KING OF PRUSSIA, PA, January 26, 2009 – MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, today announced that two of its top scientific experts will participate in a panel discussion with experts from the United States Food and Drug Administration (FDA) and the National Institutes of Health (NIH) at the 7th Annual Partnering with Central Labs, ECG & Imaging Labs conference January 26-28 in Las Vegas. The session featuring the MDS Pharma Services scientists, Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints, will be held on Wednesday, January 28.
Patrice Hugo, Ph.D, Vice President Scientific Affairs for MDS Pharma Services’ Global Central Lab network, and William Wheeler, M.D., FACC, Global Medical Director for the contract research organization’s Centralized Cardiac Services, will join Wendy Sanhai, PhD, Senior Scientific Advisor, Office of the Commissioner, FDA; and Samir Khleif, Cancer Vaccine Section Investigator, National Cancer Institute (NCI) at the NIH, Co-Chair NCI-FDA-American Association of Cancer Research Cancer Biomarkers Collaborative, and Special Assistant to the Commissioner, FDA Critical Path, on the panel.
The panel will address the development of partnerships between researchers, regulators and developers to accelerate drug development and improve patient safety. It will discuss the use of biomarkers to facilitate the FDA’s Critical Path Initiative aimed at modernizing the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery, or “proof of concept,” into a medical product.
“Dr. Hugo and Dr. Wheeler are well respected thought leaders in our industry and specifically on the subject of biomarkers, and their participation on this panel with peers from the FDA and NCI-NIH demonstrates the esteem in which the scientific community holds them,” said MDS Pharma Services President, David Spaight. “We are pleased key members of our staff are using their expertise in collaboration with government and academic scientists to advance the use of biomarkers so that new drugs can reach those who need them, as quickly and effectively as possible” Mr. Spaight added.
A key component of the FDA’s Critical Path Initiative is to systematically integrate biomarkers – which are quantitative measures of biological effects – into the drug development path to provide informative links between mechanism of action and clinical effectiveness. Developing, qualifying and validating new biomarkers requires assembling data on the association of the biomarker with existing clinical data, and then analyzing the performance of that biomarker compared to current outcomes measured in intervention trials where gaps or remaining uncertainties are analyzed. The panel will discuss how researchers, regulators and drug developers can partner to accelerate analytical qualification and validation of biomarkers to accelerate drug development and improve patient safety and welfare.
Dr. Hugo has more than 15 years of relevant experience in discovery, preclinical, clinical development, diagnostics and biotechnology, with a focus on biomarker evaluation and development. His biomarker experience crosses various therapeutic areas including oncology, infectious disease, inflammation, metabolic disease, and women’s health. He joined MDS Pharma Services in June 2008 from Caprion Proteomics, where he was Executive Vice President, Research and Development. He spent six years with PROCREA BioSciences, first as the Vice President of Scientific Research and then as Chief Scientific Officer. Earlier, he worked for the Institut de Recherches Cliniques de Montréal (Montreal Institute of Clinical Research). Dr. Hugo holds a Master of Science in Immunotoxicology from the University of Quebec and a PhD in Immunology from McGill University in Montreal. He also conducted five years of post doctoral training in Australia and the United States.
Dr. Wheeler is a board certified cardiologist with more than 30 years experience in clinical research. In his current role, Dr. Wheeler advises clients on study protocol design, cardiac monitoring and safety, and related regulatory issues. He also leads MDS Pharma Services’ Cardiac Safety Advisory Board, which is responsible for quality control program reviews, best practices for cardiac interpretations and future development of relevant technology. Prior to joining MDS Pharma Services in 2007, Dr. Wheeler was Chief Medical Officer for Spacelabs Healthcare Clinical Trials Services. Before that, he served as Vice President and Chief Medical Officer for Aderis Pharmaceuticals and as Vice President of Cardiovascular/Critical Care at another leading contract research organization. Dr. Wheeler earned his medical degree from the University of California at Los Angeles. He completed his internship and residency at the Los Angeles County/University of Southern California Medical Center and completed his cardiology fellowship at Cedars-Sinai in Los Angeles.
About MDS Pharma Services MDS Pharma Services, a business unit of MDS Inc., is committed to delivering quality service on time. We offer a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, we apply advanced scientific and technological expertise throughout the drug discovery and development process - from lead optimization, pre-IND research, early clinical research (bioequivalence, phases I-IIa) and bioanalysis, through to global clinical development (phases IIb-IV), central lab and centralized cardiac services. For more information, visit our website at www.mdsps.com.
About MDS Inc. MDS Inc. (TSX: MDS; NYSE: MDZ) is a global life-sciences company that provides market-leading products and services our customers need for the development of drugs and diagnosis and treatment of disease. We are a leading global provider of pharmaceutical contract research, medical isotopes for molecular imaging, radiotherapeutics, and analytical instruments. MDS has more than 5,000 highly skilled people in 29 countries. Find out more at www.mdsinc.com or by calling 1-888-MDS-7222, 24 hours a day.
SOURCE: MDS Inc.
