Oct 6, 2011 (CIDRAP News) – In releasing a new 5-year strategic plan yesterday, the federal agency tasked with developing new medical countermeasures (MCMs) for bioterrorist attacks and emerging diseases said many such products will be ready for regulatory review within the next 5 years.
Robin A. Robinson, PhD, director of the Biomedical Advanced Research and Development Authority (BARDA), says in the plan that the agency now has a "robust product development pipeline for nearly all threats." BARDA is part of the Department of Health and Human Services (HHS).
"Many of these products in the development pipeline will become mature enough for acquisition and regulatory review over the next five years," he adds.
The 15-page plan says little about specific products, focusing instead on five broad goals and related strategies. But it does mention that two manufacturers plan to file for regulatory approval of cell-based influenza vaccines this year and that new flu vaccines based on recombinant technologies are expected in the following years.
BARDA was established in 2007 with the purpose of promoting the development, manufacture, and acquisition of medical defenses against chemical, biological, radiological, and nuclear threats, pandemic flu, and emerging infectious diseases. The new strategic plan replaces one that was issued in 2007.
In large part the new plan reflects the goals and recommendations of a major HHS review of the nation's biodefense efforts released in August 2010: the Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range Medical Needs, also known as the PHEMCE review. That review was prompted mainly by the delays in production of the 2009 pandemic H1N1 flu vaccine, which wasn't widely available until after the peak of the fall 2009 wave of cases.
The new document states, "BARDA's vision for the next five years is to enhance the capability of the U.S. Government to respond quickly to both known and emerging threats by supporting the development of a comprehensive portfolio of medical countermeasures, needed manufacturing infrastructure, and countermeasure production platforms while establishing an affordable and sustainable foundation for the maintenance and future operations of PHEMCE."
The first of the five goals calls for "an advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs." Related strategies include, among others:
- Supporting the development of MCMs for special populations, such as children, pregnant women, the elderly, and those with weakened immune systems
- Expanding BARDA's Broad-Spectrum Antimicrobials and Innovations programs to address an array of threats
- Investing in "host-directed therapeutics," such as immune modulators, anti-inflammatories, and regulators of innate immunity
The second goal calls for providing "enabling core services" to MCM innovators. A key objective is to set up the Centers for Innovation in Advanced Development and Manufacturing," as described in the PHEMCE review. Another step, also described in the PHEMCE review, is to establish an MCM "Strategic Investor," or venture capital firm, to provide financial and business services to biotechnology companies.
A third goal is to develop a strong manufacturing infrastructure for rapid production of vaccines for pandemic flu and other emerging threats, the plan says. Related strategies include adding cell-based flu vaccines to the nation's defenses, supporting the development of next-generation recombinant flu vaccines, completing the development and testing of adjuvanted vaccines, and enhancing domestic vaccine fill-finish capacity. The goal and strategies focus on speeding up the production of flu vaccines and do not address improving vaccine efficacy.
The fourth goal is to achieve "responsive and nimble programs and capabilities to address novel and emerging threats." The specific strategies include several of those already mentioned, such as developing broad spectrum antimicrobial and host-directed therapeutics.
Goal 5 is a capability to make and facilitate distribution of MCMs during public health emergencies. To that end, BARDA plans to draw on lessons from the 2009 pandemic and develop, along with other agencies, comprehensive pandemic response plans.
BARDA's 5-year strategic plan
BARDA press release
Aug 19, 2010, CIDRAP News story "HHS sees greater federal role in building biodefense tools"