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Register
by August 4th and SAVE up to $350!
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DAY ONE:
Wednesday, November 1, 2006
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7:30 Tutorial Registration
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| 8:00 AM
PRE-CONFERENCE TUTORIAL*
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"Circulating Tumor Cells as Biomarkers and Their use in Oncology Clinical Trial Design and Drug
Development"
Leon W.M.M. Terstappen, M.D., Ph.D., Senior Vice President of R&D and Chief Scientific Officer, Immunicon
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"Rationale for Inclusion of CTCs in Clinical Trials"
Monica Motwani, Ph.D., Laboratory Head for Oncology Biomarkers, Biomarkers
Development, Novartis Pharmaceuticals
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"Circulating Tumor Cells expressing IGF-1R: Method of Detection, Incidence and Potential Applications in the Development of IGF-1R Targeted
Therapy"
Candace Fuchs, Clinical Oncology Biomarker Clinician, Pfizer
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Circulating tumor cells (CTCs) and Circulating Endothelial Cells (CECs) can be detected in blood from patients with metastatic and primary carcinomas. Pivotal clinical trials have shown that the number of CTCs before treatment is an independent predictor of progression-free and overall survival in patients with metastatic breast cancer. Interim analyses of data from clinical trials in prostate and colorectal cancer appear to mirror data from the breast cancer trial. The workshop will discuss the methodologies for CTCs and CECs counting, biomarker assay development on CTCs and CECs, antisense RNA library construction from CTCs obtained from hormone-refractory prostate cancer patients, as well as global gene expression profiling of CTCs and Circulating Endothelial Cells (CECs). FISH analysis and protocols will be also
considered.
Workshop Attendees will acquire an understanding of:
- The role of Circulating Tumor Cells and Circulating Endothelial Cells in the metastatic
process.
- Current methodologies used to assay for CTCs and their clinical significance.
- Molecular Profiling and FISH analysis of CTCs.
- Designing clinical trials that Incorporate CTCs as biomarkers.
- The rationale for incorporating CTCs in clinical trial designs.
- Method of detection, incidence and potential applications in the development of IGF-1R targeted therapy.
Leon W.M.M. Terstappen, M.D., Ph.D., Senior Vice President of R&D and CSO, is an internationally recognized authority on hematopoietic cell differentiation and analysis. Prior to joining Immunicon in October 1994, Dr. Terstappen was Associate Scientific Director with Becton Dickinson’s Immunocytometry Division, responsible for BD’s research in experimental hematology. Dr. Terstappen is the author of more than eighty peer-reviewed articles as well as the inventor or co-inventor of 30 issued US patents, including patents that formed the basis of Abbott’s Cell-Dyn Hematology Analyzer. Dr. Terstappen holds a Ph.D. in Applied Physics from Twente University, The Netherlands, and an M.D. from Groningen University Medical School, The Netherlands.
Monica Motwani, Ph.D., Laboratory Head for Oncology Biomarkers, Biomarkers Development, Novartis Pharmaceuticals, is internally regarded as an expert for cellular assays development for Oncology indications. Prior to joining Novartis, Dr. Motwani was Senior Research Scientist in Department of Medicine, Memorial Sloan Kettering Cancer Center. The primary focus for Dr. Motwani’s research was to preclinically develop CDK inhibitors in combination with cytotoxics for treatment of gastrointestinal malignancies. Dr. Motwani is the author of more than fifteen peer-reviewed articles.
Candace Fuchs, Ph.D., is Clinical Oncology Biomarker Clinician with Pfizer. Her experience covers the transition of drug candidates from discovery to clinical development in the areas of breast and lung cancers. Candace Fuch’s research expertise is in immunology, molecular biology and high-throughput screening.
11:00 Close of Pre-Conference Tutorial
* Separate registration required
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EXECUTIVE FORUM
11:30 Executive Forum
Registration
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11:30
Chairperson’s Opening Remarks
Christian Burks, Ph.D., President & Chief Executive
Officer, Ontario Genomics Institute |
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| KEYNOTE
PRESENTATIONS |
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11:45pm Changing the Late Stage
Development Paradigm: Enhancing Benefit/Risk and Data Transparency
Alan Breier, M.D., Vice President for Medical and Chief Medical
Officer, Eli Lilly and Company
- Understand new approaches to
post-launch benefit/riskassessment
- Demonstrate a drug development model that combines Phase II and
Phase III, and relies mores heavily on Phase IV
- Discuss new approaches to data access and transparency, including a
status report on clinical trial registries
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12:15 Clinical Sciences Integration: The
Impact Ten Years from Now
Lionel Edwards, M.B.B.S., F.F.P.M., Director, Medical Affairs,
Novartis Pharmaceuticals
- Can the past produce a vector of
directions into the future?
- Impact of current and new emerging
technologies on clinical study programs
- Impact of new biomarkers on proof of
concept and approval metrics
- Impact of new animal models based on
genetic knock out techniques
- Will AI have any impact by them?
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| 12:45
Luncheon |
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Generating and Managing Biomarker Data
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Chairpersons: Kenneth Evans, Ph.D., President and Chief Executive Officer, Ontario Cancer Biomarker Network, and Robert Phillips, Ph.D., Chief Operating Officer, Ontario Institute for Cancer Research
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1:30
Special Guest Speaker
Update on HER-2 Directed Therapy
Dennis J. Slamon, M.D., Ph.D., Chief, Division of Hematology/Oncology, David Geffen School of Medicine, UCLA, and Director Revlon/UCLA Womens Cancer Research Program, Jonsson Comprehensive Cancer
Center
- Processes used for identification and validation of relevant clinical targets in human breast cancer using HER-2 as a paradigm
- Clinical development and clinical data generated to date from Herceptin
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2:00 How Biomarkers Are Changing the
Landscape of Drug Development
Todd Georgieff, B.Sc.Phm., M.B.A., Senior Manager, Clinical
Research Operations, Abbott Laboratories Ltd.
