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Keynote Address: Innovation in Medical Product Development: An Industry Perspective
Session Chair(s)
John Weiner, JD
Associate Director for Policy, Office of Combination Products, OCPP, OC
FDA, United States
Many of the most promising and productive areas of medical progress – e.g., biologic therapies, targeted/personalized therapies, regenerative medicine, disease interception/prevention – are supported in important part by the potential for combination of drugs/biologics and devices. However, in both industry and government, the discovery/invention, development, testing, and regulation of drugs and devices evolved quite separately and distinctly. As a result, despite the recognized importance of combination products, systems for their development and approval are far from optimized. After decades of incremental progress, a consensus has grown about the importance of combination products and the need to improve their regulation.
Speaker(s)
Speaker
Jay P. Siegel, MD
Johnson & Johnson, United States
Chief Biotechnology Officer and Head of Scientific Strategy and Policy
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