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Monday, June 15
 

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures
Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB
Component Type: Session
Level: Intermediate

This 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, PHD

Speaker

Panelist
Lawrence Tallon

Panelist
David Pfeiffer

Panelist
Greg Sarafin

Panelist
Rahul Gupta, MD, MBA, MPH

Panelist
David Fajgenbaum

Panelist
Audrey Greenberg, CPA, MBA


Speakers
avatar for David Fajgenbaum

David Fajgenbaum

Co-Founder & President of Every Cure, Every Cure, United States
avatar for Audrey Greenberg

Audrey Greenberg

Mayo Clinic, Venture Partner and Chair, Mayo Ventures, United States
avatar for Rahul Gupta

Rahul Gupta

President, GATC Health, United States
Dr. Gupta was appointed President of GATC Health, a tech-bio company advancing drug discovery and development, in February 2025. He previously served as Director of the White House Office of National Drug Control Policy (ONDCP) from 2021 to January 2025—the first physician to lead... Read More →
DP

David Pfeiffer

SVP, Head of ARCAS, Bio-Tech, Acrisure Re, United States
avatar for Greg Sarafin

Greg Sarafin

Chief Administrative Officer, Sovereign AI, United States
Greg Sarafin is the Chief Administrative Officer of Sovereign AI where he oversees corporate functions, capital, partnerships, and vendors. Sovereign AI is a vertically integrated, country-first AI infrastructure and platform designed to support governments, regulated industries... Read More →
avatar for Lawrence Tallon

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
avatar for Maria Vassileva

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →
Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   05: PersonalizedMed-ComboProd-Diagnostics, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   00: Plenary, Session

10:00am EDT

#401 SCC: Student Case Competition
Monday June 15, 2026 10:00am - 11:00am EDT
Content Hub
Component Type: Session

Each 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

Speakers
avatar for Sorcha McCrohan

Sorcha McCrohan

Sr. Scientific Project Manager, DIA, United States
Sorcha McCrohan is a Senior Scientific Project Manager for Global Science at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics... Read More →
Monday June 15, 2026 10:00am - 11:00am EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  15: Networking-Opportunities, Session

10:15am EDT

#401.1 IT: Box Innovation Theater: From Digital Debt to Strategic Asset - Making Regulated Clinical Content AI-Ready
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3
Component Type: Session

Biopharma 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

Speaker
Manu Vohra

Speaker
Ali Shamoun

Speaker
Boris Braylyan, MBA


Speakers
avatar for Boris Braylyan

Boris Braylyan

Chief Digital & Data Officer, Parexel, United States
Boris Braylyan is a technology leader with over two decades of experience advancing digital innovation in regulated industries. His career spans large scale transformations in life sciences, including 20 years at Pfizer, where he modernized global clinical and regulatory systems and... Read More →
avatar for Box, Inc.

Box, Inc.

United States
avatar for Ali Shamoun

Ali Shamoun

Director, Global Development Systems, Regeneron, United States
avatar for Manu Vohra

Manu Vohra

Vice President and Managing Director, Life Sciences, Box, United States
Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After two decades deploying ECM solutions in a regulated industry, he's spending his efforts supporting Life Sciences companies to ride the Digital Transformation wave... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#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
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2
Component Type: Session

Japanese 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 LIMITED

Speaker

Speaker
Shinya Yamamoto, PHD, MS


Speakers
DI
avatar for Shinya Yamamoto

Shinya Yamamoto

General Manager, Deep Intelligent Pharma ( Singapore) private limited, Japan
Shinya Yamamoto, PhD currently serves as GM of Deep Intelligent Pharma K.K., leading AI-driven innovation in drug development and clinical research. He is passionately committed to unlocking tacit knowledge from Japanese universities and medical institutions and transforming it into... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

10:15am EDT

#401.3 IT: IQVIA Innovation Theater: Transforming Clinical Development - Harnessing AI for Predictive Simulation and Agentic Automation
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1
Component Type: Session



Chair

IQVIA

Speaker

Speaker
Raja Shankar, MS


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Raja Shankar

Raja Shankar

VP, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
Monday June 15, 2026 10:15am - 10:45am EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

11:00am EDT

#402: Future Vigilance Approaches: What Data Sources will have the Biggest Impact on Patient Care?
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-510-L04-P; CME 1.25; RN 1.25

This 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 Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff


Speakers
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →
AR

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance,Data Management & Data Standards
  • Tags Forum

11:00am EDT

#404: Evidence-Based Insights Informing Participant Compensation Strategies
Monday June 15, 2026 11:00am - 12:15pm EDT
108B
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-512-L04-P; CME 1.25; RN 1.25

This 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 execution

Learning 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, MBA

Speaker

Panelist
Lindsay McNair, MD, MPH, MS

Panelist
Sabina Kineen

Panelist
Brittany Niland

Panelist
Elizabeth Smith Morris


Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Sabina Kineen

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States
Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In this role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
ES

Elizabeth Smith Morris

Director, Product Management, Patient Engagement, Suvoda, United States
avatar for Brittany Niland

Brittany Niland

Senior Director- Patient Engagement, Recruitment, Diversity & Retention, Eli Lilly and Company, United States
Brittany Niland is Senior Director of Patient Engagement, Recruitment, Diversity & Retention, leading global, patient-centered recruitment and retention strategies across the Oncology portfolio. She focuses on expanding equitable access to clinical trials, accelerating enrollment... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

11:00am EDT

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution
Monday June 15, 2026 11:00am - 12:15pm EDT
108A
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P; CME 1.25; RN 1.25

Clinical 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 Dustin

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Nikki Amaratunge, MA, PMP

Panelist
Rosalie Filing

Panelist
Emily Walker, MBA


Speakers
avatar for Joe Dustin

Joe Dustin

Founder and Principal, Dauntless eClinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
avatar for Joseph Dustin

Joseph Dustin

Founder and Principal, Dauntless eClinical Strategies, United States
Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →
RF

Rosalie Filing

Vice President, Clinical Operations, Keenova Therapeutics, United States
NA

Nikki Amaratunge, MA, PMP

Director Clinical Operations, Allergan, United States
avatar for Jennifer Sheller

Jennifer Sheller

Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc., United States
Jennifer Sheller is Senior Vice President and Head of Global Clinical Trial Operations at Merck, where she leads the global infrastructure responsible for the operational delivery of Merck’s clinical development portfolio. With more than 25 years of experience across pharma, biotech... Read More →
EW

Emily Walker

Vice President, Study Management, Alnylam, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Project Management & Strategic Planning
  • Tags Session

11:00am EDT

#405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-514-L04-P; CME 1.25; RN 1.25

AI 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, PHD

Speaker

Industry Perspective
Alain Silk, PHD

Patient Advocate Perspective
Jason Binder, MA

Industry Perspective
Mike Montalto, PHD


Speakers
JB

Jason Binder

Founder & CEO, Ember, United States
Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →
avatar for Alain Silk

Alain Silk

Senior Director, Regulatory Affairs, Tempus AI, Inc., United States
Alain Silk is a Senior Director of Regulatory Affairs at Tempus AI, a technology company applying analytic tools to provide data driven insights from clinical and molecular data. Dr. Silk has over a decade of experience as a medical device regulatory professional across diverse diagnostic... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Tags Forum

