Artificial Intelligence Archives

Artificial Intelligence in Drug & Biological Product Development Hybrid Public Workshop 2025

Posted on November 4, 2025November 14, 2025 by Hannah Faulkner

Webinars | November 4, 2025

Topics Included: Artificial Intelligence

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Hybrid Public Workshop Resources:

Meeting Webpage

Full agenda

Download the full PowerPoint slide set

Meeting Recordings:

Welcome & Session 1: Where Are We Now?

Session 2: Data Quality, Reliability, Representativeness, and Access in AI-Driven Drug Development

Session 3: Model Performance, Explainability, Transparency, and Interpretability in AI-Driven Drug Development

Session 4: Navigating the Future of AI in Drug Development

Discussion & Concluding Remarks

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We welcome your questions and feedback about this workshop. If you have follow-up thoughts or comments on the topics discussed, please share them using the brief form linked below. Your input will help inform future discussions and events.

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Recent News Feed

FDA, CTTI Convening 2025 Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development

Posted on August 25, 2025August 25, 2025 by Hannah Faulkner

CTTI News | August 25, 2025

Topics Included: Artificial Intelligence

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Registration is now open for the second Hybrid Public Workshop on Artificial Intelligence in Drug and Biological Product Development, hosted by the U.S. Food and Drug Administration in collaboration with the Clinical Trials Transformation Initiative. The event will take place on October 7, 2025, in person at The National Press Club in Washington, DC, and online via Zoom.

Join experts from across sectors for a forward-looking discussion on how artificial intelligence (AI) is transforming drug and biological product development. Building on momentum from the first workshop in 2024, this year’s event will highlight real-world breakthroughs and explore how AI is advancing the safety, efficacy, and quality of drugs and biological products.

Speakers will address best practices, cross-disciplinary collaboration, and practical strategies to improve data quality, reduce bias, and increase transparency in AI models. Attendees will gain insights into responsible applications of AI in clinical research and to support regulatory decisions, along with opportunities to support innovation across the field.

The workshop will run from 9:00 a.m. to 5:00 p.m. Eastern Daylight Time. Attendance is free and open to the public.

Register now to be part of this important conversation on the future of AI in medical product development.

Recent News Feed

Recording of Hybrid Public Workshop Now Available: AI in Drug and Biological Product Development

CTTI News | August 23, 2024

Topics Included: Artificial Intelligence

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The recording for the hybrid public workshop on AI in Drug and Biological Product Development convened and hosted by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI), held August 6, is now available. Over 9,000 registrants from diverse backgrounds and perspectives joined to explore the responsible use of AI in drug development.

During the workshop, we learned from experts as they discussed guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts discussed their rationale for particular approaches, shared their methods for evaluating success, recounted challenges and obstacles, explored options for scaling and wider applicability, and outlined considerations for moving forward. Presentations can also be found here.

Recent News Feed

Hybrid Public Workshop on AI in Drug and Biological Product Development

Webinars | August 22, 2024

Topics Included: Artificial Intelligence

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Hybrid Public Workshop Resources:

Full Agenda

Download full PowerPoint slide set

Hybrid Public Workshop Speakers, Moderators, & Panelists (in order of appearance):

Morgan Hanger, Clinical Trials Transformation Initiative
Patrizia Cavazzoni, Director, Center for Drug Evaluation and Research (CDER), United States
Food and Drug Administration (FDA)
Tala Fakhouri, Associate Director for Data Science and Artificial Intelligence Policy, CDER, FDA
Anindita Saha, Associate Director for Strategic Initiatives, Digital Health Center of Excellence
(DHCoE), Center for Devices and Radiological Health (CDRH), FDA
Elazer Edelman, Edward J. Poitras Professor in Medical Engineering and Science, and Director,
Institute of Medical Engineering and Science, Massachusetts Institute of Technology (MIT)
Sam Glassenberg, Founder & CEO, Level Ex
Charles Fisher, CEO, Unlearn.AI
Stephen Pyke, Chief Clinical Data & Digital Officer and Executive Vice President, Parexel;
Chair, AI/ML Committee, ACRO
Marsha Samson, Senior Analyst, CDER, FDA
Ittai Dayan, Co-Founder & CEO, Rhino Health
Merage Ghane, Principal Behavioral Designer, ideas42
Wade Davis, Vice President, Computational Science, Moderna
Hussein Ezzeldin, Senior Digital Health Expert, Office of Biostatistics and Pharmacovigilance
(OBPV), CDER, FDA
Artem Trotsyuk, AI Ethics and Policy Research Fellow, Stanford University
Luca Emili, Founder & CEO, InSilicoTrials
Michael Lingzhi Li, Assistant Professor, Technology and Operations Management Unit,
Harvard Business School
Subha Madhavan, Head of Clinical AI/ML & Digital Sciences, Pfizer
Scott Steele, Senior Advisor for Translational Science, Center for Biologics Evaluation and
Research (CBER), FDA
Dina Katabi, Thuan and Nicole Pham Professor of Electrical Engineering and Computer
Science, and Director, Center for Wireless Networks and Mobile Computing, MIT
Andrew Bate, Vice President & Head of Safety Innovation & Analytics, GSK
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie
Nicole Mahoney, Executive Director, Regulatory Policy, and Global Regulatory Policy Lead,
Data and Digital Technologies, Novartis
Hesha Jani Duggirala, Senior Epidemiologist, Center for Veterinary Medicine (CVM), FDA
Qi Liu, Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology
(OCP)/ Office of Translational Sciences, CDER, FDA
Jacqueline Corrigan-Curay, Principal Deputy Center Director, CDER, FDA

Recent News Feed

FDA, CTTI Convening Hybrid Public Workshop on Artificial Intelligence in Drug & Biological Product Development

Posted on May 7, 2024March 3, 2025 by Hannah Faulkner

The Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a hybrid public workshop on the use of AI in drug and biological product development. Registration is now open for this free hybrid public workshop, which will be held both in person and virtually via Zoom.

Please join us as we discuss guiding principles for the responsible use of AI in the development of safe, effective, and high-quality drugs. Drawing on real case examples, experts will discuss their rationale for particular approaches, share their methods for evaluating success, recount challenges faced, explore options for scaling and wider applicability, and outline considerations for moving forward.

The public workshop is scheduled from 10 a.m. to 5:30 p.m. EDT and is free for all to attend. Participants have the option to attend either virtually or in person at the FDA Great Room, located at 10903 New Hampshire Avenue, Silver Spring, MD 20993.

Update: As of July 16, 2024, in-person registration is now closed. Registration for virtual attendance will remain open until the workshop begins on August 6, 2024.