Monrovia, CA (PressExposure) March 04, 2012 -- Hans-Juergen Woerle, MD, Associate Professor, Internal Medicine, Vice President and Head of Therapeutic Area Metabolism at Boehringer Ingelheim, Ingelheim, Germany, will be giving a plenary keynote presentation entitled "Diabetes Drug Development in Light of the New FDA CV Guidance: Experience from the Recent Linagliptin Registration" at the 2nd Diabetes Summit to be held on April 19-20, 2012 in Boston, MA by GTC.
Dr. Woerle's presentation will provide a brief outline of the FDA CV guidance regarding required evidence for CV safety of new drugs seeking approval for the treatment of type 2 diabetes mellitus. He will provide a brief retrospective look at the CV safety data contained in the submission package of rosiglitazone in light of the controvery related to this compound. Examples on how excess CV risk was ruled out for some compounds recently approved (saxagliptin, liraglutide) will also be given.Finally, experiences related to registration of linagliptin with respect to the regulatory CV safety requirements, including a perspective on the recently introduced paradigm shift in choise of comparator for required large outcome/safety trials in type 2 diabetes mellitus, will be presented.
In his current role, Dr. Woerle is responsible for the global development of compounds from Phase I-IV, primarily within the field of diabetes. Moreover, he is also the head of the Global Medical Affairs team, and is a member of the Collaboration Leadership Team for the Diabetes Alliance, Boehringer Ingelheim and Eli Lilly. Dr. Woerle joined Boehringer Ingelheim in 2007, as the Associate Therapeutic Head of Metabolism. Dr. Woerle is also a lecturer of internal medicine at the University of Ulm, Germany, and besides that is a specialist in Diabetes and Endocrinology.
With more than 400 drug candidates for diabetes in active development and in light of the recent US Food and Drug Administration (FDA) guidance to assess cardiovascular risk in clinical trials, the burden to develop novel drugs is greater and the barrier for success has become higher than ever. What will be the next block-buster drug target for T1DM and T2DM? How does the recent FDA guidance affect our approach to develop new medications for diabetes? How do different size companies adapt the best strategy to be competitive in this field?
Come and join other diabetes experts at GTC's 2nd Diabetes Summit and hear key thought-leader's opinions to these questions and many more. This important meeting will be held on April 19-20, 2012 in Boston, MA. The conference will bring together the leading experts on diabetes from both industry and academia to discuss novel targets for diabetes, lessons to learn from current clinical drug development, and business strategies and opportunities under the current regulatory landscape.
The 2nd Diabetes Summit will consist of 2 tracks:
5th Diabetes Drug Discovery and Development 2nd Diabetes Partnering & Deal Making
For more information, please visit http://www.gtcbio.com