0edc93813aa225e53541dddb3
URL:http://dia2026globalannualmeeting.sched.com/event/8e2f30e0edc93813aa225e53541dddb3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T171500Z
DTEND:20260615T174500Z
SUMMARY:#426 SS: Spark Stage: One Small Change
DESCRIPTION:Component Type: SessionThis session challenges a core assumption in clinical operations: that “more technology” drives progress. Instead\, it introduces a single\, high-impact shift—moving from connected systems to embedded\, site-centric workflows. By aligning technology with how sites actually work\, rather than forcing sites to adapt to fragmented tools\, organizations can reduce operational burden\, improve data quality\, and accelerate study timelines.Learning Objectives Why paper persists—not as a preference\, but as a coping mechanism for fragmented digital ecosystems\; The hidden cost of disconnected technologies on site performance\, audit readiness\, and study timelines\; How embedding workflows (vs. layering tools) transforms site engagement and data integrity\; What a site-first operating model looks like in practice for sponsors and CROs.Chair Catherine Gregor\, MA\, MBA
CATEGORIES:11: SPARK STAGE
LOCATION:Spark Stage\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d47ac3e8447f2559f96db4ce632fab57
URL:http://dia2026globalannualmeeting.sched.com/event/d47ac3e8447f2559f96db4ce632fab57
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T173000Z
DTEND:20260615T180000Z
SUMMARY:#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products
DESCRIPTION:Component Type: WorkshopLevel: AdvancedDevelop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed productsLearning Objectives Benchmark key drivers for assessing supply- and demand-related risks that may lead to drug shortages. Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products. Apply risk-based decision making to strengthen global supply continuity and regulatory compliance.
CATEGORIES:12: CONTENT-HUBS
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8a9f101c697e86de9687256dca5532f4
URL:http://dia2026globalannualmeeting.sched.com/event/8a9f101c697e86de9687256dca5532f4
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T174500Z
DTEND:20260615T180000Z
SUMMARY:#427.1 SS: Spark Stage: Solve the Funding Paradox - Deploy Capital Smarter to Turn Promising Drug Candidates into Therapies
DESCRIPTION:Component Type: SessionAs biomedical science grows more sophisticated\, the number of drug development pathways is multiplying exponentially — yet most biopharma companies still deploy capital using strategies that fail to account for this complexity. The result: good science lost to bad finance. This session introduces a quantitative framework for biotech portfolio optimization\, combining Monte Carlo simulation with a first-of-its-kind binary optimizer to model correlations\, budget constraints\, and risk across drug pipelines. Attendees will walk away with a concrete approach to constructing optimal portfolios — allocating capital more strategically\, reducing correlated risk\, and giving promising therapies a better chance of reaching patients.Learning Objectives Understand why advances in biomedical science are paradoxically making capital allocation more difficult — and why traditional financial frameworks are failing to keep pace\; Apply Monte Carlo simulation and correlation structure to quantify and diversify drug development risk\; Construct optimal portfolios using a binary optimization framework that balances expected return against risk.Chair Shomesh Chaudhuri\, PHD\, MS
CATEGORIES:11: SPARK STAGE
LOCATION:Spark Stage\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:07494f8991ad634ee423e425211f4bc2
URL:http://dia2026globalannualmeeting.sched.com/event/07494f8991ad634ee423e425211f4bc2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T174500Z
DTEND:20260615T181500Z
SUMMARY:#428 IT: Evernorth Health Services Innovation Theater: Enabling Real World Patient Reported Outcomes Collection Through Specialty Pharmacy Engagement
DESCRIPTION:Component Type: SessionPatient-reported outcomes (PROs) are increasingly central to understanding real-world treatment experiences\, yet recruiting patients into longitudinal PRO studies remains operationally challenging. Specialty pharmacies represent a high-frequency\, trusted point of contact with patients receiving complex therapies\, offering a scalable and underutilized opportunity for patient engagement. This presentation will discuss study design considerations\, early engagement outcomes\, and implications for scalable\, patient-centered real-world evidence generation using existing healthcare touchpoints.Learning Objectives Describe the role of specialty pharmacy touchpoints in facilitating recruitment for real-world PRO studies\; Evaluate early feasibility and engagement outcomes from a longitudinal PRO study leveraging pharmacy-based patient outreach\; Identify design and operational considerations for integrating PRO data collection into real-world evidence generation.Chair EvernorthSpeaker SpeakerKrystyna Amalfe\, MPH
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 3\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:bdc2fe367ece81432fb587f51832fc45
URL:http://dia2026globalannualmeeting.sched.com/event/bdc2fe367ece81432fb587f51832fc45
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T174500Z
DTEND:20260615T181500Z
SUMMARY:#429 IT: Verily Health Inc Innovation Theater: Bridge the Evidence Gap - Integrating Consumer Wearables and Real-World Data for Continuous\, Participant-Centric Insights
DESCRIPTION:Component Type: SessionLife sciences sponsors invest heavily in clinical trials\, yet frequently lose visibility into patient outcomes the moment a study ends. While traditional real-world data attempts to bridge this gap\, it relies on episodic snapshots that miss the continuous health signals that matter most: functional status and quality of life\, reflected in sleep quality\, daily physical activity\, and autonomic function. This session presents a practical framework for integrating consumer wearable data with recontactable participant registries and curated electronic health records. By utilizing an open platform approach\, sponsors can build a continuous evidence engine that generates actionable insights across the entire product lifecycle. Drawing from a decade of digital measures research across neurology\, cardiovascular\, and metabolic conditions\, this presentation will share concrete strategies for designing wearable-enabled studies that balance data quality\, participant experience\, and scientific rigor.Chair VerilySpeaker SpeakerSooyoon Shin\, PHD
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e93f72e340e9f56b69911bb7083785e0
URL:http://dia2026globalannualmeeting.sched.com/event/e93f72e340e9f56b69911bb7083785e0
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P\; CME 1.00\; RN 1.00The CIOMS Working Group XIV\, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance\, transparency\, robustness\, fairness\, and regulatory expectations using real examples.Learning Objectives Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports\; Describe a practical framework for critically appraising of AI models and systems\, with focus on risk based approaches\, human oversight\, validity and robustness\, transparency\, data privacy\, fairness and equity and governance.Chair Phil TregunnoSpeaker Principles and recommendations from CIOMS WG XIVNiklas Noren\, PHD\, MSCPanelistBeth Anne MacEntee Pileggi\, BSN\, MBAPanelistWalter Straus\, DrMed\, MD\, MPH\, FACP
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:124571c5cd4832e69e7c46065e5f396c
URL:http://dia2026globalannualmeeting.sched.com/event/124571c5cd4832e69e7c46065e5f396c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#432: Industry Collaboration 2030: Head\, Heart and Gut Perspectives
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P\; CME 1.00\; RN 1.00No one can solve today’s R&D challenges alone. But are industry consortia fit for 2030? We examine the "head\, heart\, and gut" to re-imagine collaboration and explore what’s needed to accelerate co-creation and innovation.Learning Objectives Recognize the value of industry collaborations\, analyze emerging trends and future innovation opportunities\; Explain how to shift from patient-centric to patient-driven design thinking. Chair Sarah TremethickSpeaker Industry Collaboration 2030: Head PerspectiveAdrian Hernandez\, MD\, MHSIndustry Collaboration 2030: Head\, Heart and Gut PerspectivesRebecca Vermeulen\, RPHIndustry Collaboration 2030: Gut PerspectiveJeff Smith
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4965ae72504b33b394b7ba0c4652686c
URL:http://dia2026globalannualmeeting.sched.com/event/4965ae72504b33b394b7ba0c4652686c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P\; CME 1.00\; RN 1.00Explore patient-focused decentralized trials and direct-to-patient shipments\, highlighting their impact on recruitment\, retention\, and trial performance—and how sites adapt operations to deliver these solutions effectively.Learning Objectives Evaluate how DCT solutions and direct-to-patient shipments enhance patient access\, recruitment\, and retention\; Identify best practices for sites to operationalize DCT workflows while ensuring quality and compliance.Chair Joan ChambersSpeaker Expanding Access and Engagement: Lessons from Decentralized Clinical Trial SolutionsKevin Hudziak\, MSExpanding Access and Engagement: Lessons from Decentralized Clinical Trial SolutionsBecky Suzanne Kottschade\, MA\, PMPExpanding Access and Engagement: Lessons from Decentralized Clinical Trial SolutionsJoan ChambersExpanding Access and Engagement: Lessons from Decentralized Clinical Trial SolutionsJane Myles
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,09: RD-QUALITY-COMPLIANCE
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:2d41657d0300e5d9f786ff99efcd91b1
URL:http://dia2026globalannualmeeting.sched.com/event/2d41657d0300e5d9f786ff99efcd91b1
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#433: ICH M11 in Action: Digital Protocols\, AI\, and Cloud for Patient-Centered Regulatory Science
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-529-L04-P\; CME 1.00\; RN 1.00Explore how ICH M11\, AI\, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design\, streamline submissions\, and foster patient-centered innovation.Learning Objectives Describe how ICH M11 and digital protocol standards enable seamless\, patient-centric clinical trial design and regulatory submissions\; Evaluate the impact of AI\, cloud\, and interoperable data platforms on accelerating regulatory review and improving patient access to innovation\; Apply strategies for integrating patient experience data and digital tools to enhance trial inclusivity\, data quality\, and regulatory confidence.Chair Vada Perkins\, MSSpeaker PanelistMumtaz SultaniPanelistJimita ParekhPanelistRobert DiCicco\, PHARMD
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:176f94a8ae144a6e17ea362036bfc266
URL:http://dia2026globalannualmeeting.sched.com/event/176f94a8ae144a6e17ea362036bfc266
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR\, Dataset-JSON\, and the Road Ahead)
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P\; CME 1.00\; RN 1.00This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.Learning Objectives Explain how current CDISC standards set the foundation for RWD/RWE submissions\; Discuss evolving data standards\, including Dataset-JSON and HL7 FHIR\, focusing on how they may complement or extend CDISC\; Identify actions sponsors can take now to prepare for evolving regulatory data standards.Chair James Browning\, MPHSpeaker PanelistChris Decker\, MSPanelistAnne-Marie Meyer\, MS
CATEGORIES:03: DATA-TECH-AI\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:21508d61afc9d1f8d8c9a46a5480c1ad
URL:http://dia2026globalannualmeeting.sched.com/event/21508d61afc9d1f8d8c9a46a5480c1ad
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-531-L04-P\; CME 1.00\; RN 1.00This session will describe essential AI-related skills for medical writers to leverage AI responsibly for greater efficiency while ensuring compliance and scientific integrity. The speakers will discuss how medical writers are becoming AI stewards.Learning Objectives Define the knowledge\, skills\, and behaviors medical writers need to responsibly and effectively integrate AI technologies in medical writing while meeting quality and compliance standards\; Discuss how the medical writer’s role in scientific communications is changing with the use of generative AI.Chair Eileen Girten\, MSSpeaker PanelistMary Ost\, PHD\, MSPanelistJeanette Towles\, MA\, RAC
CATEGORIES:04: MEDAFFAIRS-SCICOMM
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:958734bc990e3d34451de1daa8141b86
URL:http://dia2026globalannualmeeting.sched.com/event/958734bc990e3d34451de1daa8141b86
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans\, Project\, Program\, and Portfolio Management\, and AI to Advance Drug Development
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P\; CME 1.00\; PDU 1.00 PMI 21665YGZQV \; RN 1.00This seminar shows how life sciences teams can align strategy with execution through integrated program plans\, AI-enabled planning\, and P3M practices to accelerate time to market\, foster innovation\, and drive organizational transformation.Learning Objectives Distinguish how to align strategy with execution by integrating program plans (IPPs) across R&D\, Clinical\, CMC\, Regulatory\, and Commercial Leverage AI-enabled planning and P3M practices to enhance visibility\, decision-making\, and risk management\, accelerating time to market\; Discuss ways to adapt leadership approaches to drive organizational transformation\, innovation\, and compliance in an evolving life sciences landscape.Chair Christine Mears\, MBA\, PMPSpeaker Aligning Strategy with Execution: Leveraging Integrated Program\, Project and Portfolio management with AI to advance drug developmentPhilip M Zack\, DVM\, PHDPanelistErin Mulrooney\, MSC\, PMP
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,07: REGCMC-PRODUCT QUALITY\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:97101cddd950bd2fb6323f605731a903
URL:http://dia2026globalannualmeeting.sched.com/event/97101cddd950bd2fb6323f605731a903
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#437: Opportunity\, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P\; CME 1.00\; RN 1.00Artificial intelligence is revolutionizing drug manufacturing\, yet regulations are still catching up. With key guidance from the EU and US in development\, a proactive and collaborative approach is needed for global regulatory alignment\, ensuring AI iLearning Objectives Identify and summarize regulatory trends specific to AI use in Manufacturing\; Distinguish AI use in manufacturing from use in product development.Chair Gert Thurau\, PHDSpeaker PMDA regulatory perspectives on AI in ManufacturingYoshihiro Matsuda\, DrMedCase Study Industry applications of AIThomas O'Connor\, PHDFDA regulatory perspectives on AI in ManufacturingTina Kiang\, PHD
CATEGORIES:07: REGCMC-PRODUCT QUALITY\,03: DATA-TECH-AI
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6054646152810cbcc281c2cdd596497e
URL:http://dia2026globalannualmeeting.sched.com/event/6054646152810cbcc281c2cdd596497e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA
DESCRIPTION:Component Type: SessionLevel: AdvancedChina is reshaping global drug development and regulatory strategy. This session equips MNC regulatory leaders with decision framework\, actionable strategies\, pathway insights\, and case studies to optimize China integration and global approvals.Learning Objectives Assess China’s evolving regulatory landscape to inform global portfolio strategy\; Examine National Medical Products Administration (NMPA) regulatory pathways to optimize timelines and market entry\; Apply decision frameworks and practical approaches to integrate China into global programs while balancing global alignment\, local requirements\, and execution risk.Chair Wenny Du\, MBA\, RACSpeaker Global Strategy and Challenges Todd Paporello\, PHARMD\, MBAChina Strategy and Solution Wei ZhangPanel Discussion Xiaoyuan Chen\, MDIndustry Case Studies Wenny Du\, MBA\, RAC
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:2b5d1a9c4657ce351643688ad159a655
URL:http://dia2026globalannualmeeting.sched.com/event/2b5d1a9c4657ce351643688ad159a655
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P\; CME 1.00\; RN 1.00Global interest in early intervention for chronic diseases is driving regulatory innovation\, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized\, patient-focused approaches.Learning Objectives Analyze global regulatory and reimbursement challenges associated with decision-making for early treatment of chronic diseases\; Assess existing gaps and opportunities within US and EU regulatory and reimbursement frameworks to advance in this area.Chair Simon Bennett\, MSSpeaker Regulatory challenges facing the development of treatments for chronic neurological disordersSteffen Thirstrup\, MD\, PHDPanelistJulian Beach\, MBAPatient PerspectiveMindy Cameron
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ad2c550511c6ff94a6c328c3e33c682c
URL:http://dia2026globalannualmeeting.sched.com/event/ad2c550511c6ff94a6c328c3e33c682c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P\; CME 1.00\; RN 1.00Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum\, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities. Learning Objectives Discuss Industry experience with reliance initiatives\; Explain ICMRA and ICH efforts to facilitate a pharmaceutical quality knowledge management capability\; Identify benefits and challenges for expanding global regulatory reliance and collaboration\; Outline how cloud-based platforms and harmonized regional requirements can strengthen reliance.Chair Amanda Roache\, MSSpeaker Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration Sarah Pope Miksinski\, PHDPanelistEvdokia Korakianiti\, PHD\, MSCFDA Reflection on Experiences with International Regulatory Collaboration and OpportunitiesAshley Boam\, MSIndustry Experiences with Regulatory Reliance and Collaboration Initiatives Joann M Parker\, MS\, RPH
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:df500c3417c719183654978f9bae4c05
URL:http://dia2026globalannualmeeting.sched.com/event/df500c3417c719183654978f9bae4c05
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA\, EMA\, MHRA\, and PMDA
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-535-L04-P\; CME 1.00\; RN 1.00Senior leaders from FDA\, EMA\, MHRA and PMDA share insights on AI’s evolving role in regulatory review & decision-making. Attendees will explore current practices\, key challenges\, and future opportunities for AI in shaping global regulatory frameworks.Learning Objectives Discuss how AI is transforming regulatory review and decision-making at FDA\, EMA\, MHRA\, and PMDA\; Analyze key challenges and opportunities facing AI adoption in regulatory review and decision-making\; Identify emerging trends and future directions for AI in shaping global regulatory practices.Chair Jingyu (Julia) Luan\, PHDSpeaker PanelistJoaquim Berenguer Jornet\, MSPanelistTomoharu Numanyu\, RPH
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,03: DATA-TECH-AI
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:fbef63b2f2668701c093dd516c2e137c
URL:http://dia2026globalannualmeeting.sched.com/event/fbef63b2f2668701c093dd516c2e137c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#438: A Conversation About Quality: A Global Regulators Discussion
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-537-L04-P\; CME 1.00\; RN 1.00This forum will present the perspectives of global regulatory agencies on encouraging a high standard for quality in pharmaceutical products. The panel will discuss their vision\, key initiatives\, challenges on how to improve drug quality worldwide.Learning Objectives Describe regulatory agencies’ shared priorities about drug quality in support of a secure\, resilient\, and high-quality pharmaceutical supply chain\; Identify the role of oversight to ensure high-quality pharmaceutical manufacturing\; Explain how regulators can work in partnership to reach a coherent\, predictable\, and efficient global regulatory environment for the benefit of global public health.
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,09: RD-QUALITY-COMPLIANCE
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4212d02b56c3f906814c7d44f8b8e39b
URL:http://dia2026globalannualmeeting.sched.com/event/4212d02b56c3f906814c7d44f8b8e39b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P\; CME 1.00\; RN 1.00This forum will present Health Authority (HA) expectations related to a robust Culture of Quality focused on Critical-to-Quality (CtQ) issue management. This session will provide specific examples of how leadership commitment and employee ownership enable a robust Quality Culture.Learning Objectives Explain Health Authority (HA) expectations of an effective Culture of Quality\, specifically around Critical-to-Quality (CtQ) issue surveillance and management\; Describe the vital link\, and cultural best practices\, between leadership commitment\, employee ownership\, and the ability to effectively manage CtQ issues.Chair Michael Torok\, PHDSpeaker The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial ExcellenceSameera IbrahimThe Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial ExcellenceLeslie SamThe Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial ExcellenceEmily Gebbia\, JD
CATEGORIES:09: RD-QUALITY-COMPLIANCE
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:2f194d14edcb4c0cf1935ee6aec1d76c
URL:http://dia2026globalannualmeeting.sched.com/event/2f194d14edcb4c0cf1935ee6aec1d76c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T183000Z
DTEND:20260615T193000Z
SUMMARY:#444: Driving Efficiency in Clinical Development with Master Protocols
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P\; CME 1.00\; RN 1.00Master protocols are innovative designs for simultaneous evaluation of multiple drug or population under one protocol\, enhancing efficiency. Despite their potential\, these protocols pose complex scientific\, operational\, and regulatory challenges.Learning Objectives Explain the different master protocols (basket\, umbrella\, platform) in various therapeutic areas\; Identify key statistical\, operational\, and governance challenges\; Describe regulatory perspectives and recent guidance\; Discuss practical case studies illustrating successes\, pitfalls\, and innovations.Chair Satrajit Roychoudhury\, PHDSpeaker Pooling shared controls in platform trials: operational and statistical considerationsMegan McCabe\, PHDThe Art of Borrowing: Practical Strategies to Power Master ProtocolsHaitao Chu\, MD\, PHDLearnings Across Master Protocols – A Design PerspectivePurvi Prajapti\, PHD\, MS
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:fdd075eb9187e13446fe1e4a1dee62a7
URL:http://dia2026globalannualmeeting.sched.com/event/fdd075eb9187e13446fe1e4a1dee62a7
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs\, Digitalization\, Global Learning
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P\; CME 1.00\; RN 1.00This session shares US\, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female\, young and older patients) in local contexts.Learning Objectives Describe needs and methods for tailoring risk minimization interventions to special patient populations\; Recognize challenges and opportunities of digital support to implementing risk minimization interventions with examples\; Discuss experiences from around the globe with localization of risk minimization interventions and reliance.Chair Priya Bahri\, PHDSpeaker PanelistShelley Gandhi\, MSLocalisation of risk minimisation interventions – Low- and middle-income countries and global reliance Jean-Christophe Delumeau\, MD\, PHDTailoring risk minimisation interventions - Applying implementation science and user-testingMeredith Yearsley Smith\, MPA\, FISPE
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:40ef863c9c96c2d576eef2b8e955c679
URL:http://dia2026globalannualmeeting.sched.com/event/40ef863c9c96c2d576eef2b8e955c679
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#446: DIA2026-001: Co-Creating the Patient-Centric Trial Live
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-541-L04-P\; CME 1.00\; RN 1.00In this interactive forum\, attendees will co-create “DIA2026-001” through live polling\, exploring how early protocol decisions shapes: patient inclusion\, recruitment feasibility\, technology strategy\, operational complexity. With perspectives from patient advocacy\, recruitment and clinical technology experts\, the session demonstrates how intentional study design and enabling technologies directly influence recruitment success and long-term retention\, critical factors given that most trials struggle to meet enrolment targets.Learning Objectives Discuss how to co-create a model protocol while examining how patient and site input influence design decisions and technology choices\; Evaluate how early protocol and technology decisions impact recruitment strategy\, inclusivity\, and operational feasibility\; Identify practical approaches to leveraging digital and hybrid delivery models to support patient-centric trial execution.Chair Farrell Healion\, MSCSpeaker PanelistAlexandra ChargePanelistRoss Jackson
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:98e5f41cfc16c50cc65d7841d9bea7fd
URL:http://dia2026globalannualmeeting.sched.com/event/98e5f41cfc16c50cc65d7841d9bea7fd
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P\; CME 1.00\; RN 1.00This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA\, NMPA\, and PMDA enable regulatory collaboration\, speeding global trial start-up\, drug development and patient access through shared data and adaptive approaches.Learning Objectives Analyze how regulatory harmonization and collaboration accelerate global study start-up\; Differentiate key principles of ICH E17\, E5\, and regional oncology MRCT guidelines\; Summarize strategies to navigate regional regulatory differences and enable global studies.Chair Angelika Joos\, MPHARMSpeaker ethical aspects of conducting MRCTs from a global perspective Sarah A. White\, MPHExperience from global conduct of MRCTsAloka Chakravarty\, PHDPanelistPaz VellankiPMDA perspectiveYoko Aoi\, PHD
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:0e3045d294d895cdae6052d7e15ba36a
URL:http://dia2026globalannualmeeting.sched.com/event/0e3045d294d895cdae6052d7e15ba36a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-543-L04-P\; CME 1.00\; RN 1.00This session shares insights from a global survey of 12\,000+ respondents\, highlighting patient comfort levels and receptivity to AI processing their medical information as part of a clinical trial. Learning Objectives Discuss patient comfort levels and receptivity to AI processing medical information as part of a clinical trial\; Describe strategies to address patient preferences and comfort levels with AI analyzing medical data. Chair Annick De Bruin\, MBASpeaker PanelistT.J. Sharpe\, PMPPanelistShanelle Gabriel\, MED
CATEGORIES:03: DATA-TECH-AI\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:00ffc7f15bb7b33660a6d9de0fbedd62
URL:http://dia2026globalannualmeeting.sched.com/event/00ffc7f15bb7b33660a6d9de0fbedd62
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-544-L04-P\; CME 1.00\; RN 1.00Discover Coalition For Epidemic Preparedness Innovations (CEPI) Pandemic Preparedness Engine (PPE) regulatory node—a forward-looking digital platform using AI and cloud technology to accelerate vaccine approvals through structured data\, automated workflows\, and global collaborative review.Learning Objectives Discuss the conceptual framework of CEPI’s Pandemic Preparedness Engine (PPE) regulatory node and its role in accelerating emergency vaccine approvals\; Recognize how AI-enabled workflows and cloud-based platforms can support concurrent\, global regulatory review through PDDF and DSVI integration\; Identify opportunities for regulatory collaboration and input to shape the future of digital dossier.Chair Ashley Jones-Mitchell\, MPHSpeaker PanelistMelody ChessiaPanelistKevin Bugin\, MS\, RACPanelistTeginder Singh\, MPHARM
CATEGORIES:03: DATA-TECH-AI\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:dd27543a746d15d02a7230512d6925ac
URL:http://dia2026globalannualmeeting.sched.com/event/dd27543a746d15d02a7230512d6925ac
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#450: Medical Writing Ted Experience
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P\; CME 1.00\; RN 1.00Medical writing myths persist\, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity\, accuracy\, and scientific integrity continue to rise. In this TED-talk–style session\, three presenters will explore why medical writing expertise matters\, how writers can evolve into influential cross-functional leaders\, and the value and limitations of AI currently in use. Attendees will leave with practical insights to elevate the role of medical writers and adopt emerging tools responsibly to improve quality\, efficiency\, and credibility in drug development communication.Learning Objectives Examine the specialized value professional medical writers bring\, including how writing expertise reduces risk\, improves efficiency\, and strengthens scientific credibility—beyond what generalist writing can achieve\; Identify the skills and mindsets needed for “future-ready” medical writers\; Describe practical ways to grow from document execution roles into strategic leadership and cross-functional influence\; Assess current AI uses in medical writing\, distinguishing opportunities from hype.Chair Monica Chiaramonte\, PHDSpeaker PanelistAnna Whitling\, PHARMDEveryone Thinks They Can Write: Why Medical Writers Make the DifferenceMonica Chiaramonte\, PHDAmid the Ballyhoo Over AI\, What Are We Losing?Steve Sibley\, MS
CATEGORIES:04: MEDAFFAIRS-SCICOMM\,03: DATA-TECH-AI
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ff06aa44fc9c362f00d7f9bd43edc2e0
URL:http://dia2026globalannualmeeting.sched.com/event/ff06aa44fc9c362f00d7f9bd43edc2e0
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#451: Race/Ethnicity\, Ancestry\, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P\; CME 1.00\; RN 1.00Real-world data that encompass race\, ethnicity\, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.Learning Objectives Describe precision medicine approaches involving clinical phenotype RWD in context with race\, ethnicity\, ancestry data\, that can be instrumental to address unmet patient and health system needs\; Discuss how regulators have reacted to precision medicine-based research approaches in context with race\, ethnicity\, ancestry information\, inclusive of research design modifications made along the way.Chair Rachele Hendricks-Sturrup\, MASpeaker PanelistCarla Rodriguez-Watson\, MPHTBDLysel Brignoli\, MS
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,03: DATA-TECH-AI\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f1a3556c484072d5b80139f1395eafe7
URL:http://dia2026globalannualmeeting.sched.com/event/f1a3556c484072d5b80139f1395eafe7
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#452: Mentorship Myth Busters: Moving Beyond Misconceptions
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P\; CME 1.00\; PDU 1.00 PMI 2166DNFT53\; RN 1.00Mentorship Myth Busters uses a courtroom-style format where attendees vote on mentorship myths and learn from experts. The REAL framework guides participants toward inclusive\, flexible\, and sustainable mentoring practices.Learning Objectives Assess mentorship myths using interactive cases\; Differentiate mentorship from management\; Apply the REAL framework to build inclusive\, flexible\, lasting mentoring relationships.Chair Carol MoralesSpeaker Mentorship Myth Busters: The Court of REAL MentorshipLeslie SamMentorship Myth Busters: The Court of REAL MentorshipTywnia BrewtonpanelistSabhorak Horn\, PHARMD\, MBA\, RPH
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:357bac82d0d0cb6e4bc28159263729f2
URL:http://dia2026globalannualmeeting.sched.com/event/357bac82d0d0cb6e4bc28159263729f2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P\; CME 1.00\; RN 1.00Explore regulatory and manufacturing challenges in cell and gene therapy\, including starting material variability\, potency testing\, comparability\, specification\, and stability strategies. Gain insights into FDA expectations\, ICH initiatives\, and collaborative approaches to harmonize definitions and accelerate development while ensuring quality and regulatory clarity across individualized therapies.Learning Objectives Identify key regulatory and manufacturing challenges in CGT development\, including starting material variability\, comparability\, stability\, setting specifications\, and post-approval changes\; Discuss FDA and global expectations\, harmonization needs\, and strategies for individualized therapies to ensure quality and compliance across development phases.Chair Lesbeth Caridad Rodriguez\, MSSpeaker Defining and Controlling Raw and Starting Materials for CGT ManufacturingKevin Carrick\, PHDComparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing ProcessAndrew Chang\, PHDSetting specifications for ATMPs: insights from the ICHQ6 revisionCecilia Tami\, PHDStability Considerations for Cell and Gene ProductsAkanksha Kaushal\, MS
CATEGORIES:07: REGCMC-PRODUCT QUALITY
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:481f81a3c3f5a469049404d73d67e323
URL:http://dia2026globalannualmeeting.sched.com/event/481f81a3c3f5a469049404d73d67e323
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P\; CME 1.00\; RN 1.00The Middle East is a fast-emerging innovation hub. Aligning with global standards\, the region is opening new opportunities and incentives. Join us to discover Middle Eastern innovations and why companies should view it as a top investment destination.Learning Objectives Discuss how the Middle East has rapidly evolved over the past decade\, benchmarking regulatory systems\, achieving higher maturity levels\, and accelerating cross-stakeholder collaboration. Chair Amira Deia Younes
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:3cbc6686cd0a9d593f674cfbddfa3747
URL:http://dia2026globalannualmeeting.sched.com/event/3cbc6686cd0a9d593f674cfbddfa3747
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P\; CME 1.00\; RN 1.00This session will explore innovative regulatory approaches\, including the ICH E11A guideline\, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis. Learning Objectives Identify innovative regulatory strategies for pediatric drug development\, including the ICH E11A guideline\; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions\; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.Chair Christina Bucci-Rechtweg\, MDSpeaker PanelistLaura Jawidzik\, MDPanelistLauren Krupp\, MDPanelistLynne Yao\, MD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:83ccbd3686f62e962735daef4cb2722a
URL:http://dia2026globalannualmeeting.sched.com/event/83ccbd3686f62e962735daef4cb2722a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#455: Japan Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P\; CME 1.00\; RN 1.00This session explores the benefits of drug development and approval in Japan\, highlighting market size\, development predictability\, and regulatory support\, with insights from administrative bodies and the international pharmaceutical industry.Learning Objectives Recognize misconceptions about Japan's drug development environment and learn the latest updates\; Discuss the benefits of drug development in Japan from regulatory and industry perspectives. Chair Daisuke Koga\, MS\, MSCSpeaker PanelistSeiko Usami\, PHDPanelistYoshiaki Uyama\, PHD\, MS\, RPH
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:62abb63ec72f4660a6c14e53566d95e2
URL:http://dia2026globalannualmeeting.sched.com/event/62abb63ec72f4660a6c14e53566d95e2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#457: Understanding the Misconceptions and Myths around Surrogate Endpoints
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P\; CME 1.00\; RN 1.00Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals\, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions. Learning Objectives Describe an evidence-based overview of the development and utilization of surrogate endpoints in FDA approvals\; Examine the increasing reliance on surrogates\, particularly case studies in fields like rare diseases and oncology\, where overall survival data may be years away\; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.Chair Bridget Doherty\, MPH\, MSSpeaker PanelistKara Berasi\, PHARMD\, MSPanelist Jenny Myers AhlstromPanelist Alexis Reisin Miller\, JD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:64ee1482ef5bce3d6d8c5f68e95bda6e
URL:http://dia2026globalannualmeeting.sched.com/event/64ee1482ef5bce3d6d8c5f68e95bda6e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P\; CME 1.00\; RN 1.00Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends\, highlighting compliance patterns\, regulatory harmonization\, and industry strategies for sustaining quality in complex global trialsLearning Objectives Examine GCP inspection classification and outcomes across regulatory agencies\, highlighting similarities and differences in enforcement\; Identify common deficiency patterns and regulatory expectations across regions\, emphasizing protocol adherence\, recordkeeping\, and data integrity\; Recognize the impact of inspection observations on regulatory decisions\; Discuss industry best practices.Chair Jenn Sellers\, MDSpeaker Overview of MHRA's GCP Inspections Rachel Mead
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f612e1ab41622736132292f4ae7848e2
URL:http://dia2026globalannualmeeting.sched.com/event/f612e1ab41622736132292f4ae7848e2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias\, Endpoint Alignment\, Unmeasured Confounding
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-554-L04-P\; CME 1.00\; RN 1.00This session highlights methodological challenges in External Control Arms (ECAs) using Real-World Data (RWD). Speakers will address time-related biases\, endpoint alignment challenges between RWD and trial standards\, and methodological strategies to address unmeasured confounding.Learning Objectives Discuss exposure and time-related issues in ECA construction\, including defining time-zero and avoiding immortal time bias\; Describe endpoint alignment challenges between RWD and trial standards\, and outline methods to address measurement error and bias. Evaluate approaches for handling missing data and unmeasured confounding\, and explain new insights on defining index dates in EC studies.Chair Ju-Young Shin\, PHDSpeaker Choosing an Index Date for Untreated Patients in External Comparator StudiesJu Hwan Kim\, PHARMD\, PHDQuantifying and mitigating measurement bias in real-world endpoints when constructing external control armsBenjamin Ackerman\, PHDChoosing an Index Date for Untreated Patients in External Comparator StudiesGerd Rippin\, PHD
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6324525ca04959a3c25de2463a0051e6
URL:http://dia2026globalannualmeeting.sched.com/event/6324525ca04959a3c25de2463a0051e6
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260615T200000Z
DTEND:20260615T210000Z
SUMMARY:#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P\; CME 1.00\; RN 1.00This session will focus on use of external controls\, including historical cohorts and real-world data\, in clinical trials across drug development\, focusing on the gaps and need for alignment between regulators from different regionsLearning Objectives Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA\, PMDA\, MHRA) and discuss recent progress within the EU on this topic\; Analyze the key similarities and differences in regulatory recommendations for study design\, and describe the rationale for greater alignments across agencies.Chair Gracy G Crane\, MSSpeaker PanelistMotiur Rahman\, PHD\, MPHARM\, MSPanelistDenise Umuhire\, MBA\, MSCPanelistTricia Luhn\, PHD\, MPH
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:32db15fd1df24b3f3f3ea27628c43579
URL:http://dia2026globalannualmeeting.sched.com/event/32db15fd1df24b3f3f3ea27628c43579
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T120000Z
DTEND:20260616T130000Z
SUMMARY:#500: Transforming Obesity Patient Care: Past\, Present\, and Future Innovation in the Age of GLP-1 Therapies
DESCRIPTION:Component Type: SessionLevel: IntermediateThis plenary session will bring together first-hand perspectives from academic and pharmaceutical experts involved in the development of the GLP1 therapies that first achieved regulatory approval for the treatment of obesity. Speakers will reflect on the scientific and clinical journey that enabled these breakthroughs\, while examining how innovation in this space continues to evolve. The session will also address the persistent access gap facing patients worldwide and explore how global companies are working closely with regulators to expand access in a sustainable and equitable manner. Key health policy implications will be discussed\, setting the stage for subsequent sessions within the new Chronic Disease and Obesity Pathway.Learning Objectives Analyze the key scientific and clinical milestones that led to the first regulatory approvals of GLP-1 therapies for obesity using expert perspectives\; Assess how innovation in GLP-1 therapies is evolving and consider its impact on future obesity and chronic disease treatment\; Examine global access gaps to obesity therapies and identify policy and regulatory strategies to expand equitable and sustainable patient access.Chair Maria Vassileva\, PHDSpeaker PanelistRobert M. Califf\, MDPanelistBrad Jordan\, PHDPanelistW. Scott Butsch\, MD\, MSC
CATEGORIES:00: PLENARY\,02: CLINICALTRIALOPS-INNOVATION\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:114\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e335263b0757b484b5931e11ec7eff3b
URL:http://dia2026globalannualmeeting.sched.com/event/e335263b0757b484b5931e11ec7eff3b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T131500Z
DTEND:20260616T134500Z
SUMMARY:#501 IT: Weave Bio Innovation Theater: Threading AI Throughout the Drug Development Lifecycle - An Enterprise Lens
DESCRIPTION:Component Type: SessionPressures to go faster and do more with less continually rise\, and enterprise pharma organizations experience these pressures at scale. Quality cannot be compromised when rapidly constructing sophisticated\, layered health authority narratives with evolving data. Questions from health authorities must be responded to with speed and precision. New technology offers relief\, but choice of partner\, workflow evolution\, and organizational adoption are major hurdles to overcome. Drawing on real-world experience from our work with partners\, we will explore how these challenges can be met in collaboration between technology builders and domain experts\, and the benefits to be gained in doing so. We share a perspective on the benefits of a holistic approach\, utilizing a single AI platform across workflows and throughout the lifecycle. We will also share our playbook: lessons learned and advice on how to approach selection\, design\, and implementation of AI systems for existing processes and systems. Pragmatic insights on where and how to lean into organizational change and where to work with existing systems and practices.Chair Weave BioSpeaker SpeakerBrandon RiceSpeakerAndrew Robertson\, JD\, PHD
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 3\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ed0389d5d11261c987603c7fcb6fb563
URL:http://dia2026globalannualmeeting.sched.com/event/ed0389d5d11261c987603c7fcb6fb563
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T131500Z
DTEND:20260616T134500Z