11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P; CME 1.25; RN 1.25

The 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 representatives

Learning 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, PHARMD

Speaker

Panelist
Marko Eric

Panelist
Julie Lepin, MA

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Vada Perkins, MS


Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil
Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →
avatar for Marko Eric

Marko Eric

Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia
Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Julie Lepin

Julie Lepin

Senior Vice President & Chief Regulatory Officer, BeOne Medicines, United States
Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#407: The Great Debate: Using AI in Patient-Facing Materials
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-515-L04-P; CME 1.25; RN 1.25

Artificial 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 Preciado

Speaker

The Great Debate: Using AI in Patient-Facing Materials
Christine Marie Von Raesfeld

The Great Debate: Using AI in Patient-Facing Materials
Kimbra Edwards, PHD

The Great Debate: Using AI in Patient-Facing Materials
Irene Kuhlman, MS


Speakers
avatar for Kimbra Edwards

Kimbra Edwards

Senior Director, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP) , United States
Kim Edwards is the Senior Director of Health Communication Services at the Center for Information and Study on Clinical Research Participation (CISCRP). CISCRP is a non-profit organization focused on increasing awareness and understanding of clinical research participation. Kim oversees... Read More →
avatar for Irene Kuhlman

Irene Kuhlman

Global Labeling Strategist, Bayer, Netherlands
After obtaining her MSc in Biomedicine, Irene began her career in various science and health communication roles at non-profit organizations. She then transitioned to Regulatory Affairs, where she worked for 14 years as a local and EU Regulatory Manager at the Dutch Bayer affiliate... Read More →
avatar for Regina Lynn Preciado

Regina Lynn Preciado

VP, Content Strategy Solutions, Content Rules, Inc., United States
Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →
avatar for Christine Von Raesfeld

Christine Von Raesfeld

Board member/community liaison, The Light Collective, United States
Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
  • Feature Topics Artificial Intelligence
  • Tags Forum

11:00am EDT

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics
Monday June 15, 2026 11:00am - 12:15pm EDT
116
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P; CME 1.25; RN 1.25

In 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, MSC

Speaker

Building Bridges, Not Silos: Lilly's IVDR-Driven Transformation
Lauren Tobe, JD

tbd. In vitro biomarker tests for patient selection for efficacy
Martin Mengel

Companion Diagnostics and Medicinal Products: A notified Body perspective on Co-development under IVDR
Rolf Thermann, PHD

Combined studies in the EU- overview and considerations for industry
Joshua D Levin, MA


Speakers
avatar for Joshua Levin

Joshua Levin

Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK, United States
MM

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany
avatar for Rolf Thermann

Rolf Thermann

Section Manager IVD, Companion Diagnostics lead, TÜV Rheinland, Germany
Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development... Read More →
avatar for Lauren Tobe

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →
avatar for Ana Trullas

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands
Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session

11:00am EDT

#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical
Monday June 15, 2026 11:00am - 12:15pm EDT
202AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-517-L04-P; CME 1.25; PDU 1.25 PMI 216647VJP8; RN 1.25

What 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, MS

Speaker

Panelist
Jill Orosz


Speakers
avatar for Robin Boss

Robin Boss

VP, Business Transformation, Campana & Schott, United States
Robin Boss is Vice President of Business Transformation Consulting at Campana & Schott, where he leads a U.S. team working with Life Sciences organizations on large-scale pharma transformation programs. His focus is on portfolio and project management as a core lever to implement... Read More →
avatar for Jill Orosz

Jill Orosz

Vice President, TKI Franchise Head, Bayer, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Workshop
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Project Management & Strategic Planning
  • Tags Workshop

11:00am EDT

#409: Evolving Role of the Quality Professional: The Future of Professional Development in the Age of AI
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-518-L04-P; CME 1.25; PDU 1.25 PMI 216641I1NS; RN 1.25

In 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, MBA

Speaker

Smarter Roles, Stronger Skills: AI in Workforce Evolution
Haleh Valian, PHD

Compliance to Competence: How AI and New Regulations Are Reshaping the Quality Professional
Jeremy Jones, MS

Quality in the Age of Agents: A Look Back From the AI-Driven Future
Roshan D'Souza


Speakers
avatar for Roshan D'Souza

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom
Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →
JJ

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States
Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →
avatar for Michael Pelosi

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Dr. Haleh Valian is a data-driven executive leader with nearly three decades of experience spanning biotechnology, healthcare, finance, and advanced analytics. She is currently the Director of R&D Decision Quality Analytics and Innovation at Biogen, where she leads the strategic transformation... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   09: RD-Quality-Compliance, Session
  • Audience Basic
  • Area Artificial Intelligence
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, PMI, RN
  • Interest Area Health Technology & AI,Quality Assurance / Control & CMC
  • Feature Topics Artificial Intelligence
  • Tags Session

11:00am EDT

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 11:00am - 12:15pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-519-L04-P; CME 1.25; RN 1.25

The 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, PHD

Speaker

Modernizing Oversight: Enabling the Future of U.S.-Based Pharmaceutical Manufacturing
Lisa Wright, MS

Innovative Regulatory Approaches to Increasing US-based Pharmaceutical Manufacturing
Cecilia Tami, PHD

Building U.S. Biopharmaceutical Manufacturing Workforce Capacity: Challenges, Opportunities, and Innovations
John Balchunas, MSC


Speakers
avatar for John Balchunas

John Balchunas

Workforce Director, National Institute for Innovation in Manufacturing Biopharma, United States
John Balchunas is the Workforce Director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) where he is responsible for guiding strategy around workforce and talent development for a federally-funded public private partnership focused on transforming... Read More →
JK

Joseph Kutza

Senior Director Regulatory Policy - CMC, Eli Lilly and Company, United States
Currently Senior Director Global Regulatory Policy and Strategy - CMC at Lilly. Focus on global regulatory policy and external engagement for all product types. Formerly in Regulatory Affairs CMC at AstraZeneca and a reviewer of monoclonal antibodies at the FDA. Ph.D. in Immunology... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Lisa Wright

Lisa Wright

Director Regulatory Policy, Novo Nordisk A/S, United States
Lisa Wright brings over a decade of experience in the pharmaceutical and biopharmaceutical industry. She has held multiple positions with a primary focus on regulatory affairs and policy. In her current role at Novo Nordisk, Lisa engages with the FDA on regulatory CMC and device issues... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

11:00am EDT

#415: Regulatory Cooperation Between the United States and Japan
Monday June 15, 2026 11:00am - 12:15pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-522-L04-P; CME 1.25; RN 1.25

This 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, MS

Speaker

Panelist
Mark Abdoo

Panelist
Naoyuki Yasuda, MSC

Panelist
Gerald Dal Pan, MD, MHS

Panelist
Miki Ota, MPHARM

Panelist
Akihiro Ishiguro, PHD


Speakers
avatar for Mark Abdoo

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States
avatar for Sema Hashemi

Sema Hashemi

Senior International Policy Advisor, FDA, United States
Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →
avatar for Akihiro Ishiguro

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →
avatar for Miki Ota

Miki Ota

Director, Office of Informatic and Manegement for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Ms. Miki Ota joined the MHLW in December 2000, when she was assigned to the Pharmaceutical and Food Safety Bureau. She was mainly involved in Safety measure of Chemical Substance. Subsequently, she worked in several organizations including Ministry of the Environment, National Personnel... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Naoyuki Yasuda

