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Remarks at the Global Summit on Regulatory Science and Innovation

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Global Summit on Regulatory Science and Innovation
Little Rock, Arkansas
August 11, 2011

Good morning—and thank you all so much for being here today as we celebrate the 40th anniversary of the National Center for Toxicology Research…and look ahead to the future of research, science, and public health in this country and around the world.

It is always a pleasure to be here in Arkansas—despite this weather!—a state I don’t get to travel to very often…but which is home to not just incredible research facilities and institutions, but also some of the kindest, friendliest people I’ve ever met.

You have had a packed schedule today of speakers and discussion. I wish I could have been here to join in the conversations, and I know that the rich agenda would have enhanced and deepened my knowledge and understanding. I am deeply committed to the need to work together as a global community of scientists and regulators.

And I am deeply committed to the topic of today’s meeting: regulatory science research and innovation.

People often ask me, “what do you mean when you say regulatory science?”

Frankly, it is an aspect of science that I had never really focused on before I joined the FDA, but today it is among my highest priorities…because it represents the very science needed to assess and evaluate a product’s safety, efficacy, quality, and performance. It involves the development of new methods, standards, and models to strengthen the review, approval, and ongoing oversight of medical products and to more effectively assess safety and wholesomeness of food and other commodities.

Regulatory science is key to effective and efficient development of new innovative medical products and their timely availability to the to the patients and consumers who need them and count on them.

In fact, regulatory science—as most of you here fully recognize—is an essential component of the scientific enterprise. But it has, for years, been under-appreciated, under-developed, and underfunded. And, as a result, we have been unable to apply the best possible science and technology to the tasks before us.

Our task today is to find a way to reverse that trend—to explore the future of regulatory research as a tool for advancing regulatory science…and then take that a step further and discuss the impact of regulatory science on opportunities to improve global health…which is increasingly important as physical distance between nations becomes less and less and neither the problems or the scientific community are limited by borders.

And importantly, this is a chance to find new ways to train our scientists and collaborate across states and time zones to strengthen this field on behalf of our citizens and citizens all over the world.

The future of this field—and of the scientific and public health enterprise more broadly—needs us right now, to come together, to build a global coalition of regulatory research scientists, and to find new ways of defining research needs, working collaboratively, building knowledge and taking actions…all in the service of improving the health of the public. I am confident that today represents a major step toward these goals.

But why is this so important? As I said before, regulatory science is a fundamental part of all of our efforts to ensure safety and efficacy—and to promote innovation—in the service of medicine and public health. If you are talking about drugs, for example, a bench scientist may develop a new approach to a disease. A clinician may be able to show it can work. But we need regulatory science to help develop the knowledge and tools to translate discovery and innovation into those products that hold so much promise.

We cannot take full advantage of the breakneck speed of scientific discovery today unless we also emphasize innovation in regulatory science. Just as life sciences research has evolved over the past few decades, regulatory science must also evolve in important and powerful ways.

The potential is great. Advancements in regulatory science can lead to more cost-effective and timely product development and evaluation; increased capacity for post-market detection of product-associated adverse events and safety assessment; and rapid resolution of incidents involving product contamination or other concerns.

So it is more important than ever that we bring 21st-century approaches to 21st-century products and problems. And toxicology is a prime example.

As you well know, there is a great deal going on in modern toxicology today. So many of you are deeply engaged…and often working on the cutting edge.

But I think it is also fair to recognize that far too many of the toxicology tools used for regulatory assessment have relied on high-dose animal studies and default extrapolation procedures—and have remained relatively unchanged for decades, despite the scientific revolutions of the past half-century. Such testing, however, is costly and time consuming and does not always provide results that reliably correlate with human responses.

We need better predictive models to identify concerns earlier in the product development process to target efforts more effectively and to reduce time and costs—and we need to modernize the tools used to assess emerging concerns about potential risks from food and other product exposures. This requires development and validation of methods that are reliable in predicting safety and other product attributes.

Advances in life sciences and engineering are ushering in the potential to dramatically change the way toxicology assessments are performed, but many of these new technologies have not yet been sufficiently studied or tested. Investments today can help seed a revolutionary change in toxicology and hazard assessment going forward.

