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Margaret A. Hamburg

FDA Compliance

Thinking Globally to Strengthen Science and Public Health Locally

FDA hosts summit to build a model for regulatory science and critical thinking

Published: Wednesday, September 18, 2013 - 11:14

There are many good reasons to go to Arkansas in September: to visit Little Rock, America’s No. 1 most livable city; or attend the annual Eureka Springs Antique Automobile Festival, to name two. But neither of these reasons are why more than 100 scientists, researchers, government regulators, and students from around the world were there recently. They came to attend the third annual Global Summit on Regulatory Science hosted by the Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR).

Attendees traveled from places as far away as Brazil, South Korea, and Australia to help plan and build an organization to ensure that, during a time of growing global demands and pressures, we can more efficiently turn the extraordinary potential and promise of science and technology into real-world products and programs that matter and make a difference to public health.

The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise as well asf the FDA’s work and mission: regulatory science. Regulatory science is critical to speeding innovation, improving regulatory decision making, and strengthening our ability to better assess the safety, quality, and efficacy of a wide range of products, including food, drugs, and devices. It is the work of regulatory science that truly enables us to have the knowledge and tools needed to translate scientific discovery and innovation into the products that hold such great promise.

That’s why one focus of the meeting was how to build a training model for regulatory scientists. Because even when individual nations have high standards for scientific training, fully leveraging the opportunities in science today requires an added focus on the specific critical-thinking skills necessary to design, implement, and interpret studies within the regulatory context.

A number of programs at the FDA, for instance, are helping to ensure that scientists—at the agency and around the globe—have this foundation. For example, the NCTR has been collaborating with various Arkansas universities for a number of years to offer research training to post-doctoral students through a fellowship program, as well as a training program for summer interns at the undergraduate level. So far these programs have helped train students from more than 47 countries.

One program I am especially excited by is the Arkansas Center of Excellence in Regulatory Science (ACERS), a public-private partnership that grew out of a Memorandum of Understanding (MOU) that I signed with the State of Arkansas in 2011. The five research universities are working collaboratively to join their computing capabilities, bioinformatics training, and other resources with the equally impressive capabilities of the NCTR and FDA to develop a powerful public resource. Just this week I signed a partnership intermediary agreement that will further strengthen the work of the ACERS by facilitating the transfer of NCTR technology to the private sector.

Another important forward-looking aspect of the ACERS is the creation of the regulatory sciences program at the University of Arkansas for Medical Sciences. This curriculum will help provide current graduate students with the decision-making skills needed for regulatory science. These students represent the shape of things to come and provide an important step toward achieving scientific innovation.

All of this speaks to the second important principle of the recent gathering in Arkansas: strengthening opportunities for collaborations being built among scientists from different governments, academia, industry, and elsewhere. Quite simply, collaboration is a cornerstone of regulatory science.

The FDA increasingly is required to act in an environment in which food and product safety and development know no global boundaries. To respond effectively we must strengthen collaboration among international partners. This will allow us to offer a unified focus on regulation in the name of science to help ensure the availability and safety of the supply of food, drugs, and other products around the world.

The discussions this week in Arkansas furthered the development of innovative technologies, approaches, and, perhaps most significant, partnerships that enhance the use and translation of basic science into regulatory applications, as well as new collaborative systems for communication, education, and training. These efforts offer extraordinary promise for the future of regulatory science in the global context and for the delivery of the kinds of innovative, safer, and more effective products that patients and consumers expect and deserve.

This article was first published Sept. 10, 2013, in FDAVoice.

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About The Author

Margaret A. Hamburg’s picture

Margaret A. Hamburg

Margaret A. Hamburg, M.D., is the commissioner of the U.S. Food and Drug Administration (FDA). The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive. As the top official of the FDA, Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.