Good Neighbors Make Good Regulatory Science Centers, FDA Decides

Georgetown, Maryland gain CERSI grants in part because of their proximity to agency staff.

FDA will work with nearby universities to pilot its Centers for Excellence in Regulatory Science and Innovation, in part to ensure researchers and educators can easily collaborate with agency staff.

Two new centers will be established at the University of Maryland and Georgetown University with renewable grants of $1 million from the agency.

Both schools will work on improving the science and training needed to modernize and improve drug and device reviews. That will include long-term projects, as well as some that could be implemented in short order, FDA said.

Georgetown and Maryland’s College Park campus are less than 14 miles from agency headquarters in Silver Spring, Md. That was partly by design, the agency said in a statement. Officials wanted to ensure researchers were close to the reviewers and other agency scientists they would be helping and could facilitate face-to-face interaction.

The new CERSIs are the second and third FDA has created this year. The first was established at the University of Arkansas for Medical Sciences in Little Rock, Ark. and the National Center for Toxicological Research in Jefferson, Ark. to study the effects of nanoparticles moving through the body (Also see "First FDA Center Of Excellence For Regulatory Science Looks At Nanotechnology" - Pink Sheet, 15 Aug, 2011.).

In addition, FDA is formalizing a collaboration with NCTR to conduct studies to improve predictive assessments of product safety.

The University of Southern California also recently announced it had established a center for regulatory science not affiliated with FDA’s centers of excellence.

USC did not apply for an FDA grant, according to university spokeswoman Kukla Vera. The regulatory science program, in existence for 10 years, will be researching challenges caused by complex regulations due to technology evolution and globalization.

Four additional CERSIs already have been established to study food safety and nutrition.

Georgetown Law School, Medical Center To Work With Agency

Maryland’s College Park and Baltimore campuses will be working together to design new tools for assessing product safety, efficacy, quality and performance, according to a university written statement.

The university said researchers will address pre-clinical assessment issues with membrane transporters in drug development, hepatotoxicity biomarkers in personalized medicine and optical imaging in device evaluation.

The Maryland CERSI also will host seminars, workshops and public forums to gather input on regulatory science from industry and academia.

Georgetown is involving its law school and medical center in its center of excellence and will look at improvements to laboratory, population, behavioral, computational and manufacturing sciences to increase medical product development efficiency, according to a written statement.

Ira Shoulson, Georgetown Medical Center professor of neurology and pharmacology and principal CERSI investigator, said in an interview that in addition to professional education programs in regulatory science, the school also will be working on bioinformatics, including how to better inform and predict adverse events.

The CERSI also will be researching supply chain safety issues for raw materials and data sharing, Shoulson said. Georgetown will not be involved in reviewing applications, he said.

Many of the research areas were included in FDA’s “Driving Biomedical Innovation” report, released earlier this year in an effort to speed up drug development pipelines. The themes are not new, however, and have been targeted in several recent FDA initiatives and reports (Also see "FDA Biomedical Innovation Initiative Draws On Familiar Themes" - Pink Sheet, 10 Oct, 2011.).

FDA As Regulatory Science Student and Teacher

Shoulson said Georgetown will be creating professional development and training programs in regulatory science that will target FDA scientists and others who are interested.

“The topics in education will be far-ranging…,” he said. “Everything from pharmacokinetics in terms of how drugs interact … to issues related to social sciences and behavioral sciences [including] how does the public understand information, the whole issue of scientific literacy.”

Certificate programs likely will be offered first, but the goal is to make more continuing education programs in regulatory science available to FDA. Eventually, masters level degrees could be offered.

Shoulson said FDA employees ideally would have adjunct faculty positions for some of the classes as well as being enrolled as students.

The idea would seem to follow along the same lines as an idea Emil Kakkis, of the Kakkis Everylife Foundation, suggested to boost the scientific capacity at FDA, particularly for orphan drug reviews. He suggested a new policy requiring reviewers to teach and conduct clinical work at the National Institutes of Health as a way of keeping reviewers up to date with the latest science and improving application reviews (Also see "FDA Must Codify Flexibility For Rare Diseases, Coté Says As He Moves To NORD" - Pink Sheet, 25 Jul, 2011.).

CERSIs A Drug Development Investment?

Commissioner Margaret Hamburg wants to establish a network of CERSIs to help the agency improve how it reviews and regulates products.

Hamburg has made it one of the focuses of her administration, partly in an effort to stimulate a drug development pipeline that has dropped off in recent years. FDA has caught some of the blame for it, even though the agency claims FDA review is the most predictable part of the entire process (Also see "FDA Still Most Predictable Part of Drug Development, Despite Bumps, Woodcock Says" - Pink Sheet, 1 Jun, 2011.).

FDA has been quick to tout the 35 novel drugs it approved in fiscal year 2011, but Hamburg also warned that figure could decrease because the development pipeline is running dry.

She told a Union of Concerned Scientists conference Nov. 15 that regulatory science investment could help reinvigorate the pipeline.

“[A robust field of regulatory science] would help prevent promising therapies from being discarded during development because we lack the tools to recognize their potential or because outdated review methods delay their access,” Hamburg said. “And it would save significant dollars and many years by ensuring we have the tools to detect unsafe or ineffective therapies at an early stage.”

Hamburg’s comments also seem to be intended to pressure Congress to limit budget cuts. FDA was able to receive a small increase in FY 2012 appropriations legislation (Also see "FDA’s Generic Drug Office Goes On Diet Before Swallowing User Fees" - Pink Sheet, 28 Nov, 2011.)

The centers of excellence were included in Hamburg’s regulatory science plan, released in October 2010, which included developing the discipline of regulatory science and creating an office within the agency dedicated to the practice (Also see "FDA Has Regulatory Science Plan; Now It Needs Funding" - Pink Sheet, 6 Oct, 2010.).