4:10-4:15 Chairperson’s Opening Remarks

4:15-4:40 The Biomarker Consortium: A New Approach to Biomarker Discovery and Qualification 
Shawnmarie Mayrand-Chung, Ph.D., J.D., NIH Program Director, The Biomarkers Consortium; Public-Private Partnership Program, Office of Science Policy, Office of the Director, National Institutes of Health
The promise of biomarkers to streamline and even revolutionize investigations of pathobiology, the conduct of clinical trials and regulatory decision-making for drugs and therapeutics, needs to be realized in an efficient, rapid and effective manner. The Biomarkers Consortium (BC), launched in October 2006, is a public-private partner-ship including the National Institutes of Health; the Food and Drug Administration; the Centers for Medicare & Medicaid Services; the pharmaceutical, biotechnology, diagnostics, and medical device industries; non-profit organizations and associations; and advocacy groups. The BC is managed by the Foundation for the National Institutes of Health (FNIH). The BC will search for and validate new biological markers ・biomarkers ・in order to accelerate the delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease. The BC is unique in its commitment cross-sector, pre-competitive and synergistic efforts. The Foundation for the NIH, a free-standing charitable foundation with a Congressionally-mandated mission to support the mission of the NIH, serves as the managing partner of the BC. Through the BC, all sectors can cost-share and leverage resources to facilitate the rapid and focused development of biomarkers as well as informing the science needed for regulatory decision-making.

4:40-5:05 Developing Biomarkers for Global Health
Yiwu He, Ph.D., MBA, Senior Program Officer, Global Health, The Bill &Melinda Gates Foundation
The mission of Bill & Melinda Gates Foundation's Global Health Program is to encourage the development of life-saving medical advances and to help ensure they reach the people who are disproportionately affected. This presentation will discuss the biomarker discovery and development needs that address the following major Global Health focus at the Gates Foundation: (1) access to existing vaccines, drugs, and other tools to fight diseases common in developing countries; and (2) research to develop health solutions that are effective, affordable, and practical.

5:05-5:30 Bridging the Gap from Discovery to Routine Application: The Predictive Safety Testing Consortium's Approach to Biomarker Qualification
Elizabeth Gribble Walker, Ph.D., Assistant Director, Toxicology, Predictive Safety Testing Consortium, Critical Path Institute
Preclinical safety biomarkers in drug development enhance compound prioritization, reveal target organs and mechanisms of toxicity, and help form clinical monitoring strategies. When appropriately translated, i.e. qualified for both pre-clinical and clinical use, they can augment therapeutic benefit through prevention of injury and modification of treatment regimen as needed. While existing biomarkers typically used in a regulated setting have amassed a useful body of evidence, it is widely recognized that more sensitive and specific measures are needed. However, establishing a process for putting new biomarkers into routine practice for regulatory submission in drug development is a complex undertaking. The Predictive Safety Testing Consortium consists of over 180 industry scientists from 16 pharmaceutical companies with FDA and EMEA scientists participating as advisors. The consortium is governed by a unique legal agreement and organized into working groups currently addressing drug-induced liver, kidney, muscle, and vascular injury, as well as non-genotoxic carcinogenicity. Through sharing of safety biomarker information and assays, the consortium works to generate cross-qualification biomarker data for voluntary submission to the regulatory agencies and support the regulatory agencies in establishing robust practices for approval of these biomarkers. Such collaborative and transparent efforts within industry and between industry and regulatory agencies hold tremendous promise for advancing drug safety and improving the efficiency of the drug development process. 

5:30-6:30 Opening Reception in the Exhibit Hall