By Marg Stark
For more than 30 years, Dr. David Shapiro has had a front-row seat to watch the growth and evolution of San Diego’s booming biotech community and its increasing impact on the world. Shapiro, who is the chief medical officer at Intercept Pharmaceuticals, a company focused on developing treatments for nonviral liver disease said the engine that drives the growth of the life sciences is clinical trials, which help to prove—or disprove—the efficacy of possible treatments. Over the years, he said, as biotech companies around the globe have raced to find treatments for a wide range of diseases, clinical trials have become more crucial and more rigorous than ever.
“The primary and secondary research endpoints have to be more defined at the outset; there’s more uniform coordination across the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, and less margin for error across the board,” Shapiro said. “Of course, even amid higher regulatory standards, we are always trying to make the pathway shorter. And drugs are now being tested globally much earlier in the development process, with patients being recruited for trials on multiple continents.”
To manage these intricacies, professionals need instruction that keeps up with a staggering pace of change and offers them global research insights. Because of the critical importance of having a talent pool with this expertise, Shapiro serves as an advisor to UC San Diego Extension’s clinical trials programs. He said the courses and certificates Extension offers in clinical trials and drug development allow professionals the opportunities to stay current and ensure San Diego continues as a leading hub in biotech and life science.
“Extension provides ideal training for professionals,” Shapiro said. “I’m extremely impressed with the energy and expertise of the program and the way it prepares students and rewards prospective employers.”
Robyn Leary is one of those professionals who has benefitted from Extension’s training. She had spent 14 years working in various roles in clinical research labs, but she yearned to see the results of her work in patients. Although Leary has a PhD, she said her lack of an MD thwarted her efforts to shift from “bench science to human work.”
So, while pursuing her second “postdoc” fellowship, Leary embarked on clinical trials administration studies at UC San Diego Extension. Within a year, she landed her dream job at Teva Pharmaceuticals, serving as a medical science liaison between the company and the outside community.
For Leary, learning the practicalities of how clinical trials are run and becoming versed in pharmaceutical industry lingo in the Extension certificate program proved essential to her career transition.
“Medical science liaison has become a hot job in the industry, and I would not otherwise have had enough insider knowledge to make the jump into it,” she said.
Shapiro said UC San Diego Extension works extremely hard to design programs that anticipate the constantly changing nature of research and clinical trials.
“Extension attends to innovations with a very fast-wheeling commitment to change and improvement,” Shapiro said.
To stay ahead of the curve, Grace Miller and Donna Stern, who oversee Extension’s clinical trials programs, travel the globe, attending international conferences and forging international partnerships. They also recruit instructors who are leaders in the field, refine curriculum, and add courses to keep the Extension program and its students at the forefront of the industry.
As an example, Miller recently noticed an uptick in interest in project management in clinical trials and attended a session on this topic at a conference in Montreal. Miller promptly recruited the instructor, who will soon teach the course for Extension. Similarly, Stern said, initial coursework in the Clinical Trials Administration Certificate Program will feature more information on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other regulatory bodies, not just the FDA and EMA. Clinical trials studies are also offered in Spanish to accommodate the emergence of clinical trials in Latin America.
At Intercept Pharmaceuticals, where Shapiro is overseeing the development of an agonist in bile acid chemistry to treat liver disease, among other therapies, clinical trials are underway in 20 countries.
“That’s an amazing global reach for a small company,” he said. “But that is typical today in drug development.”
International trial recruitment comes earlier in the research process, and global trials are no longer pursued just by field giants such as Merck and Pfizer, both of which Shapiro worked for.
Trained in the United Kingdom, Shapiro said San Diego is the perfect training post for this fast-moving industry. Some of the seminal work on the nuclear receptor FXR, which Shapiro’s company is advancing, was performed two decades ago by UC San Diego professor Alan Hofmann and his team of scientists. UC San Diego’s intense study of this complex molecule, including examining bile samples from animals from the San Diego Zoo, paved the way for the practical-applications work Intercept is forging. If all goes well, patients across the world with liver disease will soon benefit from therapies created in San Diego.
“So often this is the case,” Shapiro said. “Biotechs here are building on the extraordinary basic science performed at UC San Diego and San Diego’s robust nonprofit research organizations.”
Indeed, UC San Diego Extension has partnerships that expose students to international research leaders, such as the University Medical Center Utrecht in the Netherlands.
“Our students spent a week at Utrecht as part of our summer intensive workshop,” Miller explained. “But more and more, students interested in our program want to come to San Diego for their classroom work, both for our weather and for the introduction to our international biotech hub.”
Having made her jump from basic to translation research, Leary said she keeps the binder from her Extension studies in her office at Teva and still calls upon it occasionally.
“Teva is an Israeli company with a very global perspective. For my work, I must know what the EMA does and keep up with the research in Europe and elsewhere,” she said. “I knew this day one because of the Extension program: all the agencies, how they differ, and how to look up all their regulations, not to mention the host of pharmaceutical abbreviations and terminology, which are not things you just Google and find.”
Having transitioned from academia to the private sector, Leary said she marvels at the considerable salary and benefits bumps she enjoys and the facets of her personality and interests she now indulges. “In the lab, my work was focused on going very deep. It was tough to find time to read the journals and get the big picture in medicine,” Leary said. “Today, I’m paid to do that—to read about scientific and medical developments and attend conferences to stay abreast of innovation. I consult and troubleshoot about clinical trials. I fly across the region, counseling doctors and answering questions for insurers and payers about the applications of Teva’s therapies. And I’m getting to see the results: the impact we are making around the world on the lives of patients who benefit.”