SUMMARY:#502 IT: IQVIA Innovation Theater: From Insight to Impact - Leveraging Patient Experience Data Through Technology and AI
DESCRIPTION:Component Type: SessionThis session examines persistent scientific and operational challenges in eCOA implementation\, particularly in studies using high frequency patient reported data. The discussion focuses on how advanced monitoring technologies and AI driven analytics can be used to detect emerging risks such as disengagement\, response drift\, and early signal degradation while data collection is ongoing. Through real world examples\, the session highlights how predictive analytics and pattern recognition can support earlier\, more informed decisions\, helping teams distinguish true clinical change from measurement artifacts and strengthen confidence in longitudinal outcome data.Learning Objectives Identify common scientific and operational risk patterns in high-frequency eCOA data\; Understand how technology-enabled monitoring and AI-driven analytics can surface early indicators of data quality risk while data collection is ongoing\; Recognize how predictive\, proactive oversight supports earlier and more targeted intervention\, strengthening confidence in endpoint integrity without replacing scientific judgment.Chair IQVIASpeaker SpeakerLindsay Hughes\, PHD\, MS
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c3ce277aa9f8a0ac89dfcf8a61282990
URL:http://dia2026globalannualmeeting.sched.com/event/c3ce277aa9f8a0ac89dfcf8a61282990
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T131500Z
DTEND:20260616T134500Z
SUMMARY:#503 IT: Parexel Innovation Theater: Human-Centered AI - A Dual-Layer Model for Clinical Research Excellence
DESCRIPTION:Component Type: SessionLearn about early wins from enterprise AI solutions: How these solutions have delivered measurable gains in speed\, automation efficiency\, and data quality without displacing human expertise. Explore Parexel use cases: the emergence of a second innovation layer driven by citizen developers (CRAs)\, who built targeted AI tools that automate labor intensive workflows and enhance operational consistency. Understand how a sustainable dual layer AI model that blends scalable enterprise automation with frontline innovation can accelerate trial execution\, improve consistent quality and compliance\, and empower clinical professionals as AI supported decision makers.Learning Objectives Participants will learn how to implement a dual-layer AI strategy that combines enterprise automation with citizen-developer innovation to reduce manual workload\, accelerate clinical operations\, and maintain regulatory compliance\, while reinforcing rather than replacing human expertise.Chair ParexelSpeaker SpeakerBoris Braylyan\, MBA
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ec149f62f097e4b0bbb445647c7e9207
URL:http://dia2026globalannualmeeting.sched.com/event/ec149f62f097e4b0bbb445647c7e9207
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P\; CME 1.25\; RN 1.25This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups\, to FDA pilots applying AI at scale\, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.Learning Objectives Identify algorithmic innovations that address signal detection challenges in vulnerable populations\; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight\; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.Chair Ju-Young Shin\, PHDSpeaker Recent advances in PV innovation: implementing/deploying for practical impactRaymond Kassekert\, MBAA method for systematically retrieving pregnancy-related reportsDaniele Sartori\, MSCPanelistGerald Dal Pan\, MD\, MHS
CATEGORIES:01: CLINSAFETY-PV-RM\,03: DATA-TECH-AI
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:9a5341aa93081d4acd9639cce2ca50d8
URL:http://dia2026globalannualmeeting.sched.com/event/9a5341aa93081d4acd9639cce2ca50d8
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-556-L04-P\; CME 1.25\; RN 1.25Too few sponsors and sites have access to primary care organizations (PCOs). PCOs deliver first-contact\, comprehensive\, and continuous care to over 100 million people. This session will bring forth easy to use and action oriented PCO tactics.Learning Objectives Distinguish between types of primary care organizations (PCOs) & their objectives to increase study participation\; Discuss common PCO research barriers to improve collaboration outcomes short and long-term\; Outline actionable tactics for study implementation and strategic initiatives.Chair Pete Fronte\, MBASpeaker PanelistAlpa PatelFrom Barriers to Bridges: Unlocking Research Potential in Primary CareRuma Bhagat\, MPHFrom Barriers to Bridges: Unlocking Research Potential in Primary CareOsa Eisele\, MD\, MPHFrom Barriers to Bridges: Unlocking Research Potential in Primary CareRakesh Patel\, MD\, MBA\, FAAFPFrom Barriers to Bridges: Unlocking Research Potential in Primary CareMaggie McGuire Kuhl
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:fcff74caa37d34abd5e5855081c8cce3
URL:http://dia2026globalannualmeeting.sched.com/event/fcff74caa37d34abd5e5855081c8cce3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P\; CME 1.25\; RN 1.25We will share case examples and trends from 24\,000 records\, analyze ethical challenges involved in paying participants\, and discuss how protective policies or administrative practices can result in unjust treatment.Learning Objectives Explain the ethical considerations that govern payment to research participants\; Evaluate the potential for institutional and administrative policies to inadvertently create unjust treatment of research participants\; Apply the Belmont Principles of Beneficence and Justice to real-world cases involving payment to research participants and propose strategies for ethical decision-making.Chair Kelly Fitzgerald\, PHDSpeaker PanelistKarla Childers\, MSPanelistWenora JohnsonPanelistSam WhitakerPanelistRobin Kuprewicz\, MA
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:97e9414926acf1813d8296c772cf2a10
URL:http://dia2026globalannualmeeting.sched.com/event/97e9414926acf1813d8296c772cf2a10
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-558-L04-P\; CME 1.25\; RN 1.25Learn how mixed FSP (functional service provider)/FSO (full-service outsourcing) models deliver additional agility to help clinical trial sponsors manage complexity\, enhance efficiency\, and facilitate the transition from FSO to FSP outsourcing. Learning Objectives Identify opportunities where mixed FSP (functional service provider)/FSO (full-service outsourcing) models create additional agility in clinical trial operations\; Discuss how mixed FSP/FSO models facilitate the transition from FSO to FSP outsourcing\; Assess flexible options to deliver drug development on time and on budget in complex\, global trials.Speaker ModeratorAndrew StudnaPanelistSamantha Hadfield PanelistNick Scott
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,01: CLINSAFETY-PV-RM\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:0bfd97b44121baed087385e5d828cbb3
URL:http://dia2026globalannualmeeting.sched.com/event/0bfd97b44121baed087385e5d828cbb3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-566-L04-P\; CME 1.25\; RN 1.25This session covers the importance of data sharing and the new tools that might enable that pooling and integration in order to facilitate progress in personalized medicine and ensure faster access to treatments for the oncology patients who need them the most.Learning Objectives Discuss the present landscape\, opportunities\, and challenges of oncology data pooling efforts and the advancements offered by AI that can allow faster integration\; Describe emerging programs and global initiatives designed to facilitate faster oncology drug development\; Assess various considerations and strategies that are meaningful to both physicians and patients.Chair Alberto Grignolo\, PHDSpeaker PanelistBeth Meagher\, MAPanelistSean Khozin\, MD\, MPHPanelistStacy Hurt\, MBA\, MHALeveraging Federated AI and Open Data to Transform Oncology Research and Development Maria Vassileva\, PHDPanelistJoseph Kannarkat\, MD
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,03: DATA-TECH-AI
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e39f2a6c031ba039134d8ba73a2d4bed
URL:http://dia2026globalannualmeeting.sched.com/event/e39f2a6c031ba039134d8ba73a2d4bed
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech
DESCRIPTION:Component Type: SessionLevel: IntermediateMany clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.Learning Objectives Design and execute a streamlined customer discovery process to validate unmet needs\, buying triggers\, and budget ownership before finalizing a go-to-market strategy\; Translate insights into a sales learning roadmap that tests positioning\, pricing\, compliance\, and objections to reduce commercial risk before raising capital\; Align GTM and fundraising with validated demand to present a credible revenue story.Chair Dan SndyerSpeaker PanelistPeter Schaeffer\, MBA\, PMPPanelistLaura HiltyPanelistJeff B Lee\, MBA
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,03: DATA-TECH-AI\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:9f3dbb2be09d3749584c073b7005790c
URL:http://dia2026globalannualmeeting.sched.com/event/9f3dbb2be09d3749584c073b7005790c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#513: Advancing Chronic Disease Development: Insights from FDA\, EMA\, PMDA\, and MHRA
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P\; CME 1.25\; RN 1.25Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development\, outlines the current landscape\, explores opportunities and challenges\, and assesses strategies to boost efficiency and accelerate therapeutic innovation. Learning Objectives Discuss the present landscape\, opportunities\, and challenges of chronic disease drug development\; Describe emerging programs and global initiatives designed to facilitate development of chronic disease drugs\; Assess various considerations and strategies to enhance the efficiency of chronic disease drug development.Chair Jingyu (Julia) Luan\, PHDSpeaker PanelistSteffen Thirstrup\, MD\, PHDPanelistAlison CavePanelistMaria Vassileva\, PHDPanelistAyaka Kubota\, RPH
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4ae6276cf403bac39a03a961c06e97fb
URL:http://dia2026globalannualmeeting.sched.com/event/4ae6276cf403bac39a03a961c06e97fb
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-560-L04-P\; CME 1.25\; RN 1.25Clinical trial start-up is often delayed by manual processes\, fragmented systems\, and inconsistent data. This workshop will explore how biopharmaceutical companies are using AI and interoperable data standards to enable patient centric study designs.Learning Objectives Explain how AI and USDM (the CDISC digital protocol data standard) work together to streamline study design and protocol development\; Discuss ways to achieve patient-centric design and reduced patient burdens using AI in conjunction with clinical standards\; Examine how data standards enable interoperability and multi-stakeholder collaboration including with sites and patients.Chair William Illis\, MPHSpeaker PanelistNicholas Brooke\, MBAPanelistPrasanna RaoPanelistVivian Dewoskin\, MBAPanelistSahishnu Patel\, PHD
CATEGORIES:03: DATA-TECH-AI
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e40de8ca53751dc50d15311e2fc38d48
URL:http://dia2026globalannualmeeting.sched.com/event/e40de8ca53751dc50d15311e2fc38d48
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P\; CME 1.25\; RN 1.25This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates\, including new Agency level initiatives.Learning Objectives Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission\; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches\; Apply FDA recommendations for use of AI/RWE in regulatory submissions.Chair Marie Bradley\, MPHSpeaker PanelistHussein Ezzeldin\, PHD
CATEGORIES:03: DATA-TECH-AI\,10: STATS-EVIDENCEGENERATION-RWE\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:a9e9327c0acbb878b3e73ebaee86a564
URL:http://dia2026globalannualmeeting.sched.com/event/a9e9327c0acbb878b3e73ebaee86a564
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-561-L04-P\; CME 1.25\; RN 1.25Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.Learning Objectives Apply FDA’s CDS guidance criteria to determine whether AI software tool (used to identify patients or risk factors) qualifies as a regulated medical device or exempt CDS\; Analyze real-world digital health scenarios using a structured decision tree to support regulatory classification\; Evaluate the impact of software classification on drug development strategy\, trial design\, and regulatory planningChair Michael Mayrosh\, PHARMDSpeaker AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory FateJeppe G. Manuel\, MLISAI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory FateLesley Maloney\, PHARMD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,02: CLINICALTRIALOPS-INNOVATION\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7ecc2bd9b7d460e8873a617640cf1a13
URL:http://dia2026globalannualmeeting.sched.com/event/7ecc2bd9b7d460e8873a617640cf1a13
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#512: Enhanced Analytical Procedure Development: Principles\, Prior Knowledge\, and Change Management
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-562-L04-P\; CME 1.25\; RN 1.25This workshop will focus on the principles of enhanced analytical procedure development\, and use of prior knowledge in creating robust methods. It will include industry case studies\, a regulator’s perspective\, and a debate-style panel. Part 2 of this workshop is Future of Enhanced Product Development: Enabled through new ICH guidelines scheduled for Wednesday\, June 17 at 10:15AM ET.Learning Objectives Describe ICH Q14 and the principles of analytical procedure development and lifecycle management\; Apply enhanced approaches to analytical procedure development through the use of prior knowledge\; Discuss health authority expectations for submission of information regarding enhanced analytical procedure development and lifecycle management.Chair Bryan Castle\, PHDSpeaker Exploring the Principles of Enhanced Analytical Procedure Development Emphasizing the Role of Prior Knowledge in Designing Robust MethodsNina S. Cauchon\, PHDPanelistJulie ArmitsteadPanelistGary McGeorge
CATEGORIES:07: REGCMC-PRODUCT QUALITY
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c3e8085939e5bab0a6f124c5d3470058
URL:http://dia2026globalannualmeeting.sched.com/event/c3e8085939e5bab0a6f124c5d3470058
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-563-L04-P\; CME 1.25\; RN 1.25This session explores the FDA and EMA’s evolving strategies to modernize nonclinical regulatory frameworks. We will examine both agency initiatives to reduce animal testing where scientifically appropriate and their roadmaps for increasing the regulatory acceptance of New Approach Methodologies (NAMs). We will discuss efforts to drive international harmonization on alternative nonclinical strategies via ICH. Participants will also gain insights into how the industry is currently integrating NAMs into submissions and broader strategies for animal testing reduction.Learning Objectives Describe FDA's objectives under their roadmap to reducing animal testing in preclinical safety studies\; Recognize EMA's ongoing activities to promote the integration of NAMs and reduce NHP studies\; Discuss international harmonization via ICH\; Discuss industry's experience to date with submitting NAMs in regulatory applications and overall reduction of animal testing strategies.Chair Imein Bousnina\, PHARMD\, MSCSpeaker FDA Presentation on Modernizing Nonclinical Safety AssessmentHaleh Saber\, PHDModernizing Nonclinical Safety Assessment via ICHAmanda Roache\, MSEMA Presentation on Modernizing Nonclinical Safety AssessmentOrla Moriarty\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6d0062624c985955f240ee22476bec3b
URL:http://dia2026globalannualmeeting.sched.com/event/6d0062624c985955f240ee22476bec3b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#517: Navigating the New FDA: Insights from Former FDA Chief of Staffs
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-638-L04-P\; CME 1.00\; RN 1.00The session will feature former FDA Chief of Staffs discussing their contributions to regulatory policies\, patient engagement\, and innovative technologies\, offering insights into the evolving regulatory landscape and helping stakeholders navigate FDALearning Objectives Identify key initiatives and challenges described by former FDA Chief of Staffs\; Explain how the regulatory landscape is evolving and how these changes may influence future drug approval processes\; Discuss FDA organizational dynamics and strategic decision-making factors that shape public health outcomes\, helping stakeholders to navigate the new FDA more effectively.Chair Elizabeth Lange\, MPH\, MSSpeaker PanelistSusan Winckler\, JDPanelistElizabeth Jungman\, JD\, MPHPanelistKalah Auchincloss\, JD\, MPHPanelistLauren Silvis\, JDPanelistJulie Tierney
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:694d24f8b304a8c8b34e2b4800c87737
URL:http://dia2026globalannualmeeting.sched.com/event/694d24f8b304a8c8b34e2b4800c87737
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#519.1: European Integration in Times of Geopolitical Crisis: Supporting Ukraine’s EU Accession and Building Resilient Public Institutions
DESCRIPTION:Component Type: SessionLevel: IntermediateThis session will explore how Ukraine’s EU accession process is driving the transformation of its healthcare and pharmaceutical regulatory system during one of the most challenging geopolitical periods in modern European history. Speakers from the Ukrainian government\, Poland\, the European Medicines Agency\, and the European Commission will discuss how resilient public institutions\, regulatory convergence\, and international cooperation contribute to European security\, democratic stability\, and health system resilience. The discussion will highlight the strategic importance of supporting Ukraine’s institutional integration into the European Union and the broader future of European cooperation in health governance.Learning Objectives Analyze the role of regulatory reform and resilient public institutions in supporting Ukraine’s EU accession process during geopolitical crisis\; Compare the contributions of EU Member States\, the EMA\, and the European Commission in advancing Ukraine’s integration into the European regulatory framework\; Assess how international regulatory cooperation and alignment with the EU acquis communautaire can strengthen health security\, governance\, and institutional resilience in candidate countries.Chair Magdalena PajewskaSpeaker PanelistMaryna SlobodnichenkoPanelistGrzegorz T Cessak
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:800c72d573564cd26e194e4ea6471766
URL:http://dia2026globalannualmeeting.sched.com/event/800c72d573564cd26e194e4ea6471766
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-564-L04-P\; CME 1.25\; RN 1.25Examines how fragmented policies\, trade barriers\, pricing pressures\, and other restrictions create innovation gridlock—blocking or stalling R&D\, delaying clinical trials\, disrupting supply\, and threatening patient access to critical therapies. Learning Objectives Identify key policy and regulatory misalignments contributing to innovation gridlock in biopharma\; Assess the global impact of these barriers on patient access to transformative therapies. and prioritize action based on criticality\; Examine opportunities and actionable policy levers to realign systems and accelerate innovation for patients.Chair Alexis Reisin Miller\, JDSpeaker PMDA perspectiveDaisuke Koga\, MS\, MSCIndustry perspectiveMichelle Rohrer\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,03: DATA-TECH-AI
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e622ea0cfa35737c8fbd6f61347a5b7e
URL:http://dia2026globalannualmeeting.sched.com/event/e622ea0cfa35737c8fbd6f61347a5b7e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-567-L04-P\; CME 1.25\; RN 1.25See how different pharmaceutical companies use advanced analytics to augment traditional quality assurance methods\, hear the Regulators’ perspective on use of innovative quality assurance methods.Learning Objectives Identify the different methods that are available to assure the quality of clinical trials that go beyond traditional on-site auditing\; Discuss how different companies have applied analytics methods and their impact on clinical trial quality assurance.Chair Jennifer Emerson\, MPH\, RN\, PMPSpeaker Regulators Perspective Next Generation Clinical Trial Quality Assurance Using Advanced AnalyticsRachel MeadSCORE - Next Generation Clinical Trial Quality Assurance Using Advanced AnalyticsJamie Bridges\, MPHCritical to Quality Assessment Report - Next Generation Clinical Trial Quality Assurance Using Advanced AnalyticsKiernan Trevett\, MSCPanelistKavita C. Dada\, PHARMD\, RAC
CATEGORIES:09: RD-QUALITY-COMPLIANCE
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8a29b9753de624a5879db40dd3a3e4e6
URL:http://dia2026globalannualmeeting.sched.com/event/8a29b9753de624a5879db40dd3a3e4e6
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T141500Z
DTEND:20260616T153000Z
SUMMARY:#519: Patient Registries: Basket Trial or Basket Case?
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P\; CME 1.25\; RN 1.25Akin to basket trials which study a single treatment for multiple conditions\, patient registries enroll people with similar conditions\, look for safe and effective treatments and disease management strategies\, and are used to guide decision-making by clinicians\, regulators and payers. Yet the very nature of real-world evidence requires that patient registries be nimble and opportunistic -- desirable attributes to maintain relevance\, but ones that inevitably raise questions about data quality and completeness\, transparency\, provenance and Fitness for Use. Recent guidance documents from regulators and professional societies hint that real-world data from patient registries may be viewed more favorably than other\, less traceable and auditable sources of real-world data. This session will illustrate key attributes of high quality\, trustworthy patient registries\, the criticisms and barriers they generally face and what they do to bolster trust. Learning Objectives Explain the value of RWE on population groups that may not be fully representative of all cases\, and who may have some missing data\; Explain expectations for quality\, transparency and provenance\; Describe key values of patient registries and common approaches to bolster trustworthiness.Chair Nancy Dreyer\, MPH\, FISPESpeaker How registries are changing with technology and AI\, and what that means for qualityRichard Gliklich\, MDGauging registry quality according to its intended useMike D'AmbrosioLife in the trenches of a patient registry: navigating the reality of RWDAngela Dobes\, MPH
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:769dd991a97733cea8787e0502a5ab1a
URL:http://dia2026globalannualmeeting.sched.com/event/769dd991a97733cea8787e0502a5ab1a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T153000Z
DTEND:20260616T173000Z
SUMMARY:#520 POS: Professional Poster Session II
DESCRIPTION:Component Type: SessionProfessional Posters provide an opportunity for methodology (“how to”)\, case study\, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery\, development\, and lifecycle management of pharmaceuticals\, biotechnology\, medical devices\, and healthcare-related products.
CATEGORIES:14: POSTERS
LOCATION:Exchange\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:25dfbb40ba3c2c0eb03e181259224e6a
URL:http://dia2026globalannualmeeting.sched.com/event/25dfbb40ba3c2c0eb03e181259224e6a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T154000Z
DTEND:20260616T161000Z
SUMMARY:#521 CH: Achieving Representative Enrollment in Phase 3 Lupus Clinical Trials: A Case Study
DESCRIPTION:Component Type: WorkshopLevel: IntermediateThis session covers the importance of representative enrollment in Phase 3 Lupus trials\, Biogen’s approach to setting and achieving these goals\, and how patient-focused strategies improve clinical trial integrity and outcomes.Learning Objectives 1. Understand the key challenges in representative enrollment in Phase 3 Lupus clinical trials. 2. Learn how Biogen approached setting enrollment goals that reflect the epidemiology of the disease and specific strategies developed and initiatives executed to achieve these goals. 3. Understand the importance of representative enrollment on trial outcomes and patient care and how this is achievable
CATEGORIES:12: CONTENT-HUBS
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:50861f72f59be7550211d1c6e30a280e
URL:http://dia2026globalannualmeeting.sched.com/event/50861f72f59be7550211d1c6e30a280e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T154500Z
DTEND:20260616T164500Z
SUMMARY:#521.1 SS: Spark Stage: Patient Appreciation Session: Celebrating the Patient Voice
DESCRIPTION:Component Type: SessionThe Drug Information Association (DIA) is committed to advancing patient-centered healthcare through collaboration among patients and key stakeholders. This Patient Appreciation Session recognizes the vital contributions of patient advocates to healthcare innovation.Learning Objectives Recognize the impact of patient advocates on research\, drug development\, and healthcare decision-making\; Explore opportunities to engage in DIA patient-focused initiatives and collaborations\; Strengthen connections among patient advocates and multidisciplinary stakeholders.Chair Maria Paula Bautista Acelas\, MSCSpeaker PanelistVictoria DiBiaso\, BSN\, MPH\, RNPanelistRobyn Bent\, BSN\, MS\, RNPanelistGloria Stone\, MBA\, MSPanelistStacy Hurt\, MBA\, MHA
CATEGORIES:11: SPARK STAGE
LOCATION:Spark Stage\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:621a130afa819ecc66369397b76a3898
URL:http://dia2026globalannualmeeting.sched.com/event/621a130afa819ecc66369397b76a3898
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T154500Z
DTEND:20260616T161500Z
SUMMARY:#522 IT: Artos\, Inc Innovation Theater: AI Isn't About Generating Documents\, it's About Generating Data
DESCRIPTION:Component Type: SessionThe speakers will discuss how AI document generation is often a misunderstood problem. Sponsors focus on finding AI that can get words on a page\, but they often lose sight of a broader\, cross-functional\, data strategy that this needs to fit within in order to achieve significant ROI. This discussion will provide a conversation around strategic adoption of AI and concrete case studies in support of that.Learning Objectives The evolving state of the regulatory landscape and the role data plays in it\; Where AI can and can't solve problems\; Successful implementations of AI in complex pharma contexts.Chair Artos AISpeaker SpeakerSean McNiffSpeakerJosh Kim
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:96ec57120d6661d9be60fcd68813b5f1
URL:http://dia2026globalannualmeeting.sched.com/event/96ec57120d6661d9be60fcd68813b5f1
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T154500Z
DTEND:20260616T164500Z
SUMMARY:#523 IT: Syneos Health Innovation Theater: More Doesn't Guarantee Better - Why AI Success Depends on Organizational Agility\, Not Just the Tech
DESCRIPTION:Component Type: SessionAcross clinical development\, a growing wave of AI tools is reshaping how work gets done\, each designed to make processes faster\, easier and more efficient. But in the rush to adopt AI\, organizations can overlook the underlying sources of friction that limit performance. At the same time\, reliance on monolithic platforms built for end-to-end standardization can limit flexibility\, making it harder to evaluate\, select and integrate the right innovations as the technology landscape continues to evolve. Drawing on our global experience supporting clinical programs across diverse sponsor models and levels of infrastructure maturity\, this session outlines how to align people\, processes\, data and AI within adaptable operating environments to enable high-performance execution\, sustained agility and the ability to continuously integrate new capabilities without disruption.Chair Syneos HealthSpeaker SpeakerMatt Harrington
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:32b133aab03ff1eff3f8d021c0bf39b3
URL:http://dia2026globalannualmeeting.sched.com/event/32b133aab03ff1eff3f8d021c0bf39b3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T162500Z
DTEND:20260616T165500Z
SUMMARY:#524 IT: Vivpro Corporation Innovation Theater: AI in Action - Scaling Regulatory Document Generation Across R&D
DESCRIPTION:Component Type: SessionAI is no longer a future consideration—it is actively reshaping how regulatory work gets done. Organizations that delay risk falling behind\, while those that move early can gain a meaningful competitive edge. This session offers a practical\, experience-driven perspective on how to operationalize AI for regulatory document generation. We will demonstrate how REGAIN enables flexible document creation with dynamic sectioning and customizable prompts\, empowering authors while maintaining quality and consistency. Attendees will also learn key lessons from a successful collaboration—highlighting the importance of governance\, cross-functional alignment\, and working as one integrated team to drive adoption and deliver measurable impact across R&D.Learning Objectives Scale AI-enabled document generation across R&D\; Embed quality\, compliance\, and governance from the start\; Leverage REGAIN to automatically generate documents with flexible sectioning\, enabling authors to tailor content through custom prompts\; Operate as one integrated team\, Pfizer and Vivpro working in lockstep as the key to successful implementationChair Vivpro CorporationSpeaker PanelistJoga Gobburu\, PHD\, MBAPanelistAngela Russell Winnier\, PHDPanelistTushar Nitave
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:5b572704cd666649c33b26c1b5a7b502
URL:http://dia2026globalannualmeeting.sched.com/event/5b572704cd666649c33b26c1b5a7b502
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T162500Z
DTEND:20260616T165500Z
SUMMARY:#525 IT: Yseop Innovation Theater: Design Regulatory Grade AI - Enable Scalable\, Consistent Workflows Across Document Types
DESCRIPTION:Component Type: SessionContent generation is easy. Delivering outputs that are accurate\, traceable\, and consistent enough for regulatory submission across diverse document types is not. As teams move beyond CSR into protocol\, CMC\, and pharmacovigilance workflows\, many AI solutions fail to adapt\, creating risk around compliance\, scalability\, and usability. This session explores what regulatory grade AI looks like in practice. Through real workflow examples\, we will show how configurable\, agentic systems embed compliance and validation behind the scenes while adapting to specific business needs\, enabling scalable\, submission ready outputs without compromising control.Chair YseopSpeaker SpeakerCamille SauderSpeakerJenni Pickett\, PHD
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:55081643de6ecf25a985f89dd6404a9f
URL:http://dia2026globalannualmeeting.sched.com/event/55081643de6ecf25a985f89dd6404a9f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T163000Z
DTEND:20260616T173000Z
SUMMARY:#526 RT: Roundtable Discussion: FDA Public Posting of Complete Response Letters: A Year in Review\, Trends\, and Impact Analysis
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Statistics & Data Science Community for a follow up round table discussion tied to session: FDA Public Posting of Complete Response Letters: A Year in Review\, Trends\, and Impact Analysis (Tuesday\, June 16 | 12:30pm - 1:30pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Matthew Vankoski
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:57b0dd4d5bcb4be2724e78b0cfc77be3
URL:http://dia2026globalannualmeeting.sched.com/event/57b0dd4d5bcb4be2724e78b0cfc77be3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T170500Z
DTEND:20260616T173500Z
SUMMARY:#527 IT: Certara Innovation Theater: LLM-Driven Submissions: From Data Preparation to eCTD
DESCRIPTION:Component Type: SessionWhen introducing efficiencies to your regulatory workflow\, it’s not simply a question of writing faster. Teams need to look up and down stream to accelerate data delivery\, automate consistent first drafts and enable faster eCTD preparation. This session presents a practical\, framework for regulatory submissions that connects data pipelines and GenAI-assisted authoring with eCTD publishing and lifecycle execution using Certara CoAuthor™ and Certara GlobalSubmit™. Attendees will learn how to design governance and workflows that make LLMs usable in regulated environments: establishing standardized templates and structured sections for repeatability\; applying “human-in-the-loop” review checkpoints\; and leveraging publishing-time validation to surface issues earlier—before they become last-minute blockers. The session will also highlight where LLM support delivers the most value (data aggregation\, first-draft acceleration\, consistency across sections\, and faster content iteration) and how submission operations can translate better-authored content into smoother assembly\, review\, and health authority–compliant deliverables.Learning Objectives A reference architecture for LLM-driven regulatory authoring through eCTD submission execution\; Practical controls for compliant GenAI use: structured content\, standardized templates\, and expert oversight\; Methods to reduce cycle time and technical risk through robust validation and streamlined eCTD review workflows.Chair CertaraSpeaker SpeakerLiam O'Leary
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:9e27e829c6240c34688a5eee10dcd465
URL:http://dia2026globalannualmeeting.sched.com/event/9e27e829c6240c34688a5eee10dcd465
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P\; CME 1.25\; RN 1.25This session explores pharmacovigilance for biosimilars\, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA\, academia\, and industry will discuss suffix-related challenges and future directions.Learning Objectives Describe the FDA’s nonproprietary naming convention for biological products and its intended role in pharmacovigilance\; Analyze empirical evidence from FAERS to evaluate how suffix reporting impacts pharmacovigilance activities\; Assess the role of naming conventions in broader active surveillance systems\, such as the Sentinel System\, and their implications for biosimilar safety monitoring.Chair Stacey Ricci\, DRSCSpeaker TBDMary Jo Carden\, JDTBDJudith Maro\, MSTBDMariana Socal\, MD\, PHD\, MS
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:fea0dd5b769ef963f4f64ead370282cf
URL:http://dia2026globalannualmeeting.sched.com/event/fea0dd5b769ef963f4f64ead370282cf
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P\; CME 1.25\; RN 1.25This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10 companies\, FDA\, EMA\, and many other advisors from patient advocacy organizations across the Americas and Europe. Learning Objectives Identify key clinically meaningful endpoints used in GLP-1 trials\; Describe current opportunities and challenges in obesity drug development\; Explain how the public private partnership led by Drug Information Association is advancing trial endpoint alignment.Chair Maria Vassileva\, PHDSpeaker PanelistKatherin RuizPanelistAlison Matsui\, MPHPanelistBrad Jordan\, PHDPanelistJingyu (Julia) Luan\, PHD
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:3920703b4d851a56e992a4bc895343fe
URL:http://dia2026globalannualmeeting.sched.com/event/3920703b4d851a56e992a4bc895343fe
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P\; CME 1.25\; RN 1.25Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials\, highlighting conceptual model progress and stakeholder insights for regulatory decisions.Learning Objectives Describe recent developments from the DIA study integrating patient experience into immuno-oncology tolerability assessments\; Examine findings from literature and KOL interviews\; Identify strategies for operationalizing a multidimensional tolerability framework\; Recognize multistakeholder perspectives to support trial design\, data collection\, and benefit–risk evaluation.Chair Devin Peipert\, PHDSpeaker PanelistEfrat Dotan\, MDPanelistMaria Paula Bautista Acelas\, MSCPanelistLia Ridout
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:973fd3360a4ecbfa2996fce57f0182da
URL:http://dia2026globalannualmeeting.sched.com/event/973fd3360a4ecbfa2996fce57f0182da
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P\; CME 1.25\; RN 1.25This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.Learning Objectives Describe how synthetic AI patient personas can augment real patient input to personalize and improve patient trial experience\; Identify the data requirements and limitations for building synthetic AI personas.Chair Robina WeermeijerSpeaker PanelistJason Binder\, MAPanelistHimanshu Manchanda\, PHDPanelistSabina Kineen
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,03: DATA-TECH-AI
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e8f0cf7a4ecca319f1489bfdfcb4c7f0
URL:http://dia2026globalannualmeeting.sched.com/event/e8f0cf7a4ecca319f1489bfdfcb4c7f0
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#532: Applied Innovation for Patients: Implementing AI\, Cloud\, and Data in Regulatory Science
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-572-L04-P\; CME 1.25\; RN 1.25This session explores strategies to implement AI\, cloud\, and different data sources across the drug lifecycle and in regulatory activities to deliver patient benefits. Experts will discuss pilots\, policies\, and partnerships that can enable faster access to safe and effective medicines.Learning Objectives Explain how AI\, cloud\, and data can be utilized in regulatory processes to accelerate patient access to therapies\; Assess implementation strategies that balance innovation with patient safety and trust\; Identify collaborative models that embed patient-centric principles into digital regulatory ecosystems. Chair Rebecca Nebel\, PHDSpeaker PanelistKimberly Ann Beer\, MAPanelistAndrew Robertson\, JD\, PHDPanelistJonathan Walsh\, PHD
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:97df8f7ebd231467e8423cacdc9b6695
URL:http://dia2026globalannualmeeting.sched.com/event/97df8f7ebd231467e8423cacdc9b6695
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P\; CME 1.25\; RN 1.25AI pilots are everywhere\; enterprise impact is rare. Governance separates AI that works once from AI that works reliably. Join pharma\, regulator\, and tech leaders to explore how data ownership\, content models\, and process controls enable trustworthy AI.Learning Objectives Explain why scalable AI requires foundational data\, content\, and process governance\; Design governance mechanisms that align data standards (IDMP\, CDISC) with structured content management principles\; Evaluate regulatory expectations and industry hurdles related to data integrity\, reliance\, and trust in AI-driven or assisted processes\; Assess and address organizational gaps that limit AI deployment.Chair Vanni Carapetian\, MPHSpeaker Industry Perspectives on AI + Governance: PolicyAndrew Robertson\, JD\, PHDIndustry Perspectives on AI + Governance: TechJeff SteinkeIndustry Perspectives on AI + GovernanceVada Perkins\, MS
CATEGORIES:03: DATA-TECH-AI
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4d9ab3323e7741c45944f762bc374005
URL:http://dia2026globalannualmeeting.sched.com/event/4d9ab3323e7741c45944f762bc374005
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#535: Unlock AI's Full Potential: The Power of FAIR Data
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-574-L04-P\; CME 1.25\; RN 1.25AI underperforms when data isn’t machine-actionable. This talk shows how FAIR + open standards turn fragmented R&D data into fuel for LLMs and analytics—via a mini-rubric\, case studies\, and a 90-day roadmap to lift AI-readiness.Learning Objectives Apply a mini-FAIR rubric to one dataset/document to diagnose AI-readiness and summarize 2–3 priority gaps\; Recognize and select the appropriate standards—such as PIDs\, metadata\, controlled vocabularies\, that best enable a target AI use case (e.g.\, RAG\, model reuse)\; Recognize the key components of a 90-day plan—including roles\, metrics\, checkpoints—designed to elevate FAIR maturity and improve AI outcomes.Chair Anuj Uppal\, MSSpeaker AI Readiness Organizational Barriers Kathleen Rand\, PHARMDAI Readiness: A Statistical ViewKaveen HinidumaThe FAIR Principles: 10 Years LaterTed Slater\, MA\, MS
CATEGORIES:03: DATA-TECH-AI
LOCATION:119AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:75ac821c638b098a7978b510f8770dde
URL:http://dia2026globalannualmeeting.sched.com/event/75ac821c638b098a7978b510f8770dde
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks\, Pitch Decks\, and Any Talk of a Lifetime
DESCRIPTION:Component Type: WorkshopLevel: IntermediateIn this interactive workshop\, coach Jeff Smith shares essential building blocks – Prep as Empathy\, the Impact Wave\, Visuals on Purpose\, and Dynamic Delivery – used to shape “talks of a lifetime\,” from founding pitch decks to keynote and TED stages.Learning Objectives Use preparation as an empathy tool to align with enterprise/pharma stakeholders\; Structure pitches using the “Impact Wave” to guide audiences from problem recognition to urgency to action\; Design clear visuals that increase trust and decision velocity\; Elevate delivery using the “Dynamism Checklist” to project confidence and persuasive presence.Chair Jeff Smith
CATEGORIES:03: DATA-TECH-AI\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:de1e82c45afe9ef9f7d0b6ef493e0b9c
URL:http://dia2026globalannualmeeting.sched.com/event/de1e82c45afe9ef9f7d0b6ef493e0b9c
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#536: Project Management as a Catalyst for Enterprise Transformation
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-575-L04-P\; CME 1.25\; PDU 1.25 PMI 21662N25CW\; RN 1.25Project Management as a Catalyst for Enterprise Transformation explores how Project Management (PM) drives strategic alignment\, organizational evolution\, and long-term sustainment across the enterprise. This session will examine how PM-led governance and decision-making frameworks bring clarity to chaos and accelerate transformation\, while positioning PM as a strategic engine regardless of company size. Participants will engage in a hands-on exercise that applies these concepts to realistic scenarios\, enabling them to identify capability gaps and define scalable PM practices that support both the evolution and the sustained success of their organizations.Learning Objectives Explain how PM-led governance and decision-making frameworks act as catalysts for strategic alignment and enterprise-wide transformation\; Describe how to position Project Management as a strategic driver of organizational transformation across companies of all sizes\; Identify PM capability gaps and define scalable practices that accelerate transformation.Chair Elizabeth Somers\, MSSpeaker Project Management as a Catalyst for Enterprise TransformationJoann O'ConnorProject Management as a Catalyst for Enterprise TransformationJayanthi Reddy\, MBA\, MS
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:85ca0ca115e2c09f34086a8800622326
URL:http://dia2026globalannualmeeting.sched.com/event/85ca0ca115e2c09f34086a8800622326
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#537: EMA Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-670-L04-P\; CME 1.25\; RN 1.25In this session\, leaders from the EMA will provide an update on regulatory priorities. The audience will be invited to submit questions of general interest.Learning Objectives Describe EMAs regulatory initiatives and strategic priorities\; Identify opportunities for engagement with the regulators.Chair Steffen Thirstrup\, MD\, PHDSpeaker PanelistSabine Haubenreisser\, PHD\, MSCPanelistAna Trullas\, PHARMD\, MSCPanelistDenise Umuhire\, MBA\, MSCPanelistJoaquim Berenguer Jornet\, MS
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:2ff00186c07732381f846d4f1296a816
URL:http://dia2026globalannualmeeting.sched.com/event/2ff00186c07732381f846d4f1296a816
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#538: Innovations in Drug Review: A Global Perspective
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-579-L04-P\; CME 1.25\; RN 1.25This roundtable will discuss innovations in drug review\, including real-time review\, AI-enabled dossier analysis\, cloud data exchange\, mid-cycle communications\, and cross-disciplinary review\, and how modern tools create a dynamic review environment.Learning Objectives Examine drug review practices\, and highlight key PDUFA VIII enhancements\; Describe the evolving role of technology (AI\, cloud) in drug evaluation\; Explain drug review practices globally. Chair Cartier Esham\, PHD\, MSCSpeaker PanelistMax Wegner\, PHARMD\, RPHPanelistDonna Boyce\, MS\, RACPanelistBrittany Avin McKelvey\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ccf4a38abe8132d12332f8b53a091154
URL:http://dia2026globalannualmeeting.sched.com/event/ccf4a38abe8132d12332f8b53a091154
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#540: Regulators Approach to Address Drug Shortages
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-578-L04-P\; CME 1.25\; RN 1.25Drug shortages are difficult to measure across healthcare systems and complex pharmaceutical supply chains. At this session\, the FDA and their international regulatory counterparts will address the key aspects of drug shortages in their region and how real-world data are used to inform on shortages and their impact on patients.Learning Objectives Discuss recent regulatory updates related to drug shortages in the United States\; Recognize how real-world data can be used to inform the identification\, mitigation\, and resolution of shortages\; Describe how recent international collaboration efforts are helping to combat drug shortages. Chair Sema Hashemi\, MSSpeaker PanelistEmily T. Thakur\, RPHPanelistGrace Chai\, PHARMDPanelistGerald Dal Pan\, MD\, MHS
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4598896b6870b199de890243c2101244
URL:http://dia2026globalannualmeeting.sched.com/event/4598896b6870b199de890243c2101244
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#541: Taiwan Town Hall: Strategies to Promote Medicine Supply Resilience
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-669-L04-P\; CME 1.25\; RN 1.25This Taiwan Town Hall showcases Taiwan’s evolving approach to medicine supply resilience. It brings together regulators\, industry\, and health systems from Taiwan\, the EU\, Japan\, and the US to explore coordinated global pathways for critical medicines.Learning Objectives Explain Taiwan’s transition from medicine shortage management to supply resilience governance\; Compare regulator\, industry\, and health system perspectives from Taiwan\, EU\, Japan\, and US on critical medicines and international cooperation\; Identify practical pathways for Taiwan to engage with global partners to strengthen coordinated frameworks for resilient medicine supply.Chair Chih-Kang Chiang\, MDSpeaker From Shortage Management to Resilience Governance: Taiwan’s Evolving Policy ApproachChih-Kang Chiang\, MDFrom Regulation to Resilience: Taiwan’s Strategy in Controlled Drug Manufacturing and Future DirectionsMeng-Hsiu WuFrom Shortage to Resilience: Building Medication Supply Preparedness in Health SystemsMatthew Eberts\, PHARMD\, MBA\, MHALessons from Japan: Rebuilding Domestic Antibiotics Production for Enhanced Supply ResilienceMasaya Tamae
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b6d0a02a213be69d5112763237a250ed
URL:http://dia2026globalannualmeeting.sched.com/event/b6d0a02a213be69d5112763237a250ed
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-577-L04-P\; CME 1.25\; RN 1.25Explore how patient-focused principles can transform product labeling into a strategic asset. Learn how to integrate patient perspectives early\, align with regulatory trends\, & leverage labeling to support decision-making and differentiate products.Learning Objectives Identify opportunities to incorporate patient experience data into product labeling that aligns with FDA/EMA guidance\; Examine case studies of successful patient-centered labeling that supports decision-making\; Outline approaches to develop labeling strategies that bridge regulatory requirements with patient value.Chair Julie Guery\, PHDSpeaker Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product CommunicationKelly Treonze\, MSLabeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product CommunicationJason HarrisPanelistKaisa Immonen\, MA
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,04: MEDAFFAIRS-SCICOMM
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6a5dd17c5ec04fc7ecc18be97d66d7de
URL:http://dia2026globalannualmeeting.sched.com/event/6a5dd17c5ec04fc7ecc18be97d66d7de
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-580-L04-P\; CME 1.25\; RN 1.25This forum will present: 1) HA expectations related to cross-functional QbD\, 2) Specific examples will highlight the change need for traditional clinical trial functions to meet QbD requirements.Learning Objectives Explain Health Authority (HA) expectations for cross-functional Quality by Design (QbD)\; Describe the current state of traditional clinical trial functions and the needed change in those functions to meet HA expectations for QbD.Chair Michael Torok\, PHDSpeaker Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?Jennifer Emerson\, MPH\, RN\, PMPQuality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?Mandy Kaur Budwal-Jagait\, MSC
CATEGORIES:09: RD-QUALITY-COMPLIANCE
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f1fa75618b35d0592f2222ededbf3f01
URL:http://dia2026globalannualmeeting.sched.com/event/f1fa75618b35d0592f2222ededbf3f01
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T174500Z
DTEND:20260616T190000Z
SUMMARY:#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making
DESCRIPTION:Component Type: ForumLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P\; CME 1.25\; RN 1.25Bayesian statistical methods are gaining increasing importance in drug development\, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials\, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel\, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique\, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope\, principles\, and current thinking reflected in their respective documents\, as well as discuss areas of alignment\, divergence\, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions\, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion\, participants will gain insight into how Bayesian methods are being evaluated in practice\, including considerations for trial design\, external data integration\, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement\, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.Learning Objectives Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods\; Compare regulatory perspectives and areas of alignment and divergence across regions\; Explain applications of Bayesian approaches in clinical trial design\, analysis\, and regulatory decision-making\; Identify current expectations\, implementation challenges\, and opportunities for industry engagement in shaping future guidance.Chair May F Mo\, MBA\, MSSpeaker PanelistJuan Jose AbellanPanelistAndrew Thomson\, PHD\, MA\, MSC
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:0e6610e3d064d34b934c559a3a94ffe1
URL:http://dia2026globalannualmeeting.sched.com/event/0e6610e3d064d34b934c559a3a94ffe1
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T191500Z
DTEND:20260616T200000Z
SUMMARY:#544 RT: Roundtable Discussion: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the AI in Healthcare Community for a follow up round table discussion tied to session: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust (Tuesday\, June 16 | 3:00pm - 4:00pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Atika Kumar\, MBA\, MS
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:a7204751ef99b8f0366dca5d41ca0291
URL:http://dia2026globalannualmeeting.sched.com/event/a7204751ef99b8f0366dca5d41ca0291
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T191500Z
DTEND:20260616T200000Z
SUMMARY:#545 RT: Roundtable Discussion: Regulators Approach to Address Drug Shortages
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Regulatory Affairs Community for a follow up round table discussion tied to session: Regulators Approach to Address Drug Shortages (Tuesday\, June 16 | 3:15pm - 4:00pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session. Chair Allison Radwick
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:05087eba9f81f09d1e10732411768f65
URL:http://dia2026globalannualmeeting.sched.com/event/05087eba9f81f09d1e10732411768f65
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T191500Z
DTEND:20260616T194500Z
SUMMARY:#546 IT: Collate Innovation Theater: A Thousand Document Types - An AI Platform Approach to Document Authoring and Intelligence Adopted by Global Enterprises
DESCRIPTION:Component Type: SessionChair CollateSpeaker SpeakerSurbhi Sarna
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:5a6133b9d31199796881401346e1e674
URL:http://dia2026globalannualmeeting.sched.com/event/5a6133b9d31199796881401346e1e674
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#547: Increasing Vigilance Transparency: When is the Right Time to Publish Safety Signals?
