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FDA's Gobburu Joins School of Pharmacy Faculty

Joga Gobburu, PhD, MBA, FCP, a leading U.S. Food and Drug Administration (FDA) scientist for more than a decade, has joined the faculty of the University of Maryland School of Pharmacy, where he will establish a research and education program in the emerging field of pharmacometrics.

Pharmacometrics measures and evaluates existing information on a given drug, a disease, and experiments, including clinical trials, to lay the groundwork for strategic decisions on drug regulation and/or drug development.

Gobburu explains: "Pharmacometrics quantifies all the information generated from hundreds of experiments conducted to develop a drug-petri dish, animal, human trials, etc. In this [drug] development process, you end up with siloed information. Pharmacometrics, together with translational medicine, transforms the siloed information into intelligence to support decisions."

The emerging field is cutting into an enormously expensive 98 percent failure rate of drug development experiments. "To learn from the failures, you must look at the failures and improve. It is the equivalent of business intelligence for R&D," says Gobburu. "We can sometimes use these approaches to gain further insights into the clinical trials thereby alleviating the need for additional clinical trials. So it cuts down the number of clinical trials, making the approval faster and conducting smaller studies."

"We are very excited to have the opportunity to expand our clinical science faculty and expertise," says Magaly Rodriguez de Bittner, PharmD, CDE, FAPhA, professor and chair of the Department of Pharmacy Practice and Science. "Dr. Gobburu brings national and international recognition to the department and the School of Pharmacy. In addition, with Dr. Gobburu's joint appointment in the Department of Medicine at the School of Medicine we will have the opportunity to increase collaboration among the two departments."

Gobburu joined the FDA in 1999 as a pharmacometrics reviewer, became team leader in 2005, and director in 2007. He was appointed senior biomedical research scientist at the FDA. Under his direction, a division of pharmacometrics was formed at the FDA and several policies were established. In that division, he established standardized disease databases.

Thomas Laughren, MD, director of FDA's Division of Psychiatry Products, says, "We will miss him greatly. However, the standards he has implemented will continue, and I know he will make major contributions in his new roles at the University of Maryland."

Gobburu is eager to stretch the already high standards of the graduates from the School of Pharmacy, which is one of the leading pharmacy schools in the United States. "There is a gap in academic institutions in [pharmacometrics]," he says. U.S. pharmacy school graduates today "do not understand drug development well. They know the theory of how to perform an analysis, how to interpret an experiment, write a report. But they do not know the business of drug development. To me, in order for a scientist to be influential, he or she should know the environment."

Gobburu wants his graduates to know the principles of negotiations and leadership in the field. "I want to create the world's most useful pharmacometrics and translational medicine program. I would like to produce scientific leaders in this field," he says.

He says he also was attracted to the University of Maryland School of Pharmacy because of the opportunity to train future leaders on pharmacometrics and translational medicine. He devoted himself to the discipline at FDA "because I believe in it. I saw value in it. And, I was lucky to get support for scientists there to work on it. But I was thinking 'what if I did it full time?'

"With Dr. Gobburu's vast experience in clinical trial design, the School of Pharmacy is demonstrating its commitment to improving the drug development and regulation process," says Natalie D. Eddington, PhD, FAAPS, FCP, professor and dean of the School of Pharmacy. "As a leader in the field of pharmacometrics, Dr. Gobburu's expertise will enhance our educational and research programs and will lead to substantial partnerships with the pharmaceutical industry and other collaborators."

Gobburu obtained a BPharm and an MSc in chemistry from the Birla Institute of Technology and Science in Pilani, India, in 1992. He earned a PhD in pharmaceutical sciences from North Dakota State University in 1996 and completed two postdoctoral fellowships, one at the University at Buffalo, the State University of New York; and another at the Center for Drug Development Science, Georgetown University in Washington, D.C., and the FDA. Most recently, he received an MBA from Johns Hopkins University. He has published more than 60 papers and book chapters, and has directed the doctoral research of two graduate students and mentored 16 postdoctoral fellows. He is a frequent speaker at national and international scientific conferences.

Posting Date: 12/20/2011
Contact Name: Steve Berberich
Contact Phone: 410-706-0023
Contact Email: sberb001@umaryland.edu