Dr. Lei Zhang of CDER’s Office of Translational Sciences gave an update at the AAPS Annual Meeting in Chicago yesterday regarding the agency’s regulatory science initiative, which was rolled out in August 2011. She noted that some of the same challenges facing regulators a few years ago continue to plague FDA drug reviewers, namely:
-products are being developed more quickly using evolving sciences and technologies
-unmet medical needs are growing
-industry is shifting from a treatment focus towards a focus on disease prevention and long-term clinical outcomes
-global drug development is leading to increased responsibilities for all.
The agency is trying to address these challenges not only with increased regulatory collaboration, which we’ve been hearing about for a few years (e.g., EMA, TGA, overseas offices) but also with grant programs to encourage academic research into how drugs and devices are reviewed and evaluated at FDA.
Both the University of Maryland and Georgetown University received FDA grants for such work earlier this year. The UMD team, CERSI, is holding monthly training programs with reviewers at FDA’s White Oak Campus as well as public information exchanges with the industry.
The work being done largely follows a circular cycle, explained Zhang, in which knowledge gaps in key areas are identified, researched, and filled—all while identifying even newer gaps and then working to research and fill those.
The UMD/Georgetown programs, along with other grant programs, are part of the Regulatory Science Initiative’s goals to identify standards, questions, and methods for improving internal drug reviews at FDA. The June 2012 FDASIA legislation (see Section 1124) also calls for improving medical product decision-making at the agency and is nudging the initiative further, she said.