VentureHHS: Government Fund Would Invest In Firms Developing Medical Countermeasures
This article was originally published in The Pink Sheet Daily
Executive Summary
While BARDA focuses on products, the new fund would support the viability of developers, NIAID Director Fauci says
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The Obama Administration plans to ask Congress to authorize an independent strategic investment fund to provide financial support for small companies developing medical products that can be used to respond to a medical emergency, such as a terrorist attack or pandemic flu. The fund would be managed by a 501(c)(3) non-profit corporation with an independent board of directors, explained Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during an Aug. 19 press conference to release an administration blueprint for accelerating the development of medical countermeasures. The MCM plan is based on a review of the existing medical countermeasures enterprise initiated by HHS Secretary Kathleen Sebelius in December 2009 to determine how MCMs can be developed and manufactured more rapidly and efficiently. The innovation fund essentially would serve as a source of capital to ensure the viability of firms that are addressing potential public health emergencies, "to make it more attractive for them to get into the business that we find so important to the protection of our citizens," Fauci said. The difference between the new fund and the Biomedical Advanced Research and Development Authority is that BARDA focuses on products, while the new entity will focus on companies, he noted. The strategic investment fund is about "enhancing and assuring the viability of a company, because the company may have a product and the investment in the product is making the product go, but the company itself is going to ultimately fail" because it doesn't have the resources to sustain itself, Fauci explained. The administration initially would provide $200 million for the investment project. As envisioned by the MCM review team, the fund manager also would provide expert consultation to companies and link them with potential private-sector partners and government resources. The focus would be on companies developing novel antimicrobials for multi-drug resistant organisms, novel mechanisms for disrupting pathogenesis through host pathway targeting, and multi-use platform technologies for diagnostics, vaccines/prophylaxis and therapeutics, according to the review report. In the area of making manufacturing processes more adaptable so they can respond to medical emergencies, HHS expects to release in coming weeks a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) would work to develop manufacturing platforms able to produce a variety of countermeasures and to meet a surge in demand using domestic facilities rather than relying on foreign manufacturing. They would also help emerging companies with little experience in large-scale production bring their products to market. Among the concerns that lead HHS to conduct its reevaluation of countermeasure development is that smaller firms often seem to struggle with regulatory requirements as they develop products, while larger firms often do not see the market opportunity as significant enough to invest in the sector (Also see "Rx Countermeasures: HHS Launching "Pivotal Studies" To Engage Industry" - Pink Sheet, 12 Apr, 2010.). Another aspect of the revamped countermeasure development plan is funding for FDA to advance its regulatory science initiative (see ). -Cathy Dombrowski ([email protected] ) |