Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary by Steve Olson

Author:Steve Olson
Language: eng
Format: epub
Tags: ebook, book
Publisher: The National Academies Press
Published: 2014-07-28T00:00:00+00:00

FDA

FDA Regulatory Science

CAN’s authorizing legislation provides that one of its functions is to “facilitate review in the Food and Drug Administration for the high need cures funded by CAN” (see Appendix B). CAN is well positioned to support such collaboration, said Jesse Goodman, Chief Scientist, FDA. It could, as an explicit part of its work, address gaps in regulatory science that, if they were filled, could greatly improve product development. In the process, CAN could help develop a regulatory science toolbox that could create a more efficient pathway to develop and evaluate products. For example, Goodman noted, there is a need for end-to-end project management and support. Innovators often do not have experience managing projects or running businesses. He suggested that it could be very helpful if NIH and CAN could provide these kinds of services or connections.

In 2011, FDA issued a regulatory science plan that also addresses gaps and opportunities in the science and in product development (FDA, 2011). Though it is a high-level plan, according to Goodman, it also lists specific areas where targeted work could accelerate the development of needed products. The report lists several FDA priority areas that are relevant to CAN:

Modernize toxicology to enhance safety.

Stimulate innovation in clinical evaluation and personalized medicine.

Support new approaches to improve product manufacturing and quality.

Ensure readiness to evaluate emerging technologies.

Harness diverse data through information sciences to improve health outcomes.

Facilitate development of medical countermeasures to protect U.S. and global health and security.

Strengthen social and behavioral science to help consumers and professionals make informed decisions.

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