Symposium on Dose Selection for Cancer Treatment Drugs

8:20am-12:00pm, Munzer Auditorium, Beckman 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

(Searchable Stanford map: )

8:25-8:30 am
Beverly Mitchell, MD
Director, Stanford Cancer Institute (SCI)
George E. Becker Professor in Medicine
Session I
Dose Selection in the Development of Cancer Treatment Drugs
Chair: Ying Lu, Ph.D.
Co-Director, Biostatistics Core, SCI
Professor of Biomedical Data Science
8:30-9:20 am
Keynote: A Life-cycle Approach to Dose Finding Studies
Rajeshwari Srihdara, Ph.D.
Director of Division of Biometrics V, CDER, US FDA
9:20-10:10 am
Keynote: Determining Dose in the Era of Targeted Anticancer Agents  (Abstract)
Shivaani Kummar, MD, FACP
Professor and Director, Phase I Clinical Research Program, Division of Oncology
Stanford Cancer Institute, Stanford University
10:10-10:20 am
Session 2
Innovations in Design for Dose Selection Trials
Chair: Manisha Desai, Ph.D.
Co-Director, Biostatistics Core, SCI
Professor of Biomedical Data Science
10:20-10:40 am
Innovative Adaptive Designs with Dose Selection in Oncology Trials  (Abstract)
Tze L. Lai, Ph.D.
Co-Director, CISD
Professor of Statistics, Stanford
10:40-11:00 pm
Collaboration of Pharmacometrics and Statistics: Concentration-response MCPMod  (Abstract)
Qi-Qi Deng, Ph.D.
Senior Principle Biostatistician
Boehringer Ingelheim Pharmaceutical
11:00-11:20 am
Clinical Challenges in Dose Selection for Combination Therapy  (Abstract)
Mark D. Pegram, MD
Associate Director for Clinical Research, SCI
Susy Yuan-Huey Hung Professor
11:20-11:40 am
Simulation Studies of Two Dose Escalation Methods for Oncology Drug Combination Therapies (Abstract)
Jing Hu, Ph.D.
Associate Director of Biostatistics
11:40-12:00 pm
Combination Dose Finding Studies in Oncology: an Industry Perspective  (Abstract)
Jian Zhu
Senior Statistician
Takeda Pharmaceuticals
12:00-1:10 pm
Afternoon Program (1:00-6:00 pm)
Location: LKSC 130, Li Ka Shing Center for Learning and Knowledge (LKSC), 291 Campus Drive, Stanford, CA 94305
Session 3
Novel Clinical Trial Designs for Cancer Treatments
Chair: Lei Nie, Ph.D.
Team Leader, Division of Biometrics V, CDER, US FDA
1:10-2:00 pm
Keynote: The Future of Bayesian Clinical Trial Design  (Abstract)
Peter Mueller, Ph.D.
Professor of Statistics
University of Texas, Austin
2:00-2:20 pm
Basket and Umbrella Trial Designs in Oncology (Abstract)
Eric C. Polley, Ph.D.
Assistant Professor of Biostatistics, Mayo Clinic
2:20-2:40 pm
Addressing Tumor Molecular Heterogeneity using a Novel Clinical Trial Design - PANGEA
Daniel Catenacci, MD
Associate Director, Gastrointestinal Oncology Program
Assistant Professor of Medicine, University of Chicago
2:40-3:00 pm
Characterizing Efficacy Risk Profiles via a Bayesian Montone Concavex Model  (Abstract)
Paul Manser
Statistical Scientist, Genentech
3:00-3:20 pm
Dose Titration Algorithm Tuning (DTAT) - MTDi should supplant 'the' MTD  (Abstract)
David C. Norris, MD
Precision Methodologies, LLC
3:20-3:30 pm
3:30-5:00 pm
Panel Discussions:
Importance, Challenges, and Innovations in Dose Selection in Cancer Drug Development

Moderator: Yuan Ji, Ph.D.
Assistant VP, NorthShore University HealthSystem (NUH), and
Professor of Biostatistics (part time),
University of Chicago
Panel Members:
Neby Bekele, Ph.D., Senior VP, Gilead
Ray Liu, Ph.D., Senior Director, Takeda Pharmaceuticals
Kevin Grimes, MD, Associate Professor, SPARK, Stanford University
Steve Goodman, MD, PhD, Associate Dean of Clinical and Translational Research, Stanford University
Lei Nie, Ph.D., Team Leader, Division of Biometrics V, CDER, US FDA
Naitee Ting, Ph.D., Director, Biostatistics and Data Sciences, Boehringer-Ingelheim Pharmaceuticals Inc.
5:00-6:00 pm
Reception and Mix