FDA collaborates to protect U.S. from CBRN threats

The U.S. Food and Drug Administration's Medical Countermeasures initiative (MCMi) collaborates with multiple sectors to best protect the U.S. from CBRN threats, Stephen Ostroff, the FDA's acting chief scientist, said on Tuesday.

Ostroff said the MCMi works with federal, academic and industry research centers; FDA product centers and offices; and other government entities to develop biodefense drugs, biologics and devices.

"Collaborating is particularly important to advancing regulatory science: developing the tools, standards, and approaches needed to evaluate FDA-regulated products-in this case, medical countermeasures-for safety, efficacy, quality, and performance," Ostroff said. "When it comes to developing the necessary data for regulatory decisions, medical countermeasures often present unique and complex challenges since the diseases they target rarely occur naturally."

The FDA manages a research portfolio under the MCMi Regulatory Science Program, funding intramural and extramural research programs to drive innovation. Some of the FDA-funded projects include developing models of radiation damage in organs-on-chips to test candidate medical countermeasures, mapping immune response to certain biothreats and countermeasures and using electronic health record systems to monitor health outcomes.

The FDA is hosting its 2014 MCMi Regulatory Science Symposium on June 2-3 at the FDA headquarters in Silver Spring, Md. Ostroff invited individuals interested in medical countermeasures to attend the meeting, which is free and open to the public with pre-registration.

Poster abstract submissions are also open through Sunday.