Cantilena appointed new ACDRS course director

Louis R. Cantilena, Jr., MD, PhD, is the newly appointed course director of the American Course on Drug Development and Regulatory Sciences (ACDRS) effective summer 2011. This two-year certificate program for pharmaceutical industry professionals is presented by the Department of Bioengineering and Therapeutic Sciences (BTS), UCSF Schools of Pharmacy and Medicine.

Cantilena is a professor of medicine and pharmacology and director of the Division of Clinical Pharmacology and Medical Toxicology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.

The comprehensive course, comprised of six 4-day sessions, is offered at the UC Center in Washington, D.C., where it is currently enrolling mid-career students for a new cycle starting September 12, 2011. A parallel ACDRS 2010-2012 is held at the Mission Bay Conference Center at UCSF.

The program was co-founded by Carl Peck, MD, UCSF faculty member and founding director of the UCSF School of Pharmacy’s Center for Drug Development Science (CDDS), along with Fritz Buhler, MD, who developed the first such course—the European Course in Pharmaceutical Medicine—at the University of Basel in Switzerland.

Experienced faculty, group problem solving

Examining the full arc of drug development, from discovery and first-in-human testing through dosing and confirmatory trials, and from global registration and approval processes to product development strategies, the course is taught by 120 faculty members drawn from academia, industry, and regulatory bodies in the U.S. and Europe.

“The course imparts all the knowledge of an incredibly experienced faculty and gives students a road map to a more efficient and informed style of drug development,” says Cantilena.

Indeed, Cantilena’s background, including 20 years running a Phase 1 clinical investigation unit at the National Naval Medical Center, serves as the basis for his own ACDRS lectures on the importance of fully using the drug safety information from Phase I clinical drug trials to predict excess dosing effects.

Along with Peck, he has mentored breakout groups in the course, which apply the lectures’ best practices to group problem solving. For example, at a June 2011 session in San Francisco, groups were assigned to develop a safe initial human dosage based on a drug’s preclinical trial animal test data—the same data that led researchers disastrously astray during a safety trial in England.

“The essence of the course is to help people find an alternate pathway other than the school of hard knocks,” says Cantilena “We teach people who are the rising stars in the pharmaceutical world… ‘These are the key concepts that you need to appreciate. These are the pitfalls you need to be on alert for.’ ”

Keeping pace with simulation, global orientation

As course director, Cantilena joins Peck, Buhler, and Charles Grudzinskas, PhD, on the ACDRS executive committee where he will help to refine curricula to keep pace with advances in drug development.

“Our hope is that the next generation of drug developers moves rapidly toward a more streamlined, science-based development paradigm that incorporates the use of simulation sciences and other tools we provide in the course,” says Cantilena.

For example, the course currently covers predicting the likely clinical consequences of drug interactions using computer simulation and limited in vitro data, thus reducing the need for such interaction testing in human volunteers.

In addition, the new director will work with the executive committee on continuing to increase the course’s global orientation. In 2009, Peck co-founded and taught in a China-based version of the American and European courses at Peking University in Beijing.

As Cantilena notes, “Many companies are simultaneously moving toward market approval in several worldwide jurisdictions. Our hope is to supplement the current involvement of our European faculty and bring real examples of efficient strategies to accomplish this into the course.”