ADMINISTRATIVE CORE: ABSTRACT The Contraception Research Center at Boston University School of Medicine (BUSM-CRC) brings together an experienced team of clinical, industrial and basic scientists to develop and test new contraceptive products based on topical administration of Human Contraceptive Antibody (HCA). HCA was originally isolated from the blood of an infertile but otherwise healthy woman. The antibody targets an antigen on the surface of human sperm and can agglutinate/immobilize sperm within seconds. We propose to release HCA monoclonal antibodies from a quick-dissolving film for short-term (on demand) protection, and from an intravaginal ring (IVR) for protection lasting up to one month. Our long term goal is to combine HCA with antibodies against pathogens such as HIV-1 and HSV that cause serious sexually-transmitted infections (STIs), to provide a new multipurpose prevention technology (MPT) platform that delivers both contraception and protection against STIs. Success of the BUSM-CRC will rely upon an Administrative Core that will provide scientific and administrative leadership in coordinating the three developmental and translational Projects that make up the program. The Administrative Core will also coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones, and foster the development of junior scientists interested in pusuing a career in contraception/MPT research.
The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, the Administrative Core will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. The Administrative Core will also convene an external Scientific Advisory Panel (SAP) to review the program in years 2 and 4. The Administrative Core will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. The Administrative Core will be responsible for the reagent/research material and data management and sharing plan, and for monitoring milestone achievements. 3. To manage the clinical database and statistical analysis for the two Phase 1 clinical trials. 4. To award pilot grants to encourage junior and other scientists to enter the contraception/MPT field.