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-582-L04-P\; CME 1.00\; RN 1.00A forum sharing different perspectives from international regulators & patients on when is the right time to publish information on safety signals from spontaneous data. We will explore how we can meet patient needs without leaving unanswered questions.Learning Objectives Discuss the challenges and opportunities that could present for patients from having early access to information on safety signals arising from spontaneous data from international regulators\; Assess how patient preferences can be evaluated and incorporated in safety monitoring and risk management communications.Chair Sarah VaughanSpeaker PanelistMichael MittelmanPanelistPeter Hjelmstrom\, MD\, PHDPanelistLisa Wolf\, PHARMD
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:eff312a6c0197fec31bf904582870233
URL:http://dia2026globalannualmeeting.sched.com/event/eff312a6c0197fec31bf904582870233
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P\; CME 1.00\; RN 1.00This pilot project aimed to upskill community cancer centers to carry out clinical trials. ACCC and ACRP identified needs and provided self-study and instructor-led training that improved learner knowledge and confidence. Learning Objectives Describe the challenges faced by research-naïve and low trial capacity programs at community cancer centers in conducting clinical research\; Recognize the role of professional training in preparing community cancer centers to implement clinical trials\; Integrate learnings from a training pilot that helped advance foundational knowledge and confidence among clinic healthcare staff.Chair David Vulcano Landis\, MBASpeaker PanelistRuma Bhagat\, MPHPanelistPete Fronte\, MBA
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:0ffc6d1748697076a78f804e19f777cc
URL:http://dia2026globalannualmeeting.sched.com/event/0ffc6d1748697076a78f804e19f777cc
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#549: Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors\, Sites\, and Patients
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-583-L04-P\; CME 1.00\; RN 1.00This session is intended to show how modern site source and integrated site solutions connect data\, people\, and processes to create a more efficient\, future-ready clinical trial ecosystem. Learning Objectives Discuss the evolving role of site source in optimizing trial execution and ensuring data quality\, compliance\, and efficiency across stakeholders\; Identify best practices for implementing digital site solutions including eSource and integrated site technologies that balance standardization with site autonomy\; Recognize how site-centered innovations connect data\, people\, and processes.Chair Jonathan Andrus\, MSSpeaker Technology PerspectiveSamir JainSite PerspectiveAneesh VazeCRO and Site Network PerspectiveMelissa Gottschlich\, MSC
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:229663efbaaa479194882837fd07c114
URL:http://dia2026globalannualmeeting.sched.com/event/229663efbaaa479194882837fd07c114
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-586-L04-P\; CME 1.00\; RN 1.00This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real world GxP implementation. Attendees will gain insight into regulatory convergence\, operational challenges\, and good practices for compliant AI adoption.Learning Objectives Compare and contrast US and EU regulatory frameworks governing AI use across the drug development lifecycle\; Assess how regulatory expectations and emerging convergence efforts translate into practical implementation challenges\; Identify good practices for operationalizing AI within GxP quality systems while maintaining compliance and innovation.Chair Junyang Wang\, MSCSpeaker PanelistMartin Benedikt Heitmann\, MSPanelistLuis Pinheiro\, PHARMD\, MSCPanelistJoaquim Berenguer Jornet\, MS
CATEGORIES:03: DATA-TECH-AI\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6a2d5c846214c2dba228782a5ad5be38
URL:http://dia2026globalannualmeeting.sched.com/event/6a2d5c846214c2dba228782a5ad5be38
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#551: Operationalizing Large Language Models in Drug Development
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-585-L04-P\; CME 1.00\; RN 1.00Generative AI and large language models (LLMs) are reshaping drug development and Real-World Evidence (RWE). This session explores real-world applications\, debunks common myths\, and outlines what’s needed for safe\, scalable\, and compliant use across the drug development lifecycle.Learning Objectives Distinguish between the current capabilities and limitations of generative AI and large language models (LLMs) in drug development\; Identify practical and regulatory challenges in adopting GenAI across evidence generation workflows\; Discuss future opportunities for integrating GenAI into the various areas of the drug development pipeline\; Identify/mitigate bias in regulated workflowsChair Wesley Anderson\, PHDSpeaker GenAI for literature-based evidence synthesis: From systematic literature review to digitization of trial publicationsEmily NievesPanelistDanielle Boyce\, MPH
CATEGORIES:03: DATA-TECH-AI\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:02df854dd09c48ff8f14664e0bbcc682
URL:http://dia2026globalannualmeeting.sched.com/event/02df854dd09c48ff8f14664e0bbcc682
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P\; CME 1.00\; RN 1.00This session explores how lean authoring streamlines clinical regulatory documents\, debunks myths about reviewer preferences\, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.Learning Objectives Identify common misconceptions around regulatory reviewer preferences and practices in reviewing CSRs and Module 2 documents\; Explain how to prepare well-informed and effective arguments to persuade cross-functional authoring teams to create leaner\, more concise\, user-focused\, and automation-ready documents\; Recognize how and when to implement successful change management practices at your own organizationChair Lauren Geary\, PHDSpeaker PanelistInger Oedum Nielsen\, PHD\, MS
CATEGORIES:04: MEDAFFAIRS-SCICOMM\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:1aae1ed7ee9f92d374d90a5507e9ea84
URL:http://dia2026globalannualmeeting.sched.com/event/1aae1ed7ee9f92d374d90a5507e9ea84
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
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SUMMARY:#563: Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-655-L04-P\; CME 1.00\; RN 1.00By placing CAR-T within a broader trajectory—from breakthrough therapies today to longevity-driven oncology tomorrow—this session challenges stakeholders to rethink how access\, value\, and sustainability must evolve to keep pace with scientific progress.Learning Objectives Assess how CAR-T experience has revealed gaps in health technology assessment and reimbursement in the US and Europe\; Examine how durable benefit\, earlier intervention\, and longer oncology horizons challenge current value\, outcomes\, and sustainability models\; Apply multi-stakeholder and patient insights to inform evolving reimbursement and access approaches for potentially curative therapies.Chair Bradley WattsSpeaker PanelistTom WhiteheadPanelistRonald DePinho\, MDPanelistLaura Okpala\, MPH
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:12265926e1a4477c63287311a908de44
URL:http://dia2026globalannualmeeting.sched.com/event/12265926e1a4477c63287311a908de44
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-588-L04-P\; CME 1.00\; RN 1.00Explore the latest combination product trends\, sustainability in design\, recent FDA/global guidelines\, post-approval device changes\, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.Learning Objectives Discuss recent FDA and global guidelines (ICH Q1\, ICH Q6\, ICH M4Q) that inform effective control strategies & stability programs\; Recognize how to manage post-approval changes for device constituents and focusing on best practices\; State recent IND and submission trends (e.g.\, Human Factors\, design verification\, stability) and successful health authority interactions to accelerate therapies to patients.Chair Rumi Raquel Young\, MSSpeaker PanelistAlan Stevens\, MSPanelistJames Bertram\, PHD\, MS\, RACPanelistChelsea O'Connell\, MS\, RACPanelistKatie Duncan\, PHD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:9769d2c1b7c319b4068d74989c342f90
URL:http://dia2026globalannualmeeting.sched.com/event/9769d2c1b7c319b4068d74989c342f90
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#554: Reverse Pitches: How Pharma Actually Buys
DESCRIPTION:Component Type: SessionLevel: AdvancedFounders pitch to pharma expecting a straightforward evaluation\, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders\, this session flips the script—showing how pharma actually evaluates\, negotiates\, and commits to partnerships with innovative companies.Learning Objectives Identify the hidden criteria and decision-makers that determine whether a pharma deal moves forward\; Understand MSAs\, compliance requirements\, and relationship dynamics that shape biopharma partnerships\; Recognize common deal-stoppers and structure early conversations to align with how pharma actually evaluates and buys.Chair Ligia Kilinski Kilinski CevascoSpeaker PanelistMindy Gruba
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:aa151b61bf212f10d81f29fa239c11bd
URL:http://dia2026globalannualmeeting.sched.com/event/aa151b61bf212f10d81f29fa239c11bd
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P\; CME 1.00\; RN 1.00This forum will address the rise of illegal mass manufacturing of unapproved medicines\, which threatens patient safety. Participants will discuss current regulations and the need for new rules to ensure drug supply chain integrity and promote safety.Learning Objectives Describe the landscape for the exponential growth in the distribution of unapproved or unauthorized medicines\; Identify risks associated with illegal large-scale manufacturing of unregulated and untested compounded drugs\; Discuss regulator perspectives on the issues relating to the mass distribution of unapproved medicines\; Explain current regulatory frameworks and how to adapt them.Chair Brad Jordan\, PHDSpeaker TBDShabbir SafdarPanelistAndrew Funk\, PHARMD\, RPHANVISA PerspectiveRenato Lopes Hurtado\, MSC\, RPH
CATEGORIES:07: REGCMC-PRODUCT QUALITY
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:70c04981f0173c3ee627ccd47203d4c8
URL:http://dia2026globalannualmeeting.sched.com/event/70c04981f0173c3ee627ccd47203d4c8
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#556: Access Consortium Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-594-L04-P\; CME 1.00\; RN 1.00The session will showcase the new Access Consortium’s GROWTH Manifesto and the resulting opportunities. It will also provide an update one year after publishing the Access Strategic plan\, highlighting our achievements in speeding up approvals through work-sharing initiatives. Learning Objectives Describe and justify the strategic developments and priorities of the Access Consortium\; Reflect and evaluate previous challenges on communication and engagement\, to discuss improvements to further strengthen international collaboration\; Demonstrate on-going regulatory developments and innovation\, which adhere to and support international harmonization aligned with global standards.Chair Lawrence TallonSpeaker PanelistRaymond S.B. Chua\, MD\, MBA\, MPH\, FRCPPanelistAnthony Lawler\, MD\, MBAPanelistVincenza TrivignoPanelistPamela Aung-Thin
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d2d85abf630bb3881f8754d3394d501e
URL:http://dia2026globalannualmeeting.sched.com/event/d2d85abf630bb3881f8754d3394d501e
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-591-L04-P\; CME 1.00\; RN 1.00This session will explore scientific and regulatory considerations unique to cell and gene therapies (CGTs)\, emphasizing the urgent need for harmonization among health authorities globally. Participants will discuss regulatory challenges and examine opportunities for regulatory collaboration\, including harmonization efforts led by the ICH Cell and Gene Therapy Discussion Group. The session will also cover recent efforts by regulatory authorities to streamline expectations for CGT manufacturing\, showcasing best practices and flexible regulatory strategies that support faster development. Attendees will gain an understanding of current collaborative efforts and policy innovations shaping the future of CGTs worldwide.Learning Objectives Analyze global regulatory considerations and opportunities posed by current frameworks for cell and gene therapy products to drive innovation and increase patient access to medicines\; Discuss work under international organizations\, such as ICH\, to align regulatory expectations and harmonize technical requirements\; Evaluate recent regulatory approaches and best practices designed to streamline CGT manufacturing\, and recognize policy initiatives shaping the advancement of CGTs.Chair Akanksha Kaushal\, MSSpeaker EMA’s role in Transforming CGT Innovation and Access Patrick Celis\, PHDIndustry Perspective on Driving Regulatory Alignment: Analyzing Regulatory Challenges and Identifying Needs and Opportunities for ConvergenceD. Allen Callaway\, II\, MBA\, MSICH Harmonization Efforts- The Cell and Gene Therapy Discussion GroupLesbeth Caridad Rodriguez\, MSFDA Initiatives to Streamline CGT Manufacturing to Accelerate DevelopmentAndrew Byrnes\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f4d66b61614617f91dcaa776c7dc2da1
URL:http://dia2026globalannualmeeting.sched.com/event/f4d66b61614617f91dcaa776c7dc2da1
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#560: Novel Endpoints\, Biomarkers\, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-590-L04-P\; CME 1.00\; RN 1.00Novel endpoints\, biomarkers\, and digital tools offer transformative potential but face regulatory acceptance challenges. Explore current landscape\, successful case studies\, and strategies for enhanced regulatory engagement through collaboration.Learning Objectives Discuss the current FDA regulatory framework for novel endpoints\, biomarkers\, and digital tools\; Identify key challenges and gaps in regulatory acceptance and validation\; Examine strategies for enhancing regulatory engagement and scientific alignment\; Apply lessons from case studies and partnerships to future development programs.Chair Pujita Vaidya\, MPHSpeaker Industry PerspectiveM. Khair ElZarrad\, PHD\, MPHDuke Margolis PerspectiveValerie J. Parker\, MSCIndustry PerspectiveLauren Tobe\, JD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:119AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e91b55e86256a7120e291a9d3d9d5966
URL:http://dia2026globalannualmeeting.sched.com/event/e91b55e86256a7120e291a9d3d9d5966
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#559: China Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-592-L04-P\; CME 1.00\; RN 1.00In this session\, speakers from NMPA\, Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulatory policy\, drug review and approval\, and international collaboration.Learning Objectives Recognize the latest information on the National Medical Products Administration (NMPA) activities in drug regulation\, supporting innovation and international collaboration\; Describe the recent update on the progress in drug review\, inspection and approvals in China\; Discuss the issues on drug regulation with NMPA officials.Chair Ling Su\, PHDSpeaker PanelistWei ZhangPanelistQinghua Wang\, MDIntroductionHui ShiUpdate on Drug Regulation in ChinaHuijuan ZhouEvolution of clinical trial landscape enabling early clinical developmentXiaoyuan Chen\, MD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:16b4968f43d670586d38f746f7b3da2f
URL:http://dia2026globalannualmeeting.sched.com/event/16b4968f43d670586d38f746f7b3da2f
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-593-L04-P\; CME 1.00\; RN 1.00This session will showcase how Real-World Evidence (RWE) supports pediatric drug development in Asian countries\, share US and EU perspectives\, and highlight innovations in regulatory strategies\, policies\, and methodologies to enhance regulatory-grade pediatric RWE.Learning Objectives Demonstrate emerging trends in the use of RWE in regulatory decision-making in Asia\, with real examples of leveraging RWE to accelerate pediatric drug development\, highlighting innovative approaches and successful outcomes\; Discuss challenges and strategies for high-quality pediatric RWE and explore regulatory frameworks for RWE evaluation through innovative cross-organizational collaborations.Chair Yongjing Zhang\, PHDSpeaker PanelistReiko NakashimaPanelistShaoqing Ni\, PHDPanelistJu-Young Shin\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:115C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:3134e2c3bbf4d1630d784fd7cc20566d
URL:http://dia2026globalannualmeeting.sched.com/event/3134e2c3bbf4d1630d784fd7cc20566d
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P\; CME 1.00\; RN 1.00In this session\, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance\, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating enabler for the business and patients.Learning Objectives Recognize the value unlocked by the incorporating AI and advanced analytics in GCP/GVP quality assurance\; Describe the short and long term transformative benefits\; Discuss how to develop strategies for demonstrating the value created by embedding AI and advanced analytics into quality assurance audits.Chair Roshan D'SouzaSpeaker Value realisation in augmenting Quality Assurance with advanced analytics & AI?Frederik Collin\, MSLessons learned in implementing advanced analytics & AI in Quality AssuranceJeremy Jones\, MSThe Why behind the Value propositionRoshan D'SouzaData & Digital: Assessing Measurable Value in QAMichael Pelosi\, MA\, MBA
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,01: CLINSAFETY-PV-RM
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:298dcbe669a30c2c4a37d62d84f9d419
URL:http://dia2026globalannualmeeting.sched.com/event/298dcbe669a30c2c4a37d62d84f9d419
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DTSTAMP:20260517T134759Z
DTSTART:20260616T201500Z
DTEND:20260616T211500Z
SUMMARY:#562: Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Diseases: Statistical Innovation and Novel Applications
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-596-L04-P\; CME 1.00\; RN 1.00Learn how the Real-World Evidence (RWE) can be utilized in studies of rare outcomes and diseases. Speakers from industry\, academia\, and regulators share insights on external controls\, causal inference\, and evidence synthesis to inform regulatory submissions.Learning Objectives Identify when to use hybrid design and or external controls for rare outcomes and diseases using RWE sources\; Design RWE-based studies and address confounding\, missing data\, and intercurrent events\; Evaluate robustness of study results with sensitivity analyses.Chair Huan Wang\, PHDSpeaker Assessing the Validity of External Versus Randomized Controls in Pancreatic Cancer and Other DiseasesRuthie Davi\, PHD\, MSReal World Evidence for Post-Marketing Drug Safety Outcomes: FDA’s Sentinel SystemJennifer Lyons\, PHD\, MPHSingle Arm\, External-Controlled Studies – Pitfalls and PathwaysVan Tran\, PHD
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:48f8cbae3610bab71370f12f81b947a2
URL:http://dia2026globalannualmeeting.sched.com/event/48f8cbae3610bab71370f12f81b947a2
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DTSTAMP:20260517T134759Z
DTSTART:20260617T120000Z
DTEND:20260617T130000Z
SUMMARY:#600: From Breakthrough to Life: Engineered T-Cells\, Patients\, and the Future of Biotech
DESCRIPTION:Component Type: SessionLevel: IntermediateFollowing a keynote presentation by Bruce Levine on the future of genetically engineered T-cells for human therapeutics\, sit down with Bruce and Brad Watts for a fireside chat. Through scientific\, policy\, and patient lenses\, the session will examine what it takes to translate high-risk science into sustainable therapies\, and what that implies for regulators\, payers\, sponsors\, and technology partners.Learning Objectives Describe how advances in engineered T-cells\, including CAR-T\, are reshaping expectations for cancer treatment and the broader pipeline\; Identify scientific\, regulatory\, and system conditions needed to translate high-risk engineered innovations into equitable\, scalable patient benefit\; Discuss how real patient and family experiences inform future strategies for regulators\, payers\, sponsors\, researchers\, and technology partners developing next-generation cell therapies.Chair Katie TruongSpeaker PanelistBradley WattsPlenary PresenterBruce Levine
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,00: PLENARY\,18: LIFT-SERIES
LOCATION:114\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e990320fa1418ae04279de7326a05593
URL:http://dia2026globalannualmeeting.sched.com/event/e990320fa1418ae04279de7326a05593
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DTSTAMP:20260517T134759Z
DTSTART:20260617T131500Z
DTEND:20260617T134500Z
SUMMARY:#601 IT: Faro Health Innovation Theater: Digital Protocols in Action - Enabling End-to-End Automation in Clinical Development
DESCRIPTION:Component Type: SessionClinical trials still rely heavily on static Word documents to define and communicate protocol intent\, creating manual handoffs\, data inconsistencies\, and delays across every downstream system. This session explores how digital\, structured protocols serve as the foundation for end-to-end automation in clinical development\, eliminating the translation layer between study design and execution. Through a live demo of the Faro platform\, attendees will see how a single structured protocol definition can simultaneously drive automation across multiple workflows — from EDC build to authoring and more. Attendees will leave with a concrete understanding of how a platform approach to protocol digitization can accelerate study startup\, reduce amendment burden\, and position their organization for AI-ready clinical development.Learning Objectives Learn how a structured\, machine-readable protocol serves as a single source of truth that can drive multiple downstream systems\; See firsthand how protocol digitization can support study design optimization\, augment medical writing\, and accelerate study startup through a live platform demo\; Identify practical first steps for transitioning from document-based to digital protocol workflows within your organization.Chair Faro Health Inc.Speaker SpeakerVivian Dewoskin\, MBA
