Innovation Sherpas
HHS also proposes establishing "Sherpa" teams of government, academic, and industry experts to guide discoverers of promising
MCM candidates through the R&D and regulatory processes. National Institutes of Health (NIH) experts provide less experienced
researchers with information on preclinical services and clinical-trial support, but the Sherpa teams would offer a more formal
effort, explained Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at the press briefing.
Probably the most problematic HHS proposal is the provision of $200 million to establish an independent, nonprofit investment
entity to fund small innovative firms that are developing novel biodefense technologies. Instead of funding research on specific
products, the MCM Strategic Investor would invest in companies, provided Congress authorizes such a plan, which would give
money to industry. A priority is to support firms developing new antimicrobials to combat multidrug-resistant organisms, which
are spreading globally. The initiative also would fund research on host pathways used by multiple agents of disease, and develop
flexible platform technologies for diagnostics, vaccines, and therapeutics.
HHS hopes to support MCM development by better coordinating and integrating its R&D programs internally and with other federal
agencies. An efficient and flexible contracting process would encourage private-sector investment, as would a five-year budget
and planning process. In addition, Sebelius plans to review current liability protections for private-sector MCM developers
to determine whether stronger safeguards are needed to spur product development and manufacture. Lurie emphasizes that the
$2-billion program is not "simply a cash infusion to industry." Rather, by eliminating technical and regulatory barriers,
the project will reduce the risk for companies that invest their own resources in vaccines and MCMs.
For the upcoming influenza season, the Centers for Disease Control and Prevention hope to vaccinate 160 million Americans
with a three-strain influenza vaccine in expectation that H1N1 will return, along with seasonal influenza. The need to produce
only one influenza vaccine should avoid many of the problems that occurred in 2009. Yet, a quiet influenza season also could
diminish interest on Capitol Hill in increasing spending on countermeasure research and vaccine development and in finding
better ways to protect against biological threats.
Jill Wechsler is Pharmaceutical Technology's Washington editor, 7715 Rocton Ave., Chevy Chase, MD 20815, tel. 301.656.4634, jwechsler@advanstar.com
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