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Session 10 – Advanced Therapies
Session Chair(s)
Robert L. Levin, MD
Lead Medical Officer for Pharmacovigilance Strategy
FDA, United States
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Strategy
Consultant, United Kingdom
Gene therapy, somatic cell therapy, and tissue engineering products represent innovative therapies with the promise of expanded treatment choices for diseases where few options exist today. To promote timely access to these advanced therapies while safeguarding the public health, informed benefit-risk decisions must be made while long-term data on both safety and efficacy are developed. In this session, regulatory and industry representatives will discuss the current rationale for clinical safety considerations in the step-wise development of advanced therapies.
Speaker(s)
Overview of Advanced Therapies
Don A. Gabriel, MD, PhD, AHIP
University of North Carolina, United States
Division of Hemotalogy
Gene Therapy: Its Promise and the Safety Issues Associated With It
Barbara Morollo, RN
Corbus Pharmaceuticals, United States
Head, Pharmacovigilance
Uncertainty and Issues Surrounding Biomedical Innovation
Kenneth Oye, PhD
Massachusetts Institute of Technology (MIT), United States
Associate Prof, Political Science; Co-Director, Program on Emerging Technologies