A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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 Peggy and then get back ho has been instigating any with infrastructure building, training and procurement of ART's and obviously, Gates could be very helpful here. Ed > -----Original Message-----
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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
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Rick: As I had mentioned in my e-mail and illustrated in the slides that I sent to you, you are correct that PAVE is for USG coordination, but also, if others want to participate, they are most welcome. Importantly, PAVE only relates to clinical trials and Enterprise is the whole picture including clinical trials. Thus, PAVE fits into the concept of Enterprise. That is the message that needs to get out It is true that the distrust of the USG is enormous, but I do not think that I can cure that; I can only try to not make it worse and hopefully dispell it a bit. In any event, your idea about having Jose visit NIAID to raise the level of communication is an excellent one. I will communicate this to Ed and Peggy. Take care of your self. Warm regards, Tony
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Tony, We have already started a dialogue with Jose - he is going to be "stationed" in Washington. This "American takeover" stuff is a smoke screen, there is precious little money being put towards vaccines except for ours; Hence, - my suspicion is that they are angling to play Gates off against us. Ed
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2003-10-26 00:24
Margaret Johnston
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