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 1\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d45148d5b161070654e0dc5617ae408d
URL:http://dia2026globalannualmeeting.sched.com/event/d45148d5b161070654e0dc5617ae408d
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DTSTAMP:20260517T134759Z
DTSTART:20260617T131500Z
DTEND:20260617T134500Z
SUMMARY:#602 IT: PhaseV Trials Innovation Theater: From Protocol to Submission - The Real-World Impact of AI in Clinical Operations
DESCRIPTION:Component Type: SessionAs clinical trials grow increasingly complex\, relying on historical correlations and rigid fixed designs is no longer viable. This session will discuss the practical application of AI across the clinical lifecycle\, from identifying predictive early-derived endpoints to dynamically optimizing site selection and patient recruitment. We will share actionable success stories demonstrating how multimodal AI platforms are currently helping biopharma and CROs navigate regulatory demands for explainability while cutting trial durations by 40%.Chair PhaseVSpeaker SpeakerRaviv Pryluk\, PHD
CATEGORIES:16: INNOVATIONTHEATERS
LOCATION:Innovation Theater 2\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:93a5d855a296372f949e89d5cb9aaf44
URL:http://dia2026globalannualmeeting.sched.com/event/93a5d855a296372f949e89d5cb9aaf44
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DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P\; CME 1.25\; RN 1.25Risk Minimization Measures (RMMs) target multiple healthcare stakeholders\, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations\, empirical examples\, methodological advances\, and insights from SmPC content analysis.Learning Objectives Discuss the US and EU regulatory rationale and expectations for RMM evaluations\; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone\; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.Chair Daniele Sartori\, MSCSpeaker PanelistGita Toyserkani\, PHARMD\, MBAPanelistElaine Lippmann\, JDPanelistHelga Gardarsdottir\, FISPEPanelistPriya Bahri\, PHD
CATEGORIES:01: CLINSAFETY-PV-RM\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c01334538ffa6987e7f88eff7388340e
URL:http://dia2026globalannualmeeting.sched.com/event/c01334538ffa6987e7f88eff7388340e
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#604.1: Trial Navigator: Sponsors and Payors Discuss a Collaborative Non-Profit Recruitment Model to Better Connect Patients to Trials
DESCRIPTION:Component Type: ForumLevel: BasicDespite major investment\, trial enrollment remains a system failure. Could a collaborative model align sponsors and payors – those who run trials & those with patient populations – via shared infrastructure and trusted human navigators? Help shape it.Learning Objectives Diagnose enrollment challenges as a system-level coordination failure\; Outline shared values and differentiate value across sponsors\, payors\, and patients\; Identify opportunities to enhance trust and build collaborative infrastructure (core governance\, incentives\, data)\; Apply cross-sector and emerging data collaboration lessons to pilot and scale solutions.Chair Van Crocker
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b5a59589dd4b406d2c0c41c3b4f9f297
URL:http://dia2026globalannualmeeting.sched.com/event/b5a59589dd4b406d2c0c41c3b4f9f297
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#604: Counting the Cost: Translating Participant Burden into Fair Compensation
DESCRIPTION:Component Type: WorkshopLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-599-L04-P\; CME 1.25\; RN 1.25This interactive workshop moves beyond analysis to implementation—translating burden into cost and exploring fair compensation models to advance equity\, access\, and the participation experienceLearning Objectives Examine how participant burdens translate into measurable costs and affect recruitment and retention\; Apply fairness-based frameworks that align compensation with lived experience\; Evaluate ethical\, regulatory\, and policy considerations to guide implementation models that improve equity and strengthen science through representative participationChair Lani HashimotoSpeaker PanelistDonna Libretti Cooke\, JDPanelistBernadette TostiPanelistT.J. Sharpe\, PMPPanelistShay Webb
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ec4e3062f59705bdab4ed6e9a42270d5
URL:http://dia2026globalannualmeeting.sched.com/event/ec4e3062f59705bdab4ed6e9a42270d5
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P\; CME 1.25\; RN 1.25In this session\, sponsor companies present use cases on strategies and solutions deployed (e.g.\, digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.Learning Objectives Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials\; Identify key factors driving burden in clinical trials\; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.Chair Abigail Dirks\, MSSpeaker PanelistStephanie Christopher\, MAPanelistKatrina Mateo\, PHD\, MPH
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,03: DATA-TECH-AI
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:50e5d205dd4cde096e56ee397e3b42be
URL:http://dia2026globalannualmeeting.sched.com/event/50e5d205dd4cde096e56ee397e3b42be
END:VEVENT
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DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#605: Bridging the AI Divide: Regulatory Trends\, Industry Innovation\, and the Future of AI in Pharma & Biotech
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-602-L04-P\; CME 1.25\; RN 1.25Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models\, examines FDA\, EMA\, and EU AI frameworks\, and delivers strategies to ensure credible\, compliant AI use in regulatory decision-making.Learning Objectives Differentiate between AI-native and traditional pharma/biotech models in drug development\; Assess regulatory expectations for AI from FDA\, EMA\, and the EU AI Act\; Apply strategies to establish AI model credibility for regulatory decision-making.Chair Mark RutterSpeaker PanelistGraziella ColluPanelistHussein Ezzeldin\, PHDPanelistDonna Rivera\, PHARMD\, MSC\, FISPEPanelistMegha Sinha
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:40119b3b580e07dc9317153583080946
URL:http://dia2026globalannualmeeting.sched.com/event/40119b3b580e07dc9317153583080946
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DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-600-L04-P\; CME 1.25\; RN 1.25This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation turning the digital by default ambition into practice\, combining legislative reforms with digital and AI strategies.Learning Objectives Describe the digital by default ambition of the New EU Pharmaceutical Legislation\; Explain how digitalization and AI enable more agile\, transparent\, and patient-centered processes\, that drive efficiency\, productivity and innovation in regulatory science and operations\; Discuss practical implementation challenges related to trust\, quality\, data interoperability\, and organizational readiness.Chair Joaquim Berenguer Jornet\, MSSpeaker PanelistDerick MitchellPanelistSteffen Thirstrup\, MD\, PHDPanelistGabriel Westman\, MD\, PHD\, MSC
CATEGORIES:03: DATA-TECH-AI\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:82094adb3d1847fcc14881fb28b04c06
URL:http://dia2026globalannualmeeting.sched.com/event/82094adb3d1847fcc14881fb28b04c06
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DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P\; CME 1.25\; RN 1.25In this session\, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.Learning Objectives Describe the core principles of Gen AI and explain their relevance to clinical operations\; Identify practical considerations for implementing AI for clinical trial oversight\; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.Chair Ioannis Spyroglou\, PHDSpeaker PanelistRoshan D'SouzaBootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation ReportingFrederik Collin\, MSOperational Impact\, Scaling\, and Limitations: From Algorithm to PracticeKarin Jonczak
CATEGORIES:03: DATA-TECH-AI\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:28c76e3c5c110bd68e7c2eed612cabd2
URL:http://dia2026globalannualmeeting.sched.com/event/28c76e3c5c110bd68e7c2eed612cabd2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#601: Inside the Investor’s Mind: How Today’s Biotech Investors Choose Where to Place Their Bets
DESCRIPTION:Component Type: SessionLevel: AdvancedThis session takes participants inside the investor’s mind in today’s complex funding environment. Investors and financial leaders will discuss how they evaluate pipelines\, platforms\, and partnerships\, where they look for differentiated deal flow\, how valuation frameworks are changing\, and what ultimately convinces them to lean in—or pass.Learning Objectives Explain how current biotech investors evaluate pipelines\, platforms\, and partnerships in today’s funding climate\; Describe how valuation frameworks\, risk appetite\, and evidence expectations are evolving across stages and modalities\; Identify what ultimately convinces investors to engage\, lean in\, or pass and how companies can position themselves accordingly.Chair Raju KucherlapatiSpeaker PanelistJay Roberts\, MBAPanelistSahirzeeshan AliPanelistMey Boukenna\, MD\, PHD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b97b30bccc1a319e111c10cda444d380
URL:http://dia2026globalannualmeeting.sched.com/event/b97b30bccc1a319e111c10cda444d380
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#609: Decision Under Uncertainty
DESCRIPTION:Component Type: WorkshopLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-603-L04-P\; CME 1.25\; PDU 1.25 PMI 2166LODLKY\; RN 1.25In this interactive workshop\, participants will participate in an interactive\, case-based racing simulation that places participants in a high-pressure “go/no-go” decision before the most important race of the season. This is one of Harvard's case studies most commonly used in business school programs. In this simulation\, participants decide whether to race in a high-stakes event\, balancing technical risks\, financial pressures\, and limited data\, highlighting decision-making under uncertainty. The exercise addresses key issues in decision-making under uncertainty and bias without awareness under time and stakeholder pressure. Upon conclusion of the exercise\, participants report increased awareness of decision drivers\, stronger analytical skills\, and strategies to mitigate bias.Learning Objectives Demonstrate teamwork and communication under time constraints\; Identify biases when making decisions under financial pressure\; Assess technical\, financial\, and reputational risks in complex business situations.Chair Valerie Huh\, PHARMD\, MBASpeaker Decision under uncertaintyDave Bezick\, RN
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c0913093efdd3edfd7d7a757eedee1ea
URL:http://dia2026globalannualmeeting.sched.com/event/c0913093efdd3edfd7d7a757eedee1ea
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#610: From Dysfunctions to Dynamics: Mapping Hidden Assumptions to Strengthen Trust\, Debate\, and Accountability
DESCRIPTION:Component Type: WorkshopLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-604-L04-P\; CME 1.25\; PDU 1.25 PMI 2166GIDLXI\; RN 1.25Link common team dysfunction signals with a practical mapping method to uncover hidden beliefs and routines. Learn small\, safe-to-learn experiments and simple indicators to build trust\, enable healthy debate\, and strengthen accountability.Learning Objectives Diagnose how common dysfunction signals relate to hidden beliefs and protective routines in team culture\; Apply a step-by-step\, unbranded mapping method to translate dynamics like low trust or weak accountability into testable insights\; Design small\, safe-to-learn experiments with lightweight indicators to build trust\, productive debate\, commitment\, and accountability.Chair John Z. Sun\, PHD\, MBA\, PMPSpeaker PanelistJeremy Jokinen\, MSPanelistSarah TremethickPanelistJohn Dobbins\, MSPanelistJessie Li
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e3aea60d9da4f3e3c745e90f83abac20
URL:http://dia2026globalannualmeeting.sched.com/event/e3aea60d9da4f3e3c745e90f83abac20
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#608: Can You Complete Your Submission in 10 Weeks?
DESCRIPTION:Component Type: WorkshopLevel: AdvancedCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-605-L04-P\; CME 1.25\; PDU 1.25 PMI 2166B0UIY1 \; RN 1.25Drug development teams are being expected to deliver marketing applications in record time\, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.Learning Objectives Recognize key factors that must be identified proactively to ensure creation of a submission timeline that is both expedited and feasible\; Diagnose the critical path and rate-limiting components in the plan\, and learn ways of mitigating the risks of those components\; Demonstrate the ability to adjust to changes and embrace scenario-planning when faced with uncertainty.Chair Steve Sibley\, MSSpeaker Can You Complete Your Submission in 10 weeks!Sharon Wolfe-Schwartz\, MS
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,04: MEDAFFAIRS-SCICOMM
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:1ebf263e2bb8850d45a162ca22cbd223
URL:http://dia2026globalannualmeeting.sched.com/event/1ebf263e2bb8850d45a162ca22cbd223
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P\; CME 1.25\; RN 1.25This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1)\, highlighting their combined impact on product control strategies. Learning Objectives Recognize how ICH guideline revisions influence analytical development in the future\; Discuss the health authority view on impact that analytical measurements have on the development of the future products\; Explain how to apply platform analytical procedures as a follow-up to Workshop 1.Chair Timothy Graul\, PHDSpeaker Shifting Analytical Procedure Development from a Reactive Activity into a Proactive\, Strategic Pillar of Product DevelopmentMargaret Ruesch\, PHDShifting Analytical Procedure Development from a Reactive Activity into a Proactive\, Strategic Pillar of Product DevelopmentPhilip Floyd\, PHDEMA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control StrategiesPeter RichardsonANVISA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control StrategiesCarolina Lopes Krahn\, MSC
CATEGORIES:07: REGCMC-PRODUCT QUALITY
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:348330dc8d7baa47dc5ad3ea5047f084
URL:http://dia2026globalannualmeeting.sched.com/event/348330dc8d7baa47dc5ad3ea5047f084
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#614: Indonesia Town Hall 2026
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-656-L04-P\; CME 1.25\; RN 1.25Indonesia is advancing coordinated reforms across governance\, regulation\, and site readiness to achieve a four-months clinical trial start-up. This session highlights regulatory alignment\, WHO recognition\, ethics harmonization\, and CRU transformation positioning Indonesia as a credible global research partner.Learning Objectives Describe Indonesia’s coordinated regulatory and governance reforms to accelerate clinical trial start-up\; Explain the impact of WHO-Listed Authority recognition and ethics harmonization on global collaboration\; Identify operational improvements at CRU level supporting trial readiness and execution.Chair Endang Wahjuningtyas HoyarandaSpeaker PanelistBudi Gunadi SadikinPanelistTaruna Ikrar\, MDINA-CRC: Harmonizing Indonesia's Clinical Research and Our Recent AchievementsIndri Rooslamiati SupriadiPanelistNina Dwi Putri
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d4f3be74c642f55f7ab88ff5f7394a3f
URL:http://dia2026globalannualmeeting.sched.com/event/d4f3be74c642f55f7ab88ff5f7394a3f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.25 Application UAN: 0286-0000-26-607-L04-P\; CME 1.25\; RN 1.25The FDA Commissioner's National Priority Voucher (CNPV) program represents a novel regulatory mechanism designed to accelerate the development and review of drugs addressing critical public health priorities. This session provides a comprehensive analysisLearning Objectives Discuss the fundamental framework and eligibility criteria of the CNPV program\; Analyze real implementation challenges and successful strategies\; Evaluate the program's impact on expediting critical drug development and public health priorities.Chair Lina AlJuburi\, PHARMD\, MSCSpeaker PanelistEmel Mashaki CeyhanPanelistLawrence Eugene Liberti\, RACPanelistKellie Taylor
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:204AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e0d6c1ceea3c7c0613d04762395c2b85
URL:http://dia2026globalannualmeeting.sched.com/event/e0d6c1ceea3c7c0613d04762395c2b85
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P\; CME 1.25\; RN 1.25Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous\, operationally feasible\, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations\; Apply selective safety data collection under ICH E19\; Incorporate decentralized elements consistent with FDA guidance\; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined\, embedded alternative. Through moderated discussion\, we will identify critical-to-quality factors\, risk mitigation strategies\, and the regulatory conversations necessary to support global implementation.Learning Objectives Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas\; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials\; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies\; Debate the tradeoffs between traditional and streamlined trial designs.Chair Kevin Bugin\, MS\, RACSpeaker PanelistMary Thanh Hai\, MDPanelistHenry Wei\, MDPanelistZhanna Jumadilova\, MD\, MBA
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:102AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:19f6092bdd13cb90db775a04e6ca74c3
URL:http://dia2026globalannualmeeting.sched.com/event/19f6092bdd13cb90db775a04e6ca74c3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#613: FDA Rare Disease Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-609-L04-P\; CME 1.25\; RN 1.25Senior FDA leaders will discuss evolving regulatory trends in rare disease development\, including accelerated approval\, innovative trial designs\, patient engagement\, and real-world evidence\, followed by open Q&A with attendees.Learning Objectives Identify current FDA regulatory trends and scientific approaches shaping rare disease drug development\; Apply FDA expectations around accelerated approval\, surrogate endpoints\, and innovative trial designs\; Integrate patient voice and real-world evidence into development strategies to support benefit-risk assessment.Chair James Valentine\, JD\, MHS
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:973442f00151c260d95614b1732aed3d
URL:http://dia2026globalannualmeeting.sched.com/event/973442f00151c260d95614b1732aed3d
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T141500Z
DTEND:20260617T153000Z
SUMMARY:#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P\; CME 1.25\; RN 1.25Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU\, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials. Learning Objectives Explain DCT regulations in Japan\, the US\, and Europe and how to overcome their differences.Chair Junko Sato\, PHDSpeaker DCT in JapanRuri Matsumoto\, RPHExperiences and expactation to DCTRasmus Enggaard\, MPHARM\, MSC
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6eac3335fa34c336c46dec434370389b
URL:http://dia2026globalannualmeeting.sched.com/event/6eac3335fa34c336c46dec434370389b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T153000Z
DTEND:20260617T173000Z
SUMMARY:#617 POS: Professional Poster Session III
DESCRIPTION:Component Type: SessionProfessional and Student Posters provide an opportunity for methodology (“how to”)\, case study\, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery\, development\, and lifecycle management of pharmaceuticals\, biotechnology\, medical devices\, and healthcare-related products.
CATEGORIES:14: POSTERS
LOCATION:Exchange\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:5f3334269b83a6a7ca6e2396f2710f72
URL:http://dia2026globalannualmeeting.sched.com/event/5f3334269b83a6a7ca6e2396f2710f72
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T154000Z
DTEND:20260617T161000Z
SUMMARY:#618 CH: Regulatory Excellence as an Enabler for Sustainable Manufacturing in Africa
DESCRIPTION:Component Type: WorkshopLevel: IntermediateThis session will explore how regulatory system strengthening and harmonization can act as a catalyst for regional pharmaceutical manufacturing in Africa\, ensuring access to quality-assured medicines and building a resilient health ecosystem.Learning Objectives 1. Discuss the role of regional regulatory harmonization initiatives in reducing duplication\, and improving patient access 2. Examine how collaboration between manufacturers and regulators can streamline product development\, improve compliance\, and reduce time-to-market for essential medicines 3. Share lessons learned to inform future efforts and actions to support supply chain resilience
CATEGORIES:12: CONTENT-HUBS
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8a2307937ee3f7ae249a410fb0e5e89b
URL:http://dia2026globalannualmeeting.sched.com/event/8a2307937ee3f7ae249a410fb0e5e89b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T162000Z
DTEND:20260617T165000Z
SUMMARY:#619 CH: The End of the Static Protocol: How Digital Blueprints Will Orchestrate the Next Generation of Clinical Trials
DESCRIPTION:Component Type: WorkshopLevel: IntermediateWhat if protocols weren’t documents - but executable trial blueprints? Learn how protocol digitization into structured USDM content\, combined with clinical operational data\, enables orchestration across systems to streamline and improve trials. Learning Objectives Identify how digital protocols and structured USDM models improve clinical operations and accelerate trial timelines through ecosystem orchestration. Evaluate how site operational data generates insights that streamline execution and improve protocol design. Learn how industry peers are approaching protocol digitization\, including key challenges and lessons learned.
CATEGORIES:12: CONTENT-HUBS
LOCATION:Content Hub\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:8aaf82c3ee50b0e4753c3f4dbfaf91fd
URL:http://dia2026globalannualmeeting.sched.com/event/8aaf82c3ee50b0e4753c3f4dbfaf91fd
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T163000Z
DTEND:20260617T173000Z
SUMMARY:#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks?
