SRI Awarded $150 Million NIAID-DAIDS Contract to Provide Development and Manufacturing Support for Promising HIV-Prevention Products | SRI International

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SRI Awarded $150 Million NIAID-DAIDS Contract to Provide Development and Manufacturing Support for Promising HIV-Prevention Products

MENLO PARK, Calif.—December 6, 2016 – SRI International has been awarded a contract of up to $150 million from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Division of AIDS (NIAID-DAIDS) to support the manufacturing and characterization of HIV microbicides and other non-vaccine pre-exposure (PreP) agents. Under the seven-year contract, SRI will provide a comprehensive suite of preclinical product development services for candidate HIV-prevention products that emerge from investigator-initiated studies or from collaborations with outside companies and organizations.

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An estimated 36.7 million people worldwide are currently living with HIV, and the development of highly effective strategies to prevent further spread of the virus remains one of the highest priorities for the NIAID and DAIDS.[i] The availability of safe, effective, and acceptable non-vaccine biomedical prevention products could play a major role in the worldwide reduction of the estimated 5,000 new HIV infections per day.[ii] However, as promising products emerge, advancement through the development process has been a significant barrier, particularly for academic groups and small to mid-sized companies.

Under the contract issued by DAIDS, SRI Biosciences, a division of SRI International, will manufacture and characterize high-quality drug products to support the progression of promising microbicide and PreP agents through both preclinical and clinical studies. SRI will also provide support for specific activities required by the U.S. Food and Drug Administration to move products into clinical testing.

“Since the early 2000s, researchers at SRI International have been involved in drug development activities to help move many microbicides, PrEP agents, and multipurpose prevention technologies through IND-enabling studies,” said Gita Shankar, Ph.D., director, Formulations R&D, Center for Pharmaceutical and Chemical Technologies, SRI Biosciences, and principal investigator for the DAIDS contract. “We are very pleased to be given an opportunity to contribute to the acceleration of promising HIV products into clinical testing and the creation of a sustainable pipeline of prevention products and strategies.”

SRI has broad experience with similar studies for DAIDS and for many other divisions of the National Institutes of Health, as well as for private sponsors. Since 2010, Dr. Shankar has led the development of a multipurpose HIV-prevention microbicide bioadhesive gel, which is funded by another NIAID grant (R33AI098658-03). Between 2000 and 2004, SRI manufactured drug products and supplied clinical sites with microbicides and contraceptive controls such as Gynol II® Vaginal Jelly, sodium cellulose sulfate 6% gel, ACIDFORM™ gel and BufferGel®.

This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201600010I.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

[i] No. NAID-DAIDS-NIHAI2015029