Environmental Factor, August 2009, National Institute of Environmental Health Sciences

NIEHS Holds Ribbon Cutting for Clinical Research Unit

By Eddy Ball
August 2009

Graedon drew upon his radio experience to make sure the talks stayed on time. He introduced his wife and "The People's Pharmacy" co-host, medical anthropologist Terry Graedon, Ph.D., who was in the audience. (Photo courtesy of Steve McCaw)

Birnbaum acknowledged the vision of former NIEHS Director David Schwartz, M.D., in recognizing the need for a clinical research facility at the Institute. "It puts the public health mission of our Institute front and center," she said of the CRU. (Photo courtesy of Steve McCaw)

Shown from left to right were Birnbaum, Gottesman, Cansler, Miller, Califf, Etheridge, Bell, Hagan, Price, Graedon, Dalton, Page and Zeldin.

With scissors in hand, NIEHS leaders and guest speakers prepared to mark the grand opening of the CRU. Shown from left to right were Birnbaum, Gottesman, Cansler, Miller, Califf, Etheridge, Bell, Hagan, Price, Graedon, Dalton, Page and Zeldin. (Photo courtesy of Steve McCaw)

Senator Kay Hagan, left, and NIEHS Director Linda Birbaum posed together during the reception at the CRU. Hagan said it is "critical to fund" research at NIEHS. (Photo courtesy of Steve McCaw)

Mayor Bell, left, talked with Congressman Price. Price praised the CRU as "an exciting part of the program of an institute on the move." He said he foresees more "life-saving and life-enhancing research" as well from such leading-edge efforts as the Sister Study. (Photo courtesy of Steve McCaw)

John Pritchard, Ph.D. and Michael Gottesman, M.D.

NIEHS Acting Scientific Director John Pritchard, Ph.D., enjoyed a photo opportunity with Gottesman, who oversees the largest clinical research hospital in the U.S. Birnbaum gave special thanks to Gottesman for his support at the NIH level. (Photo courtesy of Steve McCaw)

Garantziotis expressed his hope that the Clinical Research Symposium would be the first in a series of symposia on clinical research and translational medicine, as results from studies at the CRU begin to emerge. (Photo courtesy of Steve McCaw)

Friends, supporters and dignitaries flocked to the NIEHS campus on July 27 in precedent-setting numbers to celebrate the grand opening of the Institute's much anticipated Clinical Research Unit (CRU).

The day's events began with addresses to a capacity audience in Rodbell Auditorium by distinguished visitors, before moving to the CRU where there was a formal ribbon cutting ceremony and refreshments. In the afternoon, visitors joined NIEHS scientists and employees for presentations on aspects of clinical research (see text box). (https://www.niehs.nih.gov/news/newsletter/2009/august/science-public.cfm#bluebox)

The morning talks, which were moderated by Emcee Joe Graedon, radio celebrity and co-host of the public radio program "The People's Pharmacy (http://www.peoplespharmacy.com/) ," opened with welcome remarks by NIEHS and National Toxicology Program Director Linda Birnbaum, Ph.D.

"Opening this unit has been a long time coming," Birnbaum said, "but I believe that it is something that will not only benefit our researchers, but our community and nation as well." She called the CRU a "clinical training ground" that will foster innovative collaborations.

Birnbaum was followed with "Greetings" from NIH Deputy Director for Intramural Research Michael Gottesman, M.D., and "A Local Partner's Perspective" by Robert Califf, M.D., vice chancellor for clinical research at Duke University.

Thanks to Graedon's vigilance, each of the politicians on hand kept remarks within the allotted three minutes. U.S. Senator Kay Hagan was lead speaker from the federal delegation, which included 4th District Congressman David Price, Ph.D., 2^nd District Congressman Bob Etheridge and 13^th District Congressman Brad Miller. Each expressed support for the environmental research and public health mission of NIEHS and NTP as well as for funding for health research at NIH.

As cameras flashed, politics became progressively more local in scope, starting with N.C. Lieutenant Governor Walter Dalton and N.C. Secretary of Health and Human Services Lanier Cansler. The state officials praised NIEHS and NTP for their contribution the state's growth in the area of biotechnology and for anticipating health issues in order to head off emerging problems.

