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Tuesday, June 16 • 8:00am - 9:00am
#202 L: Novel Approaches to Study Prevalent Chronic Diseases as Alternatives to Large-Scale Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-551-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Max Wegner, PharmD, RPh

Speaker

Industry Perspective
James T. Mayne, PhD

Regulator perspective
Peter P. Stein, MD

Patient Perspective
Sue Peschin, MHS


Speakers
avatar for Max Wegner

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany
After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →
JM

James Mayne

Vice President, Scientific Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jim Mayne is Vice President, Science & Regulatory Advocacy at PhRMA, where he provides leadership for PhRMA involvement in a number of science based public-private partnerships and works to support pharma industry efforts to evolve the contemporary R&D ecosystem and drug development... Read More →
avatar for Sue Peschin

Sue Peschin

President and Chief Executive Officer, Alliance for Aging Research
Susan Peschin, MHS, is president and CEO at the Alliance for Aging Research the leading national non-profit organization dedicated to accelerating research to improve aging and health. Ms. Peschin has led the Alliance in efforts to: boost older adult immunization rates; increase NIH... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA, United States
Dr. Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions... Read More →

Tuesday June 16, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session