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Remarks at the Global Summit on Regulatory Science Research

Remarks by Dr. Margaret Hamburg, M.D.
Commissioner of Food and Drugs
Global Summit on Regulatory Science Research (CSCR)
National Center for Toxicological Research (NCTR)
Little Rock, Arkansas/Jefferson, Arkansas
September 10, 2013


Thank you Bill [Slikker] for that kind introduction, and for inviting me to be with you today. I also want to thank Mary Lou Valdez, the Associate Commissioner for International Programs at FDA, for her leadership in this area. I also want to acknowledge Dr. Martin Philbert who is on the program as a featured speaker. He is Dean of the University of Michigan’s School of Public Health and serves on FDA’s Scientific Advisory Board, most recently as its chair.

I had the good fortune to attend the initial Global Summit here two years ago and I was disappointed not to be able to join you in China last year. Needless to say, I am delighted to be back with you again.

It is always a pleasure to come to Arkansas and especially to have the opportunity to return to this impressive research facility. I meet and talk with scientists all around the globe about advances in science and our shared public health and medical needs. But when it comes to cutting edge research and solutions to our global challenges, you don’t need to go any farther than Arkansas and NCTR. The continuing excellence and the quality of the scientific talent it brings together on this campus are real sources of pride for FDA.
 
I should point out that in addition to its superb scientists and research activities, the buildings themselves here also have a notable place in history. As some of you may know, this center used to house a key part of the U.S. Army’s Directorate of Biological Operations within the Pine Bluff Arsenal.  Basically it was the home of the US Biological Weapons Program.  But in 1969, President Nixon publicly opposed biological weapons and in a presidential order barred US participation in the production, storage or use of biological weapons for military purposes. As a result, the Pine Bluff facility became available for "reassignment." It was demilitarized and transferred from the Department of Defense.

Today, as you know, it is part of the Department of Health and Human Services, a vital component of FDA, and most importantly, a thriving center of scientific research and training dedicated to supporting the FDA Product Centers in their efforts to advance safer, more innovative and more effective medical products. To my mind, this transition wonderfully epitomizes the biblical phrase "turning swords into plowshares." What could be more fitting than to transform buildings and labs designed to make weapons of death and destruction into places of groundbreaking research in the promotion and protection of the public health? Particularly at such a difficult time in world events we can take inspiration from this.

NCTR plays an integral role in advancing the missions of FDA and the Department of Health and Human Services, helping to deepen our understanding of important scientific issues and health and disease-related phenomena, developing important analytical tools and procedures, fostering national and international collaborations between scientists in government, academia, and industry, and providing training in regulatory science.

As the focus of this Summit makes clear, regulatory science is fundamental and must be a priority for us all.  It speeds innovation, improves regulatory decision-making, and strengthens our ability to get safe and effective products to people who need them.  And yet, for many, it is a concept that often is not fully understood or appreciated.
 
Regulatory science brings together several principles at the core of FDA’s work. The first is the critical role of science itself. When FDA started more than a century ago we didn’t have the kinds of resources and technology we do today. Nevertheless, from the very beginning, one of the driving forces was the understanding that “the science” must be the guidepost of our work. And that’s why the decisions we make in furtherance of our mission to protect the public health are always based on the best available science. 

To achieve this goal we must pursue the strongest and most modern research and technologies, of course, but it also requires that we develop strong partnerships—within government and with academia, industry, and a range of stakeholders throughout our nation and across the globe. Only in this way can we be sure we live up to the challenge to employ the best science and tools, and to anticipate and respond to future challenges. So partnership represents another critical element of our work.

A third critical aspect of regulatory science is the significance of regulatory questions and needs as a legitimate part of science.  Too often these two concepts—regulation and science—are considered separately, or one or the other is an afterthought. Regulatory science must be understood as an essential component of the overall scientific enterprise…an integral part of the scientific process and absolutely crucial if we are to achieve our goal of harnessing science and technology to improve the treatment, diagnosis and prevention of disease, safer food and other products and ultimately to improve the quality of all of our lives.

In recent years, we have been working hard to advance regulatory science and devoting time and resources to identify areas ripe for strategic, targeted investments. This includes, of course, strengthening the science base at the FDA, including the good work going on here at NCTR. But we are also focusing on building the partnerships that are so necessary for advancing regulatory science…for identifying research questions and a shared research agenda, for training regulatory scientists, and ultimately for developing the critical knowledge and tools that will enable us to translate discovery and innovation into the products that hold such great promise.

Your focus for this meeting is an important dimension of all of this activity. First of all, science—and our ability to unravel the mysteries of health and disease—is an intrinsically global proposition. To be successful, we must work together.

Moreover, we live today in a time when science and technology—as well as systems of communication and transportation—are changing our world dramatically. We are part of an explosion of knowledge, ideas, and capabilities emerging across the globe.

By considering regulatory science—together—in the context of growing global demands and pressures, your discussions and your work will become even more timely and relevant.

Clearly we all must increasingly act on an international scale and strengthen collaboration among international partners. By working together and sharing knowledge we can 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. In addition, through gatherings like this, we are working to reverse trends that have led to the under development, underfunding, and a lack of understanding of the importance of regulatory science.