Closing out the "Officials" portion of the program were Durham County Commissioner Michael Page and Durham Mayor William Bell, who thanked NIEHS for being the source for the many jobs his constituents fill at the Institute and for ensuring diversity among study participants.

NIEHS Acting Clinical Director Darryl Zeldin, M.D., concluded the formal portion of the celebration with the presentation of awards to 12 employees for their contributions to realizing the dream of clinical research at NIEHS, as well as thanks to many others who supported the CRU since its initial conception in 2005.

Under an unforgiving sun, visitors, many dressed to the nines, trekked to the other end of the main building and across the parking lot to the CRU. Following the ribbon cutting at the front door, they enjoyed a light buffet and the company of friends old and new - to say nothing of blessed sanctuary from the noontime heat and humidity.

After a lunch break, an equally enthusiastic audience returned to Robell Auditorium for talks about clinical research and public health translation hosted by NIEHS CRU Medical Director Stavros Garantziotis, M.D. Three distinguished physician scientists addressed their own work along the broad spectrum of what Birnbaum has called "bench-to-bedside and bench-to-public health" translational research - Robert Califf, M.D., vice chancellor for clinical research at Duke University; National Children's Study Principal Investigator Philip Landrigan, M.D., of Mt. Sinai Medical Center; and Franck Mauvais-Jarvis, M.D., Ph.D., a Northwestern University Division of Endocrinology, Metabolism and Molecular Medicine associate professor of medicine.

Califf, center, enjoys banter with his host prior to his talk. He described his experience with the intervention drugs encainide and flecainide that taught him to question the validity of surrogate endpoints in true clinical outcomes. "Most of the time what we thought would work, didn't," he noted. (Photo courtesy of Steve McCaw)

Landrigan referred to the legacy of former NIEHS Director David Rall, M.D., Ph.D., as he recalled meeting in the 1970s at NIEHS in the campaign to ban lead from gasoline. His Queens site was one of the first two counties to begin recruitment for the National Children's Study earlier this year. (Photo courtesy of Steve McCaw)

Mauvais-Jarvis' bedside observation that human pancreatic islet failure is much more common in men than in women with Type 1 diabetes took him back the bench for animal studies. He discovered that raising estrogen to physiologic levels could be protective - a strategy he hopes soon to test with humans. (Photo courtesy of Steve McCaw)

Clinical Research Symposium

Back at the podium for a talk on "A Strategic Approach to Addressing the Needs for Mechanistic Clinical Research," Robert Califf explored the leadership challenges of realizing the integrated, multi-disciplinary model that is at the heart of the NIH Clinical and Translational Science Awards program. Looking back on his own experience with medicines that delivered less than they promised - or even produced adverse effects in patients - Califf argued that a network of multi-disciplinary programs could help researchers understand more completely the true clinical outcomes that may be obscured by focusing too intently on surrogate endpoints in drug development. He also told the audience about Duke's global initiatives in Singapore and New Delhi.
Long-time NIEHS grantee Philip Landrigan spoke on the "The National Children's (NCS) Study - The Need and the Promise." Landrigan began his talk with a look back at the success of translating research on lead into a public health policy that has reduced blood levels in the population by some 90 percent in the past 30 years. He expressed his confidence that the growing network of NCS research sites, such as the one he leads in Queens, will use data from the long-term prospective study of 100,000 children to have similar effects in decades to come - translating the results of molecular epidemiology from the bench, the clinic and the desk to public health policy.
The final speaker of the afternoon was Franck Mauvais-Jarvis, who recounted his clinical research in a talk on "Estrogen Receptors and Pancreatic Islet Survival in Diabetes: An Example of Bidirectional Translational Research." Helped by his collaborations with NIEHS Principal Investigator Ken Korach, Ph.D., Mauvais-Jarvis explored an hypothesis born of clinical observation and tested in engineered mice that he anticipates within five years will help patients in clinical trials - just where his bidirectional bedside-to-bench/bench-to-beside odyssey originally began.

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