Drug development course teaches professionals to see bigger picture

The path from scientific insight to a new drug used to treat patients is a long, expensive, inefficient, hazard-strewn obstacle course requiring many steps before the drug arrives at the pharmacy. Unfortunately, the specialists working at each of these steps do not necessarily have a clear vision of what goes on outside their own areas of expertise. As a result, they can be unaware of how the decisions they make impact other points in the cycle of drug or medical product development.

The UCSF School of Pharmacy now offers a postgraduate course to help working professionals better understand the entire drug and medical device development process. The American Course on Drug Development and Regulatory Sciences (ACDRS) is based on a proven European model developed 2 decades ago. The course is taught by international leaders in pharmaceutical sciences and manufacturing, business, and regulation.

The course consists of 6, 4-day sessions spread over 2 years. Two separate courses are being offered. A Washington, DC, course began in September 2007 with 60 participants. A second course is now being taught to 40 enrollees in San Francisco. The first San Francisco session met in October 2008. Attendees include leaders in the pharmaceutical, biotechnology, and medical device industries; regulatory authorities; and universities.

Fritz Buhler, MD, from the European Center of Pharmaceutical Medicine in Basel, Switzerland, was instrumental in establishing the European course and—along with co-founders Ellen Feigal, MD, Charles Grudzinskas, PhD, and Carl Peck, MD, PhD, with program manager Jaime Kenyon, MPH—in helping to adapt it for the US.

"We are trying to improve the drug development process in terms of speed and the quality of drugs that come to market," Buhler says. "We want to see patients' needs being served more quickly, effectively, and economically."

Leslie Benet, PhD, and Kathleen Giacomini, PhD, catalyzed support for bringing the program to the US. Partners from industry, academia, and regulatory agencies, including the US Food and Drug Administration, have been involved in shaping the ACDRS. The Department of Biopharmaceutical Sciences and the Washington, DC-based Center for Drug Development Science, both within the UCSF School of Pharmacy, established the course.

According to Benet, professor in the UCSF School of Pharmacy's Department of Biopharmaceutical Sciences, "The ACDRS is targeted to the biopharmaceutical and service industries, to academic and government scientists, and to decision makers and policy makers who already have a good grounding in the basics and who will benefit from a more in-depth, comprehensive and systematic immersion into modern medical product development, regulation, and market introduction."

"Translational scientists who wish to advance basic discoveries into approved drug products will benefit enormously from the ACDRS," says Giacomini, chair of the Department of Biopharmaceutical Sciences. "By gaining a better understanding of why drugs fail, they will be better able to design new drugs and to implement strategies to identify drugs that are going to fail early. That way, they can focus their attention on developing the successful drugs that will eventually be approved for therapeutic use."

From molecule to marketplace

"The syllabus of the ACDRS program covers all aspects of pharmaceutical medicine and medical product development sciences," says Feigal, who is executive director of the course. "This includes the discovery and development of new medicines, biopharmaceutical sciences, clinical pharmacology and trial methodology, good clinical practice and ethics, pharmacovigilance and epidemiology, biostatistics, regulatory affairs, health economics, project management, marketing, and new therapeutic approaches."

In addition to lectures, workshops and panel discussions, the sessions feature case studies in which the participants work in groups mentored by international faculty experts from universities, companies and regulatory agencies.

Peter Langecker, MD, PhD, has broad responsibilities as chief medical officer of a small drug delivery company, DURECT Corporation, and enrolled in the course in San Francisco to obtain more background in a range of areas, as well as tools for management. Langecker found the group breakout sessions especially valuable.

"It is the one exercise that I have found personally to provide the greatest learning experience—and very much unparalleled," he says. "The other nice thing about these breakout sessions is that fact that you are working on solving problems or proposing a strategy with colleagues who come from across the map in drug development—preclinical, clinical, legal, FDA, small cap companies or Big Pharma. Everyone comes together, and there are really no boundaries."

Those who have completed the European course have benefited their careers, Buhler says. "Some have formed their own companies or set up contract-research organizations."

Feigal points out that the class engenders long-term connections among the students who participate, and offers unprecedented access to the experience of the instructors, including leaders from industry and regulatory agencies.

The organizers expect that the networking and brainstorming spawned during these classes will be long-lived. Individual participants will benefit professionally, but more important, over time the course may help participants contribute to significant, broad-reaching improvements in the way drugs and medical products are developed.

Enrollment remains open

Most of the participants in the Washington, DC course are from the East Coast, while the San Francisco course attracts primarily California-based attendees. Both courses have international attendees.

The San Francisco course is more heavily represented by individuals from smaller biotechnology companies who can benefit, in particular, from a course that addresses the full breadth of drug development, Buhler notes.

Enrollment is still open for the San Francisco ACDRS course. Those interested can sign up now, receive study materials from the first session, and attend the second session in February. "In Europe, we have trained 1,200 holistic drug developers," Buhler says. "The potential impact of this course in the US is tremendous."

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American Course on Drug Development and Regulatory Sciences