FAUCI ARCHIVE — EMAIL THREAD: Discussion about Cures Acceleration Network and the President's https://faucisdiary.com/correspondence/discussion-about-cures-acceleration-network-and-the-president-s 11 messages, Nov 17, 2010 to Nov 18, 2010 Text below is verbatim from the released PDFs, with the original line breaks. ============================================================================== Subject: Re: Discussion about Cures Acceleration Network and the President's From: Rajesh Ranganathan To: Richard Hatchett Sent: Wed, 17 Nov 2010 20:50:57 -0500 Source: Reading Room, pp. 210–211 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Medical Countermeasures Initiative (MCMI) Richard: Can you give me some background on what Ms. Avery is likely to be interested in hearing about. Is there anything I should know about MCMI to be appropriately prepared? On 11/17/10 5:55 PM, "Hatchett, Richard J." < @nss.eop.gov> wrote: Cyndi, Rajesh -- > Thanks for being flexible. Ms. Avery was very interested in joining the > discussion. We'll meet in her office (EEOB 426) but why don't you come a few minutes early and meet me in 421? > Best, > Richard > -----Original Message----- From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] > Sent: Wednesday, November 17, 2010 5:50 PM To: Hatchett, Richard J. > Cc: Ranganathan, Rajesh (NIH/OD) [C] Subject: RE: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. Please confirm that the location is still the same (EEOB, 421). Many thanks. > Best, > Cyndi > -----Original Message----- From: Hatchett, Richard J. [mailto @nss.eop.gov] > Sent: Wednesday, November 17, 2010 5:46 PM To: Burrus-Shaw, Cyndi (NIH/OD) [E] > Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Cyndi, > Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p on > Monday, but not 11:00a. Would this work for Dr. Ranganathan? > Thanks, Richard ------ End of Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's From: Rajesh Ranganathan To: Richard Hatchett Sent: Wed, 17 Nov 2010 20:50:57 -0500 Source: Reading Room, pp. 223–224 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Medical Countermeasures Initiative (MCMI) Richard: Can you give me some background on what Ms. Avery is likely to be interested in hearing about. Is there anything I should know about MCMI to be appropriately prepared? On 11/17/10 5:55 PM, "Hatchett, Richard J." < @nss.eop.gov> wrote: Cyndi, Rajesh -- > Thanks for being flexible. Ms. Avery was very interested in joining the > discussion. We'll meet in her office (EEOB 426) but why don't you come a few minutes early and meet me in 421? > Best, > Richard > -----Original Message----- From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] > Sent: Wednesday, November 17, 2010 5:50 PM To: Hatchett, Richard J. > Cc: Ranganathan, Rajesh (NIH/OD) [C] Subject: RE: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. Please confirm that the location is still the same (EEOB, 421). Many thanks. > Best, > Cyndi > -----Original Message----- From: Hatchett, Richard J. [mailto @nss.eop.gov] > Sent: Wednesday, November 17, 2010 5:46 PM To: Burrus-Shaw, Cyndi (NIH/OD) [E] > Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Cyndi, > Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p on > Monday, but not 11:00a. Would this work for Dr. Ranganathan? > Thanks, Richard ------ End of Forwarded Message Subject: FW: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Rajesh Ranganathan To: Kathy Hudson, Lawrence Tabak Sent: Thu, 18 Nov 2010 21:30:16 -0500 Source: Reading Room, p. 202 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ This is what I wrote back...I hope it strikes the right tone... R ------ Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's From: Rajesh Ranganathan To: Richard Hatchett Cc: Cyndi Burrus-Shaw Sent: Thu, 18 Nov 2010 21:29:23 -0500 Source: Reading Room, pp. 202–204 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Medical Countermeasures Initiative (MCMI) Richard: We have discussed this internally amongst a subset of the exec. Team and the consensus is that it is too early for us to have a conversation about CAN, not yet having implemented anything related to CAN. Furthermore, I have only been here 2+ weeks and hence would be out of my depth with respect to MCMI. The main concern is that we would be wasting Ms. Avery's time. It would be unfortunate to risk any dampening of enthusiasm around what CAN could achieve by having a briefing at this high level prematurely. Would it be possible at this point to diplomatically request that the meeting with Ms. Avery be postponed to a later date, when we are in fact ready to brief her in a substantive way? And given that you are about to move to BARDA, would it make sense for you and I to chat once you get settled in that new role? However, if you feel that there would still be value in us talking now, I would be happy to come over on Monday to meet 1 on 1 with you. Please let me know what you think. Rajesh On 11/18/10 8:51 AM, "Hatchett, Richard J." @nss.eop.gov wrote: > Rajesh, > Sorry, I should have clarified that in our initial exchanges, as I assumed that was the context in which JJ spoke with you. We have an overlapping (and > in fact prior) interest in CAN because of the President's biodefense initiative, and I was taking advantage of JJ's intro to contact you on MCMI (I > hadn't heard that you'd been selected for the position before JJ contacted me). > I'm actually in the late stages of negotiating a move to BARDA (the Biomedical > Advanced Research & Development Authority) as deputy director and I don't think JJ knew this when he spoke