DIA 2026 Global Annual Meeting: Full Schedule

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures

Monday June 15, 2026 8:00am - 10:00am EDT

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

David Fajgenbaum

Co-Founder & President of Every Cure, Every Cure, United States

Audrey Greenberg

Mayo Clinic, Venture Partner and Chair, Mayo Ventures, United States

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 →

David Pfeiffer

SVP, Head of ARCAS, Bio-Tech, Acrisure Re, United States

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 →

Lawrence Tallon

Chief Executive Officer, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

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

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Interest Area Health Technology & AI,Biotechnology & Investors
Feature Topics Digital Enablement and Modernization
Tags 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

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 →

Angela Radcliff

Lead, Research and Early Development, Digital Performance, Bristol Myers Squibb, United States

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

#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

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 →

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

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 →

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 →

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 →

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States

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 →

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

Audience Intermediate
Area Cross-Functional Collaboration, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Cross-Functional Collaboration,Digital Enablement and Modernization
Tags 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

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 →

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 →

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 →

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

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

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 →

Jimita Parekh

Managing Director, Independent, United States

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

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

Audience Intermediate
Area Artificial Intelligence, Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Artificial Intelligence,Global Alignment in Practice
Tags 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

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 →

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 →

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

#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

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 →

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 →

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 →

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

#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

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 →

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 →

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

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

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 →

Shanelle Gabriel

Patient Advocate, N/A, United States

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 →

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 →

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

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Development & Operations
Feature Topics Patient-Centered Design and Experience
Tags 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

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 →

Melody Chessia

Director of Product Management, Accumulus Technologies, United States

Melody Chessia

Director of Product Management, Accumulus Technologies, United States

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 →

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

Audience Intermediate
Area Artificial Intelligence, Global Alignment in Practice, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence,Global Alignment in Practice,Digital Enablement and Modernization
Tags 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

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 →

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 →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States

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

Audience Intermediate
Area Artificial Intelligence, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence,Student and Early Career Pathway
Tags 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

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 →

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 →

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

10:15am EDT

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration

Tuesday June 16, 2026 10:15am - 11:30am EDT

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P; CME 1.25; RN 1.25

This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.

Learning Objectives

Identify algorithmic innovations that address signal detection challenges in vulnerable populations; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.

Chair

Ju-Young Shin, PHD

Speaker

Recent advances in PV innovation: implementing/deploying for practical impact
Raymond Kassekert, MBA

A method for systematically retrieving pregnancy-related reports
Daniele Sartori, MSC

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Raymond Kassekert

Executive Director, PV Systems Management, GSK, United States

Ray is Executive Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the MedDRA... Read More →

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 →

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre (UMC), Sweden

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →

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 →

Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Safety & Pharmacovigilance
Feature Topics Artificial Intelligence
Tags Session

10:15am EDT

#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development

Tuesday June 16, 2026 10:15am - 11:30am EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-566-L04-P; CME 1.25; RN 1.25

This session covers the importance of data sharing and the new tools that might enable that pooling and integration in order to facilitate progress in personalized medicine and ensure faster access to treatments for the oncology patients who need them the most.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of oncology data pooling efforts and the advancements offered by AI that can allow faster integration; Describe emerging programs and global initiatives designed to facilitate faster oncology drug development; Assess various considerations and strategies that are meaningful to both physicians and patients.

Chair

Alberto Grignolo, PHD

Speaker

Panelist
Beth Meagher, MA

Panelist
Sean Khozin, MD, MPH

Panelist
Stacy Hurt, MBA, MHA

Leveraging Federated AI and Open Data to Transform Oncology Research and Development
Maria Vassileva, PHD

Panelist
Joseph Kannarkat, MD

Speakers

Alberto Grignolo

Editor-in-Chief, DIA Global Forum, United States

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion... Read More →

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States

Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →

Sean Khozin

CEO, Roundtable on Cancer (CEORT) and Project Data Sphere (PDS), United States

Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine... Read More →

Beth Meagher

Principal, Deloitte Consulting, United States

Beth Meagher is a Deloitte Consulting LLP principal and leader of the Federal Monitor Deloitte Strategy practice. She started and leads Deloitte's Translational Medicine, which bring strategy, informatics, clinical, and research capabilities together on collaborative teams. Beth focuses... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Therapeutic Pathways, Artificial Intelligence, Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Therapeutic Pathways,Artificial Intelligence,Therapeutic Pathways
Tags Session

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech

Tuesday June 16, 2026 10:15am - 11:30am EDT

103A

Component Type: Session
Level: Intermediate

Many clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.

Learning Objectives

Design and execute a streamlined customer discovery process to validate unmet needs, buying triggers, and budget ownership before finalizing a go-to-market strategy; Translate insights into a sales learning roadmap that tests positioning, pricing, compliance, and objections to reduce commercial risk before raising capital; Align GTM and fundraising with validated demand to present a credible revenue story.

