Feds aim to fortify biodefense by fixing product development pipeline

A leaky product development pipeline is hampering the country's ability to ensure a steady output of new medical countermeasures, such as medications, vaccines, equipment and supplies needed for health emergencies, HHS Secretary Kathleen Sebelius said Thursday.

She spoke at the unveiling of a report that reviewed the federal government's system for producing medical countermeasures and recommended fixes including an accelerated microscope-to-market product development process.
 
"Today, we really don't know where our next public health crisis could come from," she said, speculating that the next could be a dirty bomb on a subway, a new superbug, or something assembled by a terrorist.

"We don't have enough flexibility to adapt to unseen threats," Sebelius said.

"Our nation must have the nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease," the report reads.

Sebelius and other officials described a plan to strengthen the countermeasures development pipeline. Five key government initiatives that emerged from the review include:

  • Strengthening regulatory science at the FDA to help get the products from test tube to market and help FDA scientists assess promising discoveries faster.
  • Developing more agile, flexible manufacturing. This would involve the development of Centers of Innovation for Advanced Development and Manufacturing to serve as resources for small, emerging biotech companies with little experience in large-scale manufacturing so that more countermeasures could make it to market and be available in an emergency.
  • Nurturing discoveries at their earliest stages. A concept acceleration program would nurture scientists who come up with concepts but don't realize how it might be translated into a medical countermeasure. The idea, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is "to not leave any promising concepts on the vine." More often than not, after publishing a paper, scientists move on to the next concept instead of developing an application. "We would serve as a guide or Sherpa for these individuals," he said. The government could do a better job of talking product developers throughout the development process, not just near the end, Sebelius noted.
  • Upgrading how flu vaccines are manufactured.
  • Creating a strategic investment fund to spur development new countermeasure technologies.

To learn more:
- read the medical countermeasure enterprise review
- check out this fact sheet
- here's the HHS press release