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Regulatory
  • Tags Forum

11:00am EDT

#416.1: International Regulatory Cooperation with the African Medicines Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
110A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-608-L04-P; CME 1.25; RN 1.25

A 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, MS

Speaker

International Regulatory Cooperation with the African Medicines Agency
Emile Bienvenu

Panelist
Aissatou SOUGOU

International Regulatory Cooperation with the African Medicines Agency
Delese Mimi Darko, MBA, RAC

International Regulatory Cooperation with the African Medicines Agency
Ahmed Mohamed

International Regulatory Cooperation with the African Medicines Agency
Heran Gerba, PHD


Speakers
EB

Emile Bienvenu

Director General, Rwanda Food and Drug Authority, Rwanda
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
HG

Heran Gerba

Director General, Ethiopian Food and Drug Authority (EFDA), Ethiopia
AM

Ahmed Mohamed

Chief Executive Officer, Pharmacy and Poisons Board, Kenya
avatar for Meisha Sampson

Meisha Sampson

Director, FDA, United States
Meisha Sampson is the inaugural Director of the FDA African Medicines Agency Liaison Office within FDA’s Office of Global Policy and Strategy, based at the U.S. Embassy in Kigali, Rwanda, home to the African Medicines Agency. In this role, she advances a collaborative FDA–AMA... Read More →
AS

Aissatou SOUGOU

Director General, Department of Pharmacy and Laboratories (DPL) , Senegal
Monday June 15, 2026 11:00am - 12:15pm EDT
110A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

11:00am EDT

#416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact
Monday June 15, 2026 11:00am - 12:15pm EDT
204AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-524-L04-P; CME 1.25; RN 1.25

This 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, MS

Speaker

-
Victoria DiBiaso, BSN, MPH, RN

-
Katherine Senter, MPH

-
Sanj Singh, MBA


Speakers
avatar for Victoria DiBiaso

Victoria DiBiaso

Head of Patient Informed Development & Health Value Translation, Sanofi, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Martin Hodosi

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United States
More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
avatar for Katherine Senter

Katherine Senter

Assistant Director, Cancer Clinical Research Operations, Sidney Kimmel Cancer Center – Jefferson Health, United States
Katherine Senter, MPH, CCRP currently serves as Assistant Director for Cancer Clinical Research Operations at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Jefferson. Here she guides Clinical Research Managers, Investigators, and their teams to conduct and streamline high... Read More →
avatar for Sanj Singh

Sanj Singh

CEO, Temple Therapeutics, Netherlands
He is a biotech leader with 20+ years of driving innovation and growth. As co-founder and CEO of Temple Therapeutics, he has built a clinical-stage company at the forefront of women’s health—advancing a differentiated pipeline, securing strategic partnerships, expanding IP, and... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

11:00am EDT

#413: Health Canada Town Hall
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25

In 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, PHD

Speaker

Panelist
Sophie Sommerer


Speakers
avatar for Alysha Croker

Alysha Croker

Director, Strategic and Horizontal Policy, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
avatar for Sophie Sommerer

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada
Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

As 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, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD


Speakers
avatar for Jeffrey Francer

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States
Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →
CP

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States
BT

Barrett Tenbarge

Partner, Faegre Drinker, United States
Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   06: ProfDevelop-Program-PortfolioMgmt, Forum

11:00am EDT

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This 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, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho


Speakers
avatar for Lina AlJuburi

Lina AlJuburi

Head, Regulatory Science and Policy, North America, Sanofi, United States
A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
avatar for Amanda Conti

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States
EG

Eric Gascho

Vice President, CRD Associates, United States
Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →
avatar for Eva Temkin

Eva Temkin

Partner, Arnold & Porter, United States
A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Forum

11:00am EDT

#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
Monday June 15, 2026 11:00am - 12:15pm EDT
117
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25

This 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, MA

Speaker

Panelist
Mandy Kaur Budwal-Jagait, MSC

Panelist
Paula Walker, MA

Panelist
Sumitra Sachidanandan

Panelist
Cheryl Grandinetti


Speakers
avatar for Mandy Budwal-Jagait

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States
Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →
avatar for sumitra_sachidanandan

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore
Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom
Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →
Monday June 15, 2026 11:00am - 12:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum |   02: ClinicalTrialOps-Innovation, Forum

12:15pm EDT

#418 POS: Student Poster Session I
Monday June 15, 2026 12:15pm - 2:15pm EDT
Exchange
Component Type: Session

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.

Speakers
avatar for Kush Amin

Kush Amin

PharmD Candidate, Fairleigh Dickinson University, United States
Kush Amin is a PharmD candidate at Fairleigh Dickinson University College of Pharmacy & Health Sciences with a research focus in pharmacovigilance, managed care pharmacy, and real-world evidence generation. His work examines the intersection of drug safety, regulatory policy, and... Read More →
avatar for Evgeniia Artamonova

Evgeniia Artamonova

Master student, Technical University of Munich, Germany
Evgeniia Artamonova is a Master's student in Health Sciences (Health Prevention and Promotion) at the Technical University of Munich (TUM). She holds a degree in General Medicine (MD) and has a background in epidemiology, global health, biostatistics, and clinical research. Her Master's... Read More →
avatar for Faith Butta

Faith Butta

MS Clinical Research and Product Development, University of North Carolina Wilmington, United States
Faith Butta is a consultant who specializes in federally funded programs in regulatory compliance, program management, and programmatic cross-functional coordination. She has spend the past decade focusing on stakeholder engagement, data integrity, and process improvement. With her... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witwatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
TE

TEST Eisenhower

Sr. Exhibit, Sponsorship and Relationship Manager, DIA, United States
avatar for Ellie Froslan

Ellie Froslan

Student, University of Southern California, United States
Ellie Froslan is an undergraduate student at the University of Southern California pursuing a B.S. in Biopharmaceutical Sciences with a minor in Consumer Behavior, alongside a progressive M.S. in Healthcare Decision Analysis. She is a student researcher at the D.K. Kim International... Read More →
MG

Mansi Gupta

none, None, United States
Mansi Gupta is an MS Regulatory Affairs candidate at Northeastern University, Boston, MA, with a bachelor's in Biotechnology Engineering and 2+ years of experience working in QMS and regulatory compliance. At Tolmar Inc., she managed CAPA, deviations, change control, and document... Read More →
avatar for Jackson Hanf

Jackson Hanf

Student, University of Southern California, United States
Jackson Hanf is a B.S./M.S. candidate in Biochemistry and Management of Drug Development at the University of Southern California, where he conducts research in regulatory science and drug development. His work includes building data-driven tools to analyze facilitated regulatory... Read More →
avatar for Alex Juma Ismail

Alex Juma Ismail

PhD Student, University of Hertfordshire, United Kingdom
10+ years in African medicines regulation across national authorities, industry, and harmonisation. Led AUDA-NEPAD’s AMRH pilots on regulatory strengthening & harmonised frameworks. Currently Technical Officer at African Medicines Agency (AMA), supporting continental regulatory... Read More →
avatar for Ali Al Juboori

