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Pharmacovigilance and Risk Management Strategies Conference


Session 8: Advanced Therapeutics Pharmacovigilance and Risk Management

    Session Chair(s)
      Barbara A Morollo, RN

      Barbara A Morollo, RN

      • Head, Pharmacovigilance Operations
      • Moderna Therapeutics, 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 A Morollo, RN

      Common Technical Platforms: Benefit-Risk Determination and Risk Management

      Barbara A Morollo, RN

      • Head, Pharmacovigilance Operations
      • Moderna Therapeutics, United States
      Jaspal  Ahluwalia, MD

      Speaker

      Jaspal Ahluwalia, MD

      • Medical Officer
      • FDA, United States
      Adrian  Dana, MD

      Speaker

      Adrian Dana, MD

      • Vice President, Global Patient Safety and Risk Management at Alnylam
      • Alnylam Pharmaceuticals Cambridge, United States
      Michael  Richardson, MD, FFPM

      Speaker

      Michael Richardson, MD, FFPM

      • International GPV&E and EU QPPV
      • Bristol-Myers Squibb, United Kingdom