Reading Room Production — page 218

We have an overlapping s biodefense >you on MCMI re JJ A (the see she is a ies of our I think she'll be most interested to sures D funds for f other pull been calling rojects are y or 'e of the active t we are doing will be of -maintain to be fungible Heidi's goal out how what we maceutical > 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).