Start-ups and small biotech companies are the most promising developers for new medical countermeasures for chemical, biological, radiological and nuclear (CBRN) threats, but they face serious challenges. Immense initial development costs, regulatory complexity and poor economic incentives make medical countermeasure development unattractive or impractical for most biotech companies. Fortunately, there is help on the horizon.
In order to meet the need for new vaccines and therapies for chemical and biological weapons, federal agencies – including the Food & Drug Administration (FDA) and Department of Defense (DoD) – and private companies will need to work together to bring down the barriers. Public-private partnerships can help bridge the gap for start-ups and smaller companies and make medical countermeasure development technically feasible and economically attractive.
There are already promising programs in place that biotech companies can take advantage of right now. These include:
The Advanced Development and Manufacturing capability (ADMc)ADMc provides development and manufacturing resources for small biotech operations that need them. The ADMc has its roots in the DoD. In 2013, the DoD contracted with Nanotherapeutics Inc. to create the organization as a shared resource for companies working on the medical countermeasures the DoD needs. The ADMc has state-of-the-art manufacturing facilities for vaccines and biologics to help smaller companies scale up from R&D to manufacturing. The ADMc also is prepared to support the production of countermeasures for pandemic diseases.
The Medical CBRN Defense Consortium (MCDC)The main goal of the MCDC is to help smaller companies who wish to work with the DoD navigate the process of becoming an approved federal contractor. The traditional Federal Acquisition Regulation (FAR) process can be time consuming and challenging. MCDC can help smooth the way by using Other Transaction Authority (OTA), a more streamlined way for a firm to contract with the DoD or other government agencies. While the role of the MCDC sounds bureaucratic, it is a key player in helping to bring new medical countermeasures to market.
Priority Review ProgramThe priority review voucher (PRV) program was put in place to provide economic incentives to encourage private companies to develop medical countermeasures for chemical and biological weapons. The PRV program gives companies who develop a new medical countermeasure for a listed threat a voucher for fast-track approval of a commercial product. This voucher reduces the FDA approval process from 12-15 months to a guaranteed six. Getting a commercial drug to market 6-12 months sooner can be worth tens or hundreds of millions of dollars for a large pharmaceutical company sitting on a potential blockbuster. Companies also can resell them – an attractive prospect for smaller companies who can then use the profits to finance development of a blockbuster of their own.
Battelle has partnered with Nanotherapeutics Inc. to help connect innovative biotech companies with the resources they need for successful development of medical countermeasures. The new collaboration brings together core research and manufacturing capabilities for development of new vaccines and therapies for chemical and biological weapons.
Leveraging public-private partnerships and incentive programs will put medical countermeasure development within reach for a broader range of biotech companies. These innovative programs will reduce barriers to entry and help ensure that the U.S. military and homeland security forces are prepared to protect warfighters and civilians and respond to new terrorist threats.
About the Author
Russell Coleman is a Senior Market Manager at Battelle. After nearly 28 years of military service, he retired as a Colonel from the Army and joined Battelle in 2016. Before his military retirement, he led the Department of Defense organization responsible for developing medical countermeasures needed to protect military members from CBRN weapons.