Ali Al Juboori

Medical Science Liaison, Azurity Pharmaceuticals, United States
TK

TzuYuan Kao

Student, University of Washington, United States
MK

Meghana Karnaty

masters in regulatory affairs, Northeastern University, United States
My name is Meghana Karnaty, and I am currently pursuing a Master of Science in Regulatory Affairs at Northeastern University in Boston, with a concentration in Clinical Research. My academic and professional journey has been shaped by a strong interest in healthcare, patient safety... Read More →
avatar for Bahar Lakeh

Bahar Lakeh

Student, Georgetown University School of Medicine, United States
avatar for Cezar Jr. Manansala

Cezar Jr. Manansala

Student, Centro Escolar University, Philippines
I am a registered Pharmacist who is in his last term of his Master of Science in Pharmacy Degree. I am a consultant to pharmaceutical and medical device companies in Japan. I am very passionate about research and would be very happy to collaborate with different organizations, profit... Read More →
JM

Julia Mauro

Project Specialist, DIA, United States
SP

Shreena Patel

Student Researcher, Massachusetts General Hospital, United States
avatar for Alex Raju

Alex Raju

Founder & Lead Researcher, Chatmedsafe | MS Candidate, LIU, United States
Alex Raju, PharmD, is a Pharmacovigilance (PV) scientist and researcher at the forefront of AI governance and global patient safety. Completing an MS in Drug Regulatory Affairs at Long Island University (LIU), his work leverages 8+ years of industry experience to focus on the compliant... Read More →
avatar for Ekaterina Shipilova

Ekaterina Shipilova

PhD Candidate, The Wistar Institute/The University of Bologna, United States
I am a PhD candidate at the Wistar Institute/University of Bologna joint program. I am a graduate of Pharmaceutical Biotechnology. Previously, I acquired a Bachelor's Degree in the Department of Natural Sciences, with a Major in Biology, a Minor in Physiology, and a thesis in Neurosciences... Read More →
avatar for Yuma Tsuboi

Yuma Tsuboi

PhD student, Waseda Univercity, Japan
Yuma Tsuboi is a regulatory science researcher and doctoral candidate at Waseda University's Cooperative Major in Advanced Biomedical Science. Regulatory science mediates three forces: translating cutting-edge technologies into measurable standards, enhancing predictability for safe... Read More →
avatar for ZIYU YE

ZIYU YE

Graduate Student, University of Macau, China
Ziyu Ye is a second-year master’s student in Medicinal Administration at the University of Macau. She received her bachelor’s degree from The Chinese University of Hong Kong, Shenzhen in 2024. With an interdisciplinary background, her research lies at the intersection of biomedical... Read More →
Monday June 15, 2026 12:15pm - 2:15pm EDT
Exchange The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  14: Posters, Session

12:25pm EDT

#419 IT: AlphaLife Sciences Innovation Theater: AI-Powered eCTD Authoring - Faster Draft-to-Submission with AI Tool Demos
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2
Component Type: Session

This 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 Sciences

Speaker

Speaker
William Chen

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen founded AlphaLife Sciences to bring enterprise-grade AI to drug development—specifically to the complex, compliance-driven world of regulatory and clinical authoring. She brings over 30 years of software engineering leadership experience, including roles as Asia Pacific... Read More →
avatar for William Chen

William Chen

Principal Business Solution Architect, AlphaLife Sciences, United States
Will Chen is Head of Solutions at AlphaLife Sciences, where he leads the design and deployment of AI-driven solutions to transform clinical development and life sciences workflows. He specializes in translating complex scientific and regulatory challenges into scalable, commercially... Read More →
avatar for AlphaLife Sciences
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:25pm EDT

#420 IT: CGS Immersive Innovation Theater: From 12 Weeks to 6 - How AI Transformed Compliance Training
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3
Component Type: Session

The 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 Immersive

Speaker

Speaker
Micah White


Speakers
CI

CGS Immersive

United States
avatar for Micah White

Micah White

VP, Research & Development, CGS Immerive, United States
Micah White leads R&D at CGS Immersive, where he applies augmented reality, mixed reality, and generative AI to transform learning and performance in highly regulated environments. He directs the development of platforms such as TeamworkAR™ and Cicero — turning complex SOPs, protocols... Read More →
Monday June 15, 2026 12:25pm - 12:55pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

12:50pm EDT

#421 CH: From Siloed Data to AI Ready Insights: How HL7 FHIR Enables Health Authority Ready Interoperability
Monday June 15, 2026 12:50pm - 1:20pm EDT
Content Hub
Component Type: Workshop
Level: Intermediate

This 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.

Speakers
JC

Joan Cheung

Principal Consultant, Epista Life Science, United States
Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →
Monday June 15, 2026 12:50pm - 1:20pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

1:00pm EDT

#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts
Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B
Component Type: Session
Level: Intermediate

Join 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

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:00pm EDT

#423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies
Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A
Component Type: Session
Level: Intermediate

Join 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

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  13: Community-Rounds, Session

1:05pm EDT

#424 IT: Kivo Innovation Theater: Nothing Changes Unless We Do - Implementing QMS with CRISPR Therapeutics in 52 Days
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2
Component Type: Session

Quality 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

Speaker
Kate Ellmer, MPH

Speaker
Chris Xistris


Speakers
avatar for Kate Ellmer

Kate Ellmer

Exec. Director, Quality and PV Operations, CRISPR Therapeutics, United States
Kate Ellmer is an Executive leader at CRISPR Therapeutics where she is responsible for Quality and Pharmacovigilance Operations. In her twenty-year industry career, she has explored her passion for implementing QMS and GxP systems that enable seamless business processes. Kate has... Read More →
KI

Kivo, Inc.

United States
avatar for Chris Xistris

Chris Xistris

Vice President of Services, Kivo, United States
Chris Xistris has 25+ years in Life Sciences, starting in Regulatory and Clinical Operations at small and mid-size biotechs. He then moved into consulting, building regulatory operations infrastructure for mid-size clients. Before joining Kivo, he spent over a decade at a Life Sciences... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 2 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

#425 IT: Parexel Innovation Theater: The Connected Submission - How AI, Automation, and Intelligence are Changing the Regulatory Ecosystem
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1
Component Type: Session

Explore 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

Parexel

Speaker

Speaker
Katie Connelly


Speakers
avatar for Katie Connelly

Katie Connelly

SVP, Global Head of Regulatory Affairs, Parexel International, United States
Katie, a senior leader at Parexel, brings extensive experience in designing, implementing, and delivering regulatory programs, with deep expertise in product leadership and change management. She oversees global regulatory affairs and operations outsourcing, regulatory FSP, submissions... Read More →
avatar for Parexel

Parexel

United States
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:05pm EDT

Google Cloud Innovation Theater: Accelerating Discovery: The Shift to Agentic Research Workflows with Google’s Co-Scientist
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3
Component Type: Session

In 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

Speaker
David Henderson, PHD

Speaker
Volker Eyrich, PHD


Speakers
avatar for Volker Eyrich

Volker Eyrich

Customer Engineer, AI Infrastructure, Google Cloud, United States
Volker Eyrich, PhD, is a Customer Engineer at Google Cloud where he focuses on the areas of Scientific Research as well as Scientific Computing. He joined Google in 2018. Prior to Google he spent 18 years in Computational Drug Discovery focusing on algorithm and infrastructure development... Read More →
avatar for David Henderson

