Gates Package — page 271

ing for Jose Esparza proached individuals ndpoint harmonization. to be confusion. From: "Johnston, Margaret (Peggy) (NIH/NIAID)" </O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=PJOHNSTON> To: "Tramont, Ed (NIH/NIAID)" @niaid.nih.gov>, "Fauci, Anthony (NIH/NIAID)" <AFAUCI@niaid.nih.gov> Cc: "La Montagne, John (NIH/NIAID)" @niaid.nih.gov>, "Moore, Marg (NIH/NIAID)" @niaid.nih.gov> Subject: RE: PAVE - please clarify Date: Sun, 26 Oct 2003 00:24:19 -0400 Importance: Normal TOny, I concur. To my knowledge, we in NIAID have all been saying the same thing about PAVE and it's relationship to Enterprise, as you outlined in NYC. My take from Aerlie is that the next step would be writing "white papers" covering a range of topics. Shortly thereafter I received a draft list of papers and possible contributors and gave feedback to Helene. I have heard nothing and when I asked Helene for an update pre-HVTN meeting she admitted they were stretched thin and were waiting for Jose Esparza to join to really get things moving. So if Gates has moved foward to "set up committees" and has approached individuals for certain tasks/committees, that is news to me. There will be overlap between PAVE and ENTERPRISE if Rick sets up new working groups to discuss what PAVE has already taken on - labs, infrastructure development, protocol/endpoint harmonization. We can not stop and wait for Enterprise to catch up. Until Enterprise is better defined, there will likely continue to be confusion. From China, Peggy -----Original Message----- From: Tramont, Ed (NIH/NIAID) To: Fauci, Anthony (NIH/NIAID); Johnston, Margaret (Peggy) (NIH/NIAID) Cc: La Montagne, John (NIH/NIAID); Moore, Marg (NIH/NIAID) Sent: 10/25/2003 10:51 AM Subject: RE: PAVE - please clarify Tony, thanks for sharing with us - I think that your response is right on the money. But I can speculate: (1) those asking have little idea of what a vaccine strategic plan is - because if they did, they would not be focusing on PAVE in the context of vaccine R&D as it addresses only one part; by that I mean that a vaccine or any product R&D progresses from discovery to product development/QA/QC manufacturing to clinical trials and PAVE addresses only the conduct of clinical trials; (2) there is growing recognition that NIAID has these steps covered, albeit with funding restrictions, and people are using PAVE as a sedge way for them to ask how the Enterprise will be of value added to our strategic plan; (3) Rick's motives are not as benevolent as he portrays or he has a very thin skin, (4) Judy Wiesherheit, Chuck Vietek (CDC), Peggy, Jorge, Barney and Sandi accompanied Debbie on a 10 day visit of the USMHRP sites in Uganda and Kenya which has resulted in a better understanding of how the partnership (PAVE) will work, and all have told me that they are excited about our expanding ability to conduct vaccine trials in Africa - I believe that this optimism was portrayed by them at the recent HVTN meeting but all recognize that there are significant issues