Public Health Emergency - Leading a Nation Prepared
The ORISE Research Participation Program at the HHS/ASPR Biomedical Advanced Research and Development Authority (BARDA) is a training and succession planning mechanism designed to provide graduate students and postgraduates, opportunities to participate in animal model and medical countermeasure (MCM) research and development. The program is a valuable human capital tool which provides educational experiences and training in a variety of disciplines supporting the advanced development of both pharmaceuticals and devices as a means to introduce highly motivated participants to public health as a viable career field.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health emergencies.
BARDA’s Mission is to support development and make available countermeasures for CBRN threats, pandemic influenza, and emerging infectious diseases by transitioning medical countermeasure (MCM) candidates from early development into advanced development and through regulatory approval. BARDA accomplishes this by forming novel public private partnerships with pharmaceutical and biotech companies to promote research and development. Through these partnerships, BARDA provides non-dilutive funding to support product development activities that range from Phase I clinical trials through NDA filing and post-marking commitments. Typical supported activities include non-clinical studies to meet commercial development requirements (PK/PD assessments, toxicology studies, in vitro/in vivo efficacy studies, etc.), human clinical trials, CMC manufacturing, and in vitro/in vivo studies that would support the use of the product during a biodefense emergency. BARDA also provides technical and programmatic support to product developers through matrixed project coordination teams. These teams provide critical assistance to product developers by identifying and managing risks and potential cost drivers early and preventing avoidable delays.
Recently BARDA has been applying its strategy to the development of Ebola, MERS, and Zika medical countermeasures in real time, as the current outbreaks are unfolding. This responsibility is tied to BARDA’s expanding role as a response organization to meet the challenge of emerging threats. Similarly, BARDA supports a sustainable manufacturing infrastructure and ensures that there is sufficient capacity to make and provide enough influenza vaccines to be able to respond to a novel influenza virus of pandemic potential. In addition to product development, BARDA also manages Project BioShield, a $2.8B fund for the procurement and stockpiling of medical countermeasures for chemical, biological, radiological and nuclear threats.
BARDA’s Research Participation program is managed by ORAU through the Oak Ridge Institute for Science and Education (ORISE) under an agreement with the U.S. Department of Energy (DOE).
Established as an official DOE institute in 1992, with programs dating back to 1946, the Oak Ridge Institute for Science and Education (ORISE) is a national leader in science education and research.
Through the management of ORISE, ORAU directly supports DOE’s national agenda. We strive to advance science education and research programs, with a vision to be a national leader in doing so. And we create opportunities for collaboration through partnerships with other DOE facilities, other federal agencies, the academic community, and industry.
Fundamental to ORISE’s mission objectives are:•Strengthening our nation’s research and development enterprise through education and research participation programs•Ensuring the readiness of our nation to respond to terrorist incidents and other emergencies•Protecting workers, the public, and the environment through research, outreach, and verification activities
Visit www.zintellect.com and search BARDA
Please send questions by email to Pamela.Payne@hhs.gov
Home | Contact Us | Accessibility | Privacy Policies | Disclaimer | HHS Viewers & Players | HHS Plain Language
Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201
U.S. Department of Health and Human Services | USA.gov |
HealthCare.gov in Other Languages