David Henderson

AI Customer Engineer, Life Sciences, Google Cloud, United States
David Henderson, PhD, is a Customer Engineer at Google Cloud within the Healthcare and Life Sciences industry team. He specializes in the application of advanced AI and high-performance computing to accelerate drug discovery and scientific research. David has played a key role in... Read More →
Monday June 15, 2026 1:05pm - 1:35pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:15pm EDT

#426 SS: Spark Stage: One Small Change
Monday June 15, 2026 1:15pm - 1:45pm EDT
Spark Stage
Component Type: Session

This 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

Speakers
avatar for Catherine Gregor

Catherine Gregor

Chief Clinical Trial Officer, Florence Healthcare, United States
Catherine Gregor is a transformational leader and business advisor with close to two decades of experience in clinical research. She currently serves as the Chief Clinical Trial Officer for Florence Healthcare, a software company focused on connecting sponsors and sites worldwide... Read More →
Monday June 15, 2026 1:15pm - 1:45pm EDT
Spark Stage The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  11: Spark Stage, Session

1:30pm EDT

#427 CH: Develop Regulatory CMC Strategies to Mitigate Global Drug Shortages Risks for Marketed Drug Products
Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub
Component Type: Workshop
Level: Advanced

Develop proactive Regulatory CMC strategies to mitigate and prevent drug shortage risks for marketed products

Learning 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.

Monday June 15, 2026 1:30pm - 2:00pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  12: Content-Hubs, Workshop

1:45pm EDT

#427.1 SS: Spark Stage: Solve the Funding Paradox - Deploy Capital Smarter to Turn Promising Drug Candidates into Therapies
Monday June 15, 2026 1:45pm - 2:00pm EDT
Spark Stage
Component Type: Session

As 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

Speakers
SC

Shomesh Chaudhuri

Co-Founder, QLS Technologies LLC, United States
Dr. Shomesh E. Chaudhuri is a Co-Founder of QLS Technologies. He's developed portfolio intelligence platforms for several biopharma companies, consulting directly with CEOs, CFOs, and their staffs to help align their financing structures with their scientific and medical objectives... Read More →
Monday June 15, 2026 1:45pm - 2:00pm EDT
Spark Stage The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  11: Spark Stage, Session

1:45pm EDT

#428 IT: Evernorth Health Services Innovation Theater: Enabling Real World Patient Reported Outcomes Collection Through Specialty Pharmacy Engagement
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3
Component Type: Session

Patient-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

Evernorth

Speaker

Speaker
Krystyna Amalfe, MPH


Speakers
avatar for Krystyna Amalfe

Krystyna Amalfe

Sr. Account Executive, Intelligence Solutions, Evernorth Health Services, United States
Krystyna Amalfe, MPH, is a public health professional with over 15 years of experience across clinical research, real world evidence, pharmaceutical lifecycle strategy, pharmacy benefit management, and payer markets. At Evernorth Health Services, she works at the intersection of data... Read More →
avatar for Evernorth

Evernorth

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 3 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

1:45pm EDT

#429 IT: Verily Health Inc Innovation Theater: Bridge the Evidence Gap - Integrating Consumer Wearables and Real-World Data for Continuous, Participant-Centric Insights
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1
Component Type: Session

Life 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

Verily

Speaker

Speaker
Sooyoon Shin, PHD


Speakers
avatar for Sooyoon Shin

Sooyoon Shin

Senior Manager, Verily Health, United States
Sooyoon Shin, PhD, is the Senior Manager of Digital Biomarkers and Science Innovation at Verily Health, where she leads research and evidence generation for digital health technologies. She oversees the development and implementation of AI/ML-enabled capabilities across clinical programs... Read More →
V

Verily

United States
Monday June 15, 2026 1:45pm - 2:15pm EDT
Innovation Theater 1 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  16: InnovationTheaters, Session

2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV
Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00

The 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 Tregunno

Speaker

Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC

Panelist
Beth Anne MacEntee Pileggi, BSN, MBA

Panelist
Walter Straus, DrMed, MD, MPH, FACP


Speakers
avatar for Niklas Noren

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden
Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →
avatar for Beth MacEntee Pileggi

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States
Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →
avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

2:30pm EDT

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives
Monday June 15, 2026 2:30pm - 3:30pm EDT
108B
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P; CME 1.00; RN 1.00

No 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 Tremethick

Speaker

Industry Collaboration 2030: Head Perspective
Adrian Hernandez, MD, MHS

Industry Collaboration 2030: Head, Heart and Gut Perspectives
Rebecca Vermeulen, RPH

Industry Collaboration 2030: Gut Perspective
Jeff Smith


Speakers
avatar for Adrian Hernandez

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States
Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →
JS

Jeff Smith

The Curator, Smith and Jones Innovation, United States
avatar for Sarah Tremethick

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom
A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Monday June 15, 2026 2:30pm - 3:30pm EDT
108A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P; CME 1.00; RN 1.00

Explore 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 Chambers

Speaker

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Kevin Hudziak, MS

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Becky Suzanne Kottschade, MA, PMP

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Joan Chambers

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Jane Myles


Speakers
avatar for Joan Chambers

Joan Chambers

Independent Senior Consultant, Tufts Center For the Study of Drug Development, United States
With 30+ years in the health and life sciences industry, Joan has led senior initiatives across multiple organizations, specializing in team leadership, strategic planning, integrated marketing, communications, and educational programs for B2B and B2C audiences. She is a Senior Independent... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Senior Director - Patient Engagement, Clinical Trial Retention, Eli Lilly and Company, United States
Kevin is Senior Director of Clinical Trial Retention on the Patient Engagement team at Lilly. He has extensive experience gathering patient and site feedback, delivering innovation, and impacting DCT capability development and implementation at Lilly. Kevin has a passion for improving... Read More →
avatar for Becky Kottschade

Becky Kottschade

Administrator, Clinical Research, Mayo Clinic, United States
Becky Kottschade is an experienced clinical research administrator. Driven by her commitment to developing innovative options for patients she takes pride in providing the best practices for implementing decentralized capabilities possible. As a research administrator her goals are... Read More →
avatar for Jane Myles

Jane Myles

VP, Programs and Initiatives, Digital Trials and Research Alliance, United States
Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   09: RD-Quality-Compliance, Forum

2:30pm EDT

#433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-529-L04-P; CME 1.00; RN 1.00

Explore 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, MS

Speaker

Panelist
Mumtaz Sultani

Panelist
Jimita Parekh

Panelist
Robert DiCicco, PHARMD


Speakers
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →
avatar for Jimita Parekh

Jimita Parekh

Managing Director, Independent, United States
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
MS

Mumtaz Sultani

European Medicines Agency, Netherlands
Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session

2:30pm EDT

#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P; CME 1.00; RN 1.00

This 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, MPH

Speaker

Panelist
Chris Decker, MS

Panelist
Anne-Marie Meyer, MS


Speakers
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 16 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Chris Decker

Chris Decker

President and CEO, CDISC, United States
Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →
AM

