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Tuesday, June 16
 

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
avatar for Raymond Kassekert

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 →
avatar for Gerald Dal Pan

Gerald Dal Pan

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

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 →
avatar for Ju-Young Shin

Ju-Young Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →
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
  • Feature Topics Artificial Intelligence
  • Interest Area Health Technology & AI,Clinical Safety & Pharmacovigilance
  • 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
avatar for Alberto Grignolo

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 →
avatar for Joseph Kannarkat

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 →
avatar for Sean Khozin

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 →
avatar for Beth Meagher

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 →
avatar for Stacy Hurt, MBA, MHA

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 →
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 →
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

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
avatar for Nicholas Brooke

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 →
avatar for Vivian Dewoskin

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 →
avatar for William Illis

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 →
avatar for Sahishnu Patel

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 →
avatar for Prasanna Rao

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

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
avatar for Marie Bradley

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 →
avatar for Hussein Ezzeldin

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

10:15am EDT

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate
Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-561-L04-P; CME 1.25; RN 1.25

Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.

Learning Objectives

Apply FDA’s CDS guidance criteria to determine whether AI software tool (used to identify patients or risk factors) qualifies as a regulated medical device or exempt CDS; Analyze real-world digital health scenarios using a structured decision tree to support regulatory classification; Evaluate the impact of software classification on drug development strategy, trial design, and regulatory planning

Chair

Michael Mayrosh, PHARMD

Speaker

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Jeppe G. Manuel, MLIS

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Lesley Maloney, PHARMD


Speakers
avatar for Lesley Maloney

Lesley Maloney

Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →
avatar for Jeppe G. Manuel

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 →
MM

Michael Mayrosh

Associate Director Global Regulatory Policy and Strategy, Eli Lilly and Company, United States
Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University... Read More →
Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  05: PersonalizedMed-ComboProd-Diagnostics, Workshop |   02: ClinicalTrialOps-Innovation, Workshop |   08: RegPolicy-Strategy-GlobalCollaboration, Workshop

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
avatar for Daisuke Koga

Daisuke Koga

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

Alexis Miller

Head, Global Regulatory Policy, MSD, United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →
avatar for Michelle Rohrer

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

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
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 Sabina Kineen

Sabina Kineen

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

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany
RW

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

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
avatar for Vanni Carapetian

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 →
avatar for Vanni Carapetian

Vanni Carapetian

CMC RA, Strategy and Operations, Executive Director, Gilead Sciences, Inc, 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 →
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 →
avatar for Andrew Robertson

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 →
JS

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

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
KH

Kaveen Hiniduma

Graduate Research Associate, Ohio State University, United States
KR

Kathleen Rand

Principal Scientist, Procter & Gamble, United States
avatar for Ted Slater

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.
AU

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

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
avatar for Martin Heitmann

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 →
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 Luis Pinheiro

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 →
JW

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

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
WA

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 →
DB

Danielle Boyce

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

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 →
EN

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

4:15pm EDT

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P; CME 1.00; RN 1.00

In this session, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating enabler for the business and patients.

Learning Objectives

Recognize the value unlocked by the incorporating AI and advanced analytics in GCP/GVP quality assurance; Describe the short and long term transformative benefits; Discuss how to develop strategies for demonstrating the value created by embedding AI and advanced analytics into quality assurance audits.

Chair

Roshan D'Souza

Speaker

Value realisation in augmenting Quality Assurance with advanced analytics & AI?
Frederik Collin, MS

Lessons learned in implementing advanced analytics & AI in Quality Assurance
Jeremy Jones, MS

The Why behind the Value proposition
Roshan D'Souza

Data & Digital: Assessing Measurable Value in QA
Michael Pelosi, MA, MBA


Speakers
FC

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.
avatar for Roshan D'Souza

Roshan D'Souza

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

Jeremy Jones

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

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States
Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
117 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  09: RD-Quality-Compliance, Session |   01: ClinSafety-PV-RM, Session
  • Audience Intermediate
  • Area Artificial Intelligence
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Feature Topics Artificial Intelligence
  • Interest Area Quality Assurance / Control & CMC,Health Technology & AI
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    Jun 8 - 18, 2026
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    1101 Arch St, Philadelphia, PA 19107, USA
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    18: Lift-Series
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  • 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
  • Timezone
DIA 2026 Global Annual Meeting
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102AB
103A
105AB
107AB
108A
108B
109AB
110A
111AB
112AB
114
115AB
115C
116
117
118AB
118C
119AB
201AB
202AB
203AB
204AB
Ballroom AB
Content Hub
Exchange
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
Spark Stage
TBD
Zone A
Zone B
  • 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
  • 13: Community-Rounds
  • 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