Biological Testing Facility: In Vivo Efficacy, Validation and Preclinical Development for Fertility Regulation, Multipurpose Prevention Technology and Reproductive Health Related Products

The development of novel solutions for fertility regulation, multipurpose prevention of pregnancy and sexually transmitted infections, and other reproductive health conditions is a global health priority. However, the translation of promising new chemical entities, biologics, and devices from discovery to clinical application is a complex process requiring extensive preclinical evaluation. This project establishes a Biological Testing Facility (BTF) to provide comprehensive project management and technical capabilities to accelerate this transition. The BTF is designed to permit the rapid and rigorous evaluation of candidate products, supporting all phases of preclinical development from initial formulation to the generation of data packages for Investigational New Drug (IND) or Investigational Device Exemption (IDE) submissions. The facility will characterize the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of agents administered through various routes (e.g., oral, vaginal, injectable). Core activities will include cGMP-compliant manufacturing of clinical lots, development of a wide range of in vitro and in vivo models to assess activity and toxicity, and specialized testing for drug-device combination products. By providing a centralized and integrated platform for preclinical development, this program will streamline the advancement of next-generation products for reproductive health.