Gates Package — page 153

Notes from meeting Bill Gates Tuesday, October 8th Meeting with Dr. Collins, Director, National Institutes of Health (NIH) Time: 9:00am-10:00am Location: BMGF Office, Houston Conference Room Foundation Participants: Bill Gates, Chris Wilson (by phone), Nageeb Sumar External Participants: = Dr. Francis Collins, Director, National Institutes of Health (NIH) - Dr. Anthony Fauci, Director National Institute of Allergy and Infectious Diseases (NIAID) -- Dr. Harold Varmus, Director, National Cancer Institute (NCI) Notes by: Chris Wilson/Nageeb Sumar Purpose: Learn more about the activities of NIH, NIAID and NCI, and overlapping interests with the foundation's priorities Summary: The group discussed the current federal budget impasse and how sequestration had already hurt R&D. Polio: On polio, Bill discussed supporting research to create safer OPV and the regulatory pathway that might be done for licensure via China. P5: Fauci introduced the P5 work and noted progress was on-track. He reiterated the biggest problem is the delay in manufacturing the protein and that the Barouch/Walker Ad26 will be part of the phase I group in the research trial; J&J Crucell will fund production of the vector for that trial. Bill asked a question related to adenoviral vectors-- Fauci made the point that induces influx and/or activation of mucosal T cells by Ad5 may be the culprit and that an Ad that does not do this may be safe(r). Fauci related that bNAb inducing immunogen work is on track between NIH and Gates, and funding of Nussenzweig to do POC studies that bNAbs can have a biological impact with NIH supporting parallel studies through the VRC candidates. Bill talked about potential use of bNAbs in therapy, less difficult/less frequent intermittent maintenance therapy and potentially functional cure. Fauci raised the possibility that vaccination in a fully suppressed person might be able to induce protective immunity, even if frequent boosters would be needed. They agreed that until an effective active vaccine is in hand, that passive immunoprophylaxis trials are an important activity that we should/will both pursue. Fauci discussed the VRC01 PMTCT trial to block breast milk transmission -- the phase I PK/PD is soon to launch in the US, and then to test benefit in African infants - to try and block the breakthrough that occurs in infants on ART prophylaxis. Fauci acknowledged that VRC01 is probably not the top bNAb for other studies. Bill talked about his enthusiasm for the AAV vectored delivery of bNAbs, acknowledging the regulatory pathway is a challenge. Malaria: