12:00 AM
Sep 12, 2011
 |  BioCentury  |  Regulation

FDA looks for helpmates

FDA needs third parties to accomplish much of regulatory science plan

FDA's strategic plan for regulatory science is huge on aspiration but short on money, which in an era of budget austerity means it is a call for industry and academics to partner with the agency to accomplish Commissioner Margaret Hamburg's top priority.

The 37-page plan, released in August, describes initiatives intended to drive or support development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

The document outlines eight priority areas: toxicology, personalized medicine and clinical trials, manufacturing, emerging technologies, data integration, food safety, medical countermeasures, and communication.

Each priority area is supported by up to five "implementation strategies," followed by a list of up to six activities intended to address the issue (see "FDA's Regulatory Science Priorities," A16).

In addition to a handful of initiatives the agency has been pursuing for some years, such as its Quality by Design (QBD) manufacturing initiative, the strategic plan includes dozens of new initiatives FDA plans to either spearhead or support.

With additional funding unlikely, FDA Chief Scientist and Deputy Commissioner for Science and Public Health Jesse Goodman told BioCentury making progress on the plan will require collaborations with industry, NIH and others.

"I think if we thought we were going to do it all ourselves, it would be a wish list. While it might be aspirational, it is also realistic," he said.

New business

Goodman told BioCentury the agency's intention was to focus on areas that "cut across multiple areas at FDA where the issues, tools and needs might apply to all drugs and devices."

The eight priority areas are divided into 31 implementation strategies with more than 100 supporting activities - the majority of which would be new projects for the agency.

All of them, Goodman said, "are what we identify as high priority. These are areas where we see agency engagement as critical."

Two priority areas that include numerous new projects are toxicology and personalized medicine.

Under toxicology, examples include modernizing development and use of animal models to account for the effects of disease progression and co-morbidities on adverse events, as well as assessing the concordance between animal and human markers of toxicity to determine how the performance of the markers and their interpretation vary across different organ systems and populations.

In the personalized medicine area, the agency hopes to use large, pooled trial data sets to identify potential endpoints, uncover differences in populations and subsets of disease and evaluate the clinical utility of biomarkers.

Such knowledge could help in disease areas like osteoarthritis or certain cancers where endpoints measuring clinical benefit are hard to quantify or could take years to evaluate.

The agency also hopes to facilitate the identification and quantification of new biomarkers for safety and efficacy, pharmacodynamic response and dose selection, disease severity, progression and prognosis.

The plan also includes many initiatives that have been under way for a while. For example, many of the activities listed under medical countermeasures were started during the swine H1N1 influenza outbreak in 2009, including enhancing and improving...

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