May 13-14, 2005
Natcher Conference Center
Bethesda, Md
Summary
Food and Drug Administration (FDA)/National Institutes of Health (NIH) Joint Symposium on Diabetes: Targeting Safe and Effective Prevention and Treatment. The purpose of the symposium is to define the current state of the prevention and management of diabetes and to identify and discuss therapeutic gaps and hurdles to safe and effective prevention and treatment of type 1 and type 2 diabetes mellitus. The symposium is intended to provide assistance to FDA, clinical and basic scientists, and the interested pharmaceutical industry in their efforts to reduce the burden of diabetes and improve the health of all people with diabetes.
The symposium will provide a forum for discussion of diabetes-related topics, including the following:
- Important disease outcomes that are or should be targeted in the development of drugs, devices, and cell-based therapies for type 1 and/or type 2 diabetes.
- Issues surrounding the use of surrogate or intermediate measures of clinical effect in assessments of novel therapeutic approaches to prevention and treatment.
- Clinical, scientific, and regulatory issues surrounding development of new medical technologies for the treatment of metabolic syndrome and for the prevention of type 2 diabetes.
Agenda
Day 1: Thursday, May 13
Major Challenges to Development of New Therapeutics and Diagnostics
7:30 am Registration
8:30 am Welcome FDA/NIH – Allen Spiegel, Director NIDDK; Lester Crawford, Acting Commissioner, FDA
Session I: Overview/Setting the Stage
8:50 am The Realities of Diabetes Mellitus in 2004 – David Nathan, Harvard Medical School
9:20 am Duality of Type 2 Diabetes Mellitus – Peter Wilson, Medical University of South Carolina
9:50 am Discussion
10:15 am BREAK
Session II: New Targets of Intervention
10:30 am Molecular Targets in Type 2 Diabetes Mellitus – Nancy Thornberry, Merck and Company
11:00 am Immunomodulation in Type 1 Diabetes Mellitus – George Eisenbarth, University of Colorado Health Sciences Center
11:30 am Discussion
11:55 am LUNCH (on your own)
Session III: Beta Cell Preservation
1:10 pm Type 1 Diabetes Mellitus – Jerry Palmer, Seattle VA Puget Sound Health Care System
1:40 pm Type 2 Diabetes Mellitus – Steven Kahn, VA Puget Sound Health Care System
2:10 pm Discussion
Session IV: Islet Transplantation
2:30 pm Islet Transplants: Past, Present, and Future – Bernhard Hering, University of Minnesota
3:00 pm Hurdles in the Clinical Application of Islet Transplantation – Robert Sherwin, Yale University School of Medicine
3:30 pm Discussion
4:00 pm BREAK
Session V: Devices
4:20 pm Continuous Glucose Sensors in Diabetes – William Tamborlane, Yale University School of Medicine
4:45 pm Pumps: Hopes and Expectations – Christopher Saudek, The Johns Hopkins Medical Institutions
5:10 pm Discussion
5:30 pm ADJOURN
Day 2: Friday, May 14
Perspectives on the Future of Prevention and Therapy
7:00 am Registration
Session VI: Prevention of Type 2 Diabetes
8:00 am Metabolic Syndrome: An Overview – Barbara Howard, MedStar Research Institute
8:25 am Metabolic Syndrome: A Potential Target for Prevention of Type 2 Diabetes Mellitus – Robert Eckel, University of Colorado Health Sciences Center
8:50 am Diabetes Prevention Program: Lessons for Therapy – Harry Shamoon, The Albert Einstein College of Medicine
9:15 am Discussion
9:35 am BREAK
Session VII: Industry and Advocacy Perspectives
9:55 am Drugs – Simeon Taylor, Bristol-Myers Squibb Pharmaceutical Research Institute
10:10 am Biologics
10:25 am Devices – Richard Naples, Roche Diagnostics
10:40 am American Diabetes Association – Nathaniel Clark
10:55 am Juvenile Diabetes Research Foundation International – Robert Goldstein
11:10 am Discussion
Session VIII: Targeting Safe and Effective Prevention
and Treatment: Steps Forward by FDA and NIH
11:35 am Panel Discussion
12:30 am Closing