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA

Speakers

Laura Hilty

Principal, HealthX Ventures, United States

Jeff Lee

Board Director, Medstar Health Research Institute, United States

Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States

Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →

Dan Sndyer

The Playbook, United States

Dan Sndyer

The Playbook, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Digital Enablement and Modernization, Cross-Functional Collaboration
Level Intermediate
format csv
Interest Area Data Management & Data Standards,Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway,Digital Enablement and Modernization,Cross-Functional Collaboration
Tags Session

10:15am EDT

#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies

Tuesday June 16, 2026 10:15am - 11:30am EDT

111AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-560-L04-P; CME 1.25; RN 1.25

Clinical trial start-up is often delayed by manual processes, fragmented systems, and inconsistent data. This workshop will explore how biopharmaceutical companies are using AI and interoperable data standards to enable patient centric study designs.

Learning Objectives

Explain how AI and USDM (the CDISC digital protocol data standard) work together to streamline study design and protocol development; Discuss ways to achieve patient-centric design and reduced patient burdens using AI in conjunction with clinical standards; Examine how data standards enable interoperability and multi-stakeholder collaboration including with sites and patients.

Chair

William Illis, MPH

Speaker

Panelist
Nicholas Brooke, MBA

Panelist
Prasanna Rao

Panelist
Vivian Dewoskin, MBA

Panelist
Sahishnu Patel, PHD

Speakers

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), The Synergist, Belgium

Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →

Vivian Dewoskin

Chief Commercial Officer, Faro Health Inc., United States

Vivian is the Chief Commercial Officer at Faro, where she leads sales, marketing, and commercial strategy. She works closely with Faro’s customers to understand their needs and goals, and translate them into Faro’s product development roadmap. Prior to Faro, Vivian held multiple... Read More →

William Illis

Executive Director, Technology and Scientific Computing, Novartis , United States

Bill is Executive Director, Technology and Scientific Computing in the Advanced Quantitative Sciences line function at Novartis. He responsible for developing and implementing the analytics technology strategy focused on end-to-end clinical data flows, systems and processes. For the... Read More →

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States

Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →

Prasanna Rao

Chief Products and Innovation Officer, Saama, United States

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Workshop

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Data Management & Data Standards
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Workshop

10:15am EDT

#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development

Tuesday June 16, 2026 10:15am - 11:30am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P; CME 1.25; RN 1.25

This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.

Learning Objectives

Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches; Apply FDA recommendations for use of AI/RWE in regulatory submissions.

Chair

Marie Bradley, MPH

Speaker

Panelist
Hussein Ezzeldin, PHD

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States

Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee... Read More →

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States

Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Evidence Innovation, Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Regulatory
Feature Topics Evidence Innovation,Artificial Intelligence
Tags Session

10:15am EDT

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

Tuesday June 16, 2026 10:15am - 11:30am EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-564-L04-P; CME 1.25; RN 1.25

Examines how fragmented policies, trade barriers, pricing pressures, and other restrictions create innovation gridlock—blocking or stalling R&D, delaying clinical trials, disrupting supply, and threatening patient access to critical therapies.

Learning Objectives

Identify key policy and regulatory misalignments contributing to innovation gridlock in biopharma; Assess the global impact of these barriers on patient access to transformative therapies. and prioritize action based on criticality; Examine opportunities and actionable policy levers to realign systems and accelerate innovation for patients.

Chair

Alexis Reisin Miller, JD

Speaker

PMDA perspective
Daisuke Koga, MS, MSC

Industry perspective
Michelle Rohrer, PHD

Speakers

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 →

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 →

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech, A Member of the Roche Group, United States

Michelle Rohrer, PhD is Global Head of Product Development Regulatory at Genentech Roche. Michelle has worked at the company for 31 years, starting as a post-doctoral fellow. Michelle's awards include SF Business Times “The Most Influential Women in Bay Area Business” and PharmaVOICE... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Digital Enablement and Modernization, Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Digital Enablement and Modernization,Artificial Intelligence
Tags Forum

1:45pm EDT

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

108B

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25

This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.

Learning Objectives

Describe how synthetic AI patient personas can augment real patient input to personalize and improve patient trial experience; Identify the data requirements and limitations for building synthetic AI personas.

Chair

Robina Weermeijer

Speaker

Panelist
Jason Binder, MA

Panelist
Himanshu Manchanda, PHD

Panelist
Sabina Kineen

Speakers

Jason Binder

Founder & CEO, Ember, United States

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 →

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany

Robina Weermeijer

Boehringer Ingelheim, Netherlands

Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Basic
Area Artificial Intelligence, Patient-Centered Design and Experience
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Patient Engagement
Feature Topics Artificial Intelligence,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-572-L04-P; CME 1.25; RN 1.25

This session explores strategies to implement AI, cloud, and different data sources across the drug lifecycle and in regulatory activities to deliver patient benefits. Experts will discuss pilots, policies, and partnerships that can enable faster access to safe and effective medicines.

