SRI International has been awarded a resource contract of up to $100 million over five years by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the development of products to mitigate or treat acute or delayed effects of radiation exposure. Under the multiyear contract, SRI Biosciences, a division of SRI International, will provide services, facilities, expertise and capabilities to advance the development of radiation/nuclear medical countermeasure therapies from early-stage discovery toward licensure or approval by the FDA.
The supported work will encompass studies performed in the drug development pathway, as well as the administrative foundation necessary to facilitate and coordinate those activities in partnership with NIAID.
NIAID has sponsored numerous early-stage research and product development programs and additional targeted initiatives focused on radiation-induced hematopoietic, gastrointestinal, pulmonary, cutaneous and combined injuries and radionuclide decorporation.
“SRI has an extensive track record of drug development and basic radiation biology research, and this project fits perfectly within our broad but very deep range of product development capabilities,” said Polly Chang, Ph.D., senior director of molecular and genetic toxicology, SRI Biosciences, and principal investigator for the NIAID contract. “We are honored to have the opportunity to work with NIAID on this large, important project designed to protect human health. I’m confident in the team of experts we've structured to support this contract, and look forward to working with our colleagues at NIAID to move this program forward expeditiously and effectively.”
Under the current contract, SRI will be responsible for a comprehensive set of tasks that could include (but will not be limited to) preclinical and nonclinical testing, formulation development, stability studies, current Good Manufacturing Practice production and human clinical safety studies. SRI will support the latter in its own phase I clinical trials facility, which enables the organization to advance promising drug candidates beyond the Investigational New Drug phase.