Establish a Public Private Partnership for COVID19 Research

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.