New Corporate Members and Leaders for C-Path’s Predictive Safety Testing Consortium Announced

November 15th, 2006 - Tuscon, AZ The Critical Path Institute (C-Path) today announced seven new members that have recently joined the Predictive Safety Testing Consortium (PSTC) [see US Food and Drug Administration Press Release March 16, 2006] bringing the total number of company members to 15. In addition, C-Path announced the appointment of William B. Mattes, Ph.D., as its Director of Toxicology and Director of the Consortium. Consortium members have elected Jacky Vonderscher, PhD, Vice-President and Head of the Novartis-GNF Discovery Science Office to serve as Co-Director.

The seven new members are Abbott, Amgen Inc., AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals, Inc., Iconix Biosciences, Inc., Eli Lilly and Company, and sanofi-aventis U.S. Inc, joining the original members: Bristol-Myers Squibb Company, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, LLC, Merck and Co., Inc., Novartis Pharmaceutical Corporation, Pfizer, Inc., Roche Palo Alto, LLC and Schering Plough Research Institute, a division of Schering Corporation. As one of C-Path’s founding partners, SRI International participates in the activities of the Consortium.

The members of the PSTC are sharing internally developed laboratory methods used to evaluate the safety of new drugs, and then testing one another’s methods. Since a primary goal of the Consortium is to identify methods for testing drug safety that are useful not only for industry, but also for the FDA, FDA scientists are participating in an advisory capacity. Since its inception, the Consortium has formed four working groups, focusing on biomarkers of liver, kidney, vascular injury and carcinogenicity. These groups have reviewed their methods and have narrowed the list of candidate tests to those most promising and suitable for extensive evaluation. Importantly, FDA scientists have provided input on the list of tests and the approaches being taken for qualification.

William B. Mattes, PhD is serving as Director of the Consortium. Prior to joining C-Path, Dr. Mattes was Senior Scientific Director of Toxicogenomics at Gene Logic where he directed the genomics-based mechanism of toxicity program. He also held positions in toxicogenomics, investigative toxicology and genetic toxicology at Pharmacia Corp, Ciba Pharmaceuticals, and Ciba-Geigy Agricultural Chemicals. Dr. Mattes received a BA from the University of Pennsylvania and PhD in biological chemistry from the University of Michigan. Dr. Mattes is a Diplomate of the American Board of Toxicology, and a member of the Society of Toxicology (SOT).

Dr. Janet Woodcock commented that this Consortium will bring together the very best minds in science and the needed resources to make sure that the most sensitive and predictive laboratory tests are being performed in drug development to protect the public. Dr. Raymond Woosley, President and CEO of C-Path said, “We are very pleased to have so many leading companies participating in the Consortium and to have Bill Mattes, an outstanding experienced scientist, coordinating this exciting work.”

About The Critical Path Institute
Based in Tucson, Arizona with offices in Phoenix and Rockville, MD, The Critical Path Institute (C-Path) was established in 2005 as a publicly funded, nonprofit research and education institute to serve as a trusted third party for collaborations between scientists and others from government, industry and academia. C-Path’s mission is to help implement the FDA’s Critical Path Initiative by developing faster, safer and smarter pathways to new medical products. Visit www.C-Path.org for more information.