2016 Program Agenda

The draft program agenda is subject to change. Please note that faculty names will be added as they are confirmed.

Monday, May 2, 2016

8:00 AM – 8:30 AM
Registration and Continental Breakfast

 

8:30 AM – 10:00 AM
Welcome and General Session 1: Introduction

 

Jan Bogaerts, PhD – Chair

European Organisation for Research and Treatment of Cancer

 

Lisa McShane, PhD

National Cancer Institute at the National Institutes of Health

Welcome and Overview: What the Faculty expects from Participants

                                     

P. Mickey Williams, PhD

Leidos Biomedical Research, Inc./Frederick National Laboratory for Cancer Research

Assay Development and Validation 

 

Jan Bogaerts, PhD

European Organisation for Research and Treatment of Cancer

Basic Statistical Issues in Marker Development


Sabine Tejpar, MD, PhD

University of Leuven

Introduction to Challenges

 

Question and Answer 

 

10:00 AM – 10:15 AM
Break

 

10:15 AM – 12:00 PM
General Session 2: General Principles

 

Scott Kopetz, MD – Chair

The University of Texas MD Anderson Cancer Center

 

Lisa McShane, PhD

National Cancer Institute at the National Institutes of Health

Clinical Trial Designs 


Michael Sachs, PhD

National Cancer Institute at the National Institutes of Health

Statistical Principles for Omics-Based Biomarker Studies 


Lyndsay Harris, MD

National Cancer Institute at the National Institutes of Health

Overview of Process of Translating Biomarkers into Clinical Practice with Case Study: NCI-MATCH Study


Scott Kopetz, MD

The University of Texas MD Anderson Cancer Center

Case Study: Circulating Biomarkers


Question and Answer 

 

12:00 PM – 1:15 PM
Challenge Group Breakout: Introductory Session
(Lunch provided)

 

1:15 PM – 2:30 PM
General Session 3: Regulatory Issues


Sabine Tejpar, MD, PhD  Chair

University of Leuven

 

Gideon M. Blumenthal, MD

Food and Drug Administration

Development of Precision Therapies in the ‘Omics’ Age – FDA Oncology Perspective

 

Robert Becker, MD, PhD

Food and Drug Administration

U.S. Regulatory Aspects of Molecular IVD Development 

 

Jorge Martinalbo, PharmD, PhD

European Medicines Agency

EMA Perspective 

 

Question and Answer 

 

2:30 PM – 3:50 PM
Challenge Group Breakout Session I

(Refreshments Provided)


3:50 PM – 5:30 PM
General Session 4: Connecting Biology to Clinical Advances: Companion Diagnostics, Novel Trial Designs, Resistance Evaluations

 

Lillian Siu, MD, FASCO  Chair

Princess Margaret Cancer Centre


Marisa Dolled-Filhart, PhD

Merck & Co, Inc.

Case Study: PD-L1 Companion Diagnostics

 

Shirin Khambata-Ford, PhD

Merck & Co, Inc.

Blueprint Multi-Partner Initiatives: Towards Facilitating Implementation of Precision Medicine

                               

Peter O'Dwyer, MD

University of Pennsylvania School of Medicine

Models for Personalized Medicine and Drug Development: Meeting the Needs of Patients and Research

 

Timothy Yap, PhD, MBBS, BSc, MRCP

The Royal Marsden NHS Foundation Trust

Mechanisms and Strategies to Overcome Resistance to Molecularly Targeted Therapies


Question and Answer 

 

5:30 PM – 6:30 PM
Dinner and Discussion
(Dinner provided)

 

6:30 PM – 9:00 PM
Challenge Group Breakout Session II

(Refreshments Provided)


Tuesday, May 3, 2016

7:00 AM – 8:00 AM

Continental Breakfast Provided


8:00 AM – 8:55 AM

General Session 5: Practical Issues/ Call of Reality

 

Lisa McShane, PhD  Chair

National Cancer Institute at the National Institutes of Health

 

Robert J. Kinders, PhD

National Cancer Institute at Frederick/Leidos Biomedical Research, Inc.

Development and Validation of Immunoassays: NCI Perspective


W. Fraser Symmans, MD

The University of Texas MD Anderson Cancer Center

Development of Clinical Assays: The Breast Cancer Experience

 

Question and Answer 

 

8:55 AM – 10:00 AM

Challenge Group Breakout Session III

 

10:00 AM – 11:45 AM

General Session 6: Challenge Group Presentations

 

11:45 AM – 12:00 PM

Feedback, Discussion, and Wrap-up

(To-go Lunch Provided)


Scott Kopetz, MD  Moderator

The University of Texas MD Anderson Cancer Center

 

 

 

 

Collaborating Organizations