Learning Objectives

Explain how AI, cloud, and data can be utilized in regulatory processes to accelerate patient access to therapies; Assess implementation strategies that balance innovation with patient safety and trust; Identify collaborative models that embed patient-centric principles into digital regulatory ecosystems.

Chair

Rebecca Nebel, PHD

Speaker

Panelist
Kimberly Ann Beer, MA

Panelist
Andrew Robertson, JD, PHD

Panelist
Jonathan Walsh, PHD

Speakers

Kimberly Beer

Senior Vice President, Policy & External Affairs, National Health Council, United States

Kimberly Beer is Senior Vice President of Policy and External Affairs at the National Health Council, where she leads policy and advocacy to improve access to affordable, high-quality care for people with chronic conditions and disabilities. She previously served as Senior Director... Read More →

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States

Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →

Rebecca Nebel

Deputy Vice President, Science and Regulatory Advocacy, Phrma, United States

Rebecca Nebel

Director, Global Regulatory Policy and Intelligence, Amgen, United States

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States

Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →

Jonathan Walsh

Chief Scientific Officer, Unlearn.AI, United States

Jon Walsh is the co-founder and Chief Scientific Officer of Unlearn.AI and a physicist by training. At Unlearn, Jon leads the integration of digital twins into drug development, with a particular focus on regulatory pathways and the intersection of statistics and machine learning... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Digital Enablement and Modernization
Tags Session

1:45pm EDT

#533: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

111AB

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-573-L04-P; CME 1.25; RN 1.25

AI pilots are everywhere; enterprise impact is rare. Governance separates AI that works once from AI that works reliably. Join pharma, regulator, and tech leaders to explore how data ownership, content models, and process controls enable trustworthy AI.

Learning Objectives

Explain why scalable AI requires foundational data, content, and process governance; Design governance mechanisms that align data standards (IDMP, CDISC) with structured content management principles; Evaluate regulatory expectations and industry hurdles related to data integrity, reliance, and trust in AI-driven or assisted processes; Assess and address organizational gaps that limit AI deployment.

Chair

Vanni Carapetian, MPH

Speaker

Industry Perspectives on AI + Governance: Policy
Andrew Robertson, JD, PHD

Industry Perspectives on AI + Governance: Tech
Jeff Steinke

Industry Perspectives on AI + Governance
Vada Perkins, MS

Speakers

Vanni Carapetian

Senior Director, Regulatory Data, Genentech, A Member of the Roche Group, United States

Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, United States

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States

Jeff Steinke

Founder, TE Digital Limited, United Kingdom

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Basic
Area Artificial Intelligence, Global Alignment in Practice
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Artificial Intelligence,Global Alignment in Practice
Tags Session

1:45pm EDT

#535: Unlock AI's Full Potential: The Power of FAIR Data

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

119AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-574-L04-P; CME 1.25; RN 1.25

AI underperforms when data isn’t machine-actionable. This talk shows how FAIR + open standards turn fragmented R&D data into fuel for LLMs and analytics—via a mini-rubric, case studies, and a 90-day roadmap to lift AI-readiness.

Learning Objectives

Apply a mini-FAIR rubric to one dataset/document to diagnose AI-readiness and summarize 2–3 priority gaps; Recognize and select the appropriate standards—such as PIDs, metadata, controlled vocabularies, that best enable a target AI use case (e.g., RAG, model reuse); Recognize the key components of a 90-day plan—including roles, metrics, checkpoints—designed to elevate FAIR maturity and improve AI outcomes.

Chair

Anuj Uppal, MS

Speaker

AI Readiness Organizational Barriers
Kathleen Rand, PHARMD

AI Readiness: A Statistical View
Kaveen Hiniduma

The FAIR Principles: 10 Years Later
Ted Slater, MA, MS

Speakers

Kaveen Hiniduma

Graduate Research Associate, Ohio State University, United States

Kathleen Rand

Principal Scientist, Procter & Gamble, United States

Ted Slater

Global Head, Knowledge Engineering & Data Advisory, EPAM Systems, United States

My work focuses on FAIR Data and the application of semantic technologies and artificial intelligence to scientific problems in pharmaceutical R&D and related fields. I am a molecular biologist and a computer scientist.

Anuj Uppal

Vice President, Life Sciences Transformation, Campana & Schott, United States

Anuj Uppal is a data scientist and AI product leader at Campana & Schott who builds intelligent platforms that transform how life sciences organizations assess data readiness. His creation, DATA Compass, challenges the industry assumption that "clean data" equals "AI-ready data"—a... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

1:45pm EDT

#534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks, Pitch Decks, and Any Talk of a Lifetime

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

103A

Component Type: Workshop
Level: Intermediate

In this interactive workshop, coach Jeff Smith shares essential building blocks – Prep as Empathy, the Impact Wave, Visuals on Purpose, and Dynamic Delivery – used to shape “talks of a lifetime,” from founding pitch decks to keynote and TED stages.

