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CONFERENCE SHORT COURSE* November 3, 2010 Course 7   6:00 pm – 9:00 pm DINNER SHORT COURSE Assessing Cardio Safety of Diabetes Drug Candidates  Assessing the cardiovascular safety of diabetes drug candidates has always been important, but it has become a more deliberate/discussed focus after the FDA issued guidance on the topic in December of 2008 for the pharmaceutical industry. This workshop is designed to help scientists understand and discuss their diabetes drug development work in the context of the new guidelines. How to evaluate CV risk of preclinical compounds What is needed for FDA approval Case Studies Instructors: G. Alexander Fleming, M.D., President and CEO, Kinexum Michael Trautmann, M.D., Senior Medical Fellow, Exenatide GBD Team, Eli Lilly *Separate registration required.

WEDNESDAY, NOVEMBER 3

12:30 - 1:30 pm Conference Registration

 

Diabetes Drug Development Challenges

1:30 pm Chairperson’s Remarks

Rebecca Taub, M.D., Senior Vice President, Research and Development, VIA Pharmaceuticals

1:40 KEYNOTE PRESENTATION Future Treatment of Diabetes: Integrating Perspectives From Bench, Bedside, and Beyond Jorge Plutzky, MD, Director, The Vascular Disease Prevention Program, Cardiovascular Division, Brigham and Women’s Hospital and Associate Professor, Harvard Medical School This presentation will look at diabetes drug development from the many perspectives relevant to a diabetes researcher in industry. Dr. Plutzky was the first cardiologist to serve on the physician’s advisory panel to the endocrine metabolism section of the FDA, is an NIH-funded scientist studying mechanisms involved in cardiometabolic disorders, and has a clinical perspective that derives from his role as the director of a lipid clinic/prevention program.

2:25 OPENING PANEL: CLINICAL DEVELOPMENT CONSIDERATIONS

Moderator: Rebecca Taub, M.D., Senior Vice President, Research and Development, VIA Pharmaceuticals

• What will the ideal future regimen look like?
• Combination therapies?
• Different regimens for different patient populations?
• How much and at what point in development is some CV risk acceptable?

3:10 Networking Refreshment Break in the Exhibit Hall

 

Targeting G Protein Coupled Receptors to Modulate Insulin Levels

3:45 Glucagon Receptor Antagonists (tentative title)

Michael Miller, Ph.D., Senior Principal Scientist, Medicinal Chemistry, Merck

4:15 Sponsored Presentation (Opportunity Available)

4:45 GPR39, A Novel Target for Type-2 Diabetes and Obesity

Birgitte Holst, Ph.D., Associate Professor, University of Copenhagen

The GPR39 is a 7TM, G-protein coupled receptor, which is highly expressed in peripheral tissues with metabolic functions such as adipose tissue, liver, GI tract and the endocrine pancreas. GPR39 knock out mice has been shown to display normal insulin sensitivity but impaired glucose tolerance both during oral and intravenous glucose tolerance tests and decreased plasma insulin response to glucose challenge. Furthermore, GPR39 knock out mice fed with high fat diet develops obesity faster than wild type littermates. It is suggested that GPR39 is involved in the control of endocrine pancreatic function and fat accumulation and that this receptor could be a novel potential target for the treatment of obesity and diabetes.

5:15 Targeting Entero-endocrine 7TM Chemo-sensors for Metabolic Diseases

Thue W. Schwartz, Ph.D., Professor, The Novo-Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen

Gut hormones such as GLP-1, GIP, PYY and CCK control a wide range of metabolic functions in the body through paracrine, neuronal and endocrine functions. These peptides are expressed and released from an array of different types of enteroendocrine cells scattered throughout the mucosal lining of the GI-tract sensing and integrating food components, metabolites, neuronal and endocrine inputs. Based on analysis of the expression of peptides and receptors in a series of different types of genetically tag’ed enteroendocrine cells – the potential of using agents which selectively target Enteroendocrine cell receptors to release the physiological mixtures of gut hormones to treat metabolic diseases will be discussed.

5:45 End of Day

6:00 pm - 9:00 pm Conference Short Course * DINNER SHORT COURSE Assessing Cardio Safety of Diabetes Drug Candidates Assessing the cardiovascular safety of diabetes drug candidates has always been important, but it has become a more deliberate/discussed focus after the FDA issued guidance on the topic in December of 2008 for the pharmaceutical industry. This workshop is designed to help scientists understand and discuss their diabetes drug development work in the context of the new guidelines. How to evaluate CV risk of preclinical compounds What is needed for FDA approval Case Studies Instructors: G. Alexander Fleming, M.D., President and CEO, Kinexum Michael Trautmann, M.D., Senior Medical Fellow, Exenatide GBD Team, Eli Lilly   *Separate registration required.