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 um AI or substantive... Thanks. Rajesh ------ Forwarded Message

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1. 2010-11-18 18:51 Rajesh Ranganathan
   @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). ll be a v lu come a few ). Many thanks. 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
2. 2010-11-18 18:51 Rajesh Ranganathan open
   @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). ll be a v lu come a few ). Many thanks. 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

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