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Monday, June 15
 

8:00am EDT

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

This opening plenary explores how patient driven science, AI enabled discovery, and regulatory innovation can uncover “hidden cures” in the medicines and data we already have. Through a keynote from David Fajgenbaum and a panel on AI in biopharma, the session asks how we can find, trust, and deliver tomorrow’s cures from today’s science.

Learning Objectives

Describe the latent potential of existing medicines and data, and how patient driven science can uncover new uses for known therapies; Explain how AI and advanced analytics can de risk drug discovery and trial design, surfacing overlooked opportunities and improving investment decisions; Identify system level levers: collaboration, regulation, and capital, that can help translate today’s science into tomorrow’s cures more quickly, safely, and equitably.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Lawrence Tallon

Panelist
David Pfeiffer

Panelist
Greg Sarafin

Panelist
Rahul Gupta, MD, MBA, MPH

Panelist
David Fajgenbaum

Panelist
Audrey Greenberg, CPA, MBA


Speakers
avatar for David Fajgenbaum

David Fajgenbaum

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

Audrey Greenberg

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

Rahul Gupta

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

David Pfeiffer

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

Greg Sarafin

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

Lawrence Tallon

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

Maria Vassileva

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

11:00am EDT

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

This forum will see different stakeholders discussing what they consider as future priority areas for our vigilance activities and what data sources offer the greatest opportunities for delivering a bigger impact on patient care.

Learning Objectives

Describe the changes in availability and use of different data sources for safety surveillance across the healthcare landscape in the future; Identify the challenges for data collection, monitoring and assessment of safety data from evolving real world use of healthcare products; Discuss the opportunities this represents for vigilance and how to deliver greater impact on patient care.

Chair

Alison Cave

Speaker

Panelist
Phil Tregunno

Panelist
Angela Radcliff


Speakers
avatar for Alison Cave

Alison Cave

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

Angela Radcliff

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

Phil Tregunno

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

11:00am EDT

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

AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities, risks, regulatory oversight, and the role of reference datasets for tool validation.

Learning Objectives

Describe the current landscape and practical applications of AI-based diagnostic tools; Examine potential regulatory frameworks and strategies to ensure oversight and reliability of AI-based diagnostics; Identify key considerations in developing reference datasets to support validation of AI tools.

Chair

Hillary Andrews, PHD

Speaker

Industry Perspective
Alain Silk, PHD

Patient Advocate Perspective
Jason Binder, MA

Industry Perspective
Mike Montalto, PHD


Speakers
JB

Jason Binder

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

Alain Silk

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

11:00am EDT

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

The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers, regulatory agencies, and industry representatives

Learning Objectives

Explain the value of regulatory collaboration and describe recent technological advancements that enable it; Identify key challenges and opportunities associated with integrating cloud technologies into regulatory processes; Examine perspectives from technology providers, regulators, and industry on the future of regulatory collaboration and outline ways to participate in these efforts.

Chair

Dominique Lagrave, PHARMD

Speaker

Panelist
Marko Eric

Panelist
Julie Lepin, MA

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Vada Perkins, MS


Speakers
avatar for Ana Carolina Moreira Marino Araujo

Ana Carolina Moreira Marino Araujo

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

Marko Eric

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

Dominique Lagrave

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

Dominique Lagrave

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

Julie Lepin

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

Vada Perkins

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

11:00am EDT

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

Artificial intelligence is influencing how pharmaceutical companies plan to develop patient-facing materials (promising faster production, improved readability, and more personalized education) —while also raising questions about accountability, empathy, trust, bias, and accuracy. In this “Great Debate” session, two industry presenters will offer contrasting perspectives on whether AI should directly generate or refine patient communications and will share practical examples of technologies being used today. A patient advocate will ground the discussion in real-world needs and expectations, helping participants leave with actionable guardrails for adopting AI responsibly and keeping patients at the center.

Learning Objectives

Discuss the role of AI in patient-facing materials and practical guardrails; Identify key benefits and limitations of AI-enabled communication workflows in the pharmaceutical industry; Assess ethical and trust considerations for AI-influenced patient communications—such as transparency, bias, inclusivity, empathy, and the potential for misinformation—through both industry and patient-advocate lenses.

