SRI International Awarded National Institutes of Health Preclinical Services Contract
Menlo Park, Calif. —March 25, 2010—SRI International, an independent nonprofit research and development organization, announced today that it has been awarded a $20 million preclinical services contract by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), one of the National Institutes of Health. In this role, SRI will serve as a resource contractor for the preclinical development of new contraceptive drugs and devices for the NICHD's Contraception and Reproductive Health Branch.
"SRI's Biosciences Division is staffed by an experienced research team that is able to provide the full range of preclinical studies and formulation services needed to support NICHD's requirements for efficacy and safety," said Karen Steinmetz, Ph.D., director of mammalian toxicology in SRI's Biosciences Division. "Our studies will help to ensure that new drugs and devices developed through the NICHD program have been screened to meet the stringent standards needed for worldwide regulatory submissions."
A major focus of SRI's efforts will be the smooth transition of multiple hits identified in early stage screening to later stage development activities, including studies that meet Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP) regulatory requirements of the U.S. Food and Drug Administration (FDA). For example, as lead compounds advance through drug development, SRI will create preclinical development plans to address their safety and testing requirements. The accumulated data will be gathered for documentation submitted to the FDA in support of regulatory applications.
This project has been funded in whole or in part with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN275200900014C.