Symposium on Dose Selection for Cancer Treatment Drugs

Event Organizers:

Stanford Cancer Institute (SCI), Stanford Center for Innovative Study Design (CISD), UCSF - Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), University of Chicago Comprehensive Cancer Center

Symposium Objective: The goal of this workshop is to exchange research progress and discuss challenges in appropriate dosage for cancer treatments.

Both academic institutions and pharmaceutical industry have conducted early phase trials to select appropriate doses for later development of cancer treatments. The increasing need for the development of combination therapy due to resistance to monotherapy and poor tolerance of approved dose regimens underscores the need for a more efficient process of dose selection in the early stages of study design and refinement through the whole cycle of drug development and post-marketing research. Furthermore, with gaining insights of pharmacology and pharmacogenomics, multidisciplinary approaches are necessary to understand the exposure - response relationships, genomic modifications, modeling and simulation for dose findings, and new design for dose-optimization studies. This symposium will bring together researchers from academia and pharmaceutical industry to exchange research progress and discuss common challenges in appropriate dosage for cancer treatments.

Program, Date and Location (searchable Stanford map: https://campus-map.stanford.edu):

May 11, 2017. Short course on “Phase I/II Clinical Trial Design and Dose Finding”

8:30am-4:00pm, Alway Building M106, 300 Pasteur Drive, Stanford, CA, United States Instructors: Naitee Ting, Ph.D., and Qiqi Deng, Ph.D., Beohringer-Ingelheim, Inc., Editor of the book published by Springer, 2006.

May 12, 2017. Symposium Program on Dose Selection for Cancer Treatments

8:20am-12:00pm, Munzer Auditorium, Beckmann Center, 279 Campus Drive West, Ground Floor, Stanford, CA 94305

1:00pm-6:00pm, LK 130, Li Ka Shing Center for Learning and Knowledge (LKSC), 291 Campus Drive, 1st Floor, Stanford, CA 94305

Keynote Speakers:

• Dr. Rajeshwari Sridhara, Ph.D., Director of Division of Biometrics V, CDER, US FDA

• Dr. Shivaani Kummar, MD, FACP, Professor and Director, Phase I Clinical Research Program, Division of Oncology, Stanford Cancer Institute, Stanford University

• Dr. Peter Mueller, Ph.D., Professor, Division of Statistics and Scientific Computation, Department of Mathematics, University of Texas, Austin

Organization Committee: Ying Lu, Ph.D. (Co-Chair, Stanford University); Yuan Ji, Ph.D. (Co-Chair, University of Chicago); Philip Lavori, Ph.D. (Stanford University), Tze L. Lai Ph.D. (Stanford University), Shivaani Kummar, MD (Stanford University)

Registration and more detailed information about this Symposium:

http://med.stanford.edu/cisd/events/symposium-May2017.html