Anne-Marie Meyer

Advisor, Lind AI, Switzerland
Dr. Meyer is Vice President of Healthcare Consulting at acc solutions and advisor to LindAI. As Adjunct Associate Professor at UNC Chapel Hill, she has bridged epidemiology and health informatics for 20+ years. At Lineberger Cancer Center, she built a secure data platform linking... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Data Management & Data Standards,Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

2:30pm EDT

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-531-L04-P; CME 1.00; RN 1.00

This 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, MS

Speaker

Panelist
Mary Ost, PHD, MS

Panelist
Jeanette Towles, MA, RAC


Speakers
avatar for Eileen Girten

Eileen Girten

Medical Writing Therapeutic Area Lead, Pfizer, United States
Eileen M. Girten serves as the Medical Writing Therapeutic Area Lead at Pfizer and brings nearly 17 years of medical writing experience spanning publications and regulatory documentation. She holds a Bachelor of Arts in Chemistry from Rosemont College, a Master of Science in Psychology... Read More →
avatar for Mary Ost

Mary Ost

Director, AI-assisted Operations, Regulatory Medical Writing, Johnson & Johnson , United States
Mary Ost, PhD, is Director of AI-assisted Operations for Regulatory Medical Writing at Johnson & Johnson Innovative Medicine, with 30 years of experience across the pharma and CRO spaces. As AI-assisted Operations Lead, Mary has defined strategy and led solution deployment for AI-driven... Read More →
avatar for Jeanette Towles

Jeanette Towles

CEO, Synterex, United States
Jeanette Towles, MA, RAC is the Founder and CEO of Synterex, Inc., a clinical and regulatory consulting firm pioneering the digital transformation of regulatory science in life sciences and healthcare. Under her leadership, Synterex is developing a digital regulatory ecosystem—a... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

2:30pm EDT

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development
Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00

This 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, PMP

Speaker

Aligning Strategy with Execution: Leveraging Integrated Program, Project and Portfolio management with AI to advance drug development
Philip M Zack, DVM, PHD

Panelist
Erin Mulrooney, MSC, PMP


Speakers
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States
avatar for Christine Mears

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States
Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →
avatar for Erin Mulrooney

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States
Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →
avatar for Philip Zack

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States
Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session |   07: RegCMC-Product Quality, Session |   02: ClinicalTrialOps-Innovation, Session

2:30pm EDT

#437: Opportunity, Caution or Reluctance: Global Trends for Regulating AI in Pharmaceutical Manufacturing
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-533-L04-P; CME 1.00; RN 1.00

Artificial 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 i

Learning 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, PHD

Speaker

PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed

Case Study Industry applications of AI
Thomas O'Connor, PHD

FDA regulatory perspectives on AI in Manufacturing
Tina Kiang, PHD


Speakers
avatar for Tina Kiang

Tina Kiang

Director, Division of Regulation and Guidance, OPPQ, OPQ, CDER, FDA, United States
Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation and Guidance in OPQ/OPPQ. She has over 20 years of combined regulatory and leadership experience at the FDA. Tina has led and supervised the development and finalization of guidance and regulations on... Read More →
avatar for Yoshihiro Matsuda

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →
TO

Thomas O'Connor

Director Process Analytics, GSK, United States
Tom is a director for process analytics at GSK. His team develops models to accelerate process development and increase the robustness of commercial manufacturing. Tom joined GSK from the FDA where he was the deputy director of the Office of Pharmaceutical Quality Research in the... Read More →
avatar for Gert Thurau

Gert Thurau

Head of CMC Regulatory Policy for Manufacturing Technology Innovation in, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session |   03: Data-Tech-AI, Session
  • Audience Advanced
  • Area Artificial Intelligence
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
  • Feature Topics Artificial Intelligence
  • Tags Session

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA
Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB
Component Type: Session
Level: Advanced

China 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, RAC

Speaker

Global Strategy and Challenges
Todd Paporello, PHARMD, MBA

China Strategy and Solution
Wei Zhang

Panel Discussion
Xiaoyuan Chen, MD

Industry Case Studies
Wenny Du, MBA, RAC


Speakers
avatar for Xiaoyuan Chen

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China
Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →
avatar for Wenny Du

Wenny Du

Sr. Director, Global Regulatory Lead, Amgen Inc., United States
Wenny Du, MS, MBA, RAC, serves as Senior Director and Global Regulatory Lead (GRL) for Oncology at Amgen Inc., where she leads global regulatory teams to shape and execute strategies that enable worldwide innovative medicine approvals. With over 25 years of biopharmaceutical industry... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
avatar for Wei Zhang

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China
Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00

Global 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, MS

Speaker

Regulatory challenges facing the development of treatments for chronic neurological disorders
Steffen Thirstrup, MD, PHD

Panelist
Julian Beach, MBA

Patient Perspective
Mindy Cameron


Speakers
avatar for Julian Beach

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →
avatar for Simon Bennett

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom
As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →
MC

Mindy Cameron

Patient Advocate, Advocacyworks, United States
Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session

2:30pm EDT

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P; CME 1.00; RN 1.00

Sponsors 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, MS

Speaker

Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration
Sarah Pope Miksinski, PHD

Panelist
Evdokia Korakianiti, PHD, MSC

FDA Reflection on Experiences with International Regulatory Collaboration and Opportunities
Ashley Boam, MS

Industry Experiences with Regulatory Reliance and Collaboration Initiatives
Joann M Parker, MS, RPH


Speakers
avatar for Ashley Boam

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States
Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s... Read More →
JP

Joann Parker

Vice President of Regulatory CMC, Pfizer, United States
avatar for Amanda Roache

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

2:30pm EDT

#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA
Monday June 15, 2026 2:30pm - 3:30pm EDT
204AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-535-L04-P; CME 1.00; RN 1.00

Senior 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, PHD

Speaker

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Tomoharu Numanyu, RPH


Speakers
JB

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands
Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States
Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →
TN

Tomoharu Numanyu

Senior Reviewer, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Tomoharu Numanyu is a Senior Scientific Officer in the Office of New Drug Review I at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. After obtaining his pharmacist license, he worked in the pharmaceutical industry for three years before joining PMDA in 2016. From 2016... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   03: Data-Tech-AI, Forum
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Health Technology & AI,Regulatory
  • Feature Topics Artificial Intelligence
  • Tags Forum

2:30pm EDT

#438: A Conversation About Quality: A Global Regulators Discussion
Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-537-L04-P; CME 1.00; RN 1.00

This 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.

Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

2:30pm EDT

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Monday June 15, 2026 2:30pm - 3:30pm EDT
117
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P; CME 1.00; RN 1.00

This 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, PHD

Speaker

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Sameera Ibrahim

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Leslie Sam

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Emily Gebbia, JD


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →
SI

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Forum
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Forum

2:30pm EDT

#444: Driving Efficiency in Clinical Development with Master Protocols
Monday June 15, 2026 2:30pm - 3:30pm EDT
116
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P; CME 1.00; RN 1.00

Master 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, PHD

Speaker

Pooling shared controls in platform trials: operational and statistical considerations
Megan McCabe, PHD

The Art of Borrowing: Practical Strategies to Power Master Protocols
Haitao Chu, MD, PHD

Learnings Across Master Protocols – A Design Perspective
Purvi Prajapti, PHD, MS


Speakers
HC

Haitao Chu

Senior Director, Pfizer, United States
Dr. Haitao Chu is a Senior Director at Pfizer’s Statistical Research and Data Science Center, a role he has held since 2022. He earned his PhD in Biostatistics from Emory University. Dr. Chu has held several academic appointments, including Assistant Professor of Epidemiology at... Read More →
avatar for Megan McCabe

Megan McCabe

Assistant Professor, Department of Biostatistics, The University of Alabama at Birmingham, United States
Megan McCabe is an Assistant Professor in the Department of Biostatistics at the University of Alabama at Birmingham (UAB), and the Assistant Director for Clinical Trials Development for the UAB DATA coordinating and Collaborative Research Unit (DATA CRU). She graduated with her PhD... Read More →
PP

Purvi Prajapati

Sr. Advisor, Eli Lilly, United States
Purvi earned her PhD in Statistics from Baylor University prior to joining Lilly in 2020. Since joining she’s been a member of the Clinical Design Team where she collaborates with multiple study teams to design clinical trials across all phases of drug development across the immunology... Read More →
avatar for Satrajit Roychoudhury

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States
Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →
Monday June 15, 2026 2:30pm - 3:30pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning
Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00

This 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, PHD

Speaker

Panelist
Shelley Gandhi, MS

Localisation of risk minimisation interventions – Low- and middle-income countries and global reliance
Jean-Christophe Delumeau, MD, PHD

Tailoring risk minimisation interventions - Applying implementation science and user-testing
Meredith Yearsley Smith, MPA, FISPE


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →
avatar for Delese Mimi Darko

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda
Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →
avatar for Jean-Christophe Delumeau

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic
Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
avatar for Meredith Yearsley Smith

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session

4:00pm EDT

#446: DIA2026-001: Co-Creating the Patient-Centric Trial Live
Monday June 15, 2026 4:00pm - 5:00pm EDT
108A
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-541-L04-P; CME 1.00; RN 1.00

In 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, MSC

Speaker

Panelist
Alexandra Charge

Panelist
Ross Jackson


Speakers
AC

Alexandra Charge

CEO, ISPEP, United Kingdom
A global life sciences executive, specialising in strategic transformation, innovation, and patient-centric approaches in healthcare, medicines development and clinical trial optimisation. As the CEO of the International Society for Patient Engagement Professionals, Alex is an active... Read More →
avatar for Farrell Healion

Farrell Healion

Founder & Managing Director, Optitrial, United Kingdom
Farrell Healion is the Founder and Principal Consultant of OptiTrial, where he partners with sponsors and study teams to deliver smarter, faster, and more connected clinical trials. With over 13 years of experience across sponsor and clinical technology roles, including at AstraZeneca... Read More →
RJ

Ross Jackson

Patient Recruitment Specialist, Ross Jackson Consulting, United Kingdom
A patient recruitment consultant who's worked on nearly 200 successful projects. Author of two Amazon best-selling books on patient recruitment, Ross provides advice and oversight to organizations that wish to improve the effectiveness of their patient recruitment activities - sponsors... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00

This 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, MPHARM

Speaker

ethical aspects of conducting MRCTs from a global perspective
Sarah A. White, MPH

Experience from global conduct of MRCTs
Aloka Chakravarty, PHD

Panelist
Paz Vellanki

PMDA perspective
Yoko Aoi, PHD


Speakers
avatar for Yoko Aoi

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
AC

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States
Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →
avatar for Angelika Joos

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →
PV

Paz Vellanki

Associate Director, OND, CDER, FDA, United States
avatar for Sarah White

Sarah White

Executive Director, MRCT Center, United States
Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  02: ClinicalTrialOps-Innovation, Forum |   08: RegPolicy-Strategy-GlobalCollaboration, Forum
  • Audience Intermediate
  • Area Global Alignment in Practice
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations,Regulatory
  • Feature Topics Global Alignment in Practice
  • Tags Forum

4:00pm EDT

#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications
Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-543-L04-P; CME 1.00; RN 1.00

This 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, MBA

Speaker

Panelist
T.J. Sharpe, PMP

Panelist
Shanelle Gabriel, MED


Speakers
avatar for Annick De Bruin

Annick De Bruin

Chief Research and Insights Officer, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP), United States
Annick de Bruin is the Chief Research and Insights Officer of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including... Read More →
SG

Shanelle Gabriel

Patient Advocate, N/A, United States
SG

Shanelle Gabriel

Patient Advocate/Speaker/Poet, Building Constellations, LLC, United States
Shanelle Gabriel is an internationally touring poet, speaker, communications consultant, and lupus patient advocate. She has performed globally gracing stages from Carnegie Hall to the Vatican. As a creative strategist, she has crafted poetry on various themes for events and for campaigns... Read More →
avatar for Ellyn Getz

Ellyn Getz

Director, R&D Patient Engagement, CSL Behring, United States
Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States
T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   02: ClinicalTrialOps-Innovation, Session

4:00pm EDT

#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-544-L04-P; CME 1.00; RN 1.00

Discover 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, MPH

Speaker

Panelist
Melody Chessia

Panelist
Kevin Bugin, MS, RAC

Panelist
Teginder Singh, MPHARM


Speakers
avatar for Kevin Bugin

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States
Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
MC

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
avatar for Ashley Jones-Mitchell

Ashley Jones-Mitchell

Head of Global Regulatory Policy, Accumulus Synergy, United States
Ashley is Head of Global Regulatory Policy for Accumulus Synergy. With over 19 years of experience in the federal government and industry, Ashley advocates for policies that will advance digital transformation. Prior to her time at Accumulus Synergy, Ashley was with the U.S. Food... Read More →
TS

Teginder Singh

Global Head Regulatory Quality Safety, Google, United States
Teginder Singh is a senior executive and pharmacist with over 25 years of leadership in health & life sciences. His early career focused on drug discovery, and he has since led complex transformation programs across R&D, Regulatory, Quality and Safety at Fortune50 companies like Google... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  03: Data-Tech-AI, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session

4:00pm EDT

#450: Medical Writing Ted Experience
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P; CME 1.00; RN 1.00

Medical 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, PHD

Speaker

Panelist
Anna Whitling, PHARMD

Everyone Thinks They Can Write: Why Medical Writers Make the Difference
Monica Chiaramonte, PHD

Amid the Ballyhoo Over AI, What Are We Losing?
Steve Sibley, MS


Speakers
avatar for Monica Chiaramonte

Monica Chiaramonte

Director, Clinical Regulatory Writing, AstraZeneca, United States
Monica Chiaramonte is a Director of Clinical Regulatory Writing at AstraZeneca, with over 35 years in the scientific field and 19 years in Medical Writing across CRO and pharmaceutical settings. She brings deep expertise in authoring and leading high quality regulatory submissions... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →
AW

Anna Whitling

Senior Manager of Medical Writing, Alcon Laboratories, Inc, United States
Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Forum |   03: Data-Tech-AI, Forum

4:00pm EDT

#451: Race/Ethnicity, Ancestry, and Clinical Phenotype Real-World Data to Precisely Anticipate Treatment Effectiveness and Patient Outcomes
Monday June 15, 2026 4:00pm - 5:00pm EDT
116
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-546-L04-P; CME 1.00; RN 1.00

Real-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, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS


