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#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

Panelist
Hussein Ezzeldin, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Panelist
Megha Sinha


Speakers
GC

Graziella Collu

Vice President, CVRM Regulatory, AstraZeneca, Netherlands
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 →
avatar for Donna Rivera

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 →
MR

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 →
MS

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

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