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Pathways to Innovation: Navigating Regulatory Expectations for AI Technologies in Drug Development
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD
Component Type: Session
Level: Intermediate

This session will explore engagement pathways with global regulators to obtain feedback on AI technologies in drug development. It will also identify effective evaluation strategies to support regulatory acceptance of novel methodologies.

Learning Objectives

Identify the appropriate regulatory pathways and mechanisms for engaging with health authorities to discuss AI technologies in drug development applications; Discuss regulatory strategies, use cases, and considerations for AI model development based on context of use; Evaluate lessons learned and experiences from manufacturers, developers and health authorities.

Chair

Ryan Hoshi, PhD, MBA, MSc

Speaker

AI and Machine Learning in Pharmaceutical Manufacturing
Gert Thurau, DrSc, PhD

Technical and Regulatory Considerations for Streamlining Drug Development with Digital Twins: Sample-size Reduction Case Study
Aaron Smith


Speakers
avatar for Ryan Hoshi

Ryan Hoshi

Director, Regulatory Policy and Intelligence, AbbVie, United States
Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the global policy lead for medical devices, combination products, personalized medicine, digital health, artificial intelligence, and advanced therapies. Before joining AbbVie, Ryan served as an international... Read More →
AS

Aaron Smith

Founder, Machine Learning Scientist, Unlearn.AI, United States
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, 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 →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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