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Session 8: Advanced Therapeutics Pharmacovigilance and Risk Management
Session Chair(s)
Barbara Morollo, RN
Head, Pharmacovigilance, Corbus Pharmaceuticals, United States
Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of innovation and offer patients hope for various diseases for which there are limited or no therapeutic options. The development of ATMPs has sparked considerable interest and debate as there are many unknowns and uncertainties concerning the effects or responses these therapies may evoke, especially in the case of genetic manipulation. This session will examine the challenges associated with monitoring safety and the benefit-risk of these therapies, both short-term and long-term, and explore the complexities associated with determining the safety profile and benefit-risk across common delivery platforms such as gene therapy vectors and lipid nanoparticle delivery systems.
Speaker(s)
Barbara Morollo, RN
Head, Pharmacovigilance, Corbus Pharmaceuticals, United States
Pharmacovigilance and Risk Management Challenges in Advanced Therapeutics
Jaspal (JP) Ahluwalia
Medical Officer, OBE, CBER, FDA, United States
Speaker
Adrian Dana, MD
Vice President, Global Patient Safety and Risk Management, Aimmune Therapeutics, United States
Common Technical Platforms: Benefit-Risk Determination and Risk Management
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety , Bristol-Myers Squibb, United Kingdom
Speaker