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Register by July 20th and save up to $300!


5:00-6:00pm Early Registration



7:30am Registration & Morning Coffee


8:30 Welcome to Toronto
Christian Burks, Ph.D., President & Chief Executive Officer, Ontario Genomics Institute
8:40 Chairperson’s Opening Remarks

Robert Phillips, Ph.D., Chief Operating Officer, Ontario Institute for Cancer Research 
Keynote Presentation
J. Carl Barrett, Ph.D., Global Head, Biomarker Development Oncology, Novartis Institutes for BioMedical Research
Featured Presentation
9:30 Overview of Biomarkers: What Needs to be Done to Identify New Ones and Validate Them
Samir M. Hanash, M.D., Ph.D., Director, Molecular Diagnostics Program, Fred Hutchinson Cancer Research Center 
Innovative strategies are needed for biomarker discovery and validation that parallel the approach to therapeutics. A collaborative approach to biomarker discovery using standardized tissue and biological fluid specimens, ideally collected as part of clinical trials, has the potential to fast-track biomarker discovery and panel development. Case studies of biomarker discovery and validation in the context of cohort studies will be presented.

10:00 Colorectal Adenomas: A Prototype for the Use of Surrogate End Points in the Development of Cancer Prevention Drugs
Gary J. Kelloff, M.D., Special Advisor, Cancer Imaging Program, National Cancer Institute, National Institutes of Health 
Focusing cancer preventive drug development efforts on precancerous lesions such as colorectal adenomatous polyps (a prototype intraepithelial neoplasm, IEN) can reduce costs and accelerate development of new cancer preventive drugs. Adenomas of the colon can serve as both risk markers and clinical end points, since they are part of the process of neoplastic progression, not just a biomarker of it. Examples of IEN conferring high risk for progression to cancer are colorectal adenomas, breast DCIS, oral dysplasia, high-grade PIN, Barrett oesophagus, and dysplastic nevi. Risk of progression is best estimated by combining IEN with other risk markers/factors. Demonstrating long-term drug safety is the toughest challenge for chemoprevention drug development. Target populations for cancer prevention drugs are asymptomatic and may take the drugs for many years, thus little toxicity can be tolerated.

10:30 Poster Session, Exhibit Viewing and Coffee Break


11:10 Chairperson’s Remarks
Robert Phillips, Ph.D.

Featured Speaker
11:15 Proteomic Technologies for Cancer Research: A Strategic Plan for Translating Discoveries to the Clinic

Henry Rodriguez, Ph.D., MBA, Director, Clinical Proteomic Technologies for Cancer, Office of Technology and Industrial Relations, Office of the Director, National Cancer Institute 
Implemented in research laboratories across the globe, proteomic technologies have provided a wealth of information on the mechanisms underlying cancer. Yet in order to complete the bridge from discovery to the patient, proteomic platforms, reagents and data analysis must be brought up to rigorous clinical standards. The National Cancer Institute has taken a leading role in facilitating the translation of proteomics from research to clinical application, through its Clinical Proteomic Technologies Initiative for Cancer. A three-part strategy for the advancement of clinical proteomic technologies that perform consistently across platforms, instruments and laboratories will be outlined.
11:45 A Fully Integrated Approach to Biomarker Discovery, Validation, and Screening: Is it Possible?
Paul Domanico, Ph.D., President, Paul Domanico Consulting LLC 
12:15pm Luncheon Workshop 

