BIOLOGICAL TESTING FACILITY - PRECLINICAL DEVELOPMENT OF CONTRACEPTIVES

Sri International, Menlo Park CA

Investigators

Abstract

NICHD has supported research to develop compounds that can disrupt normal ovulation, sperm production or sperm function so that safe, effective and inexpensive contraceptives can be developed for men or women. The Biological Testing Facility 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 and development of contraceptives: these are but not limited to in vitro and in vivo assays, absorption, distribution, metabolism, excretion and toxicity (ADMET) and pharmacokinetics (PK) 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 Good Manufacturing Practices (GMP) to allow clinical evaluation in the CDDB Contraceptive Clinical Trials Network (CCTN). The CCTN investigators have prepared the protocols and tasks are awarded or in the process of award to the CCTN sites to conduct the clinical trials. The BTF has been working with the CORs (for the Chemical Synthesis Facility and the CCTN) and the investigators in the CCTN to develop and test the appropriate formulations for clinical batches. The next 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 task will support all preclinical activities using either in house or appropriate subcontract facilities as described in the Background including but not limited to in vivo and in vitro assay, efficacy, safety and toxicology of new chemical entities (NCEs) and or active pharmaceutical ingredients (API) in appropriate vehicles and appropriate concentrations that will be suitable for use as a contraceptive product. The agents may be administered orally, intramuscularly, transdermally or other routes of administration that are acceptable for clinical materials. The formulated products shall be characterized for in vivo safety and toxicology in all areas and species that would be appropriate to the route of administration and duration of activity pursuant to filing an IND that would support testing in clinical trials.