with you. It will be good to be coordinated > with you in that regard as well. > With respect to Heidi, she comes from the intelligence community so doesn't have a scientific or pharmaceutical background, but as you'll see she is a > very quick study. She oversaw White House coordination of the response to the pandemic and has been acutely sensitized to the deficiencies of our > countermeasures development efforts. I think she'll be most interested to hear about your and Dr. Collins's vision for CAN and how it will facilitate > translational efforts at NIH. > It's probably worth your reviewing the HHS Medical Countermeasures Enterprise Review document just to get your head in the game. For the better part of a > decade, our efforts on MCMs have focused on traditional government approaches to financing technology development (R&D funds for academia, advanced > development contracts for industry, and procurement contracts serving as the main "reward") with some twiddling of other pull incentives, with only > marginal success against threats we can define and not much progress in developing true rapid response capabilities. > The main conceptual novelty of MCMI is the focus on adjusting the cost side of > the equation by making strategic investments at what we've been calling the "chokepoints" of product development - the places where projects are failing > or dying on the vine for reasons other than lack of safety or efficacy. The overarching goal of MCMI is to change the nature of the public-private > partnership governing product development efforts in this area, changing the role of government from one of "funder" to active strategic collaboration. > This is where I think what we are doing will be of interest to you: we are using the national security imperative to maintain focus and drive budgets but > adopting an approach which ought to be fungible to other areas where our translational efforts are faltering. Heidi's goal won't be to co-opt CAN but > to think strategically with you about how what we are doing might serve to enhance our drug development efforts more broadly (and hopefully preserve the > competitiveness of the US biopharmaceutical industry in the process). > Happy to chat further but I think that's the kernel of what she'll be interested in discussing with you. > Do you have a brief bio you could send over by any chance? > Best regards, and I look forward to meeting you on Monday - > Richard > Best, Richard > > ----- Original Message ----- From: Ranganathan, Rajesh (NIH/OD) [C] @nih.gov > To: Hatchett, Richard J. Sent: Wed Nov 17 21:02:12 2010 > Subject: Re: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > > Rajesh > On 11/17/10 5:55 PM, "Hatchett, Richard J." @nss.eop.gov wrote: > Cyndi, Rajesh -- >> Thanks for being flexible. Ms. Avery was very interested in joining the >> discussion. We'll meet in her office (EEOB 426) but why don't you come a few minutes early and meet me in 421? >> Best, >> Richard >> -----Original Message----- From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] >> Sent: Wednesday, November 17, 2010 5:50 PM To: Hatchett, Richard J. >> Cc: Ranganathan, Rajesh (NIH/OD) [C] Subject: RE: Discussion about Cures Acceleration Network and the President's >> Medical Countermeasures Initiative (MCMI) >> Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. Please confirm that the location is still the same (EEOB, 421). Many thanks. >> Best, >> Cyndi >> -----Original Message----- From: Hatchett, Richard J. [mailto @nss.eop.gov] >> Sent: Wednesday, November 17, 2010 5:46 PM To: Burrus-Shaw, Cyndi (NIH/OD) [E] >> Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) >> Cyndi, >> Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p >> on Monday, but not 11:00a. Would this work for Dr. Ranganathan? >> Thanks, >> Richard ------ End of Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Rajesh Ranganathan To: Kathy Hudson Cc: Lawrence Tabak Sent: Thu, 18 Nov 2010 21:17:50 -0500 Source: Reading Room, pp. 205–208 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Ok, thanks. Will deflect. I was not asking to be involved in this stuff - it was just meant to be a casual conversation with one of our detailees... Rajesh On 11/18/10 9:14 PM, "Hudson, Kathy (NIH/OD) [E]" @nih.gov wrote: Thanks for asking. My knee jerk reaction is to support your misgivings. I > think it is a bad idea for a whole bunch of reasons. JJ erred in pointing you to the white house. Protocol dictates that we don't talk to the white house > without going through hhs. It would be okay to yak with one of our detailees but this has taken a turn. Plus, I suspect you know next to nothing about > biosecurity and BARDA. This is not really your domain and frankly, not a central issue to NCTS at the outset. It IS the domain of other NIH staff who > would probably be a little miffed about why you are suddenly in the middle of their "space." NIAID has programs in this arena and you should learn about > them but they ain't coming into to ncts at the get go and the politics around biosecurity is complex. > I would suggest to Richard that the meeting be "delayed" until you have a > better understanding of what Francis has in mind, yadda yadda. > > > -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] > Sent: Thursday, November 18, 2010 6:51 PM To: Hudson, Kathy (NIH/OD) [E] > Cc: Tabak, Lawrence (NIH/OD) [E] Subject: FW: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Kathy: > Some background for you (I was able to tell Larry in person)..Tony sent me to JJ McGowan, who thought that Richard Hatchett, currently on detail to the > White House is someone I should talk to because he might have the skill set to help with NCTS. I checked in with Larry and we agreed that I should > certainly meet such people and hear them out. So, when Richard reached out, I agreed to go down to the EEOB to meet him. He appears to have mentioned > that he is meeting me to Ms. Heidi Avery (Deputy Homeland Security Adviser > to the President), who now wants to join in and the meeting got moved to Monday to accommodate her schedule. Please see below for what Richard thinks > Ms. Avery wants to know. > Two issues: a) there is not much I can say about CAN or anything else re: NCTS on Monday, and b) as a contractor, I should not be reprenseting the NIH > externally. Larry has arranged from Robin from DPCPSI to go with me to ensure that the NIH is represented by an employee. > But I am wondering if this meeting with Ms. Avery should even happen - feels > too early in the process Please advise on the ramifications of cancelling/postponing on her vs. taking the meeting and not saying anything > substantive... Thanks. > Rajesh > ------ Forwarded Message From: "Hatchett, Richard J." @nss.eop.gov > Date: Thu, 18 Nov 2010 08:51:35 -0500 To: "Ranganathan, Rajesh (NIH/OD) [C]" @nih.gov > Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Rajesh, > Sorry, I should have clarified that in our initial exchanges, as I assumed > that was the context in which JJ spoke with you. We have an overlapping (and in fact prior) interest in CAN because of the President's biodefense > initiative, and I was taking advantage of JJ's intro to contact you on MCMI (I hadn't heard that you'd been selected for the position before JJ > contacted me). > I'm actually in the late stages of negotiating a move to BARDA (the Biomedical Advanced Research & Development Authority) as deputy director and > I don't think JJ knew this when he spoke with you. It will be good to be coordinated with you in that regard as well. > With respect to Heidi, she comes from the intelligence community so doesn't > have a scientific or pharmaceutical background, but as you'll see she is a very quick study. She oversaw White House coordination of the response to > the pandemic and has been acutely sensitized to the deficiencies of our countermeasures development efforts. I think she'll be most interested to > hear about your and Dr. Collins's vision for CAN and how it will facilitate translational efforts at NIH. > It's probably worth your reviewing the HHS Medical Countermeasures > Enterprise Review document just to get your head in the game. For the better part of a decade, our efforts on MCMs have focused on traditional > government approaches to financing technology development (R&D funds for academia, advanced development contracts for industry, and procurement > contracts serving as the main "reward") with some twiddling of other pull incentives, with only marginal success against threats we can define and not > much progress in developing true rapid response capabilities. > The main conceptual novelty of MCMI is the focus on adjusting the cost side of the equation by making strategic investments at what we've been calling > the "chokepoints" of product development - the places where projects are > failing or dying on the vine for reasons other than lack of safety or efficacy. The overarching goal of MCMI is to change the nature of the > public-private partnership governing product development efforts in this area, changing the role of government from one of "funder" to active > strategic collaboration. This is where I think what we are doing will be of interest to you: we are using the national security imperative to maintain > focus and drive budgets but adopting an approach which ought to be fungible to other areas where our translational efforts are faltering. Heidi's goal > won't be to co-opt CAN but to think strategically with you about how what we are doing might serve to enhance our drug development efforts more broadly > (and hopefully preserve the competitiveness of the US biopharmaceutical industry in the process). > Happy to chat further but I think that's the kernel of what she'll be > interested in discussing with you. > Do you have a brief bio you could send over by any chance? > Best regards, and I look forward to meeting you on Monday - Richard > Best, > Richard > ------ Forwarded Message From: "Ranganathan, Rajesh (NIH/OD) [C]" @nih.gov > Date: Wed, 17 Nov 2010 20:50:57 -0500 To: "Hatchett, Richard J." @nss.eop.gov > Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Richard: > Can you give me some background on what Ms. Avery is likely to be interested > in hearing about. Is there anything I should know about MCMI to be appropriately prepared? > On 11/17/10 5:55 PM, "Hatchett, Richard J." >< @nss.eop.gov> wrote: >> Cyndi, Rajesh -- >> Thanks for being flexible. Ms. Avery was very interested in joining the discussion. We'll meet in her office (EEOB 426) but why don't you come a few >> minutes early and meet me in 421? >> Best, Richard >> -----Original Message----- >> From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] Sent: Wednesday, November 17, 2010 5:50 PM >> To: Hatchett, Richard J. Cc: Ranganathan, Rajesh (NIH/OD) [C] >> Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) >> >> Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. Please confirm that the location is still the same (EEOB, 421). Many thanks. >> Best, >> Cyndi >> -----Original Message----- From: Hatchett, Richard J. [mailto @nss.eop.gov] >> Sent: Wednesday, November 17, 2010 5:46 PM To: Burrus-Shaw, Cyndi (NIH/OD) [E] >> Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) >> Cyndi, >> Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p >> on Monday, but not 11:00a. Would this work for Dr. Ranganathan? >> Thanks, >> Richard > ------ End of Forwarded Message > Subject: FW: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Rajesh Ranganathan To: Kathy Hudson Cc: Lawrence Tabak Sent: Thu, 18 Nov 2010 18:51:28 -0500 Source: Reading Room, p. 209 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Kathy: Some background for you (I was able to tell Larry in person)..Tony sent me to JJ McGowan, who thought that Richard Hatchett, currently on detail to the White House is someone I should talk to because he might have the skill set to help with NCTS. I checked in with Larry and we agreed that I should certainly meet such people and hear them out. So, when Richard reached out, I agreed to go down to the EEOB to meet him. He appears to have mentioned that he is meeting me to Ms. Heidi Avery (Deputy Homeland Security Adviser to the President), who now wants to join in and the meeting got moved to Monday to accommodate her schedule. Please see below for what Richard thinks Ms. Avery wants to know. Two issues: a) there is not much I can say about CAN or anything else re: NCTS on Monday, and b) as a contractor, I should not be reprenseting the NIH externally. Larry has arranged from Robin from DPCPSI to go with me to ensure that the NIH is represented by an employee. But I am wondering if this meeting with Ms. Avery should even happen - feels too early in the process Please advise on the ramifications of cancelling/postponing on her vs. taking the meeting and not saying anything substantive... Thanks. Rajesh ------ Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's From: Richard Hatchett To: Rajesh Ranganathan Sent: Thu, 18 Nov 2010 08:51:35 -0500 Source: Reading Room, pp. 209–210 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Medical Countermeasures Initiative (MCMI) Rajesh, Sorry, I should have clarified that in our initial exchanges, as I assumed that was the context in which JJ spoke with you. We have an overlapping (and in fact prior) interest in CAN because of the President's biodefense initiative, and I was taking advantage of JJ's intro to contact you on MCMI (I hadn't heard that you'd been selected for the position before JJ contacted me). I'm actually in the late stages of negotiating a move to BARDA (the Biomedical Advanced Research & Development Authority) as deputy director and I don't think JJ knew this when he spoke with you. It will be good to be coordinated with you in that regard as well. With respect to Heidi, she comes from the intelligence community so doesn't have a scientific or pharmaceutical background, but as you'll see she is a very quick study. She oversaw White House coordination of the response to the pandemic and has been acutely sensitized to the deficiencies of our countermeasures development efforts. I think she'll be most interested to hear about your and Dr. Collins's vision for CAN and how it will facilitate translational efforts at NIH. It's probably worth your reviewing the HHS Medical Countermeasures Enterprise Review document just to get your head in the game. For the better part of a decade, our efforts on MCMs have focused on traditional government approaches to financing technology development (R&D funds for academia, advanced development contracts for industry, and procurement contracts serving as the main "reward") with some twiddling of other pull incentives, with only marginal success against threats we can define and not much progress in developing true rapid response capabilities. The main conceptual novelty of MCMI is the focus on adjusting the cost side of the equation by making strategic investments at what we've been calling the "chokepoints" of product development - the places where projects are failing or dying on the vine for reasons other than lack of safety or efficacy. The overarching goal of MCMI is to change the nature of the public-private partnership governing product development efforts in this area, changing the role of government from one of "funder" to active strategic collaboration. This is where I think what we are doing will be of interest to you: we are using the national security imperative to maintain focus and drive budgets but adopting an approach which ought to be fungible to other areas where our translational efforts are faltering. Heidi's goal won't be to co-opt CAN but to think strategically with you about how what we are doing might serve to enhance our drug development efforts more broadly (and hopefully preserve the competitiveness of the US biopharmaceutical industry in the process). Happy to chat further but I think that's the kernel of what she'll be interested in discussing with you. Do you have a brief bio you could send over by any chance? Best regards, and I look forward to meeting you on Monday - Richard Best, Richard ------ Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Robin Kawazoe To: Lawrence Tabak Sent: Thu, 18 Nov 2010 22:30:37 -0500 Source: Reading Room, pp. 212–215 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Larry, Do you know what Raj means when he said he would "deflect?" Does that mean postpone the meeting? Robin ----- Original Message ----- From: Tabak, Lawrence (NIH/OD) [E] To: Ranganathan, Rajesh (NIH/OD) [C]; Hudson, Kathy (NIH/OD) [E] Cc: Burrus-Shaw, Cyndi (NIH/OD) [E] Sent: Thu Nov 18 21:27:59 2010 Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Agree Thanks larry -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] Sent: Thursday, November 18, 2010 9:18 PM To: Hudson, Kathy (NIH/OD) [E] Cc: Tabak, Lawrence (NIH/OD) [E] Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Ok, thanks. Will deflect. I was not asking to be involved in this stuff - it was just meant to be a casual conversation with one of our detailees... Rajesh On 11/18/10 9:14 PM, "Hudson, Kathy (NIH/OD) [E]" @nih.gov wrote: Thanks for asking. My knee jerk reaction is to support your misgivings. I > think it is a bad idea for a whole bunch of reasons. JJ erred in pointing you to the white house. Protocol dictates that we don't talk to the white house > without going through hhs. It would be okay to yak with one of our detailees but this has taken a turn. Plus, I suspect you know next to nothing about > biosecurity and BARDA. This is not really your domain and frankly, not a central issue to NCTS at the outset. It IS the domain of other NIH staff who > would probably be a little miffed about why you are suddenly in the middle of their "space." NIAID has programs in this arena and you should learn about > them but they ain't coming into to ncts at the get go and the politics around biosecurity is complex. > I would suggest to Richard that the meeting be "delayed" until you have a > better understanding of what Francis has in mind, yadda yadda. > > > -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] > Sent: Thursday, November 18, 2010 6:51 PM To: Hudson, Kathy (NIH/OD) [E] > Cc: Tabak, Lawrence (NIH/OD) [E] Subject: FW: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Kathy: > Some background for you (I was able to tell Larry in person)..Tony sent me to JJ McGowan, who thought that Richard Hatchett, currently on detail to the > White House is someone I should talk to because he might have the skill set to help with NCTS. I checked in with Larry and we agreed that I should > certainly meet such people and hear them out. So, when Richard reached out, I agreed to go down to the EEOB to meet him. He appears to have mentioned > that he is meeting me to Ms. Heidi Avery (Deputy Homeland Security Adviser to the President), who now wants to join in and the meeting got moved to > Monday to accommodate her schedule. Please see below for what Richard thinks Ms. Avery wants to know. > Two issues: a) there is not much I can say about CAN or anything else re: > NCTS on Monday, and b) as a contractor, I should not be reprenseting the NIH externally. Larry has arranged from Robin from DPCPSI to go with me to > ensure that the NIH is represented by an employee. > But I am wondering if this meeting with Ms. Avery should even happen - feels too early in the process Please advise on the ramifications of > cancelling/postponing on her vs. taking the meeting and not saying anything substantive... Thanks. > Rajesh > ------ Forwarded Message > From: "Hatchett, Richard J." < @nss.eop.gov> Date: Thu, 18 Nov 2010 08:51:35 -0500 > To: "Ranganathan, Rajesh (NIH/OD) [C]" < @nih.gov> Subject: Re: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Rajesh, > Sorry, I should have clarified that in our initial exchanges, as I assumed that was the context in which JJ spoke with you. We have an overlapping > (and in fact prior) interest in CAN because of the President's biodefense initiative, and I was taking advantage of JJ's intro to contact you on MCMI > (I hadn't heard that you'd been selected for the position before JJ contacted me). > > I'm actually in the late stages of negotiating a move to BARDA (the Biomedical Advanced Research & Development Authority) as deputy director and > I don't think JJ knew this when he spoke with you. It will be good to be coordinated with you in that regard as well. > With respect to Heidi, she comes from the intelligence community so doesn't > have a scientific or pharmaceutical background, but as you'll see she is a very quick study. She oversaw White House coordination of the response to > the pandemic and has been acutely sensitized to the deficiencies of our countermeasures development efforts. I think she'll be most interested to > hear about your and Dr. Collins's vision for CAN and how it will facilitate translational efforts at NIH. > It's probably worth your reviewing the HHS Medical Countermeasures > Enterprise Review document just to get your head in the game. For the better part of a decade, our efforts on MCMs have focused on traditional > government approaches to financing technology development (R&D funds for academia, advanced development contracts for industry, and procurement > contracts serving as the main "reward") with some twiddling of other pull incentives, with only marginal success against threats we can define and not > much progress in developing true rapid response capabilities. > The main conceptual novelty of MCMI is the focus on adjusting the cost side of the equation by making strategic investments at what we've been calling > the "chokepoints" of product development - the places where projects are failing or dying on the vine for reasons other than lack of safety or > efficacy. The overarching goal of MCMI is to change the nature of the public-private partnership governing product development efforts in this > area, changing the role of government from one of "funder" to active strategic collaboration. This is where I think what we are doing will be of > interest to you: we are using the national security imperative to maintain focus and drive budgets but adopting an approach which ought to be fungible > to other areas where our translational efforts are faltering. Heidi's goal won't be to co-opt CAN but to think strategically with you