SCIENTIFIC PROGRAMS AND ACTIVITIES

OVERVIEW

Recent advances in molecular biology promise biomarkers that may establish diagnosis, indicate prognosis, predict therapeutic response, and provide insights into disease etiology. Advances in our understanding of cancer biology, in molecularly targeted therapies, and pharmacogenomics make it possible for personalized/precision medicine, while presenting new challenges for the design and analysis of clinical trials for new targeted agents. Tissue and blood (DNA, plasma, serum) samples are now frequently collected with clinical trials; urine and saliva are collected less frequently. Sometimes collections are sequential during therapy or follow-up. We are beginning to understand the challenges arising from different biomarker assessment modalities, and the importance of laboratory quality assurance measures. We have seen paradigm shifts in monitoring and utilizing toxicity data, away from collection solely for the purpose of investigational drug safety, to certain toxicities as surrogate indicators of drug efficacy, or as arising from pharmacogenetics. These new toxicity indicators imply a different approach to designing and delivering targeted therapy. Recent initiatives to increase clinical and scientific research lead to a concomitant need for increased statistical research beginning with designs for collecting high dimensional complex data, handling missing data, possibly longitudinally.

The one and a half day (Bio)Statistics Workshop in biomarker and drug co-development aims to educate researchers about emerging developments in statistical designs and analyses for clinical trials and translational research, as well as to identify open statistical problems for which attendees will consider organizing research proposals. International experts will provide an introduction to biomarker data and an overview of current design, analysis, and reporting principles with issues for research. Workshop participants will solidify their knowledge about the current state of the field(s); have opportunities to network, to identify knowledge gaps, and to propose research initiatives that will be the focus of a full grant application which will globally enhance and expedite biomarker research.

A poster session and Round Table discussions will encourage knowledge exchange.

Speakers:

Soren Bentzen (University of Maryland),
Judy-Anne Chapman (Queen's University)
Gary Clark (Array Biopharma US),
Richard Cook (University of Waterloo)
Keyue Ding (Queen's University)
Susan Hilsenbeck (Baylor College of Medicine US),
Antje Hoering (Cancer Research and Biostatistics, US)
Krishna R (Rani) Kalari (Mayo Clinic, US),
Michael LeBlanc (SWOG Statistical Center, US)
Longhai Li (University of Saskatchewan)
Lisa McShane (NCI US),
Olli Saarela (McGill University)
Richard Simon (NCI US)

Program

Final List of Workshop Participants

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