The Regulatory Approval of Glucose-Lowering Agents - An Evolving Landscape
Riccardo Perfetti, MD, PhD, Vice President, Global Medical Affairs, Diabetes Division at Sanofi-Aventis will give a keynote presentation on "The Regulatory Approval of Glucose-Lowering Agents.
- (1888PressRelease) January 21, 2011 - Philadelphia, PA - Riccardo Perfetti, MD, PhD, Vice President, Global Medical Affairs, Diabetes Division at Sanofi-Aventis to give a keynote presentation at GTCbio's Diabetes Summit taking place on March 7-8, 2011 in Philadelphia, PA.
Dr. Perfetti will present "The Regulatory Approval of Glucose-Lowering Agents - An Evolving Landscape". Dr. Perfetti will discuss the significant changes in the medical management of diabetes. New drugs and new mechanisms of action have been proposed as means to lower blood glucose. The post-approval experience with novel glucose lowering agents have seen major successes and unprecedented failures. The use of HbA1c as a biomarker of efficacy has been put into question and the regulatory requirements have included more direct and indirect evidence of safety. Dr. Perfetti will discuss how the requirements for more definitive proofs of efficacy and safety will continue to evolve and lead to changes in the regulatory requirements in the years ahead of us. Dr. Perfettis presentation is meant to review the latest real-life experience with the approval process of new glucose lowering agents, critically discuss the current regulatory requirements, and analyze the possible evolution of the regulatory landscape.
In his current role Dr. Perfetti is engaged in defining the interaction between the Diabetes Division and the outside interlocutors, including the Academia, the Key Opinion Leaders, the Regulatory bodies; and the Payors. Dr. Perfetti is also the Head of the Diabetes Medical Group which includes the top appointed medical personnel in the countries affiliate organizations. Together with the Vice President for R&D, Dr. Perfetti co-leads the Development Department which includes all clinical activities from phase 1 to post-marketing-phase-4 type of studies. Prior to joining Sanofi-Aventis in autumn 2007, Dr. Perfetti held a variety of positions in Amgen Inc over a 3 year period, including Director, Department of Medical Sciences; Global Development Leader responsible for designing and executing from phase 1 to phase 2a clinical studies for type 2 diabetes, obesity, metabolism, and endocrinology programmes; and Biomarker Development Team Member for first-in-class; Diabetes, Metabolism and Endocrine Group.
Also presenting at the Diabetes Summit are prestigious organizations including Sanofi-Aventis, VeroScience LLC, INSERM, Thermalin, Merck, Decision Resources, Metabolic Solutions Development Company, Pfizer, Inspherion, PhysioGenix, Intarcia Therapeutics, Inc., University of Pennsylvania, Abramson Family Cancer Research Institute, Exsulin Corporation, Arisaph Pharmaceuticals, ActivX, Amarex Clinical Research, Children's Hospital of Philadelphia, Division of Endocrinology & Diabetes, Johnson and Johnson, Macrogenics, Phase Bioscience, Novo-Nordisk Foundation Center for Basic Metabolic Research University of Copenhagen, Merck, Array BioPharma, Comus Bioventures, VIA Pharmaceuticals, Amgen, and Bristol-Myers Squibb.
This Diabetes Summit includes two concurrent tracks: The 4th Diabetes Drug Discovery and Development Conference and the Diabetes Partnering and Deal Making Conference.
For more information, visit www.gtcbio.com.
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