Experts Speak About Developing Diabetes Therapeutics

Speid & Associates, a San Diego-based regulatory affairs and drug development consultancy, is hosting a six session Webinar series on diabetes and related metabolic diseases during the months of March and April. Speakers will include former Food and Drug Administration officials Dr. Alexander Fleming and Dr. Ray Lipicky, as well as a distinguished list of other guest speakers and panelists.

Researchers and companies involved in diabetes therapeutic development are finding a complex array of possible targets across diabetes (both type 1, type 2), the metabolic syndrome, and the complications and causes of diabetes. This translates into a complex pathway for therapeutic development and registration with many potential pitfalls along the way. The webinar series will promote discussion on the inter-related issues of diabetes/metabolic therapeutic development and registration.

Dr. Speid said, "I am delighted that the series will feature such a stellar list of speakers, to address these important topics and issues." Dr. Alexander Fleming, ex-FDA (formerly headed diabetes drug review) said, "There is no more active and controversial therapeutic development area than for diabetes drugs. I look forward to discussing the implications of the ACCORD trial and a number of other timely topics."

For many years, Dr. Ray Lipicky headed FDA's Division of Cardiorenal Drug Products. Among his many drug approvals was the first and essentially only approval of treatments for a diabetic complication. The participation of Drs. Lipicky and Fleming in this series mirrors the convergence of cardiovascular and metabolic therapeutics at multiple levels -- pathophysiology, drug targets, trial design, and clinical disciplines.

Republished from: http://www.foxbusiness.com/article/diabetes-series-2008-experts-speak-developing-diabetes-therapeutics_492046_1.html