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 theUnited States in 1990 as a not-for-profit 501(c)(3) charitable organization and has been working to facilitategroundbreaking research at the National Institutes of Health (NIH) and worldwide since 1996, creating andmanaging numerous biomedical public-private research partnerships that support the NIH's mission. The FNIHtherefore has extensive experience working with both NIH and the biopharmaceutical industry and deep familiaritywith 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 theCOVID-19 crisis. The aim of this collaboration is to accelerate NIH research urgently required to respond to thispublic health threat and to save lives by leveraging private-sector scientific expertise, in-kind assets and financialresources to augment federal efforts.Dr. Collins' request that the FNIH help create a COVID-19 public-private partnership (PPP) to accelerate thedevelopment of therapeutics and vaccines under the Accelerating Medicines Partnership (AMP) is consistent withthe FNIH's own mission and the Congressional statute by which the FNIH was established to support the NIH inits mission and to advance collaboration with biomedical researchers from universities, industry, nonprofitorganizations 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 multiplebiopharmaceutical companies and not-for-profit organizations. Managed by the FNIH, AMP programs bringtogether the resources of the NIH and industry to improve our understanding of disease pathways and facilitatebetter selection of targets for treatment. Multimillion dollar collaborations supported by the private sector throughthe FNIH have been established in four major disease areas: Alzheimer's disease, Type 2 diabetes, RheumatoidArthritis (RA)/Lupus and Parkinson's disease. The FNIH is also preparing to launch an AMP in Schizophrenia inpartnership 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 strategicand 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 theFNIH 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 theImplementation Plan (sometimes referred to as the White Paper). The resulting Implementation Phase is a multiyeareffort in which the PPP, through management by the FNIH, operationalizes the scientific plan and coordinatesthis 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 FNIHresponded immediately to NIH's call to action, redirecting staff from active, fully funded donor-supported programsto begin work on the Design Phase for the proposed PPP even though no financing for the FNIH's work has yetbeen secured. In fact, for the past four weeks, the FNIH staff has been working non-stop on ACTIV, includingnights and weekends, and has already achieved in record time what under normal circumstances would have takenmonths. This redeployment of staff is not sustainable, and the resulting costs and lost revenue are imposing anunacceptable 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 theFNIH. While other funding sources have been explored and fundraising continues, none have or are likely to beforthcoming in a manner that is sufficiently timely to support the FNIH's efforts. Quite simply, without immediatefunding the FNIH will not be able to continue working on ACTIV and hence will be unable to support the NIH andits mission in this devastating COVID-19 health crisis.As requested in the Request for Negotiation to Establish a Public Private Partnership for COVID19 Researchsubmitted by the NIH, the FNIH provides herein information concerning the work the FNIH has and willundertake until July 31, 2020 and the costs to underwrite that work. While much of this activity concerns the DesignPhase, given the urgent need to make progress now, several critical implementation activities are anticipated tocommence 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 andvolume of work required for ACTIV.