"Clinical Trials in the Era of Personalized Medicine"
This two day symposium will consist of an interdisciplinary series of presentations centered around clinical trials and personalized medicine. Biostatisticians, clinical scientists, computational biologists and statistical geneticists will describe recent advances ranging from practical aspects to methodological developments in four scientific sessions covering the following topics:
| Challenges in Developing Targeted Therapies | Stephen George, Duke |
| Adaptive Clinical Trial Designs | Sin-Ho Jung, Duke |
| Comparative Effectiveness and Big Data | Joseph Ibrahim, UNC |
| Dynamic Treatment Regimes | Eric Laber, NC State |
Also, during Day One:
- Workshop on Personalized Medicine and Dynamic Treatment Regimes
- Poster Session and Reception
This symposium will be of interest to clinical trial practitioners in industry and academia as well as others who have interest in recent and future directions in clinical trials and personalized medicine. We also hope the presentations and accompanying discussions will initiate future discoveries and progress in these important areas.
Date: Thursday, November 1st and Friday, November 2nd, 2012
Agenda
Day 1 (Thursday, November 1, 2012)
Workshop on Personalized Medicine and Dynamic Treatment Regimes
7:30-8:00AM Continental Breakfast
8:00-11:30AM Workshop (Marie Davidian, Eric Laber, and Anastasios Tsiatis, NC State; and Michael Kosorok, UNC) [Description]
11:30-1:00PM Lunch (not provided)
Scientific Program
1:00-1:10PM Welcome and Introduction
1:10-2:40PM Session I: Challenges in Developing Targeted Therapies; org. by Stephen George, Duke
1:10-1:40PM Speaker 1: Howard L. McLeod, UNC,
"Pharmacogenomics: discovery is necessary, but not sufficient"
1:40-2:10PM Speaker 2: Kouros Owzar, Duke,
"Challenges in genome-wide association analysis of drug-induced toxicity data from clinical trials"
2:10-2:40PM Speaker 3: Richard Simon, NCI,
"Development of Predictive Biomarkers for Molecular Targeted Therapy" [Abstract]
2:40-2:50PM Short Break
2:50-4:20PM Session II: Adaptive Clinical Trial Designs; org. by Sin-Ho Jung, Duke
2:50-3:20PM Speaker 1: Shein-Chung Chow, Duke,
"Benefits, Challenges, and Obstacles of Adaptive Clinical Trial Designs"
3:20-3:50PM Speaker 2: Daniel J. Sargent, Mayo Clinic,
"Biomarker-based clinical trials"
3:50-4:20PM Speaker 3: Anastasia Ivanova, UNC,
"Oncology phase II trials with ordinal outcome"
4:20-4:30PM Short Break
4:30-6:30 Poster session and reception (with snacks)
6:30PM Dinner (not provided)
Day 2 (Friday, November 2, 2012)
7:30-8:00AM Continental Breakfast
8:00-9:30AM: Session III: Comparative Effectiveness and Big Data; org. by Joseph Ibrahim, UNC
8:00-8:30AM: Speaker 1: Constantine Gatsonis, Brown,
"Clinical Evaluation of Diagnostic Tests and Biomarkers in CER"
8:30-9:00AM: Speaker 2: William Carpenter, UNC,
"Data needs for cancer comparative effectiveness research, and the Integrated Cancer Information and Surveillance System"
9:00-9:30AM: Speaker 3: Georgiy Bobashev, RTI,
"Prediction of the Best Treatment Assignment Using Random Forest with Regression in the Nodes"
9:30-9:40AM: Short Break
9:40-11:10AM Session IV: Dynamic Treatment Regimes; org. by Eric Laber, NC State
9:40-10:10AM Speaker 1: Rui Song, NC State,
"Penalized Q-Learning for Dynamic Treatment Regimes"
10:10-10:40AM Speaker 2: Daniel Almirall and Susan A. Murphy, U. Michigan,
"Getting SMART about developing individualized sequences of health interventions"
10:40-11:10AM Speaker 3: Kristin Linn, NC State,
"IQ-Learning"
11:10-11:20AM Closing remarks and scientific session adjourns
Speakers
Daniel Almirall, PhD, Faculty Research Fellow, Institute of Social Research, University of Michigan "Getting SMART about developing individualized sequences of health interventions"
Georgiy Bobashev, PhD, Senior Research Statistician, RTI International "Prediction of the Best Treatment Assignment Using Random Forest with Regression in the Nodes"
William Carpenter, PhD Assistant Professor, UNC-Chapel Hill Department of Health Policy and Management "Data needs for cancer comparative effectiveness research, and the Integrated Cancer and Surveillance System"
Shein-Chung Chow, PhD, Professor, Duke University Department of Biostatistics and Bioinformatics and Professor of Clinical Sciences, Duke-NUS Graduate Medical School in Singapore "Benefits, Challenges, and Obstacles of Adaptive Clinical Trial Designs"
Constantine Gatsonis, PhD, Henry Ledyard Goddard University Professor of Biostatistics, Chair of the Department of Biostatistics, and Director of the Center for Statistical Sciences, Brown University "Clinical Evaluation of Diagnostic Tests and Biomarkers in CER"
Anastasia Ivanova, PhD Associate Professor, UNC-Chapel Hill Department of Biostatistics "Oncology phase II trials with ordinal outcome"
Kristin Linn, PhD Student, NCSU Department of Statistics "IQ-Learning"
Howard L. McLeod, PharmD, Fred Eshelman Distinguished Professor of Pharmacogenomics and Individualized Therapy, UNC Eshelman School of Pharmacy and Director, Institute for Pharmacegenomics and Individualizes Therapy, UNC-Chapel Hill "Pharmacogenomics: discovery is necessary, but not sufficient"
Susan A. Murphy, PhD, H.E. Robbins Professor of Statistics & Professor of Psychiatry, and Research Professor, Institute for Social Research, University of Michigan "Getting SMART about developing individualized sequences of health interventions"
Kouros Owzar, PhD, Assistant Professor, Duke University Department of Biostatistics and Bioinformatics "Challenges in genome-wide association analysis of drug-induced toxicity data from clinical trials"
Daniel J. Sargent, PhD, Professor of Biostatistics and Professor of Oncology, Mayo Clinic "Biomarker-based clinical trials"
Richard Simon, PhD, Chief, Biometric Research Branch, National Cancer Institute "Development of Predictive Biomarkers for Targeted Therapies"
Rui Song, PhD, Assistant Professor, NCSU Department of Statistics "Penalized Q-Learning for Dynamic Treatment Regimes"