Administrative Core

项目总结(见说明)： 这一HIV局部杀菌剂临床前/临床综合计划(IPCP-HTM)汇集了代表两家公司和五家学术机构的研究人员网络，进行多学科临床前和探索性临床研究，目标是开发一种安全的新型三价局部杀菌剂Mapp66。这种杀微生物剂配方由三种通过基因工程在本氏烟草(-N)中产生的单抗(MAb)组成，旨在阻断HIV性传播的不同机制。这一IPCP-HTM计划的成功将依赖于一个行政核心(核心A)，该核心将在协调六个科学项目以及构成这一IPCP-HTM计划的多个地点方面提供科学和行政领导。行政核心还将协调数据和材料的获取和共享，以便研究以综合迭代的方式取得进展，以满足个别项目和方案里程碑的要求。 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，核心A将设立一个执行委员会(EC)，负责持续评估项目和核心里程碑、资源分配和实验设计变更。核心A还将召集一个科学咨询小组(SAP)在第3年和第5年审查该计划。核心A将通过预定的电话会议和研究人员会议促进沟通，提供财务和行政支持，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，以确保项目和计划里程碑的实现。具体而言，如果个别项目/核心需要，核心A将负责试剂/研究材料和数据管理和共享计划、监测里程碑成就和协调生物统计服务。

PROJECT SUMMARY (See instructions): This Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP-HTM) brings together a network of investigators representing two companies and five academic institutions to perform multidisciplinary preclinical and exploratory clinical studies with the goal of advancing a safe, novel trivalent topical microbicide, mapp66. This microbicide formulation is comprised of three monoclonal antibodies (Mabs), produced by genetic engineering in Nicotiana benthamiana (-N), that are designed to block distinct mechanisms of HIV sexual transmission. Success of this IPCP-HTM will rely upon an Administrative Core (Core A) that will provide scientific and administrative leadership in coordinating the six Scientific Projects, and the multiple sites that make up this IPCP-HTM 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. The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, Core A will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. Core A will also convene a Scientific Advisory Panel (SAP) to review the program in years 3 and 5. Core A 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. Specifically, Core A will be responsible for the reagent/research material and data management and sharing plan, for monitoring milestone achievements and coordinating biostatistical services, if required by the individual projects/cores.