Today’s Summit—and the commitment to collaboration—will be vital to the future of regulatory science in the global context. By partnering to build systems to strengthen communication, education and training about this important topic, you can develop a foundation upon which scientists, regulators, and policy makers from around the globe can exchange views, discuss successes and failures, and improve the public health.

I am particularly excited by the focus of this year’s summit on the cutting edge issue of nanotechnology—which aligns well with the theme of regulatory science and the integration of education and training to advance it. The promise of nanotechnology is clear, and reflected in both worldwide investments and exciting new approaches and products, but we must also carefully study it risks as we seek to achieve a full understanding of the impact these emerging technologies have on the products we regulate.  Today’s meeting will help shed important light on these issues, as well as help illuminate the path forward.

There is no better place for these discussions than here at NCTR. I am very proud of the leadership and the research spearheaded here at FDA’s state-of-the-art Nanotechnology Core Facility, a collaborative venture between NCTR and our Arkansas Regional labs on this campus. Facilities like this, and at our research labs at our headquarters in White Oak, Maryland, are helping us better understand the issues surrounding the safety, quality and effectiveness of products that use nanomaterials, and information that will help us develop standards for the preclinical safety assessment of products.

As an example, NCTR has partnered with other FDA scientists to study the potential risks of increased dermal penetration when nanoparticles are used in sunscreens. The methods they developed and used are also relevant to evaluating products that may use similar sized materials.

Other research is being conducted at FDA on medical devices such as orthopedic screws, dental implants, and wound dressings, which use nanostructured surfaces to help achieve outcomes such as enhanced device/tissue integration, improved antimicrobial activity, and enhanced biocompatibility.  We are working to develop a greater understanding of how such surfaces affect tissues and cells, which in turn influence the safety and effectiveness of medical devices. 

Nanotechnology offers an excellent context for international collaboration. There are already many international organizations working on standards for determining the potential toxicity of nanoparticles. But much more is needed. We must continue to strengthen collaboration among comparable regulatory agencies to share information, harmonize standards and approaches, and partner on research and investigation.

Part of this means strengthening education and training, particularly regarding the value, concepts and strategic approaches of regulatory science. We’ve found that even when individual nations have high standards for scientific training, all of our programs can benefit by focusing on the specific critical thinking skills required to design, implement, and interpret studies within the regulatory context.

A number of programs at FDA are helping to ensure that scientists—both at the agency and around the world—gain 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 those within Arkansas and across the nation.

Another activity, the Science Training and Exchange Professional Development Program offers FDA and other scientists and officials responsible for food and medical product safety issues around the world the opportunity to spend time in the laboratories at NCTR. They learn the skills to succeed in the regulatory research environment and have the opportunity to collaborate with other scientists on advanced regulatory techniques.

In 2009 we expanded the Science and Training program to include the International Scientist Exchange Program, which is designed specifically to teach international scientists core concepts, skills, and techniques to design, conduct, and interpret regulatory research studies. Participants gain hands-on training that enhances their understanding of regulatory science and helps them build strong regulatory structures in their own countries.

Finally, I am especially pleased today to highlight one other significant program, 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 Center supports collaborative, targeted regulatory science research that addresses the priorities defined by FDA as well as academics and industry scientists. A working group appointed by Arkansas Governor Mike Beebe to oversee the ACERS implementation and operation has already begun a program of research investigating the public health impact of nanomaterials. After extensive review of existing research, the group is focusing its initial efforts on graphene, a material that is challenging to detect and likely to present significant questions regarding human exposures and regulatory approval challenges.
 
So far, the team has developed a number of novel methods for detecting carbon-based nanomaterials in cells and tissues, demonstrated the environmental and health impacts of impurities in commercial products, and produced graphenes containing metallic markers to enhance the potential for tracking them in cells, organisms, and the environment.

We are also seeing great progress in the realm of bioinformatics, a key component of regulatory science. The five research universities that are part of the MOU are working to join their vast computing capabilities, bioinformatics training, and other resources, with the equally impressive capabilities in this area of NCTR and FDA to develop a powerful public resource.

And last night, at the Governor’s mansion, I signed the Partnership Intermediary Agreement, which will further strengthen the role and work of the Center, by facilitating the transfer of NCTR technology to the private sector. This is just the latest in a long and productive history of such public private partnership involving NCTR and FDA.

One of the most exciting parts 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. In a few minutes you will meet some of these students. They represent the shape of things to come and provide an important step toward achieving the global promise of scientific innovation.
 
As you can tell, regulatory science is a very important and very dynamic field. The activities here in Arkansas show how partnerships and collaborations can speed the advancement of regulatory science.  Our next goal must be to extend this model to the global scientific community. But fulfillment of the promise of these programs and partnerships depends to a large extent on your efforts and those of your countries. As I’ve tried to make clear, outreach and collaboration are central to strong regulatory science.

If we are successful, and I am confident that we will be, our efforts will help pave the way for a system in which the best discoveries are translated as quickly as possible into the kinds of innovative, safe and effective products that patients and consumers expect and deserve in all our countries. I look forward to working with you to achieve this goal.

Thank you.