BARDA, the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (HHS), recently awarded four contracts for the research and development of innovative platform technologies in medical countermeasure development.
BARDA was established within HHS to manage the procurement and development of medical countermeasures, such as vaccines, drugs, and diagnostic tools, for biological, chemical, radiological, and nuclear agents, as well as for other public health emergencies, such as pandemic influenza and emerging infectious diseases. BARDA’s Strategic Science and Technology Division identifies and selectively funds research and technology that will improve the effectiveness and shorten the time and cost of medical countermeasure development. The innovative technologies awarded have all demonstrated success in late-stage clinical development for countermeasures against pandemic influenza and anthrax, two prevalent diseases of concern in public health and biosecurity.
Contracts were awarded to the following organizations to continue development: the Program for Appropriate Technology in Health (PATH), the Infectious Disease Research Institute (IDRI) in Seattle, VaxDesign Corp. in Orlando and Pfenex Inc. in San Diego. A collective total of $24.6 million is allotted for initial phases and up to $53.6 million over three years.
PATH and IDRI, two global health non-profit organizations based in Seattle, Washington, were each awarded contracts for their work in ”…formulation chemistry, protein stabilization, and vaccine delivery technologies.” The two organizations entered into a Research Collaborative Agreement in June 2010 to “evaluate novel adjuvants for their ability to enhance the immune response of pandemic influenza vaccines in development.” PATH has discovered multiple strategies to extend the shelf-life of influenza vaccines for use in stockpiling or international shipping. IDRI, a biotechnology institute, will develop formulations for immunologic and cross-protection adjuvants (a drug-modifying/enhancing agent) to enhance the recipient’s immune response to the influenza vaccine and to protect against multiple novel strains that may emerge. The joint collaboration will bring the new technologies together to create a flu vaccine that is more cost-effective, affordable, and accessible on a global scale.
VaxDesign, a corporation that develops, manufactures, and markets in vitro models of the human immune system, was awarded the third contract for its work in “… technologies to accelerate evaluation of candidate vaccines and therapeutics.” Its Modular Immune In-Vitro Construct, MIMIC®, features an in vitro human immune system that enables researchers to test a human-like immune response to a vaccine or drug. This platform will be used to predict effectiveness, cross-protection capability, potency, as well as dosing and timing, of drugs and vaccines before costly clinical trials. MIMIC® technology can speed up evaluations of vaccines and vaccine stockpiles for safety and effectiveness before administering to the public.
Pfenex Inc. was awarded the last contract for up to a total of $18.8 million for “… innovative methods in bioprocess development and manufacturing.” With funding, the San Diego protein production company will continue to develop its recombinant protective antigen development program using the Pfenex Expression Technology Platform™ to identify protein expression strains that will produce stable high quantities of recombinant protective antigen (rPA) from anthrax. Applied technology will then be used to further develop bioproduction processes for a possible anthrax vaccine candidate.