Reading Room Production — page 359

um AI or 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).