Collaboration and Medical Countermeasures: Furthering Regulatory Science

By: Dr. Stephen M. Ostroff

“I hope no one ever needs these products,” isn’t something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense professionals apart.

Stephen OstroffWithin FDA, our Medical Countermeasures initiative (MCMi) does things a little differently as well. Managed by the Office of Counterterrorism and Emerging Threats, in the Office of the Chief Scientist, MCMi thrives on collaborations. We work proactively with industry, academic and federal research centers, FDA product centers and offices, and other government entities in our mission to help protect the U.S. from chemical, biological, radiological, nuclear, and emerging infectious disease threats.

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. 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.

To support regulatory decision-making for medical countermeasures, FDA manages a robust research portfolio under the MCMi Regulatory Science Program. Working with other federal agencies to ensure alignment with U.S. priorities, we fund both intramural and extramural research programs to drive innovation in regulatory science.

Ongoing research projects include:

  • Developing models of radiation damage in lung, gut, and bone marrow organs-on-chips, and using these models to test candidate medical countermeasures to treat such damage;
  • Mapping immune responses to certain biothreat agents and medical countermeasures in humans and animal models to create species-specific immune function maps;
  • Assessing the feasibility of using electronic health record systems to conduct near real-time monitoring of health outcomes, including serious or unexpected adverse events associated with medical countermeasures used during public health emergencies.

For those interested in these and other medical countermeasure-related regulatory science developments, FDA will be hosting our 2014 MCMi Regulatory Science Symposium at FDA headquarters in Silver Spring, Maryland, June 2-3, 2014. The meeting is free and open to the public (pre-registration required).

We welcome poster abstract submissions until April 27, 2014, in topic areas including: animal models, biomarkers and correlates of protection, devices, diagnostics, emergency communication, new technologies, product quality, and surveillance.

I also encourage you to read more about MCMi in action in our Fiscal Year 2013 Program Update.

Stephen M. Ostroff, M.D., is FDA’s Acting Chief Scientist

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