Sunday, October 30, 2011

Advancing Regulatory Science

FDA just awarded $2 million to support two regional “Centers of Excellence in Regulatory Science and Innovation” (CERSI). The Centers to be located at the University of Maryland and Georgetown University will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated.

Working closely with FDA scientists, CERSI researchers will assist FDA in driving innovation in medical product development as well as advance laboratory, population, behavioral, and manufacturing sciences. The agency will pilot the CERSIs in the Washington D.C. area to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Starting in August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”. In October, the agency released the blueprint “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. The biomedical blueprint addresses concerns on how to sustain the medical development pipeline which is slowing down despite record investments in research and development.

The focus of the blueprint is to rebuild FDA’s small business outreach services, drive personalized medicine, create a rapid drug development pathway for important targeted therapies, harness the potential of data mining and information sharing, improve the clarity in the medical device review process, train the next generation of innovators, and streamline and reform FDA regulations.

In 2010, FDA entered in a partnership agreement with the University of Rochester to form the Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION) Initiative. The initiative is designed to streamline the discovery and development process for new pain-reducing drug products and will establish a scientific and administrative infrastructure to support a series of projects.