# BIOLOGICAL TESTING FACILITY, TASK ORDER 7: CONTRACEPTIVE PRECLINICAL RESEARCH AND DEVELOPMENT

> **NIH NIH N01** · SRI INTERNATIONAL · 2021 · $1,087,798

## Abstract

The Contraceptive Development Program (CDP) within Division of Intramural Population Health
Research at NICHD supports research to develop compounds that can disrupt normal ovulation,
sperm production or sperm function for the purpose of developing safe, effective and affordable
contraceptives for men or women. The Biological Testing Facility (BTF) is designed to allow
rapid evaluation of new chemical entities (NCE), drug formulations, delivery systems, and devices
for contraceptive and endocrine activity. The BTF provides overall project management and the
capabilities to support all phases of preclinical activities pursuant to development of new
contraceptive methods: these include, but are not limited to in vitro assays and in vivo studies,
plasma and microsomal stability studies, absorption, distribution, metabolism, excretion and
toxicity (ADMET), pharmacokinetic (PK) and pharmacodynamic (PD) profiling, animal activities
and studies, manufacture of active pharmaceutical ingredients (APIs), process and product
development, formulation, clinical lot production, preclinical enabling studies and associated tasks
leading to the filing of investigational new drug (IND) applications. Compounds formulated by
the BTF are prepared under current Good Manufacturing Practices (cGMP) to allow clinical
evaluation in the CDP Contraceptive Clinical Trials Network (CCTN). The CCTN investigators
have develop protocols to evaluate the drug candidates identified as high priority by the Program.
The BTF has been working with the CORs for the Chemical Synthesis Facility and the CCTN and
with the investigators in the CCTN to develop and test the appropriate formulations for clinical
batches of the candidate compounds. The next clinical study for each candidate drug is dependent
on timely receipt of clinical batches to begin the process of recruitment and enrollment. Drugs
that are currently in ongoing clinical trials require stability testing of the clinical formulations. The
Biological Testing Facility plays a critical role in the drug development mission of the CDP.

## Key facts

- **NIH application ID:** 10369889
- **Project number:** 75N94020D00003-0-759402100004-1
- **Recipient organization:** SRI INTERNATIONAL
- **Principal Investigator:** Deborah  Bunin
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,087,798
- **Award type:** —
- **Project period:** 2021-03-05 → 2023-03-04

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10369889

## Citation

> US National Institutes of Health, RePORTER application 10369889, BIOLOGICAL TESTING FACILITY, TASK ORDER 7: CONTRACEPTIVE PRECLINICAL RESEARCH AND DEVELOPMENT (75N94020D00003-0-759402100004-1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10369889. Licensed CC0.

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