BIOLOGICAL TESTING FACILITY - DISCOVERY, CLINICAL FORMULATION, AND MANUFACTURE OF CONTRACEPTIVES

Within the Division of Population Health Research (DiPHR), the Contraceptive Development Program (CDP) 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 women or men. The Biological Testing Facility (BTF) is a critical component in this process designed to allow 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 administrative support, manuscript support, contraceptive target discovery database, in vitro and in vivo assays, plasma and microsomal stability studies, absorption, distribution, metabolism, excretion and toxicity (ADMET), pharmacokinetic (PK) and pharmacodynamic (PD) profiling, animal 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 that are prepared under current Good Manufacturing Practices (cGMP) will allow clinical evaluation in the CDP’s Contraceptive Clinical Trials Network (CCTN).

The CCTN investigators have developed 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.

The objective of this task order is to support services for manufacture, stability testing, and clinical formulation development using in house or appropriate subcontract facilities including but not limited to administrative support, manuscript support, discovery database, clinical formulation research and development, stability testing, and clinical manufacturing for use in preclinical studies and clinical trials of potential contraceptive products. New chemical entities (NCEs) and/or active pharmaceutical ingredients (API) in appropriate formulation and appropriate concentrations will be provided under this task. The task requires that the contractor provide documentation and reports of studies to support regulatory filings acceptable to stringent regulatory agencies in support of clinical trials and ultimately toward filing a New Drug Application (NDA) for approval of a contraceptive method.

Grant Number: 75N94020D00003-0-759402400001-1
NIH Institute/Center: NIH
Principal Investigator: DEBORAH BUNIN