Establish a Public Private Partnership for COVID19 Research

建立新冠肺炎研究公私合作伙伴关系

• 批准号: 10427583
• 负责人: David N. Wholley
• 金额: $ 19.98万
• 依托单位: FOUNDATION FOR THE NIH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-02 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10427583
• 关键词: Establish; Public; Private; Partnership; COVID19

The Foundation for the National Institutes of Health (FNIH) (www.fnih.org) was chartered by the Congress of the United States in 1990 as a not-for-profit 501(c)(3) charitable organization and has been working to facilitate groundbreaking research at the National Institutes of Health (NIH) and worldwide since 1996, creating and managing numerous biomedical public-private research partnerships that support the NIH’s mission. The FNIH therefore has extensive experience working with both NIH and the biopharmaceutical industry and deep familiarity with NIH’s people, science, practices, and policies. The FNIH has been asked by Dr. Francis S. Collins, Director of the NIH, to assist the agency in its response to the COVID-19 crisis. The aim of this collaboration is to accelerate NIH research urgently required to respond to this public health threat and to save lives by leveraging private-sector scientific expertise, in-kind assets and financial resources to augment federal efforts. Dr. Collins’ request that the FNIH help create a COVID-19 public-private partnership (PPP) to accelerate the development of therapeutics and vaccines under the Accelerating Medicines Partnership (AMP) is consistent with the FNIH’s own mission and the Congressional statute by which the FNIH was established to support the NIH in its mission and to advance collaboration with biomedical researchers from universities, industry, nonprofit organizations and other federal agencies, including the US Food and Drug Administration (FDA). AMP is a nimble and powerful public-private partnership that includes the NIH, FNIH, FDA and multiple biopharmaceutical companies and not-for-profit organizations. Managed by the FNIH, AMP programs bring together the resources of the NIH and industry to improve our understanding of disease pathways and facilitate better selection of targets for treatment. Multimillion dollar collaborations supported by the private sector through the FNIH have been established in four major disease areas: Alzheimer's disease, Type 2 diabetes, Rheumatoid Arthritis (RA)/Lupus and Parkinson's disease. The FNIH is also preparing to launch an AMP in Schizophrenia in partnership with the National Institute on Mental Health (NIMH). The overarching goal of the FNIH in this new AMP is to support the NIH in designing and implementing a strategic and coordinated cross-sector approach to end the current COVID-19 pandemic and to manage future such threats. This PPP is now known as ACTIV, the Accelerated COVID-19 Therapeutic Intervention and Vaccine partnership. Notably, most AMP projects start with a Design Phase that takes approximately 9 months to complete in which the FNIH identifies key partners, establishes scientific working and sub-groups, puts in place governance structures, executes contracts and agreements, deploys and trains appropriate staff, and identifies potential sources of funding. The result of the Design Phase is a detailed scientific and business plan for the PPP, which is called the Implementation Plan (sometimes referred to as the White Paper). The resulting Implementation Phase is a multiyear effort in which the PPP, through management by the FNIH, operationalizes the scientific plan and coordinates this work with critical support provided by NIH using its grants and contracts mechanisms. However, given the acute public health threat that has resulted in tens of thousands of COVID-19 deaths, the FNIH responded immediately to NIH’s call to action, redirecting staff from active, fully funded donor-supported programs to begin work on the Design Phase for the proposed PPP even though no financing for the FNIH’s work has yet been secured. In fact, for the past four weeks, the FNIH staff has been working non-stop on ACTIV, including nights and weekends, and has already achieved in record time what under normal circumstances would have taken months. This redeployment of staff is not sustainable, and the resulting costs and lost revenue are imposing an unacceptable burden on the FNIH’s finances. This request for support under NIH’s Other Transaction Authority (OTA) is, in fact, a do-or-die matter for the FNIH. While other funding sources have been explored and fundraising continues, none have or are likely to be forthcoming in a manner that is sufficiently timely to support the FNIH’s efforts. Quite simply, without immediate funding the FNIH will not be able to continue working on ACTIV and hence will be unable to support the NIH and its mission in this devastating COVID-19 health crisis. As requested in the Request for Negotiation to Establish a Public Private Partnership for COVID19 Research submitted by the NIH, the FNIH provides herein information concerning the work the FNIH has and will undertake until July 31, 2020 and the costs to underwrite that work. While much of this activity concerns the Design Phase, given the urgent need to make progress now, several critical implementation activities are anticipated to commence before July 31, 2020. Please note that this request also includes a separate request for support of the Deloitte Consulting, LLC (Deloitte) contract with the FNIH. Deloitte was contacted to expand and support the FNIH capabilities given the speed and volume of work required for ACTIV.

