The University of Maryland School of Pharmacy has launched a Center for Translational Medicine (CTM) under the leadership of Joga Gobburu, PhD, FCD, MBA, to help improve medical product development efficiency.
"By establishing the Center for Translational Medicine, 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 as director of the center will enhance our educational and research programs and will lead to substantial partnerships with the pharmaceutical industry and other collaborators."
Gobburu, hired by the School from the U.S. Food and Drug Administration (FDA) in October 2011, is a leading expert in the field of pharmacometrics, a study of groundwork strategies in drug regulation and/or drug development.
"The center will apply the best resources of the University of Maryland to advance public health by developing scientific leaders and tools to foster innovation in the field of medical product development and therapeutics," he says.
The uniqueness of the CTM is to employ advanced and innovative quantitative analyses to create intelligence from information, or in other words, ideas from raw data. "The immediate focus of the Center is accessing data and creating tools for industry and government," says Gobburu. Initially, data from already conducted experiments and trials will be used. The National Institutes of Health and FDA are rich sources of such data.
He says, "The center will bring together the diverse expertise within the University System of Maryland solve public health challenges. Within our system, we have renowned scientists who can analyze clinical trial data, build pharmacoeconomic models, estimate net present value, and project comparative effectiveness." CTM commits to on-time project delivery and with the highest quality. It is equipped with state-of-the art computational infrastructure including servers, widely used pharmacometrics and statistical software packages, and robust backup/recovery processes.
These quantitative models, along with cutting-edge development techniques such as adaptive and enrichment trials, will be integrated into tools that drug developers, regulatory agencies, and other research organizations can use to guide decisions pertaining to "go/no-go" dosage, patient population, design, endpoint, analyses, and therapeutics choices.
"As home to the Center for Translational Medicine, the Department of Pharmacy Practice and Science [PPS]is 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 PPS. "Dr. Gobburu brings national and international recognition to the department and the center will provide us with numerous opportunities to advance our clinical science initiatives."
The CTM also will provide executive leadership training in the field of translational medicine to foster innovation in medical product development.
The agenda for the center will be driven by emerging public health needs, says Gobburu. The CTM also will seek opportunities to train international regulatory bodies on innovative approaches.
This fall, the center will initiate graduate education programs for doctorate degrees, executive master's degrees and a visiting scholar program.
"The School of Pharmacy's Center for Translational Medicine will be an excellent forum for bringing together the diverse expertise within the University System of Maryland to accelerate medical product development," says G. "Anand" Anandalingam, PhD, dean of the University of Maryland's Robert H. Smith School of Business. "We look forward to collaborating with the CTM in training future scientific leaders and in conducting research on pharmaceutical industry business models, financial models for decision-making, and strategic IT utilization."