BIOLOGICAL TESTING FACILITY (BTF) - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVE PRODUCTS

The Contraception Research Branch (CRB) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) supports research to develop compounds that can disrupt oogenesis, spermatogenesis, normal ovulation, sperm maturation and/or function to afford safe and effective contraceptives for men and/or women.
The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions of matter, use cases for existing chemical matter, drug formulations, delivery systems, and devices for contraceptive, endocrine and/or contraceptive-containing multipurpose prevention (cMPT) activity. The BTF provides overall project management and the capabilities to support all phases of nonclinical activities pursuant to development of new contraceptives methods. These capabilities include but are not limited to assays (in vitro, ex vivo and in vivo); plasma and microsomal stability studies; absorption, distribution, metabolism, excretion (ADME); toxicity; 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 filing of US Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE) applications, or similar filings for other regulatory agencies. In addition to the work mentioned above, the BTF has the capability to prepare compounds under current good manufacturing practices (cGMP) to allow clinical evaluation and conduct studies under current good laboratory practices (cGLP), though not all studies conducted in the BTF need to engage these enhanced services. The BTF plays a critical role in the product development mission of the CRB.
The objective of this task order is to obtain services for Preclinical Development of Contraceptive Products to determine, as appropriate, the efficacy, safety, toxicity, pharmacology, and pharmacokinetic (PK) and toxicokinetic (TK) properties of novel chemical entities (NCEs), other active pharmaceutical ingredients (APIs), biologics, or devices that are being developed for male and/or female contraception. These studies will be conducted to evaluate and/or select the best candidate to move forward to further product development or enable service requestors to obtain pivotal data for their preclinical development programs. The services may be conducted by the contractor or appropriate reputable subcontract facilities, as necessary.
The ultimate objective is to obtain high quality data that could support FDA Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA) or similar documentation for regulatory authorities in other countries/regions.

Grant Number: 75N94020D00003-0-759402400002-1
NIH Institute/Center: NIH
Principal Investigator: DEBRA BURNIN