about how what we > are doing might serve to enhance our drug development efforts more broadly (and hopefully preserve the competitiveness of the US biopharmaceutical > industry in the process). > Happy to chat further but I think that's the kernel of what she'll be interested in discussing with you. > Do you have a brief bio you could send over by any chance? > Best regards, and I look forward to meeting you on Monday - > Richard > Best, Richard > ------ Forwarded Message > From: "Ranganathan, Rajesh (NIH/OD) [C]" < @nih.gov> Date: Wed, 17 Nov 2010 20:50:57 -0500 > To: "Hatchett, Richard J." < @nss.eop.gov> Subject: Re: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Richard: > Can you give me some background on what Ms. Avery is likely to be interested > in hearing about. Is there anything I should know about MCMI to be appropriately prepared? > On 11/17/10 5:55 PM, "Hatchett, Richard J." >< @nss.eop.gov> wrote: >> Cyndi, Rajesh -- >> Thanks for being flexible. Ms. Avery was very interested in joining the discussion. We'll meet in her office (EEOB 426) but why don't you come a few >> minutes early and meet me in 421? >> Best, Richard >> -----Original Message----- >> From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] Sent: Wednesday, November 17, 2010 5:50 PM >> To: Hatchett, Richard J. Cc: Ranganathan, Rajesh (NIH/OD) [C] >> Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) >> Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. >> Please confirm that the location is still the same (EEOB, 421). Many thanks. >> Best, Cyndi >> -----Original Message----- >> From: Hatchett, Richard J. [mailto @nss.eop.gov] Sent: Wednesday, November 17, 2010 5:46 PM >> To: Burrus-Shaw, Cyndi (NIH/OD) [E] Subject: RE: Discussion about Cures Acceleration Network and the President's >> Medical Countermeasures Initiative (MCMI) >> Cyndi, >> Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p on >> Monday, but not 11:00a. Would this work for Dr. Ranganathan? >> Thanks, Richard > > ------ End of Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Robin Kawazoe To: Lawrence Tabak Sent: Thu, 18 Nov 2010 22:46:32 -0500 Source: Reading Room, pp. 216–220 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Yes! Thank you. Robin ----- Original Message ----- From: Tabak, Lawrence (NIH/OD) [E] To: Kawazoe, Robin (NIH/OD) [E] Sent: Thu Nov 18 22:33:02 2010 Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Yes ----- Original Message ----- From: Kawazoe, Robin (NIH/OD) [E] To: Tabak, Lawrence (NIH/OD) [E] Sent: Thu Nov 18 22:30:37 2010 Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Larry, Do you know what Raj means when he said he would "deflect?" Does that mean postpone the meeting? Robin ----- Original Message ----- From: Tabak, Lawrence (NIH/OD) [E] To: Ranganathan, Rajesh (NIH/OD) [C]; Hudson, Kathy (NIH/OD) [E] Cc: Burrus-Shaw, Cyndi (NIH/OD) [E] Sent: Thu Nov 18 21:27:59 2010 Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Agree Thanks larry -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] Sent: Thursday, November 18, 2010 9:18 PM To: Hudson, Kathy (NIH/OD) [E] Cc: Tabak, Lawrence (NIH/OD) [E] Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Ok, thanks. Will deflect. I was not asking to be involved in this stuff - it was just meant to be a casual conversation with one of our detailees... Rajesh On 11/18/10 9:14 PM, "Hudson, Kathy (NIH/OD) [E]" @nih.gov wrote: Thanks for asking. My knee jerk reaction is to support your misgivings. I > think it is a bad idea for a whole bunch of reasons. JJ erred in pointing you to the white house. Protocol dictates that we don't talk to the white house > without going through hhs. It would be okay to yak with one of our detailees but this has taken a turn. Plus, I suspect you know next to nothing about > biosecurity and BARDA. This is not really your domain and frankly, not a central issue to NCTS at the outset. It IS the domain of other NIH staff who > would probably be a little miffed about why you are suddenly in the middle of their "space." NIAID has programs in this arena and you should learn about > them but they ain't coming into to ncts at the get go and the politics around biosecurity is complex. > I would suggest to Richard that the meeting be "delayed" until you have a > better understanding of what Francis has in mind, yadda yadda. > > > -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] > Sent: Thursday, November 18, 2010 6:51 PM To: Hudson, Kathy (NIH/OD) [E] > Cc: Tabak, Lawrence (NIH/OD) [E] Subject: FW: Discussion about Cures Acceleration Network and the President's > Medical Countermeasures Initiative (MCMI) > Kathy: > Some background for you (I was able to tell Larry in person)..Tony sent me to JJ McGowan, who thought that Richard Hatchett, currently on detail to the > White House is someone I should talk to because he might have the skill set to help with NCTS. I checked in with Larry and we agreed that I should > certainly meet such people and hear them out. So, when Richard reached out, I agreed to go down to the EEOB to meet him. He appears to have mentioned > that he is meeting me to Ms. Heidi Avery (Deputy Homeland Security Adviser to the President), who now wants to join in and the meeting got moved to > Monday to accommodate her schedule. Please see below for what Richard thinks Ms. Avery wants to know. > Two issues: a) there is not much I can say about CAN or anything else re: > NCTS on Monday, and b) as a contractor, I should not be reprenseting the NIH externally. Larry has arranged from Robin from DPCPSI to go with me to > ensure that the NIH is