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Medical Writing Community for a follow up round table discussion tied to session: Can You Complete Your Submission in 10 weeks? (Wednesday\, June 17 | 12:30pm - 1:30pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Steve Sibley\, MSSharon Wolfe-Schwartz\, MS
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f4f4ade9deb6500eb947ffc00d9fc48f
URL:http://dia2026globalannualmeeting.sched.com/event/f4f4ade9deb6500eb947ffc00d9fc48f
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T163000Z
DTEND:20260617T173000Z
SUMMARY:#621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Cooperation with the African Medicines Agency Wednesday\, June 17 | 12:30pm -1:30pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Chaitanya Koduri\, DDS\, MHS
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:Zone A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c46126bbde081ab7e99ba588d978f6da
URL:http://dia2026globalannualmeeting.sched.com/event/c46126bbde081ab7e99ba588d978f6da
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-612-L04-P\; CME 1.00\; RN 1.00This forum will explore how pharmacovigilance strengthens vaccine confidence and reduces hesitancy through safety monitoring\, transparent communication\, and healthcare professional training\, with lessons from Brazil and international perspectives.Learning Objectives Describe how pharmacovigilance can strengthen vaccine confidence and address hesitancy\; Identify strategies to empower healthcare professionals to improve safety data reporting\; Discuss global and national approaches to transparent risk–benefit communication in immunization.Chair Mayra Martho Moura Oliveira\, BSNSpeaker Pharmacovigilance as a Trust-Building Tool: From Surveillance to ConfidencePatrícia Mouta Nunes Oliveira\, MDThe role of healthcare professionals: how training and information dissemination transform trust in vaccines.Vera Lúcia Gattás\, PHD
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7913a1e1769e5224857039df2657b44b
URL:http://dia2026globalannualmeeting.sched.com/event/7913a1e1769e5224857039df2657b44b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P\; CME 1.00\; RN 1.00This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends\, benchmarking protocol data collection practices\, and offering new\, practical strategies to simplify protocol designs and reduce participant and site burden.Learning Objectives Analyze new benchmarks on the distribution of protocol data across core\, standard\, and non-core endpoints\; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden\; Discuss strategies to evaluate protocol data collection\, simplify design and lower participation burden.Chair Kenneth Getz\, MBASpeaker New Benchmarks on Clinical Trial Data Collection Practices and their ImpactKenneth Getz\, MBAFrameworks and Tools Guiding Optimization of Protocol Data CollectionJackie Cole\, MS
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,03: DATA-TECH-AI\,04: MEDAFFAIRS-SCICOMM
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:987dc293989865f645a79857ba7e0752
URL:http://dia2026globalannualmeeting.sched.com/event/987dc293989865f645a79857ba7e0752
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P\; CME 1.00\; RN 1.00Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges. Learning Objectives Explain how trial emulation using real-world data can be used to enhance design of future clinical trials\; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice\; Discuss the challenges of emulating trial endpoints\, eligibility criteria\, and other design elements. Chair Leo Russo\, MSSpeaker PanelistJingchuan Serena Guo\, MD\, PHDPanelistDonna Rivera\, PHARMD\, MSC\, FISPE
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,10: STATS-EVIDENCEGENERATION-RWE
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:a4e728be6e8c207f88e87c29e46c0307
URL:http://dia2026globalannualmeeting.sched.com/event/a4e728be6e8c207f88e87c29e46c0307
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#625: Building AI Governance Frameworks: Classification\, Validation and Regulatory Alignment in Life Sciences
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-618-L04-P\; CME 1.00\; RN 1.00This session presents AI consortium working group assessments on regulatory frameworks\, use case classification\, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.Learning Objectives Apply standardized AI use case classification frameworks to drug development and research-related scenarios\; Recognize risk-based\, practical assessment\, governance and validation approaches for AI systems across regulatory contexts and use cases\; Demonstrate utilizing aligned terminology for cross-jurisdictional AI discussions.Chair Sridevi Nagarajan\, PHDSpeaker PanelistCarrie Nielson\, MPHPanelistMichael Lingzhi Li\, PHDPanelistJoaquim Berenguer Jornet\, MSPanelistVenkatraman Balasubramanian\, MBAPanelistLeon Rozenblit\, JD\, PHDPanelistChristina Mack\, MPH
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:ef88ababf8f9fe172bab20460052cbab
URL:http://dia2026globalannualmeeting.sched.com/event/ef88ababf8f9fe172bab20460052cbab
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-616-L04-P\; CME 1.00\; RN 1.00Comprehensive benchmarking of four major LLMs across 100 FDA approval packages identifies optimal models for regulatory tasks. Study provides critical insights on accuracy\, limitations\, and implementation strategies for regulatory AI adoption.Learning Objectives Identify which LLM models demonstrated highest accuracy of generative AI for extracting critical regulatory data from FDA approval packages\; Recognize key limitations and failure modes when using LLMs for regulatory intelligence\, including hallucination rates and performance degradation patterns\; Apply evidence-based benchmarking to select an LLMChair Sam Kay\, RACSpeaker Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?Cameron Kieffer\, PHDNavigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?Jeff MacDonald\, PHARMDNavigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?Aleksandr Merenkov
CATEGORIES:03: DATA-TECH-AI
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7cada9ab9637f44b00bed8efd93b4f85
URL:http://dia2026globalannualmeeting.sched.com/event/7cada9ab9637f44b00bed8efd93b4f85
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use
DESCRIPTION:Component Type: ForumLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P\; CME 1.00\; RN 1.00We’ll review the history\, laws\, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of paLearning Objectives Describe the history of data sharing and the laws and policies that have informed it\; Discuss the ethical considerations for shifting our mindset about data access permissions\; Apply a patient-directed mindset to data access to unlock innovation and improve data utilityChair Karla Childers\, MSSpeaker PanelistMary Gray\, PHDPanelistAaron LeibtagPanelistSarah Chamberlin
CATEGORIES:03: DATA-TECH-AI\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:3cc59ee58b88049d77b2b1f312e695a3
URL:http://dia2026globalannualmeeting.sched.com/event/3cc59ee58b88049d77b2b1f312e695a3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#628: Beyond the Keyboard: Elevating Regulatory Writing with a Business Mindset
DESCRIPTION:Component Type: SessionLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-619-L04-P\; CME 1.00\; RN 1.00This session provides a framework and tools to adopt a business mindset\, helping regulatory writing leaders and teams shift from document/submission execution to strategic influence. Learning Objectives Discuss building a business mindset\; Identify practical methods to incorporate business thinking into day-to-day decision-making\; Recognize how to apply frameworks to evaluate team influence and cross-functional collaboration. Chair Robin WhitsellSpeaker PanelistTatyana Wanderer\, PHDPanelistAngela Russell Winnier\, PHD
CATEGORIES:04: MEDAFFAIRS-SCICOMM
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f153faf456684d140e100b492735b9ed
URL:http://dia2026globalannualmeeting.sched.com/event/f153faf456684d140e100b492735b9ed
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P\; CME 1.00\; RN 1.00Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks. Learning Objectives Evaluate current global regulatory frameworks for E&L assessment in complex generic products\; Analyze risk-based approaches for leachable impurity control across different jurisdictions\; Synthesize harmonization opportunities to streamline product development and regulatory submissions.Chair Allison RadwickSpeaker PanelistChaitanya Koduri\, DDS\, MHSPanelistKarthik Balasubramanian\, PHD\, MSPanelistJames Wabby\, MHSPanelistJi Guo\, PHD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6f7e1018f8cbeb63f4699e43467302a8
URL:http://dia2026globalannualmeeting.sched.com/event/6f7e1018f8cbeb63f4699e43467302a8
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies
DESCRIPTION:Component Type: SessionLevel: IntermediateThis candid panel looks inside notable biotech breakthroughs to explore what “success” really takes beyond the headlines. Through case studies from leading venture groups and founders\, speakers will unpack key decisions\, near misses\, pivots\, and partnership strategies\, translating them into practical lessons for emerging companies and their partners.Learning Objectives Describe the strategic and operational decisions that shape successful biotech trajectories from idea to inflection point\; Analyze real-world case studies to identify patterns in pivots\, near misses\, financing\, and partnership strategies\; Translate investor and founder perspectives into practical lessons for emerging companies and their partners.Chair Robert TepperSpeaker PanelistAbbie Celniker\, PHDPanelistGabriela Apiou\, PHD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:5658271ec7c22960e60567c6319737c5
URL:http://dia2026globalannualmeeting.sched.com/event/5658271ec7c22960e60567c6319737c5
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-621-L04-P\; CME 1.00\; PDU 1.00 PMI 21663K6JS3\; RN 1.00This workshop helps break through habitual thinking and guide teams toward inventive\, high-impact strategies. Participants will engage in activities to encourage team engagement\, uncover hidden constraints\, and practice leading with confidence.Learning Objectives Analyze psychological and organizational factors that inhibit idea generation\; Explain how to adopt techniques for leading scenario exploration.Chair Larissa Wilsie\, MBA\, MS\, PMPSpeaker Workshop Exercise 2Nathan Kreischer\, MS\, PMPWorkshop Exercise 1Amanda Adamek\, MBA\, PMP
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:3cb9647a049d1a8f724a0d9e3fb3eeb5
URL:http://dia2026globalannualmeeting.sched.com/event/3cb9647a049d1a8f724a0d9e3fb3eeb5
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#632: Program Manager: Jack of All Trades\, Master of None?
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-622-L04-P\; CME 1.00\; PDU 1.00 PMI 21668R8O1J \; RN 1.00The program manager role can be found within many functional areas\, including discovery research\, manufacturing\, regulatory\, and\, the ultimate jack of all trades\, the global program manager. Learning Objectives Recognize the diversity of PM role with respect to technical expertise and background required\; Describe the importance of explicit roles and responsibilities and recognize the importance of not leaving anything unspoken or assume anything.Chair Rosa Tarng\, MASpeaker PanelistSimina Grigoriu\, PHD
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:e8ca5da4de1a0560bd010f38313e2e11
URL:http://dia2026globalannualmeeting.sched.com/event/e8ca5da4de1a0560bd010f38313e2e11
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-672-L04-P\; CME 1.00\; RN 1.00EU’s Reflection Paper introduces a tailored clinical approach for biosimilars\, driving an optimised and efficient development programme by reducing unnecessary studies\, as regulators and industry discuss opportunities for patient access and global harmonization.Learning Objectives Describe the scientific basis and regulatory rationale behind the EU’s tailored clinical approach for biosimilar development\; Discuss how enhanced analytical similarity assessments can support leaner clinical development programs\; Explain circumstances under which comparative clinical efficacy studies may be reduced or waived.Chair Peter RichardsonSpeaker PanelistSteffen Thirstrup\, MD\, PHD
CATEGORIES:07: REGCMC-PRODUCT QUALITY\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:f6b24e04256154faf73ca73fa2d075aa
URL:http://dia2026globalannualmeeting.sched.com/event/f6b24e04256154faf73ca73fa2d075aa
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#635: MHRA Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-626-L04-P\; CME 1.00\; RN 1.00In this session\, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.Learning Objectives Describe MHRA’s regulatory initiatives and strategic priorities\; Identify opportunities for engagement with MHRA regulators.Chair Lawrence TallonSpeaker PanelistAlison CavePanelistJulian Beach\, MBA
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:119AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:23db832cdb9454d46bdda4597ae04f63
URL:http://dia2026globalannualmeeting.sched.com/event/23db832cdb9454d46bdda4597ae04f63
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#636: The Next Frontier: Autoimmune Cell and Gene Therapy\, Regulation\, and Patient Access
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-625-L04-P\; CME 1.00\; RN 1.00This panel will explore how patient advocacy can shape regulatory strategy\, trial design\, and access planning for autoimmune cell and gene therapies as they move toward future approvals.Learning Objectives Identify how patient advocacy can shape regulatory strategy and access for future autoimmune CGTs\; Describe approaches to incorporating patient priorities such as quality of life and treatment burden into trial design\; Discuss strategies to ensure equitable and sustainable patient access.Chair Samantha Roberts\, PHDSpeaker Perspectives from the Myositis CommunityPaula Eichenbrenner\, MBAPatient PerspectiveJoy Buie\, BSN\, PHD\, MS\, RNPatient advocacy perspectiveBrian KennedyFDA perspectiveVijay Kumar
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:fca7f64a95dfe9703fadf1048c3a91b2
URL:http://dia2026globalannualmeeting.sched.com/event/fca7f64a95dfe9703fadf1048c3a91b2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P\; CME 1.00\; RN 1.00Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs\, Medical Affairs\, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.Learning Objectives Examine the dynamic collaboration between Regulatory Affairs\, Medical Affairs\, and Market Access to effectively address current regulatory and payor requirements\; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.Chair Alison Maloney\, MBA\, MSSpeaker An Academic PerspectiveSean D. Sullivan\, PHDA Medical PerspectiveEmma LeeA Regulatory PerspectiveTodd Paporello\, PHARMD\, MBA
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,04: MEDAFFAIRS-SCICOMM
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:241d34295bfbacbf4fb8149fa764b417
URL:http://dia2026globalannualmeeting.sched.com/event/241d34295bfbacbf4fb8149fa764b417
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#637: Destigmatizing 483 Observations
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P\; CME 1.00\; RN 1.00Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.Learning Objectives Discuss the impact of 483 observations on Risk-Based Quality Management (RBQM) strategies\; Describe how perceptions about the criticality of 483 observations are influencing clinical monitoring strategy decisions\; Identify opportunities to mitigate anxiety related to 483 observations and to support cohesion between sponsors\, CROs\, and regulatory agencies to enable future adoption of centralized monitoring strategies.Chair Erin Brown\, MPHSpeaker PanelistCris McDavid\, MSPanelistNicole StansburyPanelistDavid C. Burrow\, JD\, PHARMDPanelistTracy Vanderslice
CATEGORIES:09: RD-QUALITY-COMPLIANCE
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:bb2b133a43daf5526940658de7a981b3
URL:http://dia2026globalannualmeeting.sched.com/event/bb2b133a43daf5526940658de7a981b3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T174500Z
DTEND:20260617T184500Z
SUMMARY:#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P\; CME 1.00\; RN 1.00Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development\, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed. Learning Objectives Discuss the use of RWE to support regulatory decisions\; Identify use cases based on regulatory assessment\, stage of lifecycle and therapeutic area\; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies. Chair Denise Umuhire\, MBA\, MSCSpeaker PanelistPatricia Furlong\, BSNPanelistRohini Hernandez\, PHD\, MPHPanelistMotiur Rahman\, PHD\, MPHARM\, MS
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7d41fe56232cc88d28f6c86260521fed
URL:http://dia2026globalannualmeeting.sched.com/event/7d41fe56232cc88d28f6c86260521fed
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T190000Z
DTEND:20260617T194500Z
SUMMARY:#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the Clinical Safety and Pharmacovigilance Community for a follow up round table discussion tied to session: Insights Regarding Implementation of the ASAP Process (Wednesday\, June 17 | 2:45pm - 3:45pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Greg Ball\, PHD
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:TBD\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d195261e72757e45199da2e622f6693a
URL:http://dia2026globalannualmeeting.sched.com/event/d195261e72757e45199da2e622f6693a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T190000Z
DTEND:20260617T194500Z
SUMMARY:Roundtable Discussion: Building AI Governance Frameworks: Classification\, Validation and Regulatory Alignment in Life Sciences
DESCRIPTION:Component Type: SessionLevel: IntermediateJoin the AI in Healthcare Community for a follow up round table discussion tied to session: Building AI Governance Frameworks: Classification\, Validation and Regulatory Alignment in Life Sciences (Wednesday\, June 17 | 2:45pm - 3:45pm EDT). Space is limited.Learning Objectives Identify ways to apply concepts and techniques from the session.Chair Sridevi Nagarajan\, PHDSpeaker SpeakerStephanie Rosner\, MA\, PMP
CATEGORIES:13: COMMUNITY-ROUNDS
LOCATION:TBD\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7f6d8925859e73c48c61e8c333c9f000
URL:http://dia2026globalannualmeeting.sched.com/event/7f6d8925859e73c48c61e8c333c9f000
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P\; CME 1.00\; RN 1.00This session will share insights into signal detection approaches across different product types\, exploring how regulators\, industry\, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.Learning Objectives Describe challenges in performing signal detection activities across a range of healthcare product types\, including devices\, combination products\, and advanced therapies\; Discuss novel approaches and data sources to enhance signal detection\; and identify opportunities to incorporate emerging signal detection approaches into your organization's vigilance activities.Chair Monica Munoz\, PHARMD\, PHDSpeaker PanelistJudith Maro\, MSPanelistJeffery L Painter\, JR\, JD\, MSC
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:71a230513a9aa7b47d07628e4a24143e
URL:http://dia2026globalannualmeeting.sched.com/event/71a230513a9aa7b47d07628e4a24143e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#645: Clinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas
DESCRIPTION:Component Type: SessionCE: ACPE 1.00 Application UAN: 0286-0000-26-631-L04-P\; CME 1.00\; RN 1.00Speaker PanelistLani HashimotoPanelistLoriana Hernandez-AldamaClinical Trial Experience Surveys: Sponsor Wide Implementation Across Countries and Therapy Areas Robina WeermeijerPanelistMitch Herndon\, MPH
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION
LOCATION:108B\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:594c7d6e0da38114950c17a9f19fd607
URL:http://dia2026globalannualmeeting.sched.com/event/594c7d6e0da38114950c17a9f19fd607
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#644: 50\,000 Participants\, Two Countries\, One DCT: Oversight That Worked
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P\; CME 1.00\; RN 1.0050\,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.Learning Objectives Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs\; Analyze how operational practices reflected RBQM and QbD principles without labels\; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.Chair Leslie SamSpeaker PanelistLisa Collins
CATEGORIES:02: CLINICALTRIALOPS-INNOVATION\,09: RD-QUALITY-COMPLIANCE
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c740c8cf77420e63a5722104d615ed6e
URL:http://dia2026globalannualmeeting.sched.com/event/c740c8cf77420e63a5722104d615ed6e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-633-L04-P\; CME 1.00\; RN 1.00Siloed data stifles advancements in AI-powered drug discovery. Federated computing (FC) provides a secure\, privacy-preserving\, decentralized approach that enables AI-model sharing\, fine-tuning and inference - moving AI demos to real-world applications.Learning Objectives Define Federated Computing and its related components\; Examine traditional data centralization methods with decentralized federated approaches\; Identify use cases for Federated AI in drug discovery and development.Chair Ittai Dayan\, MD\, MPHSpeaker Accelerating AI-Enabled Drug Discovery and Development with Federated ComputingJonathan GilbertAccelerating AI-Enabled Drug Discovery and Development with Federated ComputingNadia HarhenAccelerating AI-Enabled Drug Discovery and Development with Federated ComputingKyle Tretina
CATEGORIES:03: DATA-TECH-AI
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c23e67361dd4209f3de7aa73ebe81edf
URL:http://dia2026globalannualmeeting.sched.com/event/c23e67361dd4209f3de7aa73ebe81edf
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#647: Not Can\, but Should: How do we WANT AI/ML to Transform Clinical Development?