Chair

Regina Lynn Preciado

Speaker

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

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

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


Speakers
avatar for Kimbra Edwards

Kimbra Edwards

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

Irene Kuhlman

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

Regina Lynn Preciado

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

Christine Von Raesfeld

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

2:30pm EDT

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

Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.

Learning Objectives

Describe how ICH M11 and digital protocol standards enable seamless, patient-centric clinical trial design and regulatory submissions; Evaluate the impact of AI, cloud, and interoperable data platforms on accelerating regulatory review and improving patient access to innovation; Apply strategies for integrating patient experience data and digital tools to enhance trial inclusivity, data quality, and regulatory confidence.

Chair

Vada Perkins, MS

Speaker

Panelist
Mumtaz Sultani

Panelist
Jimita Parekh

Panelist
Robert DiCicco, PHARMD


Speakers
avatar for Robert DiCicco

Robert DiCicco

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

Jimita Parekh

Managing Director, Independent, United States
avatar for Vada Perkins

Vada Perkins

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

Mumtaz Sultani

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

2:30pm EDT

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

This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.

Learning Objectives

Explain how current CDISC standards set the foundation for RWD/RWE submissions; Discuss evolving data standards, including Dataset-JSON and HL7 FHIR, focusing on how they may complement or extend CDISC; Identify actions sponsors can take now to prepare for evolving regulatory data standards.

Chair

James Browning, MPH

Speaker

Panelist
Chris Decker, MS

Panelist
Anne-Marie Meyer, MS


Speakers
avatar for James Browning

James Browning

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

Chris Decker

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

Anne-Marie Meyer

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

2:30pm EDT

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

Artificial intelligence is revolutionizing drug manufacturing, yet regulations are still catching up. With key guidance from the EU and US in development, a proactive and collaborative approach is needed for global regulatory alignment, ensuring AI i

Learning Objectives

Identify and summarize regulatory trends specific to AI use in Manufacturing; Distinguish AI use in manufacturing from use in product development.

Chair

Gert Thurau, PHD

Speaker

PMDA regulatory perspectives on AI in Manufacturing
Yoshihiro Matsuda, DrMed

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

FDA regulatory perspectives on AI in Manufacturing
Tina Kiang, PHD


Speakers
avatar for Tina Kiang

Tina Kiang

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

Yoshihiro Matsuda

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

Thomas O'Connor

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

Gert Thurau

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

2:30pm EDT

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

Senior leaders from FDA, EMA, MHRA and PMDA share insights on AI’s evolving role in regulatory review & decision-making. Attendees will explore current practices, key challenges, and future opportunities for AI in shaping global regulatory frameworks.

Learning Objectives

Discuss how AI is transforming regulatory review and decision-making at FDA, EMA, MHRA, and PMDA; Analyze key challenges and opportunities facing AI adoption in regulatory review and decision-making; Identify emerging trends and future directions for AI in shaping global regulatory practices.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Tomoharu Numanyu, RPH


Speakers
JB

Joaquim Berenguer Jornet

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

Jingyu (Julia) Luan

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

Tomoharu Numanyu

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

4:00pm EDT

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

This session shares insights from a global survey of 12,000+ respondents, highlighting patient comfort levels and receptivity to AI processing their medical information as part of a clinical trial.

Learning Objectives

Discuss patient comfort levels and receptivity to AI processing medical information as part of a clinical trial; Describe strategies to address patient preferences and comfort levels with AI analyzing medical data.

Chair

Annick De Bruin, MBA

Speaker

Panelist
T.J. Sharpe, PMP

Panelist
Shanelle Gabriel, MED


Speakers
avatar for Annick De Bruin

Annick De Bruin

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

Shanelle Gabriel

Patient Advocate, N/A, United States
SG

Shanelle Gabriel

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

Ellyn Getz

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

T.J. Sharpe

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

4:00pm EDT

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

Discover Coalition For Epidemic Preparedness Innovations (CEPI) Pandemic Preparedness Engine (PPE) regulatory node—a forward-looking digital platform using AI and cloud technology to accelerate vaccine approvals through structured data, automated workflows, and global collaborative review.