represented by an employee. > But I am wondering if this meeting with Ms. Avery should even happen - feels too early in the process Please advise on the ramifications of > cancelling/postponing on her vs. taking the meeting and not saying anything > substantive... Thanks. > Rajesh > ------ Forwarded Message From: "Hatchett, Richard J." @nss.eop.gov > Date: Thu, 18 Nov 2010 08:51:35 -0500 To: "Ranganathan, Rajesh (NIH/OD) [C]" @nih.gov > Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Rajesh, > Sorry, I should have clarified that in our initial exchanges, as I assumed > that was the context in which JJ spoke with you. We have an overlapping (and in fact prior) interest in CAN because of the President's biodefense > initiative, and I was taking advantage of JJ's intro to contact you on MCMI (I hadn't heard that you'd been selected for the position before JJ > contacted me). > I'm actually in the late stages of negotiating a move to BARDA (the Biomedical Advanced Research & Development Authority) as deputy director and > I don't think JJ knew this when he spoke with you. It will be good to be coordinated with you in that regard as well. > With respect to Heidi, she comes from the intelligence community so doesn't > have a scientific or pharmaceutical background, but as you'll see she is a very quick study. She oversaw White House coordination of the response to > the pandemic and has been acutely sensitized to the deficiencies of our countermeasures development efforts. I think she'll be most interested to > hear about your and Dr. Collins's vision for CAN and how it will facilitate translational efforts at NIH. > It's probably worth your reviewing the HHS Medical Countermeasures > Enterprise Review document just to get your head in the game. For the better part of a decade, our efforts on MCMs have focused on traditional > government approaches to financing technology development (R&D funds for academia, advanced development contracts for industry, and procurement > contracts serving as the main "reward") with some twiddling of other pull incentives, with only marginal success against threats we can define and not > much progress in developing true rapid response capabilities. > The main conceptual novelty of MCMI is the focus on adjusting the cost side of the equation by making strategic investments at what we've been calling > the "chokepoints" of product development - the places where projects are failing or dying on the vine for reasons other than lack of safety or > efficacy. The overarching goal of MCMI is to change the nature of the public-private partnership governing product development efforts in this > area, changing the role of government from one of "funder" to active strategic collaboration. This is where I think what we are doing will be of > interest to you: we are using the national security imperative to maintain focus and drive budgets but adopting an approach which ought to be fungible > to other areas where our translational efforts are faltering. Heidi's goal won't be to co-opt CAN but to think strategically with you about how what we > are doing might serve to enhance our drug development efforts more broadly (and hopefully preserve the competitiveness of the US biopharmaceutical > industry in the process). > Happy to chat further but I think that's the kernel of what she'll be > interested in discussing with you. > Do you have a brief bio you could send over by any chance? > Best regards, and I look forward to meeting you on Monday - Richard > Best, > Richard > ------ Forwarded Message From: "Ranganathan, Rajesh (NIH/OD) [C]" @nih.gov > Date: Wed, 17 Nov 2010 20:50:57 -0500 To: "Hatchett, Richard J." @nss.eop.gov > Subject: Re: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) > Richard: > Can you give me some background on what Ms. Avery is likely to be interested > in hearing about. Is there anything I should know about MCMI to be appropriately prepared? > On 11/17/10 5:55 PM, "Hatchett, Richard J." >< @nss.eop.gov> wrote: >> Cyndi, Rajesh -- >> Thanks for being flexible. Ms. Avery was very interested in joining the discussion. We'll meet in her office (EEOB 426) but why don't you come a few >> minutes early and meet me in 421? >> Best, Richard >> -----Original Message----- >> From: Burrus-Shaw, Cyndi (NIH/OD) [E] [mailto @nih.gov] Sent: Wednesday, November 17, 2010 5:50 PM >> To: Hatchett, Richard J. Cc: Ranganathan, Rajesh (NIH/OD) [C] >> Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) >> Yes - that is fine. Dr. Ranganathan will be there on 11/22 at 12:00 pm. >> Please confirm that the location is still the same (EEOB, 421). Many thanks. >> Best, Cyndi >> -----Original Message----- >> From: Hatchett, Richard J. [mailto @nss.eop.gov] Sent: Wednesday, November 17, 2010 5:46 PM >> To: Burrus-Shaw, Cyndi (NIH/OD) [E] Subject: RE: Discussion about Cures Acceleration Network and the President's >> Medical Countermeasures Initiative (MCMI) >> Cyndi, >> Ms. Avery (Deputy Homeland Security Adviser to the President) can do 12:00p >> on Monday, but not 11:00a. Would this work for Dr. Ranganathan? >> Thanks, >> Richard > ------ End of Forwarded Message > Subject: RE: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) From: Kathy Hudson To: Rajesh Ranganathan Cc: Lawrence Tabak Sent: Thu, 18 Nov 2010 21:14:33 -0500 Source: Reading Room, pp. 221–222 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Thanks for asking. My knee jerk reaction is to support your misgivings. I think it is a bad idea for a whole bunch of reasons. JJ erred in pointing you to the white house. Protocol dictates that we