- New study designs and re-defining the
traditional pathway of drug development
- Implications of the new need for
collaboration among basic and clinical researchers
- Dealing with diverse technical
requirements - production, collection, processing and reporting of
data
- Recruitment and outcome issues related
to biomarker studies and the new paradigm
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2:30 Identifying Molecular Biomarkers in Blood to Identify Patients with Early-Stage Heart Failure, or Who Are at Risk
Peter P. Liu, M.Sc., M.D., F.R.C.P.C., Scientific Director, Institute of Circulatory and Respiratory Health, Canadian Institutes of Health Research (CIHR) and Professor in Medicine and Physiology, Toronto General Hospital
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| 3:00 Refreshment Break (Sponsorship Available)
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3:30 Biomarkers for Tracking DNA Repair within Radiotherapy Clinical Trials
Robert G. Bristow, M.D., Ph.D., F.R.C.P.C., Head, Prostate Clinical Research Program and Clinician-Scientist, Applied Molecular Oncology and Radiation
Medicine, Ontario Cancer Institute-Princess Margaret Hospital, University of Toronto
Biological targeting using molecular-targeted agents in combination with radiotherapy can decrease DNA repair in tumour tisues as compared to normal tissues. In response to DNA damage, human cells delay their progression through cell cycle checkpoint responses and activation of DNA double-strand break (DNA-dsb) repair complexes (e.g. DNA-PK, RAD51 and BRCA1/2 proteins). Increasingly, there are a number of molecular strategies that target each of these pathways using siRNA, antisense, small molecule inhibition or novel pharmacologics. Hypoxic cells can have decreased rates of homologous recombination (HR), potentially allowing for novel hypoxia-targeted therapies. Although exciting in concept, clinical trials for many DNA repair-targeted agents are in their infancy. Clinical trials using such agents will require novel correlative endpoints to track DNA repair foci in oxic and hypoxic tumour tissues to afford maximal therapeutic benefit. At the end of this talk, attendees will understand:
- The basis of DNA repair as a therapeutic target in cancer therapy
- Novel DNA repair-based agents in pre-clinical and clinical testing
- The need to track DNA repair within individual patients' normal and tumour tissues as a means to define a molecular
therapeutic ratio
- Novel DNA repair biomarkers as a means to determine the efficacy of molecular-targeted therapies
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4:00 Mass Spectrometry and Proteomics: Biomarker Discovery, Identification and Validation
K.W. Michael Siu, Ph.D., Professor of Chemistry, Chair Director, Centre for Research in Mass Spectrometry, Associate Vice-President Research, Science & Technology, York University
Current capabilities and shortcomings of mass spectrometry (MS) and proteomics in discovering, identifying and validating disease biomarkers will be discussed. Different MS and immunochemical strategies and methodologies will be outlined. Examples will be drawn from the speaker’s work on endometrial cancer biomarkers. Attendees will learn the applications of the following:
• SELDI / MALDI QqTOF MS and protein identification
• Mass-tagging with ICAT and iTRAQ reagents and isotope
dilution MS
• Biomarker validation by immunohistochemistry and tissue
microarrays
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4:30 Linking Biomarker Data with Cancer Cooperative Group Clinical Trials
Ralph M. Meyer, M.D., Director Designate, National Cancer Institute of Canada Clinical Trials Group and Queen’s University
Improved understandings of the molecular basis of cancer have resulted in the development of new anti-cancer therapies through the targeting of molecular mechanisms. These mechanisms are exemplified by the development of biomarkers that identify key processes in the pathogenesis of different forms of cancer. Biomarkers may be used to develop hypotheses upon which new clinical trials are based, to provide evidence supporting biologic activity of new anti-cancer agents, to prognosticate outcomes for subpopulations with a given tumour, to predict treatment efficacy in subgroups, and to develop new hypothesis for future study. These various objectives have implications for study design and conduct, specimen collection, and eventual analyses. To meet these objectives requires special considerations when trials are conducted by cooperative groups.
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What are the linkages between biomarkers and clinical
trials?
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How do these linkages influence the overall conduct of clinical
trials?
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What are the special issues for trials conducted by cooperative groups?
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STUDY KEYNOTE |
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5:00 Strategies for New Cancer Biomarker
Identifications
Eleftherios P. Diamandis, Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Department of Clinical Biochemistry,
University Health Network and Toronto Medical Laboratories, Ontario Cancer Biomarker
Network and Department of Laboratory Medicine and Pathobiology, University of Toronto
There is tremendous interest in discovering new biomarkers for cancer diagnosis, prognosis, prediction of therapy and monitoring disease progression. Recently, various genomic, proteomic, bioinformatic, mass spectrometric and microarray strategies have been applied for biomarker discovery. In this presentation, I will outline these general strategies, as well as their advantages and pitfalls. I will further stress the importance of biomarker validation after the discovery phase. After the session, the attendees will be able to:
- Appreciate why there is so much interest in cancer biomarkers
- Develop general strategies for discovering cancer biomarkers
- Determine the advantages and disadvantages of these methods
- Understand the current state-of-the art
- Ascertain what needs to be done in order to bring these new biomarkers to clinical practice
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5:30 INTERACTIVE PANEL
- What does biomarker validation mean?
- How do you design clinical trials using surrogate endpoints?
- How do you analyze subsets of patients?
- How do you use biomarkers in pivotal studies?
- Who is going to do pharmacogenomic studies?
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6:00 Networking Cocktail Reception
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Sponsored by
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7:00 PM Close of Day One
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