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Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials
Session Chair(s)
Max Wegner, PharmD, RPh
Head Regulatory Affairs
Bayer AG, Germany
The current paradigm of conducting large-scale clinical trials in highly prevalent and chronic diseases does not support timely access of patients to innovative medicines. We will discuss possible ways to transform drug development in these areas.
Learning Objective : Summarize the patient, regulatory,and industry perspectives on the sustainability of doing large-scale clinical development programs for highly prevalent and chronic diseases and conditions; Name possible alternate and novel approaches to drug development in highly prevalent and chronic disease areas, outside of large-scale clinical trials.
Speaker(s)
Biopharmaceutical Industry Perspective
James T. Mayne, PhD
Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Vice President, Scientific Advocacy
Addressing Reduced Investment in Drug Development for Many Common Chronic Diseases
Peter P. Stein, MD
FDA, United States
Director, Office of New Drugs, CDER
Novel Approaches to Study Diseases in Older Adults
Sue Peschin, MHS
Alliance for Aging Research, United States
President and Chief Executive Officer
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