Sponsored by 

Biomarker Development from Validation to Clinical Implementation

1:25 Chairperson’s Remarks
Kenneth Evans, Ph.D., President and Chief Executive Officer, Ontario Cancer Biomarker Network 
Predictive Biomarkers for Response to EGFR Therapy
If predictive biomarkers in EGFR therapy are validated prospectively, the potential impact on oncologic practice may be huge, similar to the transformative nature of using ER/PR or her2neu status to determine appropriate therapy in breast cancer. Current challenges, such as choosing the right biomarkers to validate, design and implement the appropriate validative clinical trials, and bringing the laboratory findings into the community setting, will be discussed. There will also be a focus on planned integration of clinical and biomarker information into the daily management of non-small cell lung cancer patients.
1:30 Validation Perspective: 
Ming Sound Tsao, M.D., FRCPC, Qasim Choksi Chair in Lung Cancer Translational Research, Pathologist and Senior Scientist, Professor of Laboratory Medicine and Pathobiology, Department of Pathology, University Health Network - Princess Margaret Hospital and Ontario Cancer Institute 
1:50 Clinical Perspective: 
Geoffrey Liu, M.D., M.Sc., Division of Applied Molecular Oncology, Ontario Cancer Institute 
2:10 Question & Answer Session
The Potential of Topoisomerase II Alpha Protein Overexpression (and Gene Alterations) as Predictive Markers in Breast Cancer
It has been suggested that Topoisomerase II alpha (TOP2A) gene status rather than HER2/neu status may predict response to anthracycline chemotherapy in breast cancer. However, anthracyclines directly target the topoisomerase II alpha protein during cell division. We thus assessed the predictive utility of both TOP2A gene alterations and topoisomerase protein overexpression in a clinical trial comparing an anthracycline vs a non-anthracycline regimen (NCIC MA5). TOP2A gene status was a significant predictive factor for benefit from CEF treatment for overall survival (OS). Topoisomerase II alpha protein overexpression was a predictive factor for benefit from CEF treatment for both DFS and OS. Both tests need further technical and clinical validation in other data sets to confirm these findings before they could be used in clinical practice.

2:20 Validation Perspective: 
Frances P. O'Malley MB, FRCPC, Professor, University of Toronto, Surgical Pathologist, Department of Pathology and Lab Medicine, Mount Sinai Hospital 

2:40 Clinical Perspective: 
Kathleen I. Pritchard, M.D., Head, Clinical Trials and Epidemiology, Sunnybrook & Womens College Health Sciences Center 

3:00 Question & Answer Session

3:10 Poster Session, Exhibit Viewing, and Refreshment Break 
Profiling ErbB/EGFR Isoforms in Cancer Patients
Over twenty years ago, the first studies were published detailing the utility of the epidermal growth factor receptor (EGFR) as a prognostic indicator for epithelial ovarian cancer patients. Despite EGFR’s demonstrated role in the etiology and progression of a number of cancers, sharply conflicting reports have alternatively pronounced EGFR as either useful or not useful in predicting patient prognosis and/or response to therapy. We have examined the expression of soluble (s)EGFR vs. EGFR in ovarian tumors. These studies have demonstrated that simultaneous evaluation of EGFR and sEGFR yields a robust prognostic marker, rivaling that of stage for the prediction of progression-free survival and overall survival of ovarian cancer patients. These results not only demonstrate the importance of discerning EGFR isotype in studies designed to correlate tissue/tumor EGFR expression with patient survival, but also implicate sEGFR expression as a confounding factor in the study of EGFR expression in general, for many types of cancer, and especially in the use of current methods of analyzing EGFR expression for the stratification of patients for anti-ErbB-directed therapies. Ongoing studies in both breast and ovarian cancer patients that address this question will be discussed.

3:45 Validation Perspective: 
Nita J. Maihle, Ph.D., Professor, Departments of OB/Gyn and Reproductive Sciences, Pathology and Pharmacology, Yale University School of Medicine 

4:05 Clinical Perspective: 
Andre T. Baron, M.S., Ph.D., M.P.H., Director, Biomarker Research Program, Markey Cancer Center and College of Medicine, Department of Internal Medicine, Division of Hematology, Oncology, and Blood & Marrow Transplantation, College of Public Health, Department of Epidemiology, University of Kentucky


4:25 Question & Answer Session

4:30 Technology Workshop (Sponsorship Available)

4:50 Close of Session

5:00 Buses depart for the MaRS Centre

5:30 Evening Networking Reception at the MaRS Centre 
The Ontario Genomics Institute, MaRS, and Toronto Region Research Alliance are delighted to welcome you to the “Implementation of Biomarkers in Clinical Trial Design” conference. Please join us for a Networking Cocktail Reception at the MaRS Centre in the heart of Toronto’s renowned Discovery District –Canada’s largest concentration of Biomedical research, spread across major teaching hospitals, the University of Toronto, and more than a dozen affiliated research centres. MaRS is designed to accelerate the commercialization of Canadian innovation by uniting the disparate worlds of science and technology with industry and capital in its award winning Centre and through its extensive services and programs. Guests will have the opportunity to visit the MaRS facility, be introduced to MaRS’ exciting programs, and network with conference delegates!

7:00 Buses return to Renaissance Hotel


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