BIOLOGICAL TESTING FACILITY - CHARACTERIZATION OF POTENTIAL OVULATION INHIBITORS

Sri International, Menlo Park CA

Investigators

Abstract

Background: The Contraception Research Branch (CRB) within NICHD supports research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe and effective contraceptives can be developed for men or women. The Biological Testing Facility (BTF) is designed to permit rapid evaluation of new compositions-of-matter, 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 and in vivo assays, 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 the filing of investigational new drug (IND) applications. The BTF has the capability to prepare compounds under current Good Manufacturing Practices (cGMP) to allow clinical evaluation. The BTF has been working with the Contracting Officer?s Representatives (CORs) for the Chemical Synthesis Facility and the Contraceptive Clinical Trials Network (CCTN) and with the investigators in the CCTN to develop and test the appropriate formulations for clinical batches of the candidate compounds. The BTF plays a critical role in the drug development mission of the CRB. Scope and Objectives: Preclinical activities of potential contraceptive products using either in-house or appropriate subcontract facilities as described in the Background including but not limited to the following: 1)Characterization of compounds including confirmation of chemical structure and development of appropriateformulations suitable for in vitro and in vivo studies. 2) Biologic testing of compounds and/or active pharmaceutical ingredients (API) by in vivo and in vitro assays to measure microsome stability, PK, PD, ADME, efficacy, safety and toxicology in appropriate vehicles and appropriate compound concentrations. These studies would support early characterization of compounds that would support eventual testing in clinical trials and ultimately toward filing a New Drug Application (NDA) for approval of a new method of achieving contraception.