UCSF helps launch Chinese course on drug development

The UCSF School of Pharmacy was a key collaborator in the early January 2009 launch of a course in China that ultimately hopes to contribute to the improved quality and broader acceptance of Chinese pharmaceuticals and pharmaceutical exports. Drug developers, academics, and officials from China's drug regulatory agency—the State Food and Drug Administration (SFDA)—participated in the inaugural session of the year-long Chinese Course on Drug Development and Regulatory Science (CCDRS), which convened at Peking University in Beijing. Course co-founders and instructors included faculty members from the department of biopharmaceutical sciences in the UCSF School of Pharmacy.

The Chinese course was adapted from American and European models. The American Course on Drug Development and Regulatory Sciences (ACDRS), which was established by the UCSF School of Pharmacy's department of biopharmaceutical sciences, was launched in Washington, DC, in 2007 and at the UCSF Mission Bay campus in 2008. The American course is based on the successful European Course in Pharmaceutical Medicine, which was developed over two decades by Fritz Buhler, MD, professor of pharmaceutical medicine, University of Basel. International leaders in pharmaceutical sciences and manufacturing, business, and regulation teach in all three courses.

Carl Peck, MD, PhD, a UCSF School of Pharmacy faculty member and founder of the UCSF Center for Drug Development Science in Washington, DC, was a co-founder of the new course in China, where he has traveled several times in recent years to lecture on drug development.

Other co-founders were Yangfeng Wu, MD, PhD, of Peking University, Buhler, and Rae Yuan, PhD, head of the Roche Pharma Development Center in Shanghai, who earlier had earned her doctorate in the UCSF lab of School of Pharmacy faculty member Leslie Benet, PhD, and had worked for the US Food and Drug Administration (FDA) before joining Roche.

Peck states that China is committed to making better, safer drugs. In fact, the Chinese government has recently dedicated close to US$1 billion to jump-start biotechnology and technology development, he explains. Yet the Chinese version of the US FDA is in a "nascent state of modernization," he says.

Instructors for the first session of the Chinese course included Peck, who previously had directed the US FDA's Center for Drug Evaluation and Research in Washington, DC, and Yuan, who lectured on integrated product development planning. Benet also lectured and was a signatory on behalf of Kathy Giacomini, PhD, chair of the UCSF department of biopharmaceutical sciences, to the memorandum of understanding that confirmed UCSF's in-kind support of the Chinese course.

Zhang Wei, MD, director general of the Chinese SFDA Department of Drug Regulation, was the senior SFDA official participating on the CCDRS faculty. Zhang had once worked in the US FDA's St. Louis District Laboratory. Alasdair Breckenridge, MB, ChB, MD, head of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), and Buhler also lectured.

The inaugural class in China included 35 students, Peck says. About half the lectures were presented in Chinese, and translation was provided for lectures given in English. The Saturday special session, "Frontiers in Drug Development," included approximately 150 attendees who were attracted by speaker Hongguang Wang, PhD, director of the China National Center for Biotechnology Development in the Ministry of Science and Technology.

The complete Chinese course will consist of four sessions convened over the course of one year, with each session meeting on six consecutive days, and will offer a Peking University certificate to participants who pass the final examination. The course organizers accommodated the Chinese participants' request for practice exams and extended sessions. "They asked to start earlier and run longer than an eight-to-five schedule," Peck says.

"I think the course is likely to grow," Peck adds. "The Chinese are hungry for knowledge that will help them modernize quickly. I'm very inspired by this. I think there is a tremendous need we are trying to satisfy."

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• American Course on Drug Development and Regulatory Sciences
  Department of Biopharmaceutical Sciences, UCSF School of Pharmacy
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