Learning Objectives

Use preparation as an empathy tool to align with enterprise/pharma stakeholders; Structure pitches using the “Impact Wave” to guide audiences from problem recognition to urgency to action; Design clear visuals that increase trust and decision velocity; Elevate delivery using the “Dynamism Checklist” to project confidence and persuasive presence.

Chair

Jeff Smith

Speakers

Jeff Smith

The Curator, Smith and Jones Innovation, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Workshop | 06: ProfDevelop-Program-PortfolioMgmt, Workshop | 18: Lift-Series, Workshop

Audience Intermediate
Area Biotech-ClinTech-Pathway
Level Intermediate
format csv
Interest Area Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway
Tags Workshop

4:15pm EDT

#550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-586-L04-P; CME 1.00; RN 1.00

This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real world GxP implementation. Attendees will gain insight into regulatory convergence, operational challenges, and good practices for compliant AI adoption.

Learning Objectives

Compare and contrast US and EU regulatory frameworks governing AI use across the drug development lifecycle; Assess how regulatory expectations and emerging convergence efforts translate into practical implementation challenges; Identify good practices for operationalizing AI within GxP quality systems while maintaining compliance and innovation.

Chair

Junyang Wang, MSC

Speaker

Panelist
Martin Benedikt Heitmann, MS

Panelist
Luis Pinheiro, PHARMD, MSC

Panelist
Joaquim Berenguer Jornet, MS

Speakers

Martin Heitmann

Volunteer – ISPE GAMP Guide Artificial Intelligence Co-Lead, Secretary of the GA, International Society for Pharmaceutical Engineering (ISPE), Germany

Martin Heitmann is a trained business mathematician and serves as consultant and advisor to organizations in the Life Sciences. He holds a decade of experience focusing on technology, innovation, and transformation. He drives progress and inspires excellence in life sciences, while... Read More →

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce at the European Medicines Agency. He is a rapporteur for the AI workstream of the NDSG Data and AI Workplan, with a special focus on Guidance Development. He coordinates the Health Data... Read More →

Junyang Wang

Global Regulatory and Scientific Policy, EMD Serono, United States

Junyang Wang, MSc has over 15 years of public health experience and over a decade of combined regulatory policy and stakeholder engagement experiences across drugs, devices, and digital. He currently serves as Director for US Global Regulatory and Scientific Policy (GRASP) at EMD... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

4:15pm EDT

#551: Operationalizing Large Language Models in Drug Development

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-585-L04-P; CME 1.00; RN 1.00

Generative AI and large language models (LLMs) are reshaping drug development and Real-World Evidence (RWE). This session explores real-world applications, debunks common myths, and outlines what’s needed for safe, scalable, and compliant use across the drug development lifecycle.

Learning Objectives

Distinguish between the current capabilities and limitations of generative AI and large language models (LLMs) in drug development; Identify practical and regulatory challenges in adopting GenAI across evidence generation workflows; Discuss future opportunities for integrating GenAI into the various areas of the drug development pipeline; Identify/mitigate bias in regulated workflows

Chair

Wesley Anderson, PHD

Speaker

GenAI for literature-based evidence synthesis: From systematic literature review to digitization of trial publications
Emily Nieves

Panelist
Danielle Boyce, MPH

Speakers

Wesley Anderson

Scientist, Quantitative Medicine, Critical Path Institute, United States

Wes Anderson, Ph.D. is a Quantitative Medicine Scientist at the Critical Path Institute, where he develops data-driven solutions to support drug development using machine learning, artificial intelligence, natural language processing, and informatics. He has also contributed to the... Read More →

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Dr. Danielle Boyce is Principal Investigator of Real World Evidence at the ALS Therapy Development Institute and a faculty member at Johns Hopkins University, with affiliations at the University of Calgary, University of Chicago, and Emory University. A mother of a child with rare... Read More →

Emily Nieves

CEO/ Co-Founder, Delineate, United States

Emily Nieves is the co-founder and CEO of Delineate, a seed-stage startup partnering with pharmaceutical companies to accelerate Model-Informed Drug Development workflows through advanced AI techniques. Prior to founding Delineate, Emily pursued graduate studies in Biological Engineering... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Artificial Intelligence, Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics,Health Technology & AI
Feature Topics Artificial Intelligence,Evidence Innovation
Tags Session

10:15am EDT

#603.1: Case Studies on AI-Enabled and Analytical Practices and Solutions Reducing Site and Participant Burden in Clinical Trials

Wednesday June 17, 2026 10:15am - 11:30am EDT

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-598-L04-P; CME 1.25; RN 1.25

In this session, sponsor companies present use cases on strategies and solutions deployed (e.g., digitized protocols and AI-enabled tool) to simplify protocol design and reduce participant and site burden.

Learning Objectives

Discuss case examples profiling solutions and practices that sponsors have implemented to measure and reduce participant and site burden in clinical trials; Identify key factors driving burden in clinical trials; Describe approaches and experience with digitized protocol designs and AI-enabled protocol planning and design solutions.