Learning Objectives

Discuss the conceptual framework of CEPI’s Pandemic Preparedness Engine (PPE) regulatory node and its role in accelerating emergency vaccine approvals; Recognize how AI-enabled workflows and cloud-based platforms can support concurrent, global regulatory review through PDDF and DSVI integration; Identify opportunities for regulatory collaboration and input to shape the future of digital dossier.

Chair

Ashley Jones-Mitchell, MPH

Speaker

Panelist
Melody Chessia

Panelist
Kevin Bugin, MS, RAC

Panelist
Teginder Singh, MPHARM


Speakers
avatar for Kevin Bugin

Kevin Bugin

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

Melody Chessia

Director of Product Management, Accumulus Technologies, United States
MC

Melody Chessia

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

Ashley Jones-Mitchell

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

Teginder Singh

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

4:00pm EDT

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

Medical writing myths persist, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity, accuracy, and scientific integrity continue to rise. In this TED-talk–style session, three presenters will explore why medical writing expertise matters, how writers can evolve into influential cross-functional leaders, and the value and limitations of AI currently in use. Attendees will leave with practical insights to elevate the role of medical writers and adopt emerging tools responsibly to improve quality, efficiency, and credibility in drug development communication.

Learning Objectives

Examine the specialized value professional medical writers bring, including how writing expertise reduces risk, improves efficiency, and strengthens scientific credibility—beyond what generalist writing can achieve; Identify the skills and mindsets needed for “future-ready” medical writers; Describe practical ways to grow from document execution roles into strategic leadership and cross-functional influence; Assess current AI uses in medical writing, distinguishing opportunities from hype.

Chair

Monica Chiaramonte, PHD

Speaker

Panelist
Anna Whitling, PHARMD

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

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


Speakers
avatar for Monica Chiaramonte

Monica Chiaramonte

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

Steve Sibley

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

Steve Sibley

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

Anna Whitling

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

4:00pm EDT

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

Real-world data that encompass race, ethnicity, or ancestry and clinical phenotypes are growing increasingly sophisticated in utility. This panel will discuss why precision medicine is ripe for new and ongoing exploration in regulatory contexts.

Learning Objectives

Describe precision medicine approaches involving clinical phenotype RWD in context with race, ethnicity, ancestry data, that can be instrumental to address unmet patient and health system needs; Discuss how regulators have reacted to precision medicine-based research approaches in context with race, ethnicity, ancestry information, inclusive of research design modifications made along the way.

Chair

Rachele Hendricks-Sturrup, MA

Speaker

Panelist
Carla Rodriguez-Watson, MPH

TBD
Lysel Brignoli, MS


Speakers
avatar for Lysel Brignoli

Lysel Brignoli

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

Rachele Hendricks-Sturrup

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

Carla Rodriguez-Watson

Director of Research, Reagan-Udall Foundation for the FDA, United States
Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together... Read More →
Monday June 15, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Session |   03: Data-Tech-AI, Session |   10: Stats-EvidenceGeneration-RWE, Session
  • Audience Advanced
  • Level Advanced
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  • Credit Type ACPE, CME, RN
  • Interest Area Biostatistics
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DIA 2026 Global Annual Meeting
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Zone A
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
  • 04: MedAffairs-SciComm
  • 05: PersonalizedMed-ComboProd-Diagnostics
  • 06: ProfDevelop-Program-PortfolioMgmt
  • 07: RegCMC-Product Quality
  • 08: RegPolicy-Strategy-GlobalCollaboration
  • 09: RD-Quality-Compliance
  • 10: Stats-EvidenceGeneration-RWE
  • 11: Spark Stage
  • 12: Content-Hubs
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  • 14: Posters
  • 15: Networking-Opportunities
  • 16: InnovationTheaters
  • 17: Short-Courses
  • 18: Lift-Series
  • Audience
  • Advanced
  • Basic
  • Intermediate
  • Area
  • Artificial Intelligence
  • Biotech-ClinTech-Pathway
  • Cross-Functional Collaboration
  • Digital Enablement and Modernization
  • Ethics
  • Evidence Innovation
  • Global Alignment in Practice
  • Patient-Centered Design and Experience
  • Student and Early Career Pathway
  • Therapeutic Pathways
  • Trust and Responsible Innovation