Diabetes Drug Discovery

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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 


This workshop is designed to help scientists understand and discuss their diabetes drug development work in the
context of the cardio-safety guidelines issued by the FDA in 2008 and recent high-profile FDA decisions related to currently marketed diabetes drugs.

  • Historical perspective on how we've gotten to this point in safety assessment
  • Basics of micro- v. macrovascular complications of diabetes (DCCT and UKPDS trials)
  • Glucose control v. CV outcome: lessons from large outcome trials such as Accord/Advance/VADT
  • Discussion of the new FDA Guidance and regulatory expectations in detail
  • Lessons learned from the Avandia cardio-safety issues
  • Case studies and interactive discussion with course participants around the challenge of conducting clinical trials in reasonable amount of time and cost

Instructors:

G. Alexander FlemingG. Alexander Fleming, M.D., President and CEO, Kinexum (formerly responsible for diabetes drugs, Division of Metabolic and Endocrine Drug Products, FDA)

Dr. Fleming brings extensive clinical experience and regulatory responsibility in the therapeutic areas of metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. Before playing leadership roles at health product development companies in the private sector (Kinexum and prior to that, CSO of Ingenix Pharmaceutical Services and CMO of Boston Medical Technologies), Dr. Fleming was at the FDA for 12 years where he served as reviewer and supervisory medical officer.   He was responsible for the regulation of biotech products including human insulin and growth hormone.  His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 1991-92.  Dr. Fleming was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH).  He was a major contributor to FDA's Good Review Practice (GRP) initiative and chair of the committee responsible for education and training at CDER.  Dr. Fleming is lead author of the book, “Optimizing Development of Therapies for Diabetes.”  He serves on numerous scientific advisory boards and expert committees and has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.

Michael TrautmannMichael Trautmann, M.D., Senior Medical Fellow, Lilly Diabetes, Eli Lilly & Company

Dr. Trautmann is Senior Medical Fellow in the Exenatide Global Medical Team. Since 1998 Dr. Trautmann has been at the Lilly Research Laboratories in Hamburg where he has coordinated early phase clinical programs and has worked on several programs in the area of GLP-1. From 1996 to 1998 Dr. Trautmann was at Lilly's Indianapolis location where he was Global Physician in the Endocrine Therapeutic Area with responsibilities for early phase development of novel therapeutic approaches in the area of obesity and Type 2 diabetes treatment. His career with Eli Lilly started in 1993 when he  joined Lilly Germany as Clinical Research Physician for Diabetes where he was responsible for the clinical development of insulin lispro (Humalog). Before Lilly, Dr. Trautmann  was conducting clinical research research focused on diabetes treatment and endocrine tumors of the gut at the Universities Goettingen and Marburg, Germany, and Geneva, Switzerland, where he trained in Internal Medicine and Diabetology. In his laboratory, intracellular mechanisms involved in controlling insulin release and cell differentiation of pancreatic beta cells were investigated. Already since 1987 he has been involved in research around Glucagon-like peptide-1 and its effects on insulin secretion.

*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 PlotzkyJorge 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?

Panelists:

 

 

Jorge Plutzky, MD, Director, The Vascular Disease Prevention Program, Cardiovascular Division, Brigham and Women’s Hospital and Associate Professor, Harvard Medical School

Michael Trautmann, M.D., Senior Medical Fellow, Exenatide GBD Team, Eli Lilly

 

 

3:10 Networking Refreshment Break in the Exhibit Hall
**Drop off a business card at CHI’s Sales Booth in the Exhibit Hall for a chance to win an iPod®!

 

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


Sponsored by
Beta Pro 
4:15 Economic and Scientific Considerations for High Throughput and Selective Drug Screening in Diabetes - The Value of Using Human Tissue

Kenneth L. Brayman, M.D., Ph.D., FACS, Principal Scientific Advisor, Betapro, LLC

 

 

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

This workshop is designed to help scientists understand and discuss their diabetes drug development work in the
context of the cardio-safety guidelines issued by the FDA in 2008 and recent high-profile FDA decisions related to currently marketed diabetes drugs.

  • Historical perspective on how we've gotten to this point in safety assessment
  • Basics of micro- v. macrovascular complications of diabetes (DCCT and UKPDS trials)
  • Glucose control v. CV outcome: lessons from large outcome trials such as Accord/Advance/VADT
  • Discussion of the new FDA Guidance and regulatory expectations in detail
  • Lessons learned from the Avandia cardio-safety issues
  • Case studies and interactive discussion with course participants around the challenge of conducting clinical trials in reasonable amount of time and cost

Instructors:

G. Alexander FlemingG. Alexander Fleming, M.D., President and CEO, Kinexum (formerly responsible for diabetes drugs, Division of Metabolic and Endocrine Drug Products, FDA)

Dr. Fleming brings extensive clinical experience and regulatory responsibility in the therapeutic areas of metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications. Before playing leadership roles at health product development companies in the private sector (Kinexum and prior to that, CSO of Ingenix Pharmaceutical Services and CMO of Boston Medical Technologies), Dr. Fleming was at the FDA for 12 years where he served as reviewer and supervisory medical officer.   He was responsible for the regulation of biotech products including human insulin and growth hormone.  His regulatory and technical expertise has been requested in numerous international settings including the World Health Organization, where he was assigned during 1991-92.  Dr. Fleming was a member of the expert working groups on Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonization (ICH).  He was a major contributor to FDA's Good Review Practice (GRP) initiative and chair of the committee responsible for education and training at CDER.  Dr. Fleming is lead author of the book, “Optimizing Development of Therapies for Diabetes.”  He serves on numerous scientific advisory boards and expert committees and has served as invited editorialist to The New England Journal of Medicine and as a commentator on National Public Radio.

 

Michael TrautmannMichael Trautmann, M.D., Senior Medical Fellow, Lilly Diabetes, Eli Lilly & Company

Dr. Trautmann is Senior Medical Fellow in the Exenatide Global Medical Team. Since 1998 Dr. Trautmann has been at the Lilly Research Laboratories in Hamburg where he has coordinated early phase clinical programs and has worked on several programs in the area of GLP-1. From 1996 to 1998 Dr. Trautmann was at Lilly's Indianapolis location where he was Global Physician in the Endocrine Therapeutic Area with responsibilities for early phase development of novel therapeutic approaches in the area of obesity and Type 2 diabetes treatment. His career with Eli Lilly started in 1993 when he  joined Lilly Germany as Clinical Research Physician for Diabetes where he was responsible for the clinical development of insulin lispro (Humalog). Before Lilly, Dr. Trautmann  was conducting clinical research research focused on diabetes treatment and endocrine tumors of the gut at the Universities Goettingen and Marburg, Germany, and Geneva, Switzerland, where he trained in Internal Medicine and Diabetology. In his laboratory, intracellular mechanisms involved in controlling insulin release and cell differentiation of pancreatic beta cells were investigated. Already since 1987 he has been involved in research around Glucagon-like peptide-1 and its effects on insulin secretion.

 

*Separate registration required.

**Apple® is not a sponsor or participant in the program.    


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