By: Margaret A. Hamburg, M.D.
There are many good reasons to go to Arkansas in September. To visit Little Rock, nestled in the rolling hills between the Ouachita Mountains and the Arkansas River, and recently chosen as America’s number one most livable city. To attend the Annual Eureka Springs Antique Automobile Festival or the Ozark Quilt Festival. Or to take in the William Jefferson Clinton Presidential Library in Little Rock or visit his childhood home in Hope. And yet, none of these were the prime rationale for why more than 100 scientists, researchers, government regulators, and students from around the world came to this state. Instead, these committed individuals traveled from places as far away as Brazil, South Korea, and Australia to attend the Third Annual Global Summit on Regulatory Science hosted this week by FDA’s National Center for Toxicological Research (NCTR).
They were here to help plan and build an organization to ensure that at 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 the public health.
The concept at the heart of this gathering is an occasionally neglected but fundamental component of the scientific enterprise and of 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 FDA for instance, are helping to ensure that scientists – both at the agency and around the globe – have this foundation. For example, NCTR has been collaborating with various Arkansas universities for a number of years to offer research training opportunities through a fellowship program that offers research training to postdoctoral students, 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, as well as within Arkansas and across the nation.
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 I signed with the State of Arkansas in 2011. The five research universities that are part of the MOU are working collaboratively to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities of NCTR and FDA to develop a powerful public resource. And just this week, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the work of the Center, by facilitating the transfer of NCTR technology to the private sector.
Another important forward-looking aspect of ACERS is the creation of the Program in Regulatory Sciences at the University of Arkansas for Medical Sciences. This curriculum will help provide both current graduate students – and their broader scientific communities — with the critical skills needed to apply their scientific expertise to the decision-making needed for regulatory science within their specialties. These students represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation.
All of this speaks to the second important principle at the center of this week’s 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.
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 significantly, 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.
Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration