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Development Challenges, Preclinical and Clinical Data and Human Factor Considerations for Combination Products
Session Chair(s)
James A. Boiani, JD, MS
Partner
Epstein Becker & Green, P.C., United States
Combination products increasingly incorporate both new technologies and novel marriages of drugs, biologicals, and medical devices. These products hold great promise, but bringing them to patients can challenge industry and regulators as they try to answer important questions about product safety and effectiveness. Nowhere is this more apparent than with combinations of drugs and biologicals with new delivery systems. This session will explore the challenges in developing combination products with a focus on drug/biological delivery systems, preclinical and clinical combination product data requirements, and human factor testing. FDA thought leaders will provide Agency perspectives, and industry experts will discuss their experiences in navigating these issues.
Speaker(s)
Recent Development in Drug Delivery Systems
Patricia Love, MD, MBA
FDA, United States
Deputy Director, Office of Combination Products, OCPP, OC
Recent Development in Drug Delivery Systems
Richard D. McFarland
FDA, United States
Medical Officer, OCTGT - CBER
Human Factor Studies and Data Bridging Issues
Valerie Fenster
Amgen Inc., United States
Senior Manager, Human Factors Engineering, Device Technologies
Industry Perspective on Combination Product Development
Hortense Allison, MS
Johnson & Johnson Vision Care, United States
Senior Manager of Regulatory Affairs
Panel Discussion
All Session Speakers, United States
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