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Senior FDA Speakers Discuss Emerging Issues in Cardiovascular Safety and Diabetic Drug Development

Washington, DC, USA — Aug 19, 2010

DIA, in collaboration with FDA and the Cardiac Research Safety Consortium, will host Development of Type 2 Diabetes Mellitus Drugs Conference: State-of-the-Art Cardiovascular Safety Assessments from October 5-6, 2010 in Washington, D.C.

This two-day workshop allows participants to join senior FDA and industry leaders to discuss important and timely issues related to cardiovascular safety in diabetic drug development. Conference topics include:

  • Optimal Clinical Trial Designs
  • Diabetes Mellitus Regulatory Guidances
  • Postmarketing Assessments
  • Preclinical Testing to Evaluate CV Risk and Mechanistic Considerations
  • Biomarkers, Pharmacogenomics, and Collaborative Efforts

FDA speakers include:

  • Dr. Robert J. Temple, Deputy Center Director for Clinical Science, CDER
  • Dr. Mary Parks, Director, Division of Metabolism & Endocrinology Products, Office of Drug Evaluation II, Office of New Drugs, CDER
  • Dr. Norman Stockbridge, Director, Division of Cardiovascular & Renal Products, Office of Drug Evaluation I, Office of New Drugs, CDER
  • Dr. Ilan Irony, Clinical Team Leader, Division of Metabolism & Endocrinology Products, Office of New Drugs, CDER
  • Dr. Hylton V. Joffe, Lead Medical Officer, Diabetes Drug Group I , Division of Metabolism & Endocrinology Products, Office of New Drugs, CDER
  • Dr. J. Todd Sahlroot, Deputy Director & Team Leader, Office of Translational Sciences, Office of Biostatistics, CDER

“The development of Type 2 Diabetic (T2DM) medications has been significantly impacted by recent data suggesting possible increases in cardiovascular (CV) risk associated with the use of aggressive glucose control with insulin or certain oral medications to treat T2DM,” explains Program Chair Philip T. Sager, MD, FACC, FAHA, Chair, Scientific Oversight Committee, Cardiac Safety Research Consortium. “Our expert presenters will discuss how the development T2DM has been significantly impacted by recent data suggesting possible increases in CV risk associated with the use of aggressive glucose control with insulin or certain oral medications to treat T2DM.”

 

 

 

 

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