This is extremely important to our work at FDA—for both food and medical products. On all counts, we must improve methods and models to assess and effectively communicate both risks and benefits to support sound regulatory decision-making, empower consumers and, above all, protect the public health.

Which is why we’re on the verge of taking significant leaps forward in our approaches to evaluating safety. We have made "Modernizing Toxicology" one of FDA’s key scientific priorities in our emerging science and innovation strategic plan. And as part of our efforts to strengthen science at FDA, reviewers and staff throughout the agency have been—and will continue to be—educated and trained in the latest and best ways to conduct safety assessment.

And NCTR, which has grown over the past 40 years into an internationally recognized research facility, provides the agency with targeted laboratory data—the regulatory science—that supports FDA regulatory decisions.

As you can see, regulatory science is essential to the work of the FDA—and many other organizations, institutions, and agencies—and it is time that we, as a community, turn our full attention to it.

Especially because in today’s globalized world of imports and exports, ensuring the safety of food and drugs is more difficult than ever.

As the world becomes smaller, and products and ideas travel seamlessly between nations, it is essential that we consider the implications of this new reality for the scientific community—and, more importantly, how to respond and how to take advantage of it.

As you heard from my colleague Lou Valdez earlier this morning, this has required a new way of doing business for the FDA—a paradigm shift, if you will, that takes into account the safety of imports and the security of the supply chain as we regulate food and medical products. We have expanded our programs in an effort to meet our global mandate and set up offices across the world.

But this is about much more than the FDA. This is about all of us working together.

Truly harnessing regulatory science for the global public health will require better ways of communicating and sharing data; new and robust training of scientists; and partnerships between regulators and across industry, academia, and government.

In toxicology specifically, there are huge opportunities to collaborate to do more targeted problem solving research, so we can bring new methods and findings that directly apply to ensuring the safety of foods and medicines.

And only together can we advance predictive toxicology to deliver the next generation of therapies to patients and promote time and cost reductions in development that will support ongoing investment in innovation.

Fortunately, this type of work has already begun. For example, the FDA and the European Medicines Agency have recently worked to characterize novel biomarkers that identify drug-induced kidney toxicity in preclinical animal models, and several of these biomarkers have now been qualified for regulatory use.

And last year, the FDA and the U.S. National Institutes of Health launched a new NIH-FDA Regulatory Science Initiative to encourage new research in the field. Last year, we awarded our first set of grants in regulatory science and we plan to make a second set of grants soon.

We are hearing from researchers and clinicians that FDA and other federal agencies need to embrace a new paradigm of toxicology, one that taps into many fields of science, such as genetics, developmental biology, reproductive biology, endocrinology, to name just a few. I fully agree with that assessment…and that call to action. But it is through global collaboration that, I believe, we will best be able to do so.

I encourage all of you to consider this as you continue your conversations today…and pursue a spirit of collaboration and a commitment and openness to new ideas.

After a very long and full day, I imagine that some of you are beginning to get a bit restless. But as I close, I want to draw on some of FDA’s early history.

Some of you probably know a bit about our roots and the two President Roosevelts—Teddy and Franklin—that made us into the agency that we are today. But our history actually stretches back even before that to our 16th president, the Great Emancipator himself, Abraham Lincoln. It was Lincoln who created the Division of Chemistry that would evolve decades later into the Food and Drug Administration.

But, back then, in 1862, that high-level support apparently didn’t translate into much. Our first offices were, and I quote, “of a dark subterranean character,” where a “great dampness,” accented by “acid fumes,” prevailed. My earliest predecessor had only resources enough to analyze a handful of grapes in his first study…and it was rather inventive toxicology research. These days I complain a lot about budget and resources, but I have to acknowledge that we have come a long way.

So I am going to leave you this afternoon with some words from President Lincoln. He said, “The dogmas of the quiet past, are inadequate to the stormy present. The occasion is piled high with difficulty, and we must rise—with the occasion. As our case is new, so we must think anew, and act anew.”

Today we face many challenges…and difficulties abound. But the opportunities to make a difference are also enormous.

Now is the time that we must think anew—about the problems before us and how we can best utilize available and advancing science to address them.

And we must act anew, as true partners across nations, across disciplines and across sectors.

So congratulations to NCTR on this important milestone of their 40th anniversary. And now let us all look together toward the future. Thank you so much.