Chair

Abigail Dirks, MS

Speaker

Panelist
Stephanie Christopher, MA

Panelist
Katrina Mateo, PHD, MPH

Speakers

Stephanie Christopher

Patient Engagement and Advocacy Lead, Pfizer, United States

Stephanie Christopher is a Patient Engagement and Advocacy Lead at Pfizer, where she supports clinical research teams to bring patient perspectives into the design and implementation of clinical trials and recruitment strategies. In this role, she supports Pfizer’s Breast, Genitourinary... Read More →

Abigail Dirks

Senior Data Scientist, Tufts Center for the Study of Drug Development, United States

Abigail Dirks is a Senior Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative... Read More →

Katrina Mateo

Associate Director, Development Innovation, Regeneron Pharmaceuticals, United States

Katrina F. Mateo, PhD MPH, is a public health researcher, interventionist, and strategist bringing evidence-based, human-centered solutions to complex challenges. She leverages qualitative/mixed-method research methodology, human-centered design thinking, systems-thinking, behavioral... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence, Digital Enablement and Modernization
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

10:15am EDT

#605: Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech

Wednesday June 17, 2026 10:15am - 11:30am EDT

109AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-602-L04-P; CME 1.25; RN 1.25

Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.

Learning Objectives

Differentiate between AI-native and traditional pharma/biotech models in drug development; Assess regulatory expectations for AI from FDA, EMA, and the EU AI Act; Apply strategies to establish AI model credibility for regulatory decision-making.

Chair

Mark Rutter

Speaker

Panelist
Graziella Collu, DRSC, MS, MSC

Panelist
Hussein Ezzeldin, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Panelist
Megha Sinha

Speakers

Graziella Collu

Vice President, Global Regulatory, AstraZeneca, Netherlands

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States

Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →

Mark Rutter

Vice President, Regulatory Affairs, Formation Bio, United States

Mark Rutter is Vice President, Regulatory Affairs at Formation Bio, where he leads regulatory strategy across the development portfolio with a focus on innovative approaches to evidence generation. He brings extensive experience from leadership roles at Biogen, AbbVie, and Celgene... Read More →

Megha Sinha

CEO, Kamet Consulting Group, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Forum

10:15am EDT

#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies

Wednesday June 17, 2026 10:15am - 11:30am EDT

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-600-L04-P; CME 1.25; RN 1.25

This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation turning the digital by default ambition into practice, combining legislative reforms with digital and AI strategies.

Learning Objectives

Describe the digital by default ambition of the New EU Pharmaceutical Legislation; Explain how digitalization and AI enable more agile, transparent, and patient-centered processes, that drive efficiency, productivity and innovation in regulatory science and operations; Discuss practical implementation challenges related to trust, quality, data interoperability, and organizational readiness.

Chair

Joaquim Berenguer Jornet, MS

Speaker

Panelist
Derick Mitchell

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Gabriel Westman, MD, PHD, MSC

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark

Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →

Derick Mitchell

Executive Director PFMD, The Synergist/Pfmd, Ireland

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 →

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden

GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

10:15am EDT

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

Wednesday June 17, 2026 10:15am - 11:30am EDT

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objectives

Describe the core principles of Gen AI and explain their relevance to clinical operations; Identify practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

Chair

Ioannis Spyroglou, PHD

Speaker

Panelist
Roshan D'Souza

Bootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation Reporting
Frederik Collin, MS

Operational Impact, Scaling, and Limitations: From Algorithm to Practice
Karin Jonczak

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.

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 →

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States

Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics,Health Technology & AI
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

108B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00

This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.

Learning Objectives

Analyze new benchmarks on the distribution of protocol data across core, standard, and non-core endpoints; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden; Discuss strategies to evaluate protocol data collection, simplify design and lower participation burden.

Chair

Kenneth Getz, MBA

Speaker

New Benchmarks on Clinical Trial Data Collection Practices and their Impact
Kenneth Getz, MBA

Frameworks and Tools Guiding Optimization of Protocol Data Collection
Jackie Cole, MS

Speakers

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States

Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →

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 →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Data Management & Data Standards
Tags Session

1:45pm EDT

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

109AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-618-L04-P; CME 1.00; RN 1.00

This session presents AI consortium working group assessments on regulatory frameworks, use case classification, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.

Learning Objectives

Apply standardized AI use case classification frameworks to drug development and research-related scenarios; Recognize risk-based, practical assessment, governance and validation approaches for AI systems across regulatory contexts and use cases; Demonstrate utilizing aligned terminology for cross-jurisdictional AI discussions.

