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nih.gov> Cc: "Glass, Roger (NIH/FIC) [E]" <{J@mail.nih.gov>, "Eiss, Robert (NIH/FIC) [E]" <{j@mail.nih.gov>, "Kilmarx, Peter (NIH/FIC) [€]" <MO nih.gov>, "Wolinetz, Carrie (NIH/OD) [E]" <i). gov>, "Lauer, Michael (NIH/OD) [E]" <O nih.gov>, "Garbarini, Nicole (NIH/OD) [E]" <I nih.gov>, "Johnson, Martin S. (NIH/NIAID) [E]" <O niaid.nih.gov>, "McGowan, John J. (NIH/NIAID) [E]" <M niaid.nih.gov>, "Schwetz, Tara (NIH/NIAID) [E]" EEE enh co Subject: Re: Need info on BMGF -- Urgent Larry: BMGF is co-funding with NIAID the Cabotegravir PrEP study. I do not know how much they are in for. Also, Bob Seder of the VRC heavily advises and consults for the BMGF; however, no $ is involved . Everything else that you have listed is correct. Tony On May 25, 2018, at 6:29 PM, Tabak, Lawrence (NIH/OD) [E] <I nih.gov> wrote: Dropping FC off. Could you all please do a quick check to make sure I haven't included anything that is wrong. I would like to get this to FC either late tonight or first thing in the AM before I get on a plane. With thanks to Mike and Nicole, here is what we have found thus far: 1. We found nothing in which the BMGF is the primary recipient of NIH funds -- they are not in our organization list meaning they have never been an applicant for grant money from NIH. I don't know anything about contracts. 2. The first attachment displays projects with co-funding- NIH $ are displayed -- that is NOT going to BMGF, it is going to the listed investigator 3. BMGF has funded various components of NIH (through the Grand Challenges Program, although that may not be the only program) - I have only listed funding from 2018-2015; there are earlier grants NIAID: https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2018/02/OPP1162695 https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2017/11/OPP1178956 https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2017/02/OPP1159915 https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2015/11/OPP1139518 FIC: https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2017/07/OPP1169078 https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2015/09/OPP1129994 NHLBI: https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2015/08/OPP1131279 NICHD: https://www.gatesfoundation.org/How-We-Work/Quick-Links/Grants-Database/Grants/2015/05/OPP1129091 larry On 5/25/18, 4:55 PM, "Collins, Francis (NIH/OD) (E]" <M od. nih.gov> wrote: For reasons I can't currently explain, I need answers to the following: 1) are we giving any grants to BMGF (I assume no) 2) what are our current collaborative projects with BMGF? For each one , what is the rough NIH annual spend, and what is it from BMGF? Hoping this won't be too hard to dig out. Ideally I need a response (at least a rough version) by Saturday 4 pm. Questions? Call I Getting on a plane in 10 minutes FC Sent from my iPhone <SR_25May2018_053723_24581657(3].xlsx> Select Recent Highlights NIH-Bill & Melinda Gates Foundation Cooperation Efficacy studies of two HIV vaccines moving forward o The PS vaccine efficacy study (HVTN 702), which launched in November 2016 in South Africa, is the first HIV vaccine efficacy study in 7 years o The Imbokodo (HVTN 705) study, which launched in November 2017, is a Phase 2b proof-of-concept study evaluating the safety and efficacy of a Ad26 mosaic vaccine and Clade C gp140. The vaccine regimen is based on "mosaic" immunogens -- vaccine components designed to induce immune responses against a wide variety of global HIV strains. Evaluation of a novel, long acting injectable antiviral for HIV Prevention o In November 2017, launched Phase III efficacy study (HPTN 084) to compare long-acting cabotegravir to daily Truvada for pre-exposure prophylaxis in HIV-uninfected women. TB Drug development and clinical endpoints o NIAID intramural collaborations with BMGF have contributed to novel clinical markers for treatment response (PET/CT, NexGenNCT02371681) that are now further evaluated in the "PREDICT TB" trial (NCTO2821832) to identify patients who may benefit from shortened therapy. o NIAID intramural, in collaboration with pharmaceutical partners (GSK, Merck) through the BMGF funded "TB Drug Accelerator" are co-developing novel anti-TB agents that are now entering clinical evaluation. o NIAID extramural programs are continuing to contribute to the establishment of best practices and preclinical/clinical evaluation of new drug candidates that are advanced through BMGF funded PDPs. Single-dose HPV vaccine o Inearly November, NCI participated in high-level meetings at the Gates Foundation to discuss ongoing efforts to evaluate single-dose protection of the HPV vaccines. o Ifthe hypothesis that one dose can confer strong protection is verified by the results of the trial, these results should enable this approach to be the standard of care and greatly increase HPV vaccination uptake -- which currently stands at around 3% of eligible girls in LMICs - throughout the world. o Inlate November, the new Costa Rica Vaccine Trial ("ESCUDDO") started-- the first girls have now been immunized. o Additional studies planned to complement Costa Rica Trial; one immunogenicity study built to harmonize with the Costa Rica trial has already been initiated. Contraception o Acomprehensive analysis of publicly available gene expression and protein expression data has been performed to identify reproductive-tract specific transcripts/proteins to serve as potential non-hormonal targets for male and/or female contraceptive development. o A web-based contraceptive target database containing all pertinent information is in development for public access with a beta version released early to mid-2018. o Results from early collaborations in two Grand Challenges Explorations topics related to contraceptive research and development for either men or women anticipated in 2018 and 2019. = Successful projects may be integrated into a small, focused program = Research resulting from these awards is expected to have a large positive impact on the quality of applications to the NIH in the near-term future e = Indoor air pollution o Jointly launched RCT of liquefied petroleum gas (LPG) cookstoves and fuel in four LMICs (India, Rwanda, Guatemala and Peru). o.