Historic Agreement Opens a Door (Commentary)

by Art Norris  on Monday, Aug. 29, 2011 12:00 am  

Two days earlier this month were exciting ones in the realm of Arkansas science.
On Aug. 11, the National Center for Toxicological Research co-hosted a Global Summit on Regulatory Science & Innovation in Little Rock.  

The next day, NCTR held its 40th anniversary celebration with Gov. Mike Beebe and Food & Drug Administration Commissioner Margaret Hamburg signing a memorandum of understanding that establishes collaborative research and training among NCTR, the University of Arkansas for Medical Sciences, the University of Arkansas at Fayetteville, Arkansas State University, the University of Arkansas at Little Rock and the University of Arkansas at Pine Bluff, as well as a framework for other novel opportunities in Arkansas.

Representatives from 16 countries attended the Global Summit, all drawn to Arkansas through the scientific contributions from NCTR. Forty foreign scientists attended, and their request was for more collaboration. Yet many Arkansans know little of this FDA presence located between Pine Bluff and Little Rock with more than 550 employees and more than 150 holders of doctoral degrees.

NCTR is a unique federal resource with state-of-the-art equipment and capabilities in areas that are on the cutting edge of developments in biomedical and food science. The richness of this resource provides a seedbed for new solutions to problems and thus new business development.   

NCTR works with food components, drugs, cosmetics and other products to find those substances that are harmful, determine if they are harmful at levels the public encounters, find ways of detecting these substances rapidly, understand the chemical and biological mechanisms by which they impose their toxicity, develop means of protecting consumers from harm, pass quality scientific information along to the FDA regulatory officials, and inform its colleagues across the world. Using tests that are gold standards, NCTR scientists often protect the marketplace from unsubstantiated claims of harm.

Recognizing that many of the approaches used today were designed for products, processes and markets of the past, the FDA just issued a request for new types of interactions with academia and industry. The old approaches are not designed for complex world markets in which other countries are directing billions of dollars into the development of medical products. Drugs and drug safety tests are coming to us from many parts of the world, and new technologies are exploding on the marketplace. So at the very time that the FDA is asking for new ideas, with this memo of understanding Beebe has provided an opportunity for us to offer an opportunity to be creative.  

Success in this changing environment depends on adaptation. NCTR is about science, not facilitating business development, even business development that improves public health. But might we as a state adapt to address some of the newer FDA problems and create more opportunities for business development?

Current rules, regulations, perhaps even laws stand between us and such opportunities. But in this new environment, should these barriers be reviewed?   

For example, what changes would be required for scientific incubation, off-hour access to sophisticated equipment, use of unused space and sharing certain resources? Might there be a way for industry to pool research data and contribute to the establishment of safety standards? Could safeguards of transparency and the highest level of public scientific review protect the public interests in a more collaborative environment?  

Could we accommodate some of these ideas, at least on a public trial basis, to determine their true worth and viability? Procedures, regulations and perhaps laws may have to be changed, but might such adaptation be timely? Can we create an environment that draws industry to work with NCTR and the universities?

The Global Summit demonstrated that people from around the world want more of what NCTR has to offer. That fact may offer Arkansas growth opportunities. But another exciting opportunity is for us to attract medical, agricultural and other high-tech businesses into a closer association with NCTR.  

A door has been opened. 

Art Norris of Little Rock is a former deputy and interim NCTR director. He is a consultant with the Economic Development Alliance of Jefferson County and co-wrote the memo of understanding signed by Gov. Mike Beebe and Commissioner Margaret Hamburg. Email ARNorris@SWBell.net.

 

 

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