Gov. Hutchinson, FDA chief sign agreement to expand five-year scientific, medical research alliance

Gov. Asa Hutchinson and U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday (Aug. 31) signed a memorandum of understanding that will allow more federal research dollars to flow into Arkansas and enhance the state’s collaboration with the National Center for Toxicological Research (NCTR) at the Pine Bluff Arsenal.

Hutchinson appeared with Califf to announce the five-year deal at a State Capitol press conference, along with University of Arkansas for Medical Sciences Director Dan Rahn; Jerry Adams of the Arkansas Research Alliance; FDA Chief of Staff Tom Krauss; and William Slikker, director of the NCTR, which is a research arm of the FDA.

As he welcomed the FDA commissioner to Arkansas, Hutchinson said the new agreement with the federal agency is a renewal of a previous five-year memorandum of understanding signed by Gov. Mike Beebe with the only FDA research center outside of Washington, D.C., metropolitan area.

“As one of the most important federal agencies, the FDA has 20% of its employees right here in Arkansas at the NCTR,” the governor said. “These are (700) high-paying jobs with researchers that are doing work of national and global significance. So the FDA’s presence in Arkansas is very, very important to our nation and state and (we) want to enhance our partnership.”

Hutchinson said renewal of the federal-state partnership will allow the state’s five research universities to continue collaborating on different cutting-edge scientific research projects with the NCTR staff, and enhance sharing of information in the areas of bioinformatics, biomedical engineering, nanotechnology, regulatory science, and environmental research. Since the previous agreement under Gov. Beebe signed in 2011, the state has seen an increase of $4.8 million in federal research dollars, he said.

“So there is a significant result from this enhanced relationship through the MOU,” the governor said. “This is a great partnership. We want make sure it continues strong.”

‘HIGH-END SCIENCE’
Califf, who is in Arkansas this week to tour the sprawling NCTR facility at the Pine Bluff arsenal, said not only does the FDA regulates food, drugs, tobacco, radiative products, cosmetics and medical devices, but also is involved in critical research and clinical trials with private industry and universities that advance scientific technologies and medical breakthroughs.

“To do that kind of work, we need to be (involved) in informatics, quantitative sciences to measure things, which we will increasingly do better and better,” said the former Duke University professor of medicine and clinical researcher. “NCTR is funded specially to do that kind of work, it is a special part of the FDA. And as the governor mentioned, we have 700 people really focused on high-end science, so we rely on the center to deal with questions about the safety and the effectiveness of products in general and principles of the science that underlie that research.”

Califf said the FDA works with the Pine Bluff research facility to measure things to predict what drugs and medicines are going to be useful, but also products that may be dangerous. He also said the alliance with Arkansas is critical to allow the federal government to interact with the top scientists in the private sector and at research universities across the nation.

“I was in academia for years before coming to the FDA, so I am highly aware of the importance of the interaction of government agencies with the brightest scientists. It is a collaborative issue,” said the FDA boss. “No one holds all the intelligence, so it is critical that we have these kinds of alliances and having the state (of Arkansas) woven together like this is a very important part of what we see as the current state of the FDA and also the future.”

NCTR, ARKANSAS COLLABORATION WORK
In response to questions from reporters concerning research the NCTR is involved in with Arkansas, Slikker said FDA scientist are collaborating with UAMS on advanced nanomaterials for potential treatment of cancer, infections and cardiovascular disorders. Those studies are ongoing and results could soon be published in scientific journals, he said. Other areas of research the FDA research center is collaboratinng with Arkansas university researchers is bioinformatics, which combines computer science, statistics, mathematics, and engineering to analyze and interpret biological data.

NCTR scientists are also working with UAMS and the state’s other four research universities on novel biomarkers and genome therapy to treat cancer. Califf called the novel biomarker research, which he termed as a less invasive “liquid” biopsy test, a potential game-changing treatment for cancer.

“We all have great hope that if were to have cancer, for example, rather than going into to get a surgical treatment and get a specimen it may be possible to just get a blood sample and use these very high fidelity measurements to make a diagnosis,” said Califf, a medical doctor. “Liquid biopsy is sort of the term that you can get your arms around and this can’t be done without this high-end informatics.”

Califf said the clinical studies and trials NCTR and Arkansas universities are involved in are critical to the regulatory efforts of the FDA. Unbeknownst to most, the FDA chief said, nearly every potential breakthrough treatment developed fails to get out of the FDA’s trial and approval pipeline.

“One of things that sort of startles people these days is that if you read the headlines – you would think that every treatment that people develops work,” Califf said. “It turns out … 92 percent of new drugs that start out in clinical trials never make it to market because there are problems. This is really hard work.”

Hutchinson and Arkansas Economic Development Commission Director Mike Preston said one of the hopes for the future for the state’s alliance with the NCTR and FDA is to direct more federal research dollars toward Arkansas. Hutchinson also said the partnership will continue to strengthen NCTR’s operations in Arkansas, which has directly impacted the hiring of 1,300 scientists and other research professionals at state universities and in high-paying private sector jobs.

“We need that partnership and we want to keep it strong,” the governor said.