Gates Package — page 267

here? From: "Tramont, Ed (NIH/NIAID)" </O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=ETRAMONT> To: "Fauci, Anthony (NIH/NIAID)" <AFAUCI@niaid.nih.gov>, "Johnston, Margaret (Peggy) (NIH/NIAID)" @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: Sat, 25 Oct 2003 10:51:03 -0400 Importance: Normal 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 with infrastructure building, training and procurement of ART's and obviously, Gates could be very helpful here. Ed -----Original Message----- From: Fauci, Anthony (NIH/NIAID) Sent: Friday, October 24, 2003 8:23 PM To: Tramont, Ed (NIH/NIAID); Johnston, Margaret (Peggy) (NIH/NIAID) Cc: La Montagne, John (NIH/NIAID); Moore, Marg (NIH/NIAID) Subject: FW: PAVE - please clarify Ed: This is the e-mail that Rick sent to me and my response to him. What is going on here? Please touch bases with Peggy and then get back to me as to what you think is happening here? Who has been instigating Rick? Tony -----Original Message----- From: Fauci, Anthony (NIH/NIAID) Sent: Friday, October 24, 2003 8:20 PM To: 'Rick Klausner' Subject: RE: PAVE - please clarify Rick: Two things: 1) I really do not have any idea what you are talking about, and 2) I am very, very sorry that you are upset and obviously angry. I cannot figure out what the issue is. I have been saying and doing nothing more or less than what we have discussed many times. The PAVE is a partnership of government agencies facilitated by NIAID. We have been planning this for a long time and it relates only to clinical trials, particularly phase 3 trials. It was further instigated by DHHS wanting to have consistency in what we do among agencies (NIH and CDC). Since the NIAID has developed a strong relationship with the DoD, they have been brought into this partnership now consisting of 3 agencies (NIAID/NIH, CDC, and DoD). The purpose was to create consistency and harmonization in clinical trials (protocols, laboratory measures, etc.) run by the government so that the agencies can synergize. Since we (mainly the NIAID) also collaborate with many other entities, we would offer our partnered network to any group that wishes to collaborate provided that they agree to share the common goal of transparency, consistency, and harmonization. This would have happened whether or not there was an Enterprise. The "Enterprise" is much bigger in scope than the PAVE, but the PAVE can certainly be an important part of the Enterprise. You and I have discussed this several times. When I speak about vaccines I almost always (with minor variations) talk about: 1) what the Federal government, particularly NIAID is doing; 2) the need for a new look and an accelerated effort, i.e. the Enterprise; and 3) the role that the PAVE may play in the Enterprise. I am attaching one of my typical talks that goes through this sequence of thoughts. I do not think that I can be any more clear. I