UF, FDA to train clinicians in pharmaceutical outcomes and policy sciences

This fall, the University of Florida College of Pharmacy has enlisted a few good men and women into graduate studies in drug evaluation, policy and safety sciences through a new scholarship opportunity.

The Food and Drug Administration's Center for Drug Evaluation and Research, working with the U.S. Public Health Service Commissioned Corps, had been seeking an educational partner that could help attract scientists and health professionals fill a growing industry need. Capt. Greg Wood, director of the CDER/FDA Academic Collaboration Program, came to UF last year with a new partnership in mind.

"This partnership is the first of its kind for our agency," Wood said. The scholarship program provides tuition, salary and housing — valued at more than $65,000 per year — and guarantees a job with CDER at the FDA upon graduation.

"It aligns with one of CDER's primary goals — to work collaboratively and cooperatively with industry, academia and other partners to improve the drug development and review process vital to improving the public health for the nation," Wood said.

The graduate program in the college's department of pharmaceutical outcomes and policy was particularly suited to the agency's mission, Wood added. The curriculum — built on pharmacoeconomics, pharmacoepidemiology, and patient safety and program evaluation, along with UF's exceptional research facilities — weighed favorably.

In addition to meeting UF graduate admission requirements, students must be commissioned as officers in the U.S. Public Health Service Commissioned Corps. They follow military customs and wear the same service khaki uniform as the U.S. Navy, with a special Commissioned Corps insignia, while attending class and during all program-related events. They must also be full-time students and agree to work for CDER/FDA for two years in return for each year of paid tuition.

The federal agency's public health directive and mission are to approve safe and effective drugs and to provide consumers and health-care practitioners with accurate drug information. This requires a greater demand for scientists and health professionals trained in regulatory and safety sciences, said Russ Abbott, director of the Office of Management of CDER/FDA. Working closely with a graduate health science educational program like the one at UF is a good way for the agency to achieve its goals, he said.

"The United States Public Health Service officers trained at the University of Florida will have the clinical and research expertise necessary to scientifically assess drug safety and effectiveness and to evaluate and participate in programs directed at the safe and effective use of medications," Abbott said.

Danielle Smith graduated with a Doctor of Pharmacy degree from Florida A&M University earlier this year and learned she was one of five students accepted into the program within days of graduation. To Smith, the partnership places her firmly on her career ladder of choice.

"It will allow me to further my education and will guarantee a job with the organization that I want to work with upon graduation," said Smith. "It's a win-win situation."

In July, Smith and the other four founding-class members — all commissioned officers in the U.S. Public Health Service — participated in a one-week FDA orientation in Silver Spring, Md., before attending two weeks of officer basic course training in Lansdowne, Va.

Jonas Santiago, a student from the Washington, D.C., area, learned of the program in January while working for the FDA during a student rotation to complete his Doctor of Pharmacy degree at Howard University.

"The FDA team highly recommended the UF program as a way to train future leaders within the CDER," said Santiago, who looks forward to a public health career with the USPHS Commissioned Corps.

"The program specializations in pharmacoepidemiology, patient safety and risk evaluation directly correlates to certain offices and divisions within CDER. The advanced training and completion of this program will help make me an important asset for the center," Santiago said.

Starting in fall 2010, up to 20 new students will be admitted to the program. Almut Winterstein, Ph.D., director of the UF FDA/CDER Scholarship Program, is encouraging qualified students to visit the college's Web site at www.cop.ufl.edu for application information under the department of pharmaceutical outcomes and policy.

"I believe that the expertise in our department and the portfolio of our specializations fits well with the FDA need for clinical research capacity," said Winterstein.

Winterstein, an associate professor in pharmaceutical outcomes and policy at UF, added that the UF College of Pharmacy was honored that they had been selected as an educational partner by the FDA. In addition to its existing curriculum, the college will tailor class projects to FDA research needs to assure that students have the best preparation possible for a career with CDER and beyond, Winterstein said.