December  4, 2023

Workshop on Statistical Issues in Biomarker and Drug Co-development
November 7-8, 2014
Fields Institute, 222 College Street, Toronto

Organizing Committee:

Judy-Anne Chapman, Keyue Ding, Bingshu Chen,
Mike McIsaac (Queen's University);
Lei Sun (University of Toronto);
Lehana Thabane, Greg Pond (McMaster University);
Wenqing He (University of Western Ontario);
Robert Platt, Celia Greenwood (McGill University);
Karen Kopciuk (University of Calgary);
Yan Yuan (University of Alberta);
Steven McKinney (British Columbia Cancer Agency);
Qian (Michelle) Zhou (Simon Fraser University)
Pre-registration is required for this Workshop:
Deadline October 31, 2014.
Regular registration $200 and Student registration $50
includes refreshment breaks, 1 dinner, 1 continental breakfast, and 1 lunch.
Abstract submissions
Reimbursement information for funded participants
Program Information for speakers
Housing and Hotels Map to Fields


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.


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)


Friday, November 7th:
Overview Tutorial Lectures on Biomarker Data
12:00 - 5:30 pm Registration on-site  
12:30 - 1:15 pm Refreshments
Potential Speaker
1:15-1:30 pm Welcome
1:30-2:00 pm

Biomarker Data 101 (Slides)

Judy-Anne W Chapman, (recently retired from)
NCIC Clinical Trials Queen's University Group

2:00-2:30 pm

Introduction to Microarray Data (Slides)

Longhai Li, University of Saskatchewan
2:30-3:30 pm Reporting and evaluation of studies of biomarkers and omics-based predictors: the REMARK guidelines and the NCI Omics Checklist (Slides) Lisa McShane, NCI, US

3:30-4:00 pm Tea Break
4:00-5:00 pm Extensions of BRB-Array Tools Richard Simon, NCI, US

5:00-5:30 pm Reception
5:30-7:30 pm Networking Dinner
Saturday, November 8th
Poster presentation throughout day - special category for students with SSC level support for travel.
8:00 am-3:30 pm Registration on-site
8:00-8:30 am Continental Breakfast
Potential Speaker
8:30-9:00 am Randomized Phase III Clinical Trial Designs for Targeted Therapies (Slides) Antje Hoering, CRAB, US
9:00-9:30 am Statistical Methods in Early Drug Development of Targeted Therapies: A Day in the Life of an Industry Statistician (Slides) Gary Clark, Array Biopharma, US

9:30-10:00 am Prognostic and Predictive Markers: What's the Difference and why should I care? (Slides)
Susan Hilsenbeck, Baylor College of Medicne
10:00-10:30 am Coffee Break
10:30-11:00 am Some experience with biomarker Driven cancer clinical trials (Slides) Michael LeBlanc, Group Statistician, SWOG Statistical Center &
Fred Hutchinson, Cancer Research Center
11:00-11:30 am TBA Soren Bentzen,
University School of Medicine
11:30am-12:00 pm Pharmacogenomics of Aromotase Inhibitors with musculoskeletal adverse events and bone fractures phenotypes (Slides)
Kishna R.(Rani) Kalari, Mayo Clinic

12:00-1:00 pm Lunch on site and poster viewing
1:00-1:30 pm Case-base sampling for fitting and validating prognostic models (Slides) Olli Saarela, University of Toronto
1:30-2:00 pm Predictive gene signature selection for Chemotherapy in early stage non-small cell lung cancer patients (Slides)

Keyue Ding, NCIC Clinical Trials Group, Queen's University


2:00-2:30 pm Variable selection and the assessment of predictive accuracy with interval-censored responses (Slides) Richard Cook, University of Waterloo

2:30-3:00 pm Tea Break (Poster Viewing)
3:00-4:30 pm Networking Group Discussions Towards
Full CANSSI grant proposal topics (TBA)

Round Tables around Thematic Areas: Discussions led by Workshop Leadership

Final List of Workshop Participants

Full Name University/Affiliation
Bentzen, Søren M. University of Maryland School of Medicine
Blais, Mathieu the Lunendeld-Tanenbaum Research Institute
Bramhecha, Yogesh McGill University
Bull, Shelley Lunenfeld-Tanenbaum Research Institute
Caetano, Samantha-Jo McMaster University
Camacho, Fernando DAMOS Inc
Chapman, Judy-Anne Queen's University
Chen, Bingshu Queen's University
Clark, Gary Array BioPharma Inc.
Cook, Richard J. University of Waterloo
Ding, Keyue Queen's University
Ennis, Marguerite  
Espin Garcia, Oswaldo University of Toronto
Gambaro, Karen McGill
Ghaffari, Abdi Queen's University, Cancer Research Institute
Gill, Bethany University of Waterloo
Greenwood, Celia Lady Davis Institute
Hilsenbeck, Susan G. Lester and Sue Smith Breast Cancer Center
Hoering, Antje Cancer Research and Biostatistics (CRAB)
Huszti, Ella UHN
Jiang, Haiyan University of Toronto
Kalari, Krishna Mayo Clinic
Kong, Qin University of Waterloo
Kopciuk, Karen AHS/U Calgary
Laforte, Veronique McGill University
Lafreniere-Roula, Myriam Dalla Lana School of Public Health
Le, Lisa Princess Margaret Cancer Centre, University Health Network
LeBlanc, Michael Fred Hutcinson Cancer Research Center
Lee, En-shiun University of Waterloo
Li, Longhai University of Saskatchewan
Li, Suzanne UHN
Li, Terry Queen's University
Lim, Lily iHPME
Lokku, Armend University of Toronto
Lou, Wendy University of Toronto
Lu, Yan ICES
Luo, Bin University of Western Ontario
Maganti, Manjula Princess Margaret Cancer Care
McGregor, Kevin McGill University
McIsaac, Michael Queen's University
McKinney, Steven British Columbia Cancer Research Centre
McShane, Lisa M. National Institute of Health
Nadon, Robert McGill University
Oweida, Ayman McGill University
Parpia, Sameer McMaster University
Parulekar, Wendy Queen's University
Platt, Robert McGill University
Pond, Gregory McMaster University
Saarela, Olli University of Toronto
Sabelnykova, Veronica Ontario Institute for Cancer Research
Simon, Richard National Institute of Health
Song, Yuyao University Health Network
Su, Jie Princess Margaret Cancer Centre
Sung, Yubin University of Guelph
Talhouk, Aline University of British Columbia
Vakaljan, Stephanie  
Xu, Changchang Lunenfeld-Tanenbaum Research institute
Xu, Wei Princess Margaret Cancer Centre
Yao, Zhan ICES
Yuan, Yan University of Alberta
Zhao, Bangxin Western University
Zhou, Qian Simon Fraser University

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