Speakers
avatar for Lysel Brignoli

Lysel Brignoli

Associate Principal, RWE, Oracle Life Sciences, France
Lysel Brignoli is an expert in Real-World Evidence and epidemiologic research, with over a decade of experience designing and leading studies that generate insights for healthcare decision-making. Her work focuses on innovative study designs, patient registries, and the integration... Read More →
avatar for Rachele Hendricks-Sturrup

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Margolis Institute For Health Policy (DMI), United States
Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →
avatar for Carla Rodriguez-Watson

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Tags Session

4:00pm EDT

#452: Mentorship Myth Busters: Moving Beyond Misconceptions
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-547-L04-P; CME 1.00; PDU 1.00 PMI 2166DNFT53; RN 1.00

Mentorship 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 Morales

Speaker

Mentorship Myth Busters: The Court of REAL Mentorship
Leslie Sam

Mentorship Myth Busters: The Court of REAL Mentorship
Tywnia Brewton

panelist
Sabhorak Horn, PHARMD, MBA, RPH


Speakers
avatar for Tywnia Brewton

Tywnia Brewton

Executive Director, Human Resources, United States
Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
avatar for Sabhorak Horn

Sabhorak Horn

Medical Omnichannel Education Manager, Eli Lilly and Company, United States
Sabhorak Horn is a licensed pharmacist with a dual degree from the Philadelphia College of Pharmacy. Sabo is driven by his long-term vision of leading innovation in pharma. He is passionate about medical affairs as the bridge between data, people, and real-world impact, with a growing... Read More →
avatar for Carol Morales

Carol Morales

Lead, Quality Management and Capabilities, Astellas, United States
Carol Morales is a Quality Management & Capabilities Lead with a strong focus on professional development, mentorship, and building sustainable learning cultures within the life sciences. She brings extensive experience in designing and leading development initiatives that bridge... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, LLC, United States
With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  06: ProfDevelop-Program-PortfolioMgmt, Session

4:00pm EDT

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00

Explore 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, MS

Speaker

Defining and Controlling Raw and Starting Materials for CGT Manufacturing
Kevin Carrick, PHD

Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
Andrew Chang, PHD

Setting specifications for ATMPs: insights from the ICHQ6 revision
Cecilia Tami, PHD

Stability Considerations for Cell and Gene Products
Akanksha Kaushal, MS


Speakers
avatar for Kevin Carrick

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States
Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →
avatar for Andrew Chang

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... Read More →
avatar for Akanksha Kaushal

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States
Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →
avatar for Lesbeth Rodriguez

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States
Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
avatar for Cecilia Tami

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, A Member of the Roche Group, United States
Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session

4:00pm EDT

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P; CME 1.00; RN 1.00

The 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

Speakers
avatar for Amira Younes

Amira Younes

Director- Europe, Middle East & Africa (EMEA), Global Regulatory Policy, MSD, United Arab Emirates
Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum

4:00pm EDT

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00

This 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, MD

Speaker

Panelist
Laura Jawidzik, MD

Panelist
Lauren Krupp, MD

Panelist
Lynne Yao, MD


Speakers
avatar for Christina Bucci-Rechtweg

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States
Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →
LJ

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States
Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →
LK

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   02: ClinicalTrialOps-Innovation, Forum

4:00pm EDT

#455: Japan Town Hall
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00

This 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, MSC

Speaker

Panelist
Seiko Usami, PHD

Panelist
Yoshiaki Uyama, PHD, MS, RPH


Speakers
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →
SU

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Session |   02: ClinicalTrialOps-Innovation, Session

4:00pm EDT

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

Explore 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, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD


Speakers
JA

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States
KB

Kara Berasi

CEO, Haystack Project, United States
Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →
avatar for Bridget Doherty

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States
Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →
avatar for Alexis Miller

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  08: RegPolicy-Strategy-GlobalCollaboration, Forum |   10: Stats-EvidenceGeneration-RWE, Forum
  • Audience Basic
  • Area Evidence Innovation
  • Level Basic
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
  • Feature Topics Evidence Innovation
  • Tags Forum

4:00pm EDT

#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations
Monday June 15, 2026 4:00pm - 5:00pm EDT
117
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P; CME 1.00; RN 1.00

Explore 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 trials

Learning 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, MD

Speaker

Overview of MHRA's GCP Inspections
Rachel Mead


Speakers
avatar for Rachel Mead

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →
avatar for Jenn Sellers

Jenn Sellers

Chief, GCP Assessment Branch, FDA, United States
Dr. Sellers serves as Chief of the Good Clinical Practice (GCP) Assessment Branch in the Office of Scientific Investigations at the U.S. FDA, where she leads the evaluation of GCP compliance and provides regulatory recommendations in support of marketing applications. She is a board-certified... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   02: ClinicalTrialOps-Innovation, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Quality Assurance / Control & CMC
  • Tags Session

4:00pm EDT

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding
Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-554-L04-P; CME 1.00; RN 1.00

This 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, PHD

Speaker

Choosing an Index Date for Untreated Patients in External Comparator Studies
Ju Hwan Kim, PHARMD, PHD

Quantifying and mitigating measurement bias in real-world endpoints when constructing external control arms
Benjamin Ackerman, PHD

Choosing an Index Date for Untreated Patients in External Comparator Studies
Gerd Rippin, PHD


Speakers
avatar for Benjamin Ackerman

Benjamin Ackerman

Principal Scientist, Biostatistics, Johnson & Johnson, United States
Ben Ackerman is a Principal Scientist at Johnson & Johnson Innovative Medicine, where he provides support across therapeutic areas to design and analyze randomized trials, namely those that combine trial data with real-world data. He has expertise in causal inference methods to address... Read More →
avatar for Benjamin Ackerman

Benjamin Ackerman

Director, Real-world Biostatistics, GSK, United States
Ben Ackerman is a Director of Real-world Biostatistics at GSK, where he designs and analyzes real-world evidence studies in oncology. He has expertise in causal inference methods to address various biases in both randomized trials and non-experimental studies. Previously, he led a... Read More →
JH

Ju Hwan Kim

Research Professor, Sungkyunkwan University, Korea, Republic of
Ju Hwan (Joe) Kim, PharmD, PhD, is a Research Professor at the School of Pharmacy, Sungkyunkwan University, South Korea. His work spans pharmacoepidemiology, clinical pharmacy, regulatory science, and real-world data/evidence. He leads international collaborative studies leveraging... Read More →
avatar for Gerd Rippin

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Session

4:00pm EDT

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00

This 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 regions

Learning 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, MS

Speaker

Panelist
Motiur Rahman, PHD, MPHARM, MS

Panelist
Denise Umuhire, MBA, MSC

Panelist
Tricia Luhn, PHD, MPH


Speakers
avatar for Gracy Crane

Gracy Crane

Policy Lead, Roche, United Kingdom
Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →
TL

Tricia Luhn

RWD Oncology, Genentech, United States
TL

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... Read More →
DU

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands
I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  10: Stats-EvidenceGeneration-RWE, Forum |   02: ClinicalTrialOps-Innovation, Forum
  • Audience Intermediate
  • Area Evidence Innovation
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Development & Operations
  • Feature Topics Evidence Innovation
  • Tags Forum
 
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DIA 2026 Global Annual Meeting
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102AB
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Ballroom AB
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TBD
Zone A
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
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  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
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  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation