Global Partnerships Advance the Regulatory Science That Protects Public Health

By: William Slikker, Jr., Ph.D.

In work, as in life, your success often comes down to the strength of your relationships. And as the director of FDA’s National Center for Toxicological Research (NCTR), among the most pre-eminent regulatory science centers in the world, I have found that this axiom, often so apt in daily life, is also true on a grander scale in the world of research.

William SlikkerNCTR scientists develop innovative tools and strategies to advance FDA’s mission to protect and promote public health. Our center sits on 500 acres in Jefferson, Arkansas, far from agency headquarters in the Washington, D. C., metropolitan area.

But the power of the safety assessment work done at NCTR has global reach, and it is leveraged by the global nature of partnerships we have developed across FDA and with research centers in other countries. Late this summer, Aug. 21-22, I will travel to Montreal for the Global Summit on Regulatory Science, where government, industry and academic scientists from all over the world will assess how to address emerging technologies and implement innovative ways to use them to determine the safety and effectiveness of FDA-regulated products when used in real-world applications.

If you imagine our scientific collaborations as a family tree of sorts, our international activities are one limb. In addition to the annual summit, we provide opportunities for scientists from other countries to work with experienced FDA researchers in all facets of safety assessment. NCTR also has outreach partnerships with the World Health Organization, the European Food Safety Authority and other international organizations such as the International Union of Toxicology (IUTOX).

Our internal partnerships are another limb to the science of public health. Of 200 active research projects ongoing at NCTR, over 100 are done in collaboration with scientists from other FDA centers and the Office of Regulatory Affairs (ORA). For example, we work with the Center for Drug Evaluation and Research in assessing the danger, or toxicology, of certain drugs on the most vulnerable populations— pregnant women and children.

We are partners with the ORA in the Nanotechnology Core Facility on our campus that supports the study of nanomaterials, so small that they can’t be seen with a regular light microscope, yet their effects can be profound on the increasing number of drugs, foods and cosmetics in which they are found. NCTR also works with state partners in this research.

In fact, this particular effort and other partnerships have put NCTR at the forefront of research on nanotechnology. The safety and effectiveness of nanotechnology is a focus of a Memorandum of Understanding signed by the FDA Commissioner in 2011 with the State of Arkansas that enables NCTR to collaborate with five major research institutions in the state, including the University of Arkansas for Medical Sciences.

Our state partnerships within Arkansas are invaluable as they add both laboratory and investigator expertise not normally available to FDA. In addition to work with nanomaterials, our projects with Arkansas researchers include research on the effects of anesthesia on the developing brains of young animals to emulate the possible effects in children, and the development of novel bioinformatic approaches to collect, analyze and visualize massive pharmacogenomics (the genetic response to drugs) or imaging data sets.

Our federal partners, including the National Institute of Environmental Health Sciences and the National Toxicology Program (NTP), both of which share our mission to keep you safe from chemical and environmental hazards, combine with NCTR to produce a world powerhouse for safety assessment.

This 20-year partnership between NCTR/FDA and NTP has produced numerous sets of safety data that provide the scientific foundation for FDA regulators and others around the world to establish guidance and set standards to control food contaminants and assess drugs. For example, NCTR’s work on a naturally-occurring fungal contaminant (fumonisin FB1) in the nation’s corn crop produced data for FDA’s Center of Food Safety and Applied Nutrition to provide new recommended limits for fumonisin, an action that reached across the world.

NCTR also engages in public-private partnerships to foster the development of innovative products. For example, we are working with the International Anesthesia Research Society to improve the safe use of anesthetics in children. FDA has many such partnerships to leverage the expertise and resources of industry, government, and non-profit organizations in developing tools that drive innovation.

The crux of regulatory science is this: Just as an art critic must be an expert in art, a scientist at FDA must be an expert in the science that he or she is evaluating. “It takes a village” has become almost a cliché, but in truth it does take a global village to give regulatory scientists the tools they need to ensure that the exciting new technologies will translate into products that are safe, effective and will enhance your life.

William Slikker, Jr., Ph.D., is the Director of FDA’s National Center for Toxicological Research

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