To Market to Market

A new breed of medical industry professionals leads companies through the rapidly changing regulatory environment.

by Kukla Vera

News headlines about problem medicines and medical devices during the past few years make it easy to conclude that no one is minding the store when it comes to emerging pharmaceuticals or medical products. For example, heart attack risk associated with the painkiller Vioxx led to its removal from pharmacy shelves by the Food and Drug Administration (FDA) and subsequent lawsuits from former consumers of the product. And Roche Diagnostics recently issued a national recall of its medical test strips used to determine blood-clotting time. These types of incidents have caused concern among patients and healthcare providers about the safety of drugs and devices.

Yet according to the Pharmaceutical Research and Manufacturers of America (PhRMA), less than 3 percent of prescription medicines have been withdrawn from the market in the past 20 years. And research is picking up, not slowing down. There are, PhRMA reports, 125 new medicines in development for respiratory disorders, 73 medicines for HIV infection and AIDS, 66 for type 2 diabetes and 178 to treat cancer.

With drug and medical device companies developing products at record levels, there is an urgent need for regulatory professionals who can carefully navigate the science, research and ethical issues confronting these companies.

That makes Frances Richmond, Ph.D., one of the hottest professors in America.

Richmond, who is director of regulatory science at the USC School of Pharmacy, has created one of the few training grounds in the nation for a new breed of medical industry professionals who will eventually lead their companies through the rapidly changing regulatory environment.

Brave new world

Pharmaceuticals are among the most profitable and highly regulated medical products. During a stint in the private sector in the early 1990s, just as biotech companies were beginning to emerge as players in the medical field, Richmond discovered a whole new world of industry positions that required a science background. In fact, she felt higher education might be shortchanging students by neither exposing them to, nor completely preparing them for, these opportunities. “I realized that to meet the needs of these careers, science students needed to enhance their backgrounds with an understanding of business, regulation, product development and clinical trials,” she says. “These skills would make them indispensable players in the new industries.”

Rapid changes in this industry are being driven by development of drug-device and biologic-device combinations. The complicated regulatory review process can delay a new medical product introduction by months or even years if the right team is not in place to shepherd the product. While regulatory affairs were once adequately handled by staffers who relied on on-the-job training, today’s complex rules for bringing a new drug or cutting-edge medical device to market require expertise in business, law, international policy and science. The regulatory affairs specialists work with cross-functional teams to develop and bring to market devices that are both safe and effective for their intended uses.

This interdisciplinary skill set, complemented by an ability to think both strategically and tactically, is what today’s medical device and pharmaceutical companies need to get the job done. And they are finding that they do not have the on-site structure or time to provide on-the-job training.

Regulatory science professionals simultaneously advocate for the product and the consumer. They pull together the divergent departments instrumental in making and launching a new product, including top management, scientists, clinicians, engineers, marketing and lawyers. In today’s heavily scrutinized, high-risk arena of complex medical devices and advanced pharmaceutical products and their high-tech delivery systems, the regulatory affairs member of the team carries the significant responsibility of efficiently moving the product through the regulatory processes.

“The first generation of regulatory specialists, for the most part, is now reaching or nearing retirement age and the industry recognizes the need for professionals to replace these people,” Richmond says. “We have to also deal with the demands of stricter regulations in a global environment. These are complicated times that demand complex thinkers. That’s where we come in.”

The USC Master in Regulatory Science program draws faculty and course options from the schools of pharmacy, engineering (Viterbi), medicine (Keck), business (Marshall), policy, planning and development, and the independent health professions. Additionally, classes greatly depend on guest lectures from industry professionals and government regulatory representatives. In an age where everything is related, this program is the poster child.

Academia and beyond

With the high demand, Richmond finds herself at the opposite end of a jobs spectrum that was particularly bleak a decade ago when she was a professor at Queen’s University in Kingston, Canada.

“I was responsible for 700 undergraduates studying life sciences, and most of them wanted to become physicians,” she recalls. “When they didn’t get into medical school, they felt devastated. They didn’t see any other options.”

Richmond set out to create a bridge for students, first offering enhancements to their science degrees through condensed, “boot-camp” type programs. She developed a “beyond academia” program that was successfully received by the university, students and industry. “Finally, we were able to provide a new career path for basic-science students,” she recalls.

In 1999, Richmond and her husband, Gerald Loeb, M.D., were recruited by USC. Loeb is a professor of biomedical engineering and director of the Medical Device Development Facility at the USC Viterbi School of Engineering. Part of Richmond’s new position at USC required her to remodel the regulatory science program that she created in Canada for the United States market. The program found a home in the USC School of Pharmacy, and Richmond went about the task in her customary accelerated manner.

With the goal of creating a flagship program at USC, and at the same time realizing that the program would have to meet the evolving needs of industry for sharp regulatory professionals, Richmond did what she did in Canada, only this time in a bigger, bolder way, following the adage that became the tagline of her USC program: faster, safer, better.

Richmond stays in touch with industry needs by partnering with such companies as Medtronic Inc., the Minneapolis-based global leader in medical technology. Medtronic alone has some 400 regulatory positions worldwide serving all the company’s locations.

“Regulatory affairs has changed dramatically over the past ten or so years,” notes Michael Morton, Medtronic’s senior director for regulatory affairs. “The products are more complicated and the markets are more diverse and challenging. For instance, many of our products are now ‘combination products’ involving both drugs and devices. These types of products raise new questions in the pre-market review process and also in the post-market environment.”

Regulatory specialists “are the ‘go-to’ people on the team,” he adds. “USC really gives students a great regulatory background, stressing technical aspects, regulations and communications.”

Neeta Sharma, who completed the regulatory science program in 2004, now works as a regulatory affairs specialist in Medtronic’s vascular unit in Santa Rosa, California.

She credits the program with giving her a thorough view of the entire product development process, including the design of regulatory strategies, quality control, operations, business ventures and clinical trials. A big part of a medical product’s budget is spent on clinical trials. An organized clinical trial can save a company millions of dollars and bring a beneficial product to market months sooner, while a poorly designed trial can result in promising compounds or devices being rejected.

“As a regulatory specialist, people often look to me for advice when they are not sure of something, especially in clinical quality and research and design. I work with almost all functions of the company at some level,” Sharma says.

Meet the need

To meet industry needs, Richmond has extended the regulatory science program to include a hybrid distance-learning version of particular value to working professionals. This personalized learning experience includes regular interactions with other students and professors via lectures that are streamed live or on-demand, weekly video conferencing and opportunities to participate in group projects using state-of-the-art multimedia tools. Distance learning students are also invited to an optional, on-campus retreat each summer.

The USC program is uniquely able to educate regulatory professionals at various stages of their careers. While most existing U.S. programs focus almost exclusively on people already working in industry, the USC program also trains a significant number of students who are not in the business yet. Once through the program, industry wants them and “they deliver,” says Richmond.

“We have a split program, educating those already working in industry who want regulatory science training and those basic-science students—undergrads as well as graduates—seeking a tremendous career path. This is a very good thing for everyone,” Richmond says.

“The program is now in its sixth year and continues to grow,” she says. “Industry needs people who can guide their product to market, control liability and eliminate the risk involved with product failure.”

When Richmond envisioned a career path for basic-science students, she was optimistic, but she is now overwhelmed with the exceptional opportunities she can offer her students.

“Regulatory science professionals play an important role in today’s healthcare environment,” she says. “Industry consumes our graduates as quickly as we can turn them out.”

For more information about the USC School of Pharmacy Regulatory Science program, visit http://regulatory.usc.edu or call (323) 442-3541.