NONCLINICAL DEVELOPMENT OF CONTRACEPTIVE PRODUCTS FOR MEN AND/OR WOMEN

Sri International, Menlo Park CA

Investigators

Abstract

The Contraception Research Branch (CRB) within 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, reproductive health, 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 contraceptive methods and/or therapeutic indications. These capabilities include but are not limited to assays (in silico, 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; endocrine profiling; manufacture of active pharmaceutical ingredients (APIs); process and product development; formulation; clinical lot production; preclinical enabling studies; 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; and all other safety and pharmacology assays and studies that may be required for a particular contraceptive and/or therapeutic agent or device. 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 via the BTF need to engage these enhanced services. Scope and Objectives: The objective of this task order is to obtain services for Nonclinical Development of Contraceptive Products for Men and/or Women 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 and/or therapeutic indications. 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 IND, IDE, New Drug Application (NDA) or similar documentation for regulatory authorities in other countries/regions.