School of Pharmacy celebrates global drug development and regulatory science collaboration

By Suzan Revah / Mon Jul 8, 2024

Yangfeng Wu, MD, PhD; Leslie Z. Benet, PhD; Carl Peck, MD, Dr. h.c. (Uppsala); and Peking University Clinical Research Institute Director of Department of Education and Training Sandy Zhang.

Fifteen years after the School helped launch a post-graduate level course at Peking University in Beijing, China, with the goal of modernizing development and regulation of Chinese medical products, leaders in a tripartite collaboration came together on June 14, 2024, to celebrate progress and strengthen connections for future cooperation.

The Chinese Course on Drug Development and Regulatory Science (CCDRS) launched in January 2009. The yearlong course was adapted from and supported by American and European models: the American Course on Drug Development and Regulatory Sciences (ACDRS), launched in 2007 and sponsored by the UCSF School of Pharmacy, and the European Center of Pharmaceutical Medicine (ECPM), upon which ACDRS was based.

ACDRS Course Director Charlie Gombar, PhD, opened the reunion with an overview of ACDRS’ mission of integrating cutting-edge concepts and best practices in medical product development and regulatory sciences. He also shared highlights of the course’s impact, methods, and challenges.

A global platform for experience exchange

Adding historical perspective, Peking University Clinical Research Institute Executive Director Yangfeng Wu, MD, PhD, who is also deputy director of Peking University’s Institute of Advanced Clinical Medicine, said CCDRS was the first drug development science training project in Asia to cover the entire enterprise of innovative drug research and regulation. A primary goal of CCDRS, Wu said, was “to create a platform for experience exchange between Asia, Europe, and the United States,” for participants spanning academia, industry, multinational corporations, and government.

Welcoming the group was CCDRS cofounder Carl Peck, MD, Dr. h.c. (Uppsala), adjunct faculty member in the Department of Bioengineering and Therapeutic Sciences (BTS) and former director of the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). Peck, who has traveled to China multiple times to lecture on drug development science, credited Dean Kathy Giacomini, PhD, BSPharm, as an honorary cofounder of CCDRS, noting that she has been highly supportive of both ACDRS and CCDRS from their very beginnings.

“We’re trying to change the academic landscape to have regulatory science be more embraced and developed as a field of study,” said Giacomini. “CCDRS has broken new ground. The feedback it has given to elevate local biotech companies as well as the country’s regulatory sciences is commendable.”

Demystifying and elevating drug development

The cooperation and courses evolved from a recognition back in the 1980s––by Peck while heading CDER, and by Fritz Buhler, MD, a professor of pharmaceutical medicine at the University of Basel in Switzerland who developed the ECPM––that there was no formal education for people working in the drug development industry.

Drug development is “mysterious to most people,” Peck said. “They have no idea just how much drug companies have to research to discover and confirm, according to FDA standards, that a drug is safe and effective.”

“You can’t be involved in drug development without being at least comfortable with regulation, because it is one of the most highly regulated industries ever,” Peck added. “We evolved the course teachings with an insistence on in-depth training and highly experienced lecturers.” In addition, the three courses are “harmonized” to create global applicability and sustainability while being agnostic to therapeutic area.

Legendary leadership

Professor Yangfeng Wu, MD, PhD, presents Leslie Z. Benet, PhD, with a letter of appreciation for his contributions to CCDRS.

The event celebrated 15 years of contributing to the improved quality and broader acceptance of Chinese pharmaceuticals and pharmaceutical exports, with special acknowledgment of another CCDRS cofounder, Leslie Z. Benet, PhD, a BTS and pharmacokinetics legend who has lectured yearly in the CCDRS.

Professor Wu presented Benet with a letter of appreciation for his exceptional dedication and contributions to CCDRS. “His vision, expertise, and passion have greatly enriched the learning experience of more than 10,000 students in CCDRS and have made a profound impact on their professional development,” Wu said.

UCSF helps launch Chinese course on drug development