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The Realities of Late Life Cycle Management for Very Old Legacy Brands
Session Chair(s)
Bijal Pandhi, PHARMD
Senior Global Program Regulatory Manager, Novartis Pharmaceuticals Corporation, United States
This forum will provide a recent case study that illustrates the challenges sponsors face when managing the life cycle of legacy brands. A panel of experts will provide their perspective and discuss ways to mitigate these challenges.
Learning Objective : Define a general understanding of the challenges of late product life cycle management; Describe a perspective of how industry and regulators manage these challenges; Restate a recent case study that provides examples of managing such changes (benefit-risk review of calcitonin-salmon drug class).
Speaker(s)
Paul Aftring, MD, PHD
Global Program Head, Established Medicines, Novartis Pharmaceuticals Corporation, United States
Industry Perspective
Theresa Kehoe, MD
Director, Division of General Endocrinology (DGE), OND, CDER, FDA, United States
FDA Perspective
Steven M. Weisman, PHD
Global President, Clinical and Regulatory, Lumanity Inc, United States
Development of An Integrated Response
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