Development of novel contraceptive methods for men and women

CDP通过研发合同实现新方法开发的目标。本项目评估非市售且必须在符合化学、制造和控制所有监管标准的现行良好生产规范（cGMP）下合成的新药。CDP维持一个合同化学合成设施，以生产该计划所需的新药。潜在的新药和设备需要毒理学测试来证明其安全性。启用ind的临床前研究必须在符合监管标准的良好实验室规范（GLP）下进行。人体试验需要在cGMP下制定和释放药物，并在试验期间进行稳定性研究。CDP拥有一个生物测试设施，以进行临床前评估和首批人体研究所需的批量准备，以及后期临床试验的长期毒理学研究。新产品的临床评估在CDP项目管理下的避孕临床试验网络（CCTN）中进行。CCTN评估妇女和男子使用的新型避孕药物和器具的安全性和有效性。新实体的临床试验结果为推进候选药物和器械的开发奠定了基础，目标是获得FDA的监管批准。CCTN由国内和国际合格机构的顶尖临床研究人员组成，具有从人体首次试验到III期所有阶段避孕评估的专业知识。临床场所是该领域下一代研究人员的培训场所。

CDP uses R&D contracts to achieve the goal of new method development. The Program evaluates new drugs that are not commercially available and 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 novel drugs required for the program. Potential new drugs and devices require toxicology testing to demonstrate safety. IND-enabling preclinical studies must be performed under Good Laboratory Practice (GLP) meeting regulatory standards. Human trials require formulation and release of agents under cGMP, and stability studies covering 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. Clinical evaluation of the novel products occurs in the Contraceptive Clinical Trials Network (CCTN) under the Program Management of the CDP. The CCTN evaluates safety and efficacy of new contraceptive drugs and devices for women and for men. Results from clinical trials on new entities form the basis for advancing candidate drugs and devices through development with the goal of FDA regulatory approval. The CCTN comprises 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 serve as the training ground for the next generation of investigators in the field. A new Cooperative Research and Development Agreement (CRADA) was negotiated and approved in 2021. The goal of the CRADA is to conduct clinical efficacy studies on a novel vaginal shield that would provide a full month of non-hormonal contraceptive activity. The protocol for the clinical trial is under development and the trial is planned to begin in Q2 2023. A Phase IIb trial of a novel hormonal male contraceptive gel is being evaluated in couples who agree to use the method for contraception. The trial is ongoing and preliminary results show high efficacy and acceptability of the product in both partners in the couple. The trial continues with completion scheduled for Q4 2024.