美国国立卫生研究院(FNIH)基金会(www.fnih.org)是由 美国于1990年作为一个非营利性的501(C)(3)慈善组织，一直致力于促进 自1996年以来，在美国国立卫生研究院(NIH)和世界各地进行了开创性的研究，创造和 管理众多支持NIH使命的生物医学公私合作研究伙伴关系。美国国家卫生研究院 因此在NIH和生物制药行业都有丰富的工作经验，并对此非常熟悉 美国国立卫生研究院的人员、科学、实践和政策。 国家卫生研究院院长弗朗西斯·S·柯林斯博士已要求国家卫生研究院协助该机构应对 新冠肺炎危机。这一合作的目的是加速NIH对此做出反应的迫切需要的研究 通过利用私营部门的科学专门知识、实物资产和财政资源，对公共健康构成威胁并拯救生命 资源，以加强联邦政府的努力。 柯林斯博士要求美国国家卫生研究院帮助创建一个公私合作伙伴关系(PPP)，以加快 加速药品伙伴关系(AMP)下的治疗和疫苗开发符合 FNIH自己的使命和国会章程，FNIH是根据该法令成立的，以支持NIH 它的使命是促进与来自大学、行业、非营利组织的生物医学研究人员的合作 组织和其他联邦机构，包括美国食品和药物管理局(FDA)。 AMP是一个灵活而强大的公私合作伙伴关系，包括NIH、FNIH、FDA和多个 生物制药公司和非营利组织。由FNIH管理，AMP计划带来 联合美国国立卫生研究院和产业界的资源，以提高我们对疾病途径的了解，并促进 更好地选择治疗目标。私营部门通过以下途径支持数百万美元的合作 FNIH已在四个主要疾病领域建立：阿尔茨海默病、2型糖尿病、类风湿 关节炎(RA)/狼疮和帕金森病。FNIH还准备在#年推出针对精神分裂症的AMP 与国家精神卫生研究所(NIMH)建立伙伴关系。 FNIH在这一新的AMP中的首要目标是支持NIH设计和实施战略 以及协调一致的跨部门方法，以结束目前的新冠肺炎大流行，并管理未来的此类威胁。 这一购买力平价现在被称为ACTV，即加速新冠肺炎治疗干预和疫苗合作伙伴关系。 值得注意的是，大多数AMP项目从设计阶段开始，大约需要9个月的时间才能完成 FNIH确定关键合作伙伴，建立科学的工作和分组，建立治理结构， 执行合同和协议，部署和培训适当的员工，并确定潜在的资金来源。 设计阶段的结果是为PPP制定了一份详细的科学和商业计划，称为 实施计划(有时称为白皮书)。由此产生的实施阶段是多年的 PPP通过FNIH的管理，实施科学计划和协调的努力 这项工作得到了美国国立卫生研究院利用其赠款和合同机制提供的关键支持。 然而，鉴于严重的公共健康威胁，已导致数万人死亡的新冠肺炎，美国国家卫生研究院 立即响应NIH的行动呼吁，将工作人员从积极的、全额资助的捐赠者支持的项目中重新定向 开始拟议的PPP的设计阶段的工作，尽管FNIH的工作还没有资金 已经安全了。事实上，在过去的四周里，FNIH的工作人员一直在不停地工作，包括 晚上和周末，并且已经以创纪录的时间完成了在正常情况下所需的时间 月份。这种工作人员的重新部署是不可持续的，由此产生的成本和收入损失正在迫使 给FNIH的财政带来了不可接受的负担。 事实上，根据NIH的其他交易管理局(OTA)提出的支持请求是一个生死攸关的问题 美国国家卫生研究院。虽然已经探索了其他资金来源，筹款活动仍在继续，但没有一个已经或可能会 将以足够及时的方式提交，以支持FNIH的努力。很简单，没有立即 为FNIH提供资金将无法继续ACTV的工作，因此将无法支持NIH和 它在这场毁灭性的新冠肺炎健康危机中的使命。 根据关于为COVID19研究建立公私伙伴关系的谈判请求中的要求 由NIH提交的，FNIH在此提供了关于FNIH已经和将会进行的工作的信息 承诺到2020年7月31日，以及承保这项工作的成本。虽然本练习的大部分内容都与设计有关 在这一阶段，鉴于目前迫切需要取得进展，预计将开展几项关键的执行活动 于2020年7月31日前开始。 请注意，此请求还包括对德勤咨询有限公司(Deloitte Consulting，LLC)的单独支持请求 与FNIH签订了合同。我们联系了德勤，以扩展和支持FNIH的能力，因为 活动所需的工作量。