Food and Drug Administration and the University of Rochester School of Medicine and Dentistry present:


1st Scientific Workshop
Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION)
an FDA Public-Private Partnership


Wednesday, June 15, 2011
8:00am - 5:00pm ET
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993


AGENDA


7:00 am - 8:30 am: Registration and Continental Breakfast

I. THE EVOLUTION OF REGULATORY SCIENCE AND PUBLIC-PRIVATE PARTNERSHIPS

8:30 am - 8:50 am: The ACTION Public-Private Partnership: Background, Rationale, and Objectives

Bob A. Rappaport, MD
Director
Division of Anesthesia and Analgesia Products
Center for Drug Evaluation and Research
Food and Drug Administration

8:50 am - 9:10 am: Evolution of the ACTION Initiative and Public-Private Partnerships in the Context of FDA's Public Health Mission and Regulatory Science

Wendy R. Sanhai, PhD, MBA
Senior Scientific Advisor
Office of the Commissioner
Food and Drug Administration

9:10 am - 9:30 am: What are the Obstacles in Analgesic Drug Development?

Kenneth I. Kaitin, PhD
Director and Research Professor
Tufts Center for the Study of Drug Development
Tufts University

9:30 am - 10:15 am: Panel Discussion with Audience: Obstacles in the Development of Improved Analgesics and Opportunities for Public-Private Partnerships

Drs. Kaitin, Rappaport, and Sanhai, plus Laurie Burke, RPh, MPH, Chekesha Clingman, PhD, Benjamin Eloff, PhD, and Sharon Hertz, MD
Moderators: Paul Desjardins, DMD, PhD, and Michael Rowbotham, MD

10:15 am - 10:45 am: Coffee Break

II. THE CHALLENGES OF ANALGESIC CLINICAL TRIALS AND WHAT ACTION CAN BE TAKEN

10:45 am - 11:05 am: Transforming Translational Research: The View from the NIH

Lawrence A. Tabak, DDS, PhD
Principal Deputy Director
National Institutes of Health

11:05 am - 11:25 am: Analgesic Clinical Trials and Their Assay Sensitivity: A Blueprint for ACTION

Robert H. Dworkin, PhD
Director, ACTION
Professor of Anesthesiology, Neurology, Oncology, and Psychiatry
Professor, Center for Human Experimental Therapeutics University of Rochester

11:25 am - 11:45 am: Factors Associated with Placebo Group Improvement in Analgesic Clinical Trials

John T. Farrar, MD, PhD
Associate Professor of Epidemiology
University of Pennsylvania

11:45 am - 12:05 pm: The Need for and Development of a STandardized ANalgesic DAtabase for Research, Discovery, and Submissions (STANDARDS)

Robert Allen, MD, and Steve Kopko
Co-Chairs, STANDARDS Working Group

12:05 pm - 12:50 pm: Panel Discussion with Audience: Assay Sensitivity, Placebo Group Responses, and Retrospective Analyses of Completed Trials

Drs. Allen, Dworkin, Farrar, and Turk and Mr. Kopko, plus Ernest Kopecky, PhD, Susan Shelby, PhD, and Michael McDermott, PhD
Moderators: Linda Porter, PhD, and Christine Rauschkolb, MD, PhD

12:50 pm - 2:00 pm: Lunch

III. A STRATEGIC PLAN FOR THE ACTION PARTNERSHIP AND ITS COLLABORATIVE ACTIVITIES

2:00 pm - 2:30 pm: Keynote Address: Unmet Needs in the Development of Pain Treatments and the Potential of Public-Private Partnerships

Janet Woodcock, MD
Director
Center for Drug Evaluation and Research
Food and Drug Administration

2:30 pm - 2:50 pm: A Proposed Strategic Plan for ACTION

Dennis C. Turk, PhD
Associate Director, ACTION
John and Emma Bonica Professor of Anesthesiology & Pain Research
University of Washington

2:50 pm - 3:30 pm: Roundtable Discussion: How can the Development of Improved Analgesic Treatments be Expedited?

Drs. Dworkin, Turk, and Woodcock, plus Penney Cowan, Tina Tockarshewsky, and Co-Chairs of the ACTION Executive Committee: Daniel Clauw, MD, John Markman, MD, Philip Mease, MD (acting), Srinivasa Raja, MD, Denham Ward, MD, PhD, and Ajay Wasan, MD
Moderators: Nathaniel Katz, MD, and Jeffrey Tobias, MD

3:30 pm - 3:45 pm: Coffee Break

3:45 pm - 5:00 pm: All Participants: ACTION Strategic Plan - Final Revisions and Proposals for Specific Activities and Working Groups

Moderators: Drs. Dworkin, Rappaport, Sanhai, Turk, and Woodcock