Chair

Sridevi Nagarajan, PHD

Speaker

Panelist
Carrie Nielson, MPH

Panelist
Michael Lingzhi Li, PHD

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Venkatraman Balasubramanian, MBA

Panelist
Leon Rozenblit, JD, PHD

Panelist
Christina Mack, MPH

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Michael Lingzhi Li

Assistant Professor, Harvard Business School, United States

Michael Lingzhi Li is an Assistant Professor in the Technology and Operations Management unit at Harvard Business School. His research focuses on the end-to-end development of decision algorithms based on machine learning, causal inference and operations research. He examines the... Read More →

Christina Mack

CSO RWE and SVP AAIS, IQVIA, United States

Christina Mack, Ph.D. is senior vice president of Applied AI Science within the AI and Technology Solutions (ATS) business, where she is responsible for driving scientific and technical innovation across the organization that has direct impact on patient health. Dr. Mack also leads... Read More →

Sridevi Nagarajan

DIA Communities Chair for AI in Healthcare, Ayusarogya, United Kingdom

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →

Leon Rozenblit

Executive Director, Q.E.D. Institute, United States

Leon Rozenblit is a nationally recognized thought leader at the intersection of clinical research informatics and AI governance. As Co-Founder and Executive Committee member of the DCI Network at Beth Israel Deaconess Medical Center, Harvard Medical School, he has co-organized two... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Forum

1:45pm EDT

#626: Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-616-L04-P; CME 1.00; RN 1.00

Comprehensive benchmarking of four major LLMs across 100 FDA approval packages identifies optimal models for regulatory tasks. Study provides critical insights on accuracy, limitations, and implementation strategies for regulatory AI adoption.

Learning Objectives

Identify which LLM models demonstrated highest accuracy of generative AI for extracting critical regulatory data from FDA approval packages; Recognize key limitations and failure modes when using LLMs for regulatory intelligence, including hallucination rates and performance degradation patterns; Apply evidence-based benchmarking to select an LLM

Chair

Sam Kay, RAC

Speaker

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Cameron Kieffer, PHD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Jeff MacDonald, PHARMD

Navigating the Regulatory Labyrinth: How Well Do Language Models Read the Fine Print?
Aleksandr Merenkov

Speakers

skay8

VP of Pharmaceutical Strategy, Basil Systems, United States

Sam Kay is Vice President of Pharma at Basil Systems, where he leads AI-powered regulatory intelligence solutions for global pharmaceutical companies. A recognized authority in the field, Sam co-authored Chapter 6 of Regulatory Intelligence Reimagined (RAPS) and teaches Regulatory... Read More →

Cameron Kieffer

Director, Global Regulatory Intelligence and Policy Research, Takeda, United States

Jeff MacDonald

Associate Director, Global Regulatory Policy and Intelligence, BeOne Medicines, United States

Aleksandr Merenkov

Associate Director, Global Regulatory Intelligence, Genmab US, Inc., United States

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence
Tags Session

1:45pm EDT

#627: Patient-Directed Data Sharing: Enabling Innovations While Including Patients in Decisions about Secondary Data Use

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

111AB

Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-615-L04-P; CME 1.00; RN 1.00

We’ll review the history, laws, and policies of the current data sharing environment. We’ll discuss ethical considerations for why the typical approach to consent and deidentification of data hinder trust and innovation. We’ll give a case study of pa

Learning Objectives

Describe the history of data sharing and the laws and policies that have informed it; Discuss the ethical considerations for shifting our mindset about data access permissions; Apply a patient-directed mindset to data access to unlock innovation and improve data utility

Chair

Karla Childers, MS

Speaker

Panelist
Mary Gray, PHD

Panelist
Aaron Leibtag

Panelist
Sarah Chamberlin

Speakers

Sarah Chamberlin

Founder and Chief Program Officer, flok, United States

Sarah Chamberlin is Founder & Chief Program Officer of flok Health, a nonprofit advancing care and research for inherited metabolic disorders. She is a leader in patient-directed research and participatory data models, building community-powered data infrastructure that centers patient... Read More →

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →

Mary Gray

Senior Principal Researcher, Microsoft Research, United States

Mary L. Gray is a Senior Principal Researcher at Microsoft Research and a leading scholar of the social and ethical dimensions of data-driven AI systems. Trained as an anthropologist, her research examines how digital infrastructures shape labor, identity, and human rights. She leads... Read More →

Aaron Leibtag

CEO, Pentavere, Canada

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Advanced
Area Ethics, Trust and Responsible Innovation
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation
Tags Forum

4:00pm EDT

#646: Accelerating AI-Enabled Drug Discovery and Development with Federated Computing

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

109AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-633-L04-P; CME 1.00; RN 1.00

Siloed data stifles advancements in AI-powered drug discovery. Federated computing (FC) provides a secure, privacy-preserving, decentralized approach that enables AI-model sharing, fine-tuning and inference - moving AI demos to real-world applications.

Learning Objectives

Define Federated Computing and its related components; Examine traditional data centralization methods with decentralized federated approaches; Identify use cases for Federated AI in drug discovery and development.

