Industry And FDA Leaders To Discuss The Evolving Science Of Cardiovascular Safety (CV) And Diabetic Drug Development

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The Drug Information Association (DIA) will host a two-day workshop on Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications from September 23-24, 2009 in Washington, DC.

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Recent data published in major medical journals suggests possible increase in cardiovascular (CV) risk associated with the use of certain drugs for the treatment of type 2 diabetes (T2DM)

The Drug Information Association (DIA) will host a two-day workshop on Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications from September 23-24, 2009 in Washington, DC.

The workshop will examine evolving scientific data surrounding CV safety and diabetic drug development, future methods to make development of these drugs more streamlined while ensuring safety. Session topics will include:

  •     Type 2 Diabetes: Clinical implications, CV manifestations, and epidemiology
  •     Therapies and targets for treatment of Diabetes Mellitus - potential implications on CV safety
  •     Glycemic control - evidence for positive and negative impacts on CV and renal outcomes in Type 2 DM
  •     New trial design approaches to assessing CV safety
  •     Clinical evidence that T2DM diabetic drugs can increase CV risk
  •     Diabetic drug development and CV safety
  •     Approaches to clinical analysis of CV risk
  •     Novel clinical trial approaches
  •     Future approaches to assessing T2DM drug development and CV safety
  •     QT experience as a model for furthering collaborative approaches/research in CV

"Recent data published in major medical journals suggests possible increase in cardiovascular (CV) risk associated with the use of certain drugs for the treatment of type 2 diabetes (T2DM)," explains Program Chair Philip T. Sager, MD, FACC, Vice President, Clinical Research, Cardiopulmonary and Metabolic Clinical Development, Gilead Sciences, Inc. "As a result, the Division of Metabolism and Endocrinology Products of the US Food and Drug Administration (FDA) issued a new guidance in December 2008 recommending that all new T2DM drugs demonstrate CV safety in appropriately designed and powered outcome studies."

About the Drug Information Association (DIA):

DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.

Contact:

Joe Krasowski
Drug Information Association
215-293-5812
http://www.diahome.org

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