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FDA Working with Patients to Explore Benefit/Risk: Opportunities & Challenges

http://www.biocenturytv.com/player/1669511147001 disclaimer icon Friday, May 18, 2012 at the FDA White Oak Campus, in Silver Spring, MD.

U.S. Food and Drug Administration Inaugural Patient Network Annual Meeting, hosted by FDA's Office of Special Health Issues (OSHI) in collaboration with the Center for Drug Evaluation and Research (CDER), the Center for Biologics Research and Evaluation (CBER), and the Center for Devices and Radiological Health (CDRH).

This meeting was held to allow FDA to gain a greater understanding of how patients define and perceive benefits and risks related to medical products. The FDA Patient Network hosted this one-day meeting to:

  • review the drug and medical device regulatory processes;
  • discuss where patient input is practical and most valuable; and,
  • explore practical approaches to collecting meaningful patient input.

The meeting included a series of presentations, exercises, and panel discussions to facilitate a conversation with the patient community about these important topics. FDA asked patients and other interested parties to consider specific questions, posed in a 4/19/2012 Federal Register Notice, designed to frame discussion at the meeting.

 Working with Patients to Explore Benefit/Risk: Opportunities & Challenges 

Video Recording of the May 18, 2012 event:

Part 1

  • Keynote Address Stephen Spielberg, M.D., Ph.D., Deputy Commissioner for Medical Products and Tobacco
  • Drug Development: Laws, Regulations, Statutory & Regulatory Limitations Janet Woodcock, M.D., Director, CDER

Part 2

  • Drugs and Biologics Development 101 Robert Yetter, Ph.D., Associate Director for Review Management, CBER
  • Devices 101 Peper Long, Associate Director, External Relations, CDRH
  • Drugs, Biologics and Devices Question and Answer
    Richard Klein, Director, Patient Liaison Program, OSHI (moderator)

Part 3

  • Benefit-Risk Framework Patrick Frey, Director, Office of Planning and Analysis, CDER
  • Patient-Focused Drug Development Theresa Mullin, Ph.D., Director, Office of Planning and Informatics, CDER
  • Making Benefit-Risk Determinations Peper Long, Associate Director, External Relations, CDRH
  • Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH

Part 4

  • Patient Risk Tolerance Survey for Obesity Devices Martin Ho, M.S., Division of Biostatistics, Office of Surveillance and Biometrics, CDRH (continued)
  • Discussion of Federal Register Notice Questions
  • Patient Perspectives Panel & Audience Discussion James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
  • FDA Reaction Panel James Valentine, M.H.S., Project Manager, FDA Patient Network, OSHI (moderator)
  • Closing Remarks Richard Klein, Director, Patient Liaison Program, OSHI
     

 

Original Federal Register Notice of Meeting, with framing questions 

 

Photos of the Meeting

 

Following up on the May 12 meeting, BioCentury This Week aired a televised discussion disclaimer icon  about the patient input into benefit/risk decision making at FDA, on June 3, 2012.