Battelle’s Coleman: Small companies are key for new CBRN medical countermeasures

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, according to Battelle’s Senior Market Manager for Medical and CBRN Products Russell Coleman.

“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,” Coleman wrote in a recent blog post.

He continued, stating that public-private partnerships could help bridge the gap for start-ups and smaller companies and make medical countermeasure development technically feasible and economically attractive.

One example used by Coleman was Advanced Development and Manufacturing capabilities (ADMc), which provides both development and manufacturing resources to smaller biotech companies as needed.

In one instance, the DoD entered into a contract with Nanotherapeutics, Inc. to develop the organization as a shared resource for companies working on medical countermeasures needed by the department.

Coleman also cited the Medical CBRN Defense Consortium (MCDC), an organization that aims to help smaller companies who wish to work with the DoD navigate the process of becoming an approval federal contractor.

While the traditional federal acquisition regulation process can be time-consuming and challenging, Coleman wrote, 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.

The 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, Coleman wrote.

Specifically, the PRV program provides companies with fast track approval if they develop a new medical countermeasure that meets an unmet medical need, shortening the typical review process from approximately 12-15 months to a guaranteed six months.

“Leveraging public-private partnerships and incentive programs will put medical countermeasure development within reach for a broader range of biotech companies,” Coleman wrote. “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.”