Program
All times are in Pacific time. Short courses will be hybrid.
Wednesday May 10
Thursday May 11
- 7:45 AM-8:20 AM Light Breakfast
- 8:30 AM-8:45 AM Opening Remarks
Brian Druker, M.D., Director OHSU Knight Cancer Institute
- 9:00 AM-9:45 AM Keynote Session 1: One Statistician's View of the Important Contributions of Statisticians to the Past 50 Years of Oncology Clinical Trials
Scott S. Emerson, University of Washington
- 10:00 AM-11:30 AM Invited Session 1: Big Data and its Use in Cancer Research
- Chair: Ying Lu, Professor of Biomedical Data Science (Biostatistics), Radiology, and Health Research and Policy, Stanford University
- Big Data in Oncology
George Sledge, CMO for Caris - Genomic, Big data
- Validation of Predictive Analyses for Interim Decisions in Clinical Trials
Lorenzo Trippa, Associate Professor of Biostatistics, Harvard School of Public Health
- Advancing Precision Oncology with Large-Scale Real-World Clinico-Genomics Data
Ruishan Liu, Postdoctoral Scholar, Stanford University
- Use of Large Datasets to Facilitate Statistical Modeling for Addressing Complex or Difficult Breast Cancer Research Questions
Yisheng Li, Professor, Department of Biostatistics, Division of Basic Science Research, The University of Texas MD Anderson Cancer Center, Houston, TX MD Anderson
- 11:45 AM-12:45 PM Poster viewing; Lunch will be provided
- 12:45 PM-2:00 PM Invited Session 2: Translational Research in Cancer Immunology
- Chair: Li Zhang, Professor of Biostatistics, UCSF
- High dimensional analysis of the circulating immune response in biliary tract cancer reveals suppressive monocytes associated with anti-PD-1 resistance
Bridget Keenan, MD, PhD, Assistant Professor, Division of Hematology/Oncology, UCSF
- The Utility of Clinical Biomarkers in Advancing Oncology Therapeutic Molecules from Phase 1 Studies to Regulatory Approval
Nathan Standifer, PhD, Executive Director, Translational Science, Tempest Therapuetics
- TCR-L: An Analysis Tool for Evaluating the Association between the T-Cell Receptor Repertoire and Clinical Phenotypes
Chad (Qianchuan) He, PhD, Associate Professor, Fred Hutch
- 2:00 PM-2:30 PM Special Session
- Gordon B. Mills, M.D., Ph.D.
- 2:45 PM-4:00 PM Invited Session 3: Panel Discussion-Decentralized Clinical Trial Design and Real-World Evidence in Oncology Research
- Chair: Jie Chen, ECR Global
- Co-Chair: Ying Lu, Stanford University
- Panelists:
- Jing Zhao, PhD, Merck, ASA/FDA Real-World Working Group,
- Hana Lee, PhD, CDER, FDA, ASA/FDA Real-World Working Group,
- Weili He, PhD, Abbvie, ASA/FDA Real-World Working Group,
- Sammi Tang, PhD, Servier, DIA/Oncology Methodology Group
- 4:15 PM-5:30 PM Invited Session 4: Dose-Finding and Dose-Optimization in Oncology Drug Development Beyond Statistics
- Chair: Hao Zheng, Associate Director, Beigene
- Clinical Pharmacology Based Strategies to Change the Dosing Paradigm for Oncology Products
Jeanne Fourie Zirkelbach, Clinical Pharmacologist Team Lead, PhD, CDER, FDA
Ye Xiong, PhD, Pharmacometrics Reviewer, FDA
- Is There a ‘Right’ Dose?
Shivaani Kummar,Oregon Health & Science University
- Discussant: Jonathon Vallejo, FDA
Friday May 12
- 7:45 AM-8:20 AM Light Breakfast
- 8:30 AM-9:40 AM Keynote Session 2: Dose Optimization of Early Phase Clinical Trials
Patricia LoRusso, D.O., Yale Cancer Center
- 9:55 AM-11:25 AM Invited Session 5: Trial Design for Rare Diseases/Childhood Cancer
- 11:25 AM Poster Lightning Talks & Award Session
- 11:40 AM-12:55 PM Lunch will be provided
- 1:00 PM-2:30 PM Invited Session 6: Strategies to Impact Diversity in Cancer Clinical Trials
- Chair: Susan Tannenbaum, UConn Health
- The Problem of URM Representation in Cancer Clinical Trials
Joseph M. Unger, PhD, MS, Fred Hutchinson Cancer Center, Public Health Sciences Division; Seattle, WA
- What Gets Measured Gets Done. Performance Measurement of Pharmaceutical Companies in Equity of Drug Approval and Access
Jennifer E. Miller, PhD,Associate Professor, Yale School of Medicine, President, Bioethics International, Director, Good Pharma Scorecard
- Improving Access and Equity in Clinical Research
Eneida R. Nemecek, MD, MS, MBA, Nancy Jaggar Blount Endowed Professor of Pediatrics & Medical Oncology, Medical Director of Clinical Research, Knight Cancer Institute
- Pharmaceutical Company Strategies to Enhance Representation of Urm in Cancer Clinical Trials
Pierre Theodore, MD, Executive Director Health Equity, Genentech–Roche, Clinical Associate Professor of Cardiac Surgery, Stanford University School of Medicine
- 2:45 PM-4:30 PM Invited Session 7: Platform Design: Lessons Learned and the Future
Saturday May 13