Pilot and Feasibility Core

先天性和围产期感染联合会(CPIC)的使命是消除疾病负担 与罕见的以先天性巨细胞病毒(CMV)病为主的儿科病毒性疾病相关，新生儿 单纯疱疹病毒(HSV)感染和新生儿肠道病毒(EV)和副病毒(HPeV)败血症 收集多点数据以改进诊断、临床试验准备和治疗。每年，我们都会支持 一个为期一年的项目，为这一使命做出贡献，并利用CPIC的优势。 虽然每个试点计划RFA的具体重点将由执行委员会确定，但所有RFA 将强调我们重点关注的疾病领域的创新，并扩大内部和 在CPIC之外。CPIC的所有试点项目都将增进这一重要领域的知识，并将成为 为对罕见疾病感兴趣的初级研究人员提供指导研究机会。与这项任务一致， 除了财政支持外，试点受助人还将受益于作为项目一部分的导师 旨在确保研究进展并在开发过程中促进成功的管理团队 独立研究项目。试点和可行性(P&F)核心的基础设施和活动是 旨在：1)确定可改进诊断、临床试验准备和/或 先天性巨细胞病毒病、新生儿HSV感染或新生儿EV和HPeV败血症的治疗；2)识别 并支持有前途的初级调查人员，他们有兴趣在以下领域进行指导研究 这些罕见疾病；以及3)聘请项目管理团队指导试点受助者，并促进他们的 走向独立的运动。 CPIC P&F核心将由Richard J.Whitley医学博士领导，他成功地开发和领导了 阿拉巴马州药物发现联盟试点计划。他将与CPIC执行委员会合作，CPIC执行委员会 包括利益相关者代表，以制定年度申请电话。CPIC P&F核心将确保 通过赞助一项经过同行审查并反映审查的资金竞赛，进行高质量的试验性研究 由美国国立卫生研究院进行。申请过程将包括一份初始意向书(LOI)，然后是 提交受邀的完整申请。审查意向书和遴选有价值的申请， 惠特利博士将担任一个遴选委员会的主席，该委员会由他本人和四名CPIC现场负责人组成。考虑到…… 扩大我们的投资，项目将有资格获得参与机构的额外支持， 在多站点应用程序的情况下，这种机会将特别受到鼓励。一旦获得资金，项目 将得到多学科项目管理团队的支持，以确保成功完成 项目。

The mission of the Congenital and Perinatal Infections Consortium (CPIC) is to eliminate the disease burden associated with rare pediatric viral diseases focusing on congenital cytomegalovirus (CMV) disease, neonatal herpes simplex virus (HSV) infection, and neonatal enterovirus (EV) and parechovirus (HPeV) sepsis by gathering multi-site data to improve diagnosis, clinical trial readiness, and treatment. Annually, we will support one year-long project that contributes to this mission and utilizes the strengths of the CPIC. Though the specific focus of each Pilot Program RFA will be determined by the Executive Committee, all RFAs will stress innovation in our focused disease areas and extension of research collaborations both within and outside of the CPIC. All CPIC pilot projects will advance knowledge in this important area and will serve as a mentored research opportunity for junior investigators interested in rare diseases. Consistent with this mission, in addition to financial support, pilot recipients will benefit from mentors who serve as part of project management teams designed to ensure research progress and to facilitate success as they develop independent research programs. The infrastructure and activities of the Pilot and Feasibility (P&F) Core are designed to: 1) identify innovative research projects that improve diagnosis, clinical trial readiness and/or treatment for congenital CMV disease, neonatal HSV infection, or neonatal EV and HPeV sepsis; 2) identify and support promising junior investigators who are interested in conducting mentored research in the area of these rare diseases; and 3) engage project management teams to mentor pilot recipients and facilitate their movement toward independence. The CPIC P&F Core will be led by Richard J. Whitley, MD, who has successfully developed and led the Alabama Drug Discovery Alliance pilot program. He will work with the CPIC Executive Committee, which includes stakeholder representation, to craft an annual call for applications. The CPIC P&F Core will ensure high-quality pilot research by sponsoring a competition for funding that is peer-reviewed and mirrors reviews conducted by the NIH. The application process will include an initial letter of intent (LOI), followed by submission of invited, full applications. For the review of LOIs and the selection of meritorious applications, Dr. Whitley will chair a Selection Committee comprised of himself and four CPIC site leads. To allow for expansion of our investment, projects will be eligible to receive additional support from participating institutions, an opportunity that will be especially encouraged in the case of multi-site applications. Once funded, projects will receive support from multidisciplinary project management teams to ensure successful completion of projects.