Slides
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]
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
Informative Studies of New
Therapeutic Agents W. Z. Potter,
M.D., Ph.D.
in Major
Depression, GAD & Panic Merck
Research Laboratories
Key Questions Engendered by
Proposal to Joseph Camardo,
M.D.
Change Long-Term Efficacy Requirements Wyeth Pharmaceuticals
Issues with Long-Term Trials
in Bipolar Disorder Gary Sachs, M.D.
[HTML] [PPT]
Long-Term Anti-Psychotic
Trials: Mihael
Polymeropoulos, M.D.
Challenges and Opportunities Vanda
Pharmaceuticals
Long-Term Anti-Psychotic
Treatment in Nina
Schooler, Ph.D.
Schizophrenia: 30 Years of Data and
Experience Department of Psychiatry
[HTML] [PPT]
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
Timing and Duration of
Relapse Prevention David
Michelson, M.D.
Trials in Psychiatric New Drug Development Eli Lilly and Company
Concluding Remarks Frederick
Goodwin, M.D.
[HTML] [PPT]
Open Public Hearing Speakers
George Awad, President ISCTM
Questions to the Committee