BIOLOGICAL TESTING FACILITY-REGULATORY, DATA ANALYSIS, DATABASE, AND PROJECT MANAGEMENT

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 composition-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: Reporting and management activities including project management, storage of current biological inventory, archived documents and data, maintenance of equipment, regulatory documents for filing an investigational new drug (IND) application that would support testing in clinical trials and toward filing a New Drug Application (NDA) for approval of a new method., and/or continued database maintenance. The activities associated with this task permit the contractor to execute effective and efficient administration, management, data storage, and communication between the contractor staff and CDP, NICHD for all activities related to fertility management product development.

Grant Number: 75N94020D00003-0-759402500005-1
NIH Institute/Center: NIH
Principal Investigator: DEBRA BURNIN