Contraceptive Development Program (CDP)

• Chemical Synthesis in Discovery and Development of New Chemical Entities (NCEs) for Clinical Evaluation: To support clinical development, the program conducts in vitro and in vivo translational studies of synthesis in discovery and optimization of NCEs. NCE clinical studies are conducted under an IND application, potentially leading to a New Drug Application. NCEs must be synthesized under current Good Manufacturing Practice (cGMP) that comply with all regulatory standards of chemistry, manufacturing, and controls. CDP maintains a contracted Chemical Synthesis Facility to produce NCEs required for the program.
• Preclinical Qualification of Drugs or Devices Prior to Clinical Evaluation: NCEs require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice and meet regulatory standards. Human trials require formulation and release of contraceptive agents under cGMP, and stability studies cover the duration of the trial. CDP maintains a Biological Testing Facility to perform preclinical evaluation and batch preparation required for first-in-human studies and longer toxicology studies for later phase clinical trials.
• Contraceptive Clinical Trials Network (CCTN): The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and men. Results of these clinical trials form the evidence base for advancing candidate drugs and devices through development toward FDA approval. The CCTN includes top clinical investigators at qualified institutions, including both domestic and international sites, with expertise to conduct all phases of contraceptive evaluation, from first-in-human through Phase III. The clinical sites also serve as the training ground for the next generation of contraceptive investigators.
• New Contraceptive Methods: Contraceptive product development is challenging. Once a candidate is identified, about 10% pass preclinical screening to enter clinical testing, and only 12% of those products complete Phase III and FDA submission. Because contraceptives are used by healthy people for long durations, long-term safety is critical. CDP has a pipeline of products in clinical evaluation, including hormonal or non-hormonal options for women and novel hormonal methods for men. Each product is developed to fill an unmet need or provide greater safety to vulnerable populations at risk of unintended pregnancy.
  • Increasing Contraception Options for Women
  • Developing Hormonal Contraception Methods for Men

Diana Blithe, Program Chief
Min S. Lee, Chemist
Jeffrey Kroopnick, Medical Officer