Chair

Ittai Dayan, MD, MPH

Speaker

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Jonathan Gilbert

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Nadia Harhen

Accelerating AI-Enabled Drug Discovery and Development with Federated Computing
Kyle Tretina

Speakers

Ittai Dayan

CEO, Rhino Federated Computing, United States

Dr. Ittai Dayan is the Co-Founder and CEO of Rhino Federated Computing, a company transforming the way data is used for creating and deploying Artificial Intelligence solutions in regulated industries. A pioneer of bringing privacy preservation technologies into regulated industries... Read More →

Jonathan Gilbert

Senior Director, Ecosystem Growth and Contributor Partnerships, Eli Lilly and Company, United States

Nadia Harhen

General Manager, AI Simulation, SandboxAQ, United States

Kyle Tretina

Product Marketing Lead, NVIDIA, United States

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

Audience Basic
Area Artificial Intelligence
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Forum

4:00pm EDT

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P; CME 1.00; RN 1.00

Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas, consider market implications, and reflect on their roles in getting us there.

Learning Objectives

Evaluate three “big goals" for AI transformation of clinical development (eg, 10xing drugs reaching the market, eliminating human trial participants); Discuss the infrastructure implications of each goal (eg., with more drug candidates advancing, how will the system need to adapt?); Identify necessary, accompanying regulatory changes (eg, how will we meet increased demand for reviews?)

Chair

Morgan Hanger, MPA

Speaker

Panelist
Tala Fakhouri, PHD, MPH

Panelist
Henry Wei, MD

Panelist
Gabriel Westman, MD, PHD, MSC

Speakers

Tala Fakhouri

Vice President, AI & Digital Policy, Real-World Research, Parexel International, United States

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States

Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Development & Operations
Feature Topics Artificial Intelligence
Tags Forum

4:00pm EDT

#651: Regulatory CMC and Product Quality Hot Topics Discussion

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

118C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P; CME 1.00; RN 1.00

This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality.

Learning Objectives

Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging technologies in pharmaceutical quality systems; Examine how to analyze strategies for managing global regulatory complexity, supply chain resiliency, and international harmonization.

Chair

Celeste Frankenfeld Lamm

Speaker

Panelist
Peter Richardson

Panelist
Mahesh R. Ramanadham, PHARMD, MBA

Panelist
Kevin Fitzpatrick, RPH

Panelist
Yoshihiro Matsuda, DrMed

Speakers

Kevin Fitzpatrick

Senior Vice President, Quality Assurance, AbbVie, United States

Kevin Fitzpatrick is Senior Vice President of Quality Assurance at AbbVie. Kevin was appointed to his current role in June 2025 after serving as Vice President, Quality Assurance, Biologics. Kevin has been with AbbVie/Abbot for 26 years, supporting CMC strategy and execution of AbbVie’s... Read More →

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States

Celeste Frankenfeld Lamm, Ph.D., is a Senior Director of Quality and Reg CMC Policy at Merck & Co., where she leads a team of policy professionals who work to capture and align subject matter expertise around manufacturing quality and regulatory science, and translate it into meaningful... Read More →

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mahesh Ramanadham

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States

Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands

Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Feature Topics Digital Enablement and Modernization
Tags Forum

4:00pm EDT

#658: Navigating the Rules of Innovation: Regulatory Expectations for Generative AI Use Cases

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

117

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-641-L04-P; CME 1.00; RN 1.00

This session explores AI's role in pharma, offers regulators' insights and Q&A, introduces a Gen AI validation framework, and showcases use cases in audit report authoring and process/knowledge management chatbot, highlighting ethical, time/cost efficient, and compliant AI adoption.

Learning Objectives

Identify regulatory expectations for implementing Generative AI in the pharmaceutical industry, focusing on practical applications such as structured authoring of audit reports, Generative AI validation frameworks, and AI-powered chatbots for knowledge management; Discuss the challenges, user experiences, cost efficiency, and compliance considerations involved in integrating AI into regulated environments.

Chair

Oliver Fink, MS

Speaker

Framework for computer system validation of Gen AI
Haleh Valian, PHD

Regulators expecatations and insights into Gen AI
Karen Bleich, MD

Gen AI-powered structured authoring for audit reports
Srilatha Endabetla, MS

Speakers

Karen Bleich

Lead Physician, OMP, CDER, FDA, United States

Dr. Bleich is a Lead Physician in the Division of Clinical Trial Quality and a member of the AI team within the Office of Medical Policy (OMP), CDER, FDA. In these roles, she drives clinical research quality and innovation through the development of medical policy programs and strategic... Read More →

Srilatha Endabetla

Senior Director, Business Intelligence - Global Quality, Bristol Myers Squibb, United States

Srilatha Endabetla is a senior leader driving Business Intelligence and Digital & Data Strategies for Global Quality, with over 30 years of experience in digital transformation, data analytics, and data governance in the pharmaceutical industry. She has spent 23 years at Bristol Myers... Read More →

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim, Germany

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 →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 03: Data-Tech-AI, Session

Audience Basic
Area Artificial Intelligence
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Feature Topics Artificial Intelligence
Tags Session

8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

Thursday June 18, 2026 8:00am - 9:00am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.