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P\; CME 1.00\; RN 1.00Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas\, consider market implications\, and reflect on their roles in getting us there. Learning Objectives Evaluate three “big goals" for AI transformation of clinical development (eg\, 10xing drugs reaching the market\, eliminating human trial participants)\; Discuss the infrastructure implications of each goal (eg.\, with more drug candidates advancing\, how will the system need to adapt?)\; Identify necessary\, accompanying regulatory changes (eg\, how will we meet increased demand for reviews?)Chair Morgan Hanger\, MPASpeaker PanelistTala Fakhouri\, PHD\, MPHPanelistHenry Wei\, MDPanelistGabriel Westman\, MD\, PHD\, MSC
CATEGORIES:03: DATA-TECH-AI\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:5ba3f02904db90b19881abcf0568e9f9
URL:http://dia2026globalannualmeeting.sched.com/event/5ba3f02904db90b19881abcf0568e9f9
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-634-L04-P\; CME 1.00\; RN 1.00Discover how Medical Affairs drives strategic value across the drug lifecycle through scientific leadership\, data-driven insights\, and digital fluency to improve patient outcomes.Learning Objectives Discuss Medical Affairs’ evolving role in driving scientific credibility and impact\; Describe how digital fluency\, data analytics\, and AI transform it into a tech-enabled function\; Identify best practices and leadership insights for advancing capabilities in a patient-centric\, data-driven ecosystem.Chair Ranjini Prithviraj\, PMPSpeaker PanelistDonna A. Holder\, PHARMDPanelistAlexander CondoleonPanelistSarah Jarvis\, MBA
CATEGORIES:04: MEDAFFAIRS-SCICOMM
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b5a74ebc7b5bad755f9b4f1f71b20682
URL:http://dia2026globalannualmeeting.sched.com/event/b5a74ebc7b5bad755f9b4f1f71b20682
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#649: Who Owns Long-Term Follow-Up? Addressing Stakeholder Gaps in Gene Therapy Evidence Generation
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-635-L04-P\; CME 1.00\; RN 1.00Multi-stakeholder research reveals why long-term follow-up fails in gene therapy despite new FDA requirements. Speakers across patient advocacy\, clinical research\, and medical ethics examine the social conception of long-term follow-up\, its challenges\, and practical solutions for sustainable participation and evidence generation.Learning Objectives Identify scientific\, operational and regulatory factors driving the growing significance of long-term follow-up (LTFU) in gene therapy\; Compare stakeholder challenges and solutions in sustaining LTFU participation and data quality for gene therapy programs\; Evaluate strategies to strengthen accountability and align incentives to ensure sustained LTFU participation.Chair Alen Agaronov\, DRSCSpeaker PanelistPatricia Furlong\, BSNPanelistDennis AkkayaPanelistCarolyn Riley Chapman\, PHD
CATEGORIES:05: PERSONALIZEDMED-COMBOPROD-DIAGNOSTICS
LOCATION:119AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:598e2d2020ef857e5258803bc9e21959
URL:http://dia2026globalannualmeeting.sched.com/event/598e2d2020ef857e5258803bc9e21959
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#650: Leading for Growth: Unlocking Individual Potential in Your Team
DESCRIPTION:Component Type: WorkshopLevel: BasicCE: ACPE 1.00 Application UAN: 0286-0000-26-657-L04-P\; CME 1.00\; PDU 1.00 PMI 2166FWL0S0\; RN 1.00This workshop equips leaders at all levels with adaptable\, evidence-based tools to meet diverse team needs\, boost motivation and performance\, and strengthen retention through interactive discussions and hands-on activities.Learning Objectives Identify and adapt leadership practices to different employee needs\, backgrounds\, and motivations\; Discuss personalized growth opportunities that align with organizational goals\; Demonstrate coaching and feedback skills that empower employees to own their growth journey.Chair Jennifer Kim\, PHDSpeaker Removing siloes and increasing information transparency in interdependent teamsTamei Elliott\, MSWhich inclusive leadership behavior matters the most for improving employee outcomes? Elizabeth Lange\, MPH\, MS
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:202AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:babbdc44b3a1a9db9d30b241c56baac3
URL:http://dia2026globalannualmeeting.sched.com/event/babbdc44b3a1a9db9d30b241c56baac3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#651: Regulatory CMC and Product Quality Hot Topics Discussion
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P\; CME 1.00\; RN 1.00This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality. Learning Objectives Discuss current regulatory CMC challenges\, including the use of AI\, digitization\, and emerging technologies in pharmaceutical quality systems\; Examine how to analyze strategies for managing global regulatory complexity\, supply chain resiliency\, and international harmonization. Chair Celeste Frankenfeld LammSpeaker PanelistPeter RichardsonPanelistMahesh R. Ramanadham\, PHARMD\, MBAPanelistKevin Fitzpatrick\, RPHPanelistYoshihiro Matsuda\, DrMed
CATEGORIES:07: REGCMC-PRODUCT QUALITY\,03: DATA-TECH-AI
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:90ea3ddd795927ce2c6a55df50b9646d
URL:http://dia2026globalannualmeeting.sched.com/event/90ea3ddd795927ce2c6a55df50b9646d
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#652: Anvisa Townhall - From Backlogs to Breakthroughs: Building a Smarter Regulatory Future
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-666-L04-P\; CME 1.00\; RN 1.00This town hall will present Anvisa’s strategy to reduce backlogs\, modernize regulatory processes\, and integrate innovation and AI into decision-making. The session will explore how Brazil is building a more agile\, risk-based\, and globally connected regulatory system.Learning Objectives Describe Brazilian Health Regulatory Agency (Anvisa)’s strategy to reduce regulatory backlogs and modernize processes\; Discuss how innovation\, digital tools\, and AI are being integrated into regulatory decision-making\; Identify how Brazil is advancing a more agile\, risk-based\, and globally connected regulatory system.Chair Diogo Penha SoaresSpeaker PanelistAna Carolina Moreira Marino AraujoPanelistMaira Ribeiro de Souza\, DRSC\, PHARMDPanelistAdriane Alves de Oliveira\, MSCPanelistDaniel R. Coradi de Freitas\, DRSC
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:69937fd1c359200fc0abaf6acb796be3
URL:http://dia2026globalannualmeeting.sched.com/event/69937fd1c359200fc0abaf6acb796be3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-640-L04-P\; CME 1.00\; RN 1.00This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA\, EMA\, NORD\, Global Genes and they will discuss how get medicines to patients faster. Learning Objectives Describe the evolving US and EU regulatory policy landscape\; Examine how to advance global harmonization efforts for rare disease drug development\; Discuss the opportunities and challenges on how to get rare disease medicines to patients faster.Chair Emel Mashaki CeyhanSpeaker PanelistCorinne de Vries\, PHD\, MA\, MSCPanelistSteffen Thirstrup\, MD\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:201AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6ce82db0c8aaa2e7d40602948f75b2ee
URL:http://dia2026globalannualmeeting.sched.com/event/6ce82db0c8aaa2e7d40602948f75b2ee
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#656: Singapore Town Hall
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-668-L04-P\; CME 1.00\; RN 1.00The Singapore Town Hall will show case how Singapore's world-class regulatory environment creates compelling business value\, showcasing innovative pathways\, digital transformation initiatives\, and strategic advantages that make Health Sciences Authority (HSA) registration essential for Asia-Pacific success.Learning Objectives Evaluate HSA's innovative regulatory frameworks and fast-track pathways that accelerate time-to-market for pharmaceutical products\, clinical trials to adoption\; Identify strategic advantages of Singapore registration for companies seeking Asia-Pacific market expansion and regional manufacturing hubs\; Discuss how to apply HSA's regulatory processes and collaborative approaches to optimize product development and approval strategies.Chair Raymond S.B. Chua\, MD\, MBA\, MPH\, FRCPSpeaker PanelistWan Yee Goh
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:112AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:a8b7fc0f26ddd31ccc5a0c612ddf773a
URL:http://dia2026globalannualmeeting.sched.com/event/a8b7fc0f26ddd31ccc5a0c612ddf773a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle
DESCRIPTION:Component Type: ForumLevel: BasicCE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P\; CME 1.00\; RN 1.00Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum\, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.Learning Objectives Demonstrate the need for a continuous approach to benefit-risk planning\; Recognize the risks of failing to conduct benefit-risk planning\; Identify ways to introduce benefit-risk planning into drug development Chair Claudia Ana Ianos\, MDSpeaker Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product LifecycleRobyn Bent\, BSN\, MS\, RNBenefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product LifecycleDiana Morgenstern\, MD\, FACPBenefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product LifecycleMegan Aragon\, MBABenefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product LifecycleBennett Levitan\, MD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,01: CLINSAFETY-PV-RM
LOCATION:115AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:c07166dbfdc7fc6ca5dc079073c78a1b
URL:http://dia2026globalannualmeeting.sched.com/event/c07166dbfdc7fc6ca5dc079073c78a1b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P\; CME 1.00\; RN 1.00India’s recent regulatory\, policy\, and digital reforms are accelerating innovation\, quality\, and global collaboration. This town hall will highlight key updates shaping clinical research\, medtech growth\, and patient safety\, and India’s rising global role.Learning Objectives Identify key regulatory\, policy\, and digital reforms transforming India’s healthcare and innovation ecosystem\; Evaluate how updates in clinical trial rules\, medical device policy\, GMP standards\, and data privacy impact global development\; Identify opportunities for global collaboration and regulatory convergence enabled by India’s evolving frameworks.Chair Vivek Ahuja\, MDSpeaker PanelistMarc FranklinPanelistShahin FesharakiPanelistRajeev Singh Raghuvanshi
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,02: CLINICALTRIALOPS-INNOVATION\,07: REGCMC-PRODUCT QUALITY
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:7d4059142f3a85776e8585aba95ac5f1
URL:http://dia2026globalannualmeeting.sched.com/event/7d4059142f3a85776e8585aba95ac5f1
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P\; CME 1.00\; RN 1.00This session explores AI's role in pharma\, offers regulators' insights and Q&A\, introduces a Gen AI validation framework\, and showcases use cases in audit report authoring and process/knowledge management chatbot\, highlighting ethical\, time/cost efficient\, and compliant AI adoption.Learning Objectives Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry\, focusing on practical applications such as structured authoring of audit reports\, Generative AI validation frameworks\, and AI-powered chatbots for knowledge management\; Discuss the challenges\, user experiences\, cost efficiency\, and compliance considerations involved in integrating AI into regulated environments.Chair Oliver Fink\, MSSpeaker Framework for computer system validation of Gen AIHaleh Valian\, PHDRegulators expecatations and insights into Gen AIKaren Bleich\, MD Gen AI-powered structured authoring for audit reportsSrilatha Endabetla\, MS
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,03: DATA-TECH-AI
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6b807e132ad2b20a47a00dc132c94d7d
URL:http://dia2026globalannualmeeting.sched.com/event/6b807e132ad2b20a47a00dc132c94d7d
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T211500Z
SUMMARY:#657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech
DESCRIPTION:Component Type: SessionLevel: IntermediateAs a closing session\, this discussion brings together key themes from the day to examine how innovators can better connect science to market realities. It will highlight practical ways to optimize product value for investors\, payers\, and regulatorsLearning Objectives Understand the factors that shape product value\; Identify critical early decisions (indication\, endpoints\, evidence) that influence downstream access and partnering outcomes\; Define opportunities to better align development strategy with payer\, provider\, and investor expectations.Chair Mark TwymanSpeaker PanelistMichael Kuchenreuther
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,18: LIFT-SERIES
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6dfc920da595767bd0687158c60c8b34
URL:http://dia2026globalannualmeeting.sched.com/event/6dfc920da595767bd0687158c60c8b34
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260617T200000Z
DTEND:20260617T210000Z
SUMMARY:#659: Real World Evidence in Regulatory Decision-Making: Challenges\, Innovations\, and Impact
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-642-L04-P\; CME 1.00\; RN 1.00This session highlights innovative Real World Data (RWD) methods\, including AI\, for enhancing Real World Evidence (RWE) for regulatory decisions. Through case studies and discussion\, it will examine practical integration strategies for these innovations. Learning Objectives Define the key challenges and limitations in the use of real-world evidence (RWE) for regulatory decision-making\; Illustrate how innovative methodologies can be integrated into study design and analysis to enhance the robustness and credibility of RWE\; Describe practical insights\, informed by multi-stakeholder perspectives\, for developing a framework of regulatory acceptability of RWE.Chair Alison CaveSpeaker Advancing Real-World Evidence for Regulatory Decision-Making: Academic perspectiveOlaf Klungel\, FISPEAdvancing Real-World Evidence for Regulatory Decision-Making: industry perspectiveGracy G Crane\, MSAdvancing Real-World Evidence for Regulatory Decision-Making: FDA perspectiveMotiur Rahman\, PHD\, MPHARM\, MS
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE
LOCATION:203AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:6e49bb43af34f8a3f31dcf7c91019a95
URL:http://dia2026globalannualmeeting.sched.com/event/6e49bb43af34f8a3f31dcf7c91019a95
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#700: Insights Regarding Implementation of the ASAP Process
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P\; CME 1.00\; RN 1.00We will focus on insights regarding implementation of the ASAP process\, how it has been beneficial to implement\, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).Learning Objectives Describe the steps to implement the ASAP process at a smaller company with limited resources\; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts\; Recognize how the ASAP process has been beneficial to implement for various projects.Chair Greg Ball\, PHDSpeaker Insights Regarding Implementation of the ASAP Process Barbara Hendrickson\, DrMed\, MDAdvantages of Earlier Systematic and Strategic Safety PlanningFamina Hemani\, PHARMDPractical Implementation of ASAP ConceptsShital Patel\, PHARMDPractical Implementation of ASAP ConceptsCynthia McShea\, MPH
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:118AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:14056256d6175c701fdff759f232ef4e
URL:http://dia2026globalannualmeeting.sched.com/event/14056256d6175c701fdff759f232ef4e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#701: No Report Left Behind: Human-Centered Safety Reporting
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P\; CME 1.00\; RN 1.00Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation\, safety processes\, and clinical operations partner to reduce missed reports\, protect patients\, and strengthen trial integrity.Learning Objectives Identify the key factors that contribute to patients underreporting adverse events and assess the resulting impact on safety\, operations\, and compliance\; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations\; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.Chair Lani HashimotoSpeaker PanelistStacy Hurt\, MBA\, MHAPanelistJennifer Miller\, PHD
CATEGORIES:01: CLINSAFETY-PV-RM
LOCATION:103A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4095bec63b670750430dd46b52d75df3
URL:http://dia2026globalannualmeeting.sched.com/event/4095bec63b670750430dd46b52d75df3
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P\; CME 1.00\; RN 1.00As pharma companies set increasingly bold ambitions for productivity\, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI\, with humans working alongside agents.Learning Objectives Describe recent trends in regulatory submission preparation acceleration\, including role of technology\; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.Chair Anton Mihic\, MSCSpeaker Agentic AI for statistical programming and rapid biostatistical analysisRalf RaschkePanel discussion: Learnings from AI-enabled clinical and regulatory decision makingJennings XuPanel discussion: Learnings from AI-enabled regulatory submissionsCassie GregsonPanel discussion: Learnings from AI-enabled end-to-end dossier generationAndrea Doyle
CATEGORIES:03: DATA-TECH-AI\,04: MEDAFFAIRS-SCICOMM\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:109AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:2cecb38bfe138f5fafce5d0c467cb77a
URL:http://dia2026globalannualmeeting.sched.com/event/2cecb38bfe138f5fafce5d0c467cb77a
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P\; CME 1.00\; RN 1.00AI adoption in RA/QA is currently fragmented and uncertain\, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident\, risk-aware AI decisions now and as the landscape matures.Learning Objectives Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable\; Differentiate near-term AI actions\, deferred investments\, and avoidable risks using a category-driven lens\; Apply a practical framework to guide compliant\, defensible AI decisions across quality and regulatory functions. Chair Nicholas Capman\, MBASpeaker Considerations for AI tool validation and implementationBenjamin C Eloff\, PHDPragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human ControlFatima Sabar\, MSCAI and the Path to Submission Ready RWE: Enabling Compliance and Data QualityCarrie Nielson\, MPH
CATEGORIES:03: DATA-TECH-AI\,09: RD-QUALITY-COMPLIANCE
LOCATION:111AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b11a0cbdd159f1557331e6970c76dc56
URL:http://dia2026globalannualmeeting.sched.com/event/b11a0cbdd159f1557331e6970c76dc56
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#704: The View from the Top: What is the Future of Medical Writing?
DESCRIPTION:Component Type: ForumLevel: AdvancedCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-646-L04-P\; CME 1.00\; RN 1.00Senior regulatory writing leaders from top pharma companies will share a candid\, strategic view of how medical/regulatory writing is evolving over the next 3–5 years. The panel will explore how technology (including AI and structured content)\, new regulatory pathways\, and shifting operating models are redefining writer responsibilities\, team structures\, and the value writers bring to development programs. Attendees will leave with clear insights on future-ready skills and practical steps to position regulatory writing as a critical driver of regulatory and clinical success.Learning Objectives Describe leadership-level forecasts for the medical/regulatory writing function over the next 3–5 years\, including key forces driving change\; Identify how top pharma organizations are redefining the role and value of regulatory writers\; Explain the implications of technology adoption on writer responsibilities\, quality oversight\, and team structures.Chair Robin WhitsellSpeaker PanelistElizabeth Brown\, MS\, PMPPanelistKrista Crenshaw\, MSPanelistNancy Tam\, MSPanelistJoanne Hilton\, MBA
CATEGORIES:04: MEDAFFAIRS-SCICOMM\,06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:105AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:bd3083a713bc347df372c680011b77f4
URL:http://dia2026globalannualmeeting.sched.com/event/bd3083a713bc347df372c680011b77f4
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#705: Fighting Medical Disinformation (Without Actually Starting a Fight)
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P\; CME 1.00\; PDU 1.00 PMI 2166KJ1ZXS\; RN 1.00We’ll discuss whether drug development professionals have an ethical obligation to confront misinformation\, effective ways to approach these conversations without confrontation\, and what techniques and messages work best in different settings. Learning Objectives Explain the ethical principles that underlie the obligation of drug development professionals to combat disinformation\; Discuss best practices for successful encounters in combatting disinformation\; Distinguish the application of different practices in their most appropriate settingsChair Lindsay McNair\, MD\, MPH\, MSSpeaker Perspectives of a Science ReporterSydney LupkinEffective Messaging to Combat Scientific Mis/DisinformationJoseph N Cappella\, PHD
CATEGORIES:06: PROFDEVELOP-PROGRAM-PORTFOLIOMGMT
LOCATION:108A\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:b5ec2cba7c842e2b8cbb6e003d6c8a7d
URL:http://dia2026globalannualmeeting.sched.com/event/b5ec2cba7c842e2b8cbb6e003d6c8a7d
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P\; CME 1.00\; RN 1.00The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration. Learning Objectives Illustrate a future state in which CMC data from internal systems can be seamlessly transferred to a cloud environment\; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.Chair Ciby Joseph Abraham\, PHDSpeaker PanelistVada Perkins\, MSPanelistOmar Serang
CATEGORIES:07: REGCMC-PRODUCT QUALITY\,03: DATA-TECH-AI
LOCATION:118C\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:960152ae87869be20454b3fcbf109737
URL:http://dia2026globalannualmeeting.sched.com/event/960152ae87869be20454b3fcbf109737
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#707: EMA - FDA Question Time
DESCRIPTION:Component Type: SessionLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-667-L04-P\; CME 1.00\; RN 1.00In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory\, scientific\, and communication challenges.Learning Objectives Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA\; Describe experience and explore specific areas of collaboration between the two Agencies\; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.Chair Corinne de Vries\, PHD\, MA\, MSCSpeaker PanelistSteffen Thirstrup\, MD\, PHDPanelistOrla Moriarty\, PHDPanelistJoaquim Berenguer Jornet\, MS
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:114\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:bb8915208f5f1213a7c1c6ef565b49f0
URL:http://dia2026globalannualmeeting.sched.com/event/bb8915208f5f1213a7c1c6ef565b49f0
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22
DESCRIPTION:Component Type: WorkshopLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-624-L04-P\; CME 1.00\; RN 1.00This workshop explores integrating patient preference studies into clinical trial design and drug application submissions\, highlighting operational strategies\, stakeholder collaboration\, and how these align with the upcoming ICH E22 guideline.Learning Objectives Recognize key aspects of patient preference studies (PPS) design using a practical\, interactive preference elicitation example\; Describe how to incorporate PPS into clinical trial design and regulatory decisions using insights from ICH E22\; Identify key operational strategies and challenges in designing PPS.Chair Bennett Levitan\, MDSpeaker Patient Perspective: Patient Preference Studies in Clinical Trials and ICH E22Megan Aragon\, MBARegulatory Perspective: Patient Preference Studies in Clinical Trials and ICH E22Robyn Bent\, BSN\, MS\, RNIndustry Perspective: Patient Preference Studies in Clinical Trials and ICH E22Leila Lackey\, MHS\, PHD
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:102AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:587b2a2b76dce6633d042b6dbb6c4f75
URL:http://dia2026globalannualmeeting.sched.com/event/587b2a2b76dce6633d042b6dbb6c4f75
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#709: PV Compliance DIY: How to Find and Fix Quality Issues Before They Find You
DESCRIPTION:Component Type: SessionLevel: BasicCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-649-L04-P\; CME 1.00\; RN 1.00How do we learn from PV compliance failures? This session will provide insights from across industry and from the regulators on how to identify\, prioritise and effectively fix non-compliance in PV\, exploring the role of psychological safety in this.Learning Objectives Describe how proactive approaches to investigating known issues\, using a better understanding of psychological safety and learning from failure can help identify deeper root causes for future proofing compliance within the PV system\; Explain how to build a proactive business case for identifying and addressing quality issues within the pharmacovigilance (PV) system and outline practical steps for initiating this work.Chair Anna Adams\, PHDSpeaker PanelistManny BurgaPanelistAndrew CooperPanelistHelen Emery
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,01: CLINSAFETY-PV-RM
LOCATION:117\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:08be717b5d416c4bcd53425da2a19087
URL:http://dia2026globalannualmeeting.sched.com/event/08be717b5d416c4bcd53425da2a19087
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches\, Industry Impact\, and Future Harmonization Opportunities
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P\; CME 1.00\; RN 1.00Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views\, using FDA data to highlight global trends\, compliance strategies\, and harmonization\, with insights on coverage of sites\, sponsors\, clinical research organizations (CROs)\, and regions.Learning Objectives Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites\; Compare inspection approaches among regulators\; Evaluate opportunities for harmonization and information sharing\; Analyze industry strategies for global inspection readiness and compliance.Chair Kassa Ayalew\, MD\, MPHSpeaker panelistThomas HaagPanelistIzumi ObaPanelistJong-Hoon Lee\, MD
CATEGORIES:09: RD-QUALITY-COMPLIANCE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:107AB\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:16f7d07c801b8201ac7eb9a5547da52b
URL:http://dia2026globalannualmeeting.sched.com/event/16f7d07c801b8201ac7eb9a5547da52b
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T120000Z
DTEND:20260618T130000Z
SUMMARY:#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P\; CME 1.00\; RN 1.00The session explores the integration of external data in clinical trials to enhance efficiency\, reduce sample sizes\, and shorten timelines. It covers methodological advances\, regulatory perspectives\, and best practices for using external controls.Learning Objectives Identify the nuances while integrating external data in trial design and analysis\; Evaluate regulatory requirements and perspectives\; Discuss the possibility of external control trial in their organization.Chair Satrajit Roychoudhury\, PHDSpeaker PanelistXiaofei Wang\, PHDPanelistScott Berry\, PHDPanelistKannan Natarajan\, PHDPanelistPralay Mukhopadhyay\, PHD
CATEGORIES:10: STATS-EVIDENCEGENERATION-RWE\,02: CLINICALTRIALOPS-INNOVATION
LOCATION:116\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:d24e3a462ce8d6c60bd28501ab95ddf2
URL:http://dia2026globalannualmeeting.sched.com/event/d24e3a462ce8d6c60bd28501ab95ddf2
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T133000Z
DTEND:20260618T143000Z
SUMMARY:#712: FDA Town Hall
DESCRIPTION:Component Type: ForumLevel: IntermediateCE: ACPE 1.00 Knowledge UAN: 0286-0000-26-652-L04-P\; CME 1.00\; RN 1.00In this session\, senior leaders from the U.S. Food and Drug Administration (FDA) will provide an update on key priorities\, including the Commissioner's National Priority Voucher Program\, artificial intelligence in drug and biological product development\, and the Agency's digital transformation efforts. The session will provide the opportunity for the audience to ask questions.Learning Objectives Discuss FDA’s key initiatives and strategic priorities\; Identify opportunities for engagement with FDA regulators.Chair Meghana Chalasani\, MHASpeaker PanelistR. Angelo De Claro\, MDPanelistKatherine SzaramaPanelistJeremy WalshPanelistMallika Mundkur\, MD\, MPH
CATEGORIES:08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION
LOCATION:114\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:4f955a909b943ebf4b285604fd44564e
URL:http://dia2026globalannualmeeting.sched.com/event/4f955a909b943ebf4b285604fd44564e
END:VEVENT
BEGIN:VEVENT
DTSTAMP:20260517T134759Z
DTSTART:20260618T150000Z
DTEND:20260618T163000Z
SUMMARY:#713: No More Incremental Change: The Radical Future of Healthcare
DESCRIPTION:Component Type: SessionLevel: IntermediateThis closing session brings together pioneering voices at the intersection of AI\, advanced computing\, and biopharma to explore how a new intelligence layer is rewiring the entire life sciences value chain—from discovery to delivery. The discussion will examine how foundational AI\, cloud-scale infrastructure\, and digital platforms are reshaping R&D\, clinical development\, manufacturing\, and patient engagement. The conversation will highlight not only breakthrough opportunities—smarter target discovery\, more adaptive trials\, real-world evidence at scale\, and hyper-personalized care—but also the governance\, ethics\, workforce\, and partnership models needed to harness these technologies responsibly in a highly regulated environment. Learning Objectives Describe key ways AI and other advanced digital technologies are reshaping the life sciences value chain\; Discuss concrete examples of how leading pharma and tech companies are using digital platforms\, cloud infrastructure\, and AI to accelerate R&D and improve patient outcomes\; Evaluate key risks and governance challenges associated with deploying powerful AI and data technologies in regulated life sciences settings\, including bias\, transparency\, and accountability.Chair Eli Weinberg\, PHD\, MSSpeaker PanelistSusan Furth\, MD\, PHDPanelistCarlos Garner\, PHD\, MSCPanelistDhruv JayanthPanelistShweta Maniar
CATEGORIES:03: DATA-TECH-AI\,08: REGPOLICY-STRATEGY-GLOBALCOLLABORATION\,00: PLENARY
LOCATION:114\, The Pennsylvania Convention Center 1101 Arch Street Philadelphia\, PA 19107 USA
SEQUENCE:0
UID:296a0126b5aece6ee29f609d85c005a3
URL:http://dia2026globalannualmeeting.sched.com/event/296a0126b5aece6ee29f609d85c005a3
END:VEVENT
END:VCALENDAR