Guest Speaker from J. Craig Venter Institute: Design and Implementation Issues in Clinical Trials

September 10, 2015

Sept. 15 event featuring Nicholas J. Schork, Ph.D., sponsored by Southern California Drug Metabolism Discussion Group and held at National University

 Researchers and members of the biomedical community are invited to attend a lecture Sept. 15 by Nicholas J. Schork, Ph.D., Professor and Director, Human Biology at the J. Craig Venter Institute on the topic of “Design and Implementation Issues in Clinical Trials Advancing Personalized Medicine." Sponsored by the Southern California Drug Metabolism Discussion Group, the event will be held at National University’s Sanford Education Center in La Jolla, Calif.

Speaker: Nicholas J. Schork, Ph.D., Professor and Director, Human Biology. J. Craig Venter Institute

Date: Tuesday, September 15, 2015. 5-7 p.m., registration/appetizers/buffet dinner; 7 p.m. presentation.

Location: National University Sanford Education Center (North building). 11355 North Torrey Pines Road. La Jolla, CA 92037

Cost: $20, to the Southern California Drug Metabolism Discussion Group

Registration highly recommended: http://www.scdmdg.org/register.html

Sponsoring organization: Southern California Drug Metabolism Discussion Group / www.SCDMDG.org

Hosting organization: National University/ www.nu.edu

Synopsis: Traditional clinical trials focus on the effect of an intervention in the population at large or, for preventive intervention trials, a subgroup of individuals based on those individuals' overall susceptibility to a disease. In an era of personalized medicine, such trials are not appropriate nor are they often biologically compelling. In this talk, concepts surrounding N-of-1 and aggregated N-of-1 trials, trials vetting algorithms for matching drugs to individual profiles, genetic-profile based trials, and real-time, adaptive trials designs are discussed. Emphasis is given on the overall strategies and the motivation for such studies, rather than their statistical properties, although reference to the results of statistical studies are provided to make claims about how efficient (logistically and financial) such trials are. The talk will end with a discussion of limitations in assessments of personalized medicines, regulatory issues, and future directions

Guest speaker Dr. Schork is Director of Human Biology and Professor with the J. Craig Venter Institute, a not-for-profit research institute in Rockville, MD and La Jolla, Calif. dedicated to the advancement of the science of genomics; the understanding of its implications for society; and communication of those results to the scientific community, the public and policy makers. Founded by J. Craig Venter, Ph.D., the JCVI is home to approximately 200 scientists and staff. http://www.jcvi.org/cms/home/

Contact for more information: John R. Cashman, Ph.D., Chairman of San Diego-based Southern California Drug Metabolism Discussion Group (858) 458-9305.