The Pandemic and All Hazards Preparedness Act (PAHPA) (PDF - 248 KB) directs BARDA to use innovation to assess and promote technologies that save time and cost in developing medical countermeasures (MCM) for public health emergencies. BARDA applies this directive in all of its specific threat and countermeasure programs, but also maintains a separate Innovations Program that seeks, identifies and supports technological solutions to improve preparedness capabilities through new tools and approaches to MCM development and manufacturing. Innovations Areas of Interest presented in the program’s Broad Agency Announcement are intended to find the best match between countermeasure need and technological opportunity, and are periodically revised as that landscape evolves. A major goal is to identify new approaches and capabilities that allow for better preparedness and response to multiple public threats by serving as platform technologies. Applying these platform technologies to candidates can enable greater success in further development and manufacturing of MCM products.
Since 2010, twelve (12) projects have been supported by the BARDA Innovations Program. Successful outcomes from three of these projects include 3M/Focus launching their novel diagnostic platform and influenza diagnostic test; VaxDesign/sanofi presenting their in vitro immune testing system to the FDA in anticipation of using these data in future product submissions; and Rapid Micro Biosystems launching their accelerated vaccine and environmental monitoring and sterility test system. Other Areas of Interest have included: more efficient manufacturing platforms; novel product testing and evaluation tools; improved formulation technologies; diagnostics platforms; host-directed or immunotherapeutic products; and improved countermeasure delivery systems. In 2015, a new Area of Interest was announced in supporting platform technologies that streamline the process of generating and manufacturing countermeasures for eliciting protective immunity (i.e., monoclonal antibodies or vaccines) against novel or emerging microbial pathogens.
The Innovations Program’s success thus far has been based on promoting technologies that have shown promise for filling a particular countermeasure need, but have not been widely adopted in research, development and manufacturing practice and thus will benefit from further BARDA support and evaluation. Innovations projects have demonstrated accomplishments tied to other BARDA programs while touching on a broad array of platforms rather than a single threat or countermeasure. These accomplishments have impacted vaccine manufacturing, product release testing, preclinical immunological evaluation and influenza diagnostics. The Innovations Program will continue to assess and promote technologies and tools enabling BARDA’s other programs to be more successful in meeting their goals. Innovations also supports the missions of BARDA’s new Emerging Infectious Diseases Program by identifying rapid response technologies that will enable us to diagnose and neutralize pathogens as they emerge and threaten the U.S.
In June of 2018 BARDA launched the Division of Research, Innovation, and Ventures (DRIVe), to revolutionize the way we prevent, detect, and respond to major 21st century health security threats. DRIVe takes a new approach to tackle the biggest national health security threats – developing innovative technologies and practices for transformative solutions. DRIVe brings together the best ideas from the medical and scientific communities, together with government and venture capital investment, to drive innovation that will strengthen our nation’s health security. For more information on DRIVe see www.drive.hhs.gov.