don't talk to the white house without going through hhs. It would be okay to yak with one of our detailees but this has taken a turn. Plus, I suspect you know next to nothing about biosecurity and BARDA. This is not really your domain and frankly, not a central issue to NCTS at the outset. It IS the domain of other NIH staff who would probably be a little miffed about why you are suddenly in the middle of their "space." NIAID has programs in this arena and you should learn about them but they ain't coming into to ncts at the get go and the politics around biosecurity is complex. I would suggest to Richard that the meeting be "delayed" until you have a better understanding of what Francis has in mind, yadda yadda. -----Original Message----- From: Ranganathan, Rajesh (NIH/OD) [C] Sent: Thursday, November 18, 2010 6:51 PM To: Hudson, Kathy (NIH/OD) [E] Cc: Tabak, Lawrence (NIH/OD) [E] Subject: FW: Discussion about Cures Acceleration Network and the President's Medical Countermeasures Initiative (MCMI) Kathy: Some background for you (I was able to tell Larry in person)..Tony sent me to JJ McGowan, who thought that Richard Hatchett, currently on detail to the White House is someone I should talk to because he might have the skill set to help with NCTS. I checked in with Larry and we agreed that I should certainly meet such people and hear them out. So, when Richard reached out, I agreed to go down to the EEOB to meet him. He appears to have mentioned that he is meeting me to Ms. Heidi Avery (Deputy Homeland Security Adviser to the President), who now wants to join in and the meeting got moved to Monday to accommodate her schedule. Please see below for what Richard thinks Ms. Avery wants to know. Two issues: a) there is not much I can say about CAN or anything else re: NCTS on Monday, and b) as a contractor, I should not be reprenseting the NIH externally. Larry has arranged from Robin from DPCPSI to go with me to ensure that the NIH is represented by an employee. But I am wondering if this meeting with Ms. Avery should even happen - feels too early in the process Please advise on the ramifications of cancelling/postponing on her vs. taking the meeting and not saying anything substantive... Thanks. Rajesh ------ Forwarded Message Subject: Re: Discussion about Cures Acceleration Network and the President's From: Richard Hatchett To: Rajesh Ranganathan Sent: Thu, 18 Nov 2010 08:51:35 -0500 Source: Reading Room, pp. 222–223 of Reading-Room-FINAL.pdf ------------------------------------------------------------------------------ Medical Countermeasures Initiative (MCMI) Rajesh, Sorry, I should have clarified that in our initial exchanges, as I assumed that was the context in which JJ spoke with you. We have an overlapping (and in fact prior) interest in CAN because of the President's biodefense initiative, and I was taking advantage of JJ's intro to contact you on MCMI (I hadn't heard that you'd been selected for the position before JJ contacted me). I'm actually in the late stages of negotiating a move to BARDA (the Biomedical Advanced Research & Development Authority) as deputy director and I don't think JJ knew this when he spoke with you. It will be good to be coordinated with you in that regard as well. With respect to Heidi, she comes from the intelligence community so doesn't have a scientific or pharmaceutical background, but as you'll see she is a very quick study. She oversaw White House coordination of the response to the pandemic and has been acutely sensitized to the deficiencies of our countermeasures development efforts. I think she'll be most interested to hear about your and Dr. Collins's vision for CAN and how it will facilitate translational efforts at NIH. It's probably worth your reviewing the HHS Medical Countermeasures Enterprise Review document just to get your head in the game. For the better part of a decade, our efforts on MCMs have focused on traditional government approaches to financing technology development (R&D funds for academia, advanced development contracts for industry, and procurement contracts serving as the main "reward") with some twiddling of other pull incentives, with only marginal success against threats we can define and not much progress in developing true rapid response capabilities. The main conceptual novelty of MCMI is the focus on adjusting the cost side of the equation by making strategic investments at what we've been calling the "chokepoints" of product development - the places where projects are failing or dying on the vine for reasons other than lack of safety or efficacy. The overarching goal of MCMI is to change the nature of the public-private partnership governing product development efforts in this area, changing the role of government from one of "funder" to active strategic collaboration. This is where I think what we are doing will be of interest to you: we are using the national security imperative to maintain focus and drive budgets but adopting an approach which ought to be fungible to other areas where our translational efforts are faltering. Heidi's goal won't be to co-opt CAN but to think strategically with you about how what we are doing might serve to enhance our drug development efforts more broadly (and hopefully preserve the competitiveness of the US biopharmaceutical industry in the process). Happy to chat further but I think that's the kernel of what she'll be interested in discussing with you. Do you have a brief bio you could send over by any chance? Best regards, and I look forward to meeting you on Monday - Richard Best, Richard ------ Forwarded Message