DIA 2026 Global Annual Meeting: Full Schedule

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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
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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

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 →

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

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 →

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
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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
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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
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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

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 →

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