Georgetown Drives Connections Between Regulatory Science and Medicine

Posted in GUMC Stories

APRIL 22, 2015—Ever since she was bitten by the regulatory bug, Shahla Riazi, MD, PhD , has wanted to work with the U.S. Food and Drug Administration to help ensure that the promise of personalized medicine becomes a reality.

Yet, even with an MD, a PhD and an MS under her belt, Riazi didn’t feel she had enough knowledge about the field of regulatory science or the complex processes behind drug development.

At Georgetown University Medical Center (GUMC), Riazi became the first to secure a new fellowship in regulatory science through a unique collaboration between GUMC and the Pharmaceutical Research and Manufacturers of America (PhRMA), a nonprofit trade organization representing U.S. and international pharmaceutical and biotechnology companies.

“I am realizing how complicated and challenging it is to apply regulatory science to biomedical research in drug development,” Riazi says. “But it is very exciting because it is so interdisciplinary. It uses all my clinical experience and basic science training—and more.”

Through this yearlong fellowship, which started in September, Riazi is delving deeply in the process of personalized medicine application in drug development, and is engaged in several projects, including one to identify potential predictive biomarkers for chemotherapy resistance in cancer as a way to tailor therapy.

This novel training opportunity—the first of what will be an annual research award—serves as a visible embodiment of GUMC’s pioneering effort to ensure regulatory science and medicine undergirds clinical drug development.

The fellowship is an acknowledgment that regulatory science and clinical medicine go hand-in-hand, Riazi says. Their convergence results in evidence-based decision-making in every step of basic and clinical research to ensure development of safe and effective medical products—such as drug therapies, vaccines and diagnostic tests.

From Google to Genentech

The fellowship is housed within GUMC’s comprehensive program in regulatory science and medicine (PRSM), established in 2011 as a hub of research, training and education to improve the success rate of clinical trials and overall efficiency of developing safe and effective medical products.

Under the direction of Ira Shoulson, MD , professor of neurology, pharmacology, and human science at GUMC, PRSM has steadily expanded since its creation and now offers a regulatory science concentration in two GUMC Master of Science programs, including the master’s degree Riazi will complete in 2015. It was through her Master of Science in Clinical and Translational Research (MS-CTR) that Riazi first gained a true appreciation of the connection between regulatory science and its importance in medicine.

The programs are intended cultivate in students a broad and diverse knowledge base about regulatory science in general, Shoulson says.

“It doesn’t just apply to clinical trials; it applies to everything from a discovery process all the way through to the research and development of medical products,” he says.

This education and training is suitable for current or prospective employees of the FDA, as well as non-government workers from industry or academia, according to PRSM Executive Director Erin Wilhelm, MPH.

There are currently six graduate students taking the regulatory concentration, and several graduates who are working in the field. For example, one graduate has been hired by Google in health and science research, and another has a paid internship at Genentech.

Riazi’s regulatory science fellowship provides another opportunity for recent graduates and early career professionals to gain mentored, hand-on experience, whether in academia, industry or government—or some combination of those fields, Shoulson says.

Growing Interest

PRSM is also bolstered by its centerpiece program, the Center of Excellence in Regulatory Science and Innovation (CERSI). CERSI was established in October 2011 with an annual $1 million grant from the FDA to strengthen science and training needed to modernize how drugs and medical devices are reviewed and evaluated, says Shoulson, CERSI’s principal investigator.

One of just two initial FDA-funded such program, Georgetown’s CERSI draws on experts in science and medicine at GUMC and in law at Georgetown University Law Center—and builds bridges between the disciplines. In fall of 2014, collaborators from GUMC and the O’Neill Institute for National and Global Health Law at the Law Center published a new report dissecting the legal issues that may pose barriers to sharing biomedical research data.

Demonstrating the growing interest in the intersection of regulatory science and clinical medicine, there are now four FDA-funded CERSIs in the country, and other medical centers have launched advanced degrees that include regulatory science components.

Given this momentum, Shoulson believes education and training in this area should start early in students’ academic careers.

 “I think eventually we will ignite an interest in regulatory science even amongst students in high school,” he says.  “This is a rapidly advancing, applied scientific field—and one where there are careers and jobs. It is in everybody’s common interest to improve drug development.”

By Renee Twombly
GUMC Communications