Administrative Core

行政核心：抽象 波士顿大学医学院避孕研究中心汇集了 由临床、工业和基础科学家组成的经验丰富的团队开发和测试新的避孕产品 基于人类避孕抗体(HCA)的局部给药。Hca最初是从 一名不孕但身体健康的女性的血液。该抗体针对人类表面的一种抗原。 精子，并能在几秒钟内凝集/固定精子。我们建议释放HCA单抗 从用于短期(按需)保护的速溶薄膜和从阴道内环(IVR)用于 保护期限长达一个月。我们的长期目标是将hca与抗病原体抗体结合起来。 例如导致严重性传播感染(STI)HIV-1和HSV，以提供一种新的多用途 预防技术(MPT)平台，提供避孕和防止性传播感染的保护。 BUSM-CRC的成功将依赖于一个行政核心，它将提供科学和行政管理 在协调组成该计划的三个开发和翻译项目方面发挥领导作用。这个 管理核心还将协调数据和材料的获取和共享，以便研究 以集成迭代的方式进行进展，以满足个别项目和规划里程碑，并促进 对推动避孕/MPT研究事业感兴趣的初级科学家的发展。 行政核心的具体目标是： 1.提供科学的领导和行政监督。具体而言，行政核心将 建立一个执行委员会(EC)，负责持续评估项目和核心里程碑、资源 对实验设计的分配和更改。行政核心还将召集外部 科学咨询小组(SAP)在第二年和第四年审查该计划。行政核心将促进 通过预定的电话会议和调查人员会议进行沟通，提供资金和 行政支持，并确保遵守机构和联邦指导方针 2.协调数据和材料的获取和共享，以确保项目和计划 达到了里程碑。行政核心将负责试剂/研究材料和数据 管理和分享计划，以及监测里程碑成就。 3.管理两个一期临床试验的临床数据库和统计分析。 4.发放试点补助金，鼓励初级和其他科学家进入避孕/MPT领域。

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.