Psychopharmacologic Drugs Advisory Committee


October 25, 2005




Topic:  issues and questions pertinent to the need for longer term efficacy data for proposed drug treatments for

chronic psychiatric disorders, and issues and questions pertinent to optimal study designs for obtaining valid information about longer-term benefits of drug treatment


Overview of Issues and Questions                                  Thomas Laughren, M.D.

[HTML]   [PPT]                                                               Director, Division of Psychiatry Products

                                                                                          CDER, FDA


Presentations from Industry


Introductory Remarks and Review of Agenda           Mark Ammann, Pharm.D.

[HTML]   [PPT]                                                   Pfizer Global Research and Development


Introduction/Overview                                             Frederick Goodwin, M.D.

            [HTML]   [PPT]                                                   George Washington University


            Rationale for Long-Term Treatment                         Earl Giller, M.D.

            [HTML]   [PPT]                                                   Pfizer Global Research and Development


                Disease and Compound Specific Approaches            Robert A. Leadbetter, M.D.

   to the Development of Psychotherapeutic Agents   GlaxoSmithKline

[HTML]   [PPT]


Informative Studies of New Therapeutic Agents       W. Z. Potter, M.D., Ph.D.

   in Major Depression, GAD & Panic                      Merck Research Laboratories

            [HTML]   [PPT]


Key Questions Engendered by Proposal to                Joseph Camardo, M.D.

 Change Long-Term Efficacy Requirements             Wyeth Pharmaceuticals

[HTML]   [PPT]


Issues with Long-Term Trials in Bipolar Disorder      Gary Sachs, M.D.

[HTML]   [PPT]                                                   Harvard Medical School

                                                                              Massachusetts General Hospital


Long-Term Anti-Psychotic Trials:                             Mihael Polymeropoulos, M.D.

   Challenges and Opportunities                                Vanda Pharmaceuticals

[HTML]   [PPT]


Long-Term Anti-Psychotic Treatment in                   Nina Schooler, Ph.D.

   Schizophrenia: 30 Years of Data and Experience    Department of Psychiatry

[HTML]   [PPT]                                                   Georgetown University School of Medicine


Some Statistical Issues Regarding the Use of            Gene Laska, Ph.D.

 Active Versus Placebo Controls in                          Nathan Kline Institute for Psychiatric Research

 Longer-Term Efficacy Trials                                   NYU School of Medicine

[HTML]   [PPT]


Timing and Duration of Relapse Prevention               David Michelson, M.D.

   Trials in Psychiatric New Drug Development         Eli Lilly and Company

[HTML]   [PPT]


            Concluding Remarks                                                Frederick Goodwin, M.D.

[HTML]   [PPT]                                                   George Washington University


Open Public Hearing Speakers

[HTML]   [PPT]


                                                                                          George Awad, President ISCTM

                                                                                          [HTML]   [PPT]


Questions to the Committee

[HTML]   [PPT]