DEPARTMENT OF HEALTH AND HUMAN SERVICES’ CENTERS FOR INNOVATION IN ADVANCED DEVELOPMENT AND MANUFACTURING
BARDA has established three 'Centers' to develop and manufacture medical countermeasures, such as vaccines and therapeutics used to protect health in emergencies, which can transition quickly and cost effectively between products. Created as public-private partnerships, the Department of Health and Human Services' Centers for Innovation in Advanced Development and Manufacturing (HHS CIADM) will provide a significant domestic infrastructure in the United States capable of producing medical countermeasures to protect Americans from the health impacts of bioterrorism as well as pandemic influenza and other disease in response to public health emergencies.
The HHS CIADM program supports the country's advanced development activities for CBRN-related products and BARDA provides guidance and management oversight in terms of specific product objectives. The Centers will help to support and develop the next generation of the medical countermeasure development workforce through training opportunities for current and future industry and government scientists who engage in advanced development and manufacturing of medical countermeasures. Finally, in public health emergencies, these Centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza.
The HHS CIADMs were created through a public-private partnership model, bringing together the innovative ideas of small biotech firms, the training expertise of academic institutions, and the development and manufacturing experience of large pharmaceutical companies. This helps to ensure a sustainable domestic medical countermeasure infrastructure with unprecedented ability to accelerate development and manufacture medical countermeasures in time of need. These Centers will also be used to explore emerging and innovative technologies that could be applied to current or future medical countermeasure development efforts to reduce risk, increase yield, and ultimately to reduce total life-cycle costs through flexible manufacturing, consolidating other costly product development expenditures, or any other economy-of-scale opportunities.
To date BARDA has funded three Centers with contracts capable of renewal for up to 25 years, representing a long-term commitment to this partnership with industry and to national security. Under these contracts, the HHS CIADM performers will retrofit existing facilities, or build new facilities to incorporate flexible, innovative manufacturing platforms that can be used to manufacture multiple products. These facilities will be capable of using modern cell- and recombinant-based vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also other threats more quickly and economically.
- Emergent Manufacturing Operations Baltimore LLC, with facilities in Baltimore and Gaithersburg, MD, will lead one Center, working with a network of partners; Michigan State University, Kettering University of Flint, Michigan, and the University of Maryland, Baltimore. This contract is for approximately $163 million over the first eight years. More Information (HTML)
- Novartis Vaccines Division will head a second Center, leveraging existing public-private investments by HHS in a state-of-the-art, multi-purpose facility in Holly Springs, NC, and working with North Carolina State University and Duke University. The Novartis contract is valued at approximately $60 million over the first four years. More Information (PDF 60KB)
- Texas A&M University System will lead a third Center collaborating with GlaxoSmithKline Vaccines of Marietta, PA, Kalon Biotherapeutics of College Station, TX, and their extensive network of institutes. This contract is valued at approximately $176 million over the first five years. More Informantion (HTML)
Establishing the centers achieves a core recommendation cited in the 2010 Public Health Emergency Medical Countermeasure Enterprise Review; a comprehensive, government-wide review called for by Secretary Sebelius to address challenges encountered in developing biodefense medical countermeasures. These centers also address concerns raised by the President's Council of Advisors on Science and Technology in the August 2010 Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza, which called for flexible, nimble, and modern vaccine manufacturing technologies.
More information on the development of the CIADMs can be found at: HTML.
More information about how the HHS CIADMs work can be found at: HTML.
Centers for Innovation in Advanced Development contract awardee map (PDF - 822KB)