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Published by: SMI Publishing, Ltd
Published: Mar. 14, 2007
Table of Contents
- Day One
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals.
- 9.10 USE OF SURROGATE BIOMARKERS AS A COMPANION DIAGNOSTIC
- Advantages for the Pharmaceutical industry in clinical trials
- Companion diagnostic approach for BPH therapy
- Large cost and time savings with accurate biomarkers
- Favorable regulatory environment means faster to market
- Herbert Fritsche, Professor, Laboratory Medicine and Chief, Clinical Chemistry Section, MD Anderson Cancer Center & Chairman, Scientific Advisory Board, Health Discovery Corporation.
- 9.50 UNRAVELING THE COMPLEXITIES OF CANCER
- You have to understand cancer first - one cell at a time
- Is finding good quality biomarkers easier said than done?
- Data-driven model extraction and simulation to identify drug MoA and biomarkers
- Case study: selecting the optimal multi-kinase inhibitor for cancer treatment
- Gene expression data versus proteomics. What is more valuable?
- The next step in personalised medicine?
- Colin Hill, CEO, Gene Network Sciences.
- 10.30 Morning Coffee
- 10.50 ASSAY VALIDATION FOR SUCCESSFUL BIOMARKER MEASUREMENT
- A look at the laboratory aspects of Biomarker analysis for quantitative assays.
- Overview of Biomarker Assay “Issues”
- Choice of Laboratory & scientific consensus
- AAPS - LBABFG Biomarker Committee
- Validation recommendations
- Case Studies
- John Allinson, Director, Veeda CR Ltd.
- 11.30 BIOMARKER STRATEGIES AND ASSAY DEVELOPMENTS FOR CANCER THERAPEUTICS
- Lessons learnt from Herceptin
- Matching clinical development with Biomarker needs
- Where are the bottle necks in the technologies
- Protein-based versus molecular technologies
- Andreas Strauss, Head PDx Portfolio Management, Biomarker Program Oncology, Roche Diagnostics GmbH.
- 12.10 MICRORNA BIOMARKERS IN CANCER
- