Posted on September 19, 2012
This past June, the Department of Health and Human Services established three new centers tasked with responding to the threat of future pandemics and biological attacks. Based in Maryland, North Carolina, and Texas, they will aid in bringing new medical countermeasures to the market faster and help to train the biopharmaceutical workforce needed in the future, according to an HHS press release.
The centers will use rapid and flexible approaches to develop and manufacture vaccines to protect against pandemic influenza; provide therapies in the event of chemical, biological, radiologic, and nuclear threats; accelerate the preclinical and clinical development of vaccines and other biosecurity products; and train the next generation of professionals in areas required to sustain this national capability.
Created as public-private partnerships, the three Centers for Innovation in Advanced Development and Manufacturing are the result of a review of federal public health emergency medical countermeasures concluded by the HHS in 2010. The review highlighted improvements needed to effectively fight disease outbreaks, such as H1N1 influenza virus in 2009, or a bioterrorism attack, such as the anthrax attacks of 2001. The HHS issued a request for proposals last year, and the following contracts, amounting to roughly $400 million, were awarded in June:
- $163 million over eight years to Emergent BioSolutions in Maryland to expand its lab facilities in Baltimore and Gaithersburg. Emergent collaborates with researchers at Michigan State University; Kettering University in Flint, Mich.; and the University of Maryland.
- $60 million over four years, in addition to previous HHS investments, to Novartis Vaccines and Diagnostics to expand its lab facilities in Holly Springs, N.C., to include a pandemic flu center and an emerging-disease center. Novartis will work with North Carolina State and Duke universities.
- $176 million over five years to the Texas A&M University System for laboratory improvements and research at its 27 public and private partner organizations. Texas A&M will also construct a center devoted to pandemic flu research. The university has also secured $109 million from private and academic partners and will receive $40 million in state funding.
The HHS’ Biomedical Advanced Research and Development Authority will oversee all three centers, with the option to renew their contracts for up to 25 years.
Under the contracts, each consortium will retrofit existing facilities or build new ones to incorporate flexible, innovative manufacturing platforms that can be used to make more than one product. The facilities will use modern cell- and recombinant-based vaccine technologies that have the potential to produce vaccines for not only pandemic influenza but also for other threats more quickly and in a more affordable way.
The government agency projects that the centers will be able to produce 25 percent of the country’s pandemic flu vaccine supply within four months of an outbreak, with the infrastructure in place by 2014 or 2015. Comparatively, in 2009, only one company had manufacturing facilities solely in the United States to produce H1N1 pandemic flu vaccine.