We took a critical step this week in creating a new capability to protect Americans’ health during an emergency. We now have three Centers for Innovation in Advanced Development and Manufacturing that, as they get up and running, will increase the U.S. domestic capability to develop and manufacture the medicines and vaccines we need to respond to bioterrorism threats, pandemic influenza, and other epidemics.
The Centers are a new model for public-private partnerships, as HHS brings together small biotech companies, academic institutions and large experienced pharmaceutical companies – each organization with unique and complementary attributes and approaches. Based in Maryland, North Carolina, and Texas, each Center will be led by an organization with experience in developing or manufacturing countermeasures.
The lead companies for the centers will assist other (usually small and less-experienced) biotech firms with technology, regulatory affairs, quality systems, and manufacturing expertise to reach the goal of licensed and readily available products for public and private use. Additionally the Centers will produce vaccines and other biological products for an influenza pandemic or other public health emergency. The Centers’ partners will also offer advanced training for the next generation of biotechnology workers.
When it comes to national health security, one of our biggest priorities is that we learn from our experiences and continuously improve. These Centers are a direct result of lessons learned. The nation’s response to the 2009 H1N1 pandemic flu vaccine saw a lot of successes – not least of which was developing and establishing the safety and immunogenicity of a vaccine in fewer than six months, and in quantities sufficient for the U.S. population. But there were challenges too, and to get to the root cause Secretary Sebelius called for a thorough review of our medical countermeasures enterprise. The review found that the nation needed the nimble, flexible capacity to produce medical countermeasures rapidly in the face of any threat, known or unknown, including a novel, previously unrecognized, naturally occurring, emerging infectious disease. Similar recommendations were raised by the President’s Council of Advisors on Science and Technology, which called for flexible, nimble, and modern vaccine manufacturing technologies.
The Centers for Innovation in Advanced Development and Manufacturing address that need. Each lead company will retrofit existing facilities or build new facilities to incorporate flexible, innovative manufacturing platforms that can be used to manufacture more than one product. Where possible, the Centers will also develop and manufacture multi-use products. 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 other threats quicker and in a more affordable way than historical technology.
The Centers’ use of these technologies also allows for development and manufacturing of a variety of products quickly enough to respond to large-scale emergencies, providing needed domestic surge capacity. We anticipate that together, the Centers will be capable of domestically producing a quarter of the nation’s pandemic influenza vaccine within four months of the onset of a pandemic.
When disaster strikes, being able to quickly get the right drugs and vaccines to people who need them means we can better protect health, save lives and strengthen our resilience in that public health emergency. Today we’ve taken a big step forward.
