NICHD: R&D: BIOLOGICAL TESTING FACILITY - DRUG PRODUCT MANUFACTURE OF ONGOING CLINICAL DEVELOPMENT: NON-SEVERABLE

Sri International, Menlo Park CA

Investigators

Abstract

Within the Division of Population Health Research (DiPHR), the Contraceptive Development Program (CDP) at NICHD supports research to identify and develop compounds that can safely and reversibly modulate human reproductive physiology such as ovulation, sperm production, or sperm function with the goal of enabling individuals to better manage fertility and optimize reproductive outcomes. 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 fertility management and endocrine activity. The BTF provides overall project management and the capabilities to support all phases of preclinical activities pursuant to development of new fertility management methods: these include, but are not limited to administrative support, manuscript support, fertility management 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 are, or will be, tested including but not limited to non-human primates. 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. Scope and Objectives: Manufacture, stability testing, and clinical formulation development using in-house or appropriate subcontract facilities as described in the Background 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 a potential fertility management products will be supported by this task. 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 fertility management method.