Learning Objectives

Describe recent trends in regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle

Speakers

Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States

Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →

Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States

Anton Mihic

Partner, McKinsey & Company, United States

Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →

Ralf Raschke

Senior Expert, McKinsey & Company, United States

Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States

Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence
Tags Session

8:00am EDT

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization

Thursday June 18, 2026 8:00am - 9:00am EDT

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00

AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.

Learning Objectives

Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.

Chair

Nicholas Capman, MBA

Speaker

Considerations for AI tool validation and implementation
Benjamin C Eloff, PHD

Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSC

AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH

Speakers

Nicholas Capman

President & CEO, The FDA Group, United States

Nicholas Capman is CEO of The FDA Group, where since 2007 he has led the company’s evolution from a specialized services firm into a service + software organization integrating AI-driven capabilities to strengthen FDA compliance. He is passionate about advancing innovation responsibly... Read More →

Benjamin Eloff

Vice President, Healthcare Innovation Catalysts, United States

Ben Eloff brings nearly 20 years of federal leadership in advancing medical innovation and regulatory science. At FDA, he pioneered the first Bayesian device trial and co-authored the agency’s real-world evidence guidance. He led the launch of public-private initiatives including... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Fatima Sabar

CEO, Bluenote Health, United States

Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 09: RD-Quality-Compliance, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Regulatory
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

8:00am EDT

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis

Thursday June 18, 2026 8:00am - 9:00am EDT

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P; CME 1.00; RN 1.00

The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration.

Learning Objectives

Illustrate a future state in which CMC data from internal systems can be seamlessly transferred to a cloud environment; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.

Chair

Ciby Joseph Abraham, PHD

Speaker

Panelist
Vada Perkins, MS

Panelist
Omar Serang

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

Omar Serang

Chief Cloud Officer, DNAnexus, United States

General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Data Management & Data Standards
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

11:00am EDT

#713: No More Incremental Change: The Radical Future of Healthcare

Thursday June 18, 2026 11:00am - 12:30pm EDT

114

Component Type: Session
Level: Intermediate

This closing session brings together pioneering voices at the intersection of AI, advanced computing, and biopharma to explore how a new intelligence layer is rewiring the entire life sciences value chain—from discovery to delivery. The discussion will examine how foundational AI, cloud-scale infrastructure, and digital platforms are reshaping R&D, clinical development, manufacturing, and patient engagement. The conversation will highlight not only breakthrough opportunities—smarter target discovery, more adaptive trials, real-world evidence at scale, and hyper-personalized care—but also the governance, ethics, workforce, and partnership models needed to harness these technologies responsibly in a highly regulated environment.

Learning Objectives

Describe key ways AI and other advanced digital technologies are reshaping the life sciences value chain; Discuss concrete examples of how leading pharma and tech companies are using digital platforms, cloud infrastructure, and AI to accelerate R&D and improve patient outcomes; Evaluate key risks and governance challenges associated with deploying powerful AI and data technologies in regulated life sciences settings, including bias, transparency, and accountability.

Chair

Eli Weinberg, PHD, MS

Speaker

Panelist
Susan Furth, MD, PHD

Panelist
Carlos Garner, PHD, MSC

Panelist
Dhruv Jayanth

Panelist
Shweta Maniar

Speakers

Susan Furth

Executive Vice President and Chief Scientific Officer, Children's Hospital of Philadelphia, United States

Carlos Garner

Senior Vice-President Global Regulatory Affairs and Head, Lilly Regenerative Med, Eli Lilly and Company, United States

Dr. Garner is executive leader for Global Regulatory Affairs for Eli Lilly and Company. The organization is responsible for the regulatory leadership, strategic and operational support for human drugs, medical devices, and global manufacturing for Eli Lilly and Company. Additionally... Read More →

Dhruv Jayanth

Business Lead, Life Sciences, OpenAI, United States

Shweta Maniar

Global Director, Strategic Industries - Life Sciences, Google, United States

Shweta leads Healthcare & Life Sciences Strategic Industries at Google Cloud, where she bridges the gap between cutting-edge technology and patient outcomes. A PharmaVoice 100 trailblazer, she is a seasoned innovator known for turning complex data ecosystems into collaborative engines... Read More →

Eli Weinberg

Partner, Bain & Co., United States

Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →

Thursday June 18, 2026 11:00am - 12:30pm EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

DIA 2026 Global Annual Meeting

Success you have shared X tickets.

8:00am EDT

11:00am EDT

11:00am EDT

11:00am EDT

11:00am EDT

2:30pm EDT

2:30pm EDT

2:30pm EDT

2:30pm EDT

4:00pm EDT

4:00pm EDT

4:00pm EDT

4:00pm EDT

10:15am EDT

10:15am EDT

10:15am EDT

10:15am EDT

10:15am EDT

10:15am EDT

1:45pm EDT

1:45pm EDT

1:45pm EDT

1:45pm EDT

1:45pm EDT

4:15pm EDT

4:15pm EDT

10:15am EDT

10:15am EDT

10:15am EDT