MENLO PARK, Calif.āOctober 28, 2020ā SRI International has been awarded a Biological Testing Facility (BTF) contract of up to $40 million from the Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD) to complete discovery and preclinical development of new contraceptive compounds. Under the five-year contract, SRI is responsible for all preclinical support services necessary to progress toward the development of high-quality, safe, and effective male and female contraceptive products.
The NICHD is the lead U.S. agency for the conduct of basic, clinical, and epidemiologic research to develop new contraceptive methods and to evaluate existing methods of contraception and reproductive health. The NICHDās BTF fulfills a unique role in bridging the discovery and optimization of contraceptive agents to the development and approval of contraceptive drugs.
āThrough this contract, our team at SRI has the opportunity to apply our state-of-the-art facilities and extensive expertise in support of NICHDās important global health goals,ā said Toufan Parman, senior director of toxicology and immunology, SRI International, and the principal investigator for the NICHD contract. āWe are honored to have been selected for this project through the Instituteās rigorous selection process, and look forward to continuing the important work weāve been doing for NICHD for more than a decade.ā
As the BTF selected to fulfill this contract, SRI will carry out in vitro receptor and cell-based assays, in vivo efficacy studies, anti-fertility/fertility assessment, endocrine activity, toxicity, absorption distribution metabolism excretion (ADME) profiling, drug metabolism and pharmacokinetics (DMPK) profiling of new chemical compounds, formulation development, testing of novel delivery systems and devices, drug product manufacturing and stability assessments, and all other activities related to preclinical development of products that can be tested in clinical trials for contraception and/or therapeutic indications.
SRI has provided preclinical services as the sole development contractor to the NICHD since 2009. Since that time, under SRIās NICHD-BTF contracts, the organization has completed numerous task orders for clinical Good Manufacturing Practices (cGMP) manufacturing, efficacy, preclinical toxicology, pharmacology testing, and regulatory support, allowing for advancement of five promising contraceptives (one female and four male) to Phase I and II clinical trials.
In the last 5 years, SRIās in-house team of software engineers, bioinformaticians, toxicologists, and chemists also developed and launched a unique contraceptive infertility target database (CITDBase). This public database is intended to aid investigators across the world in selecting a druggable human reproductive contraceptive protein target for their research. This database has been praised by numerous universities and organizations working in the field of contraceptive development.
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About SRI International
SRI International, a non-profit research institute founded in 1946 and headquartered in Menlo Park, California, creates world-changing solutions to make people safer, healthier, and more productive. SRI Biosciences, a division of SRI International, integrates basic biomedical research with drug and diagnostics discovery, and preclinical and clinical development. SRI Biosciences has advanced more than 175 drugs to clinical trials, and approximately 20 have reached the market. The division is focused on novel platforms and programs in a variety of therapeutic areas targeting high unmet medical needs. SRI Biosciences collaborates with a broad range of partners from small and virtual biotechnology companies to top 10 pharmaceutical companies and other leading industry partners. More information is available at www.sri.com.
This project has been funded in whole or in part with Federal funds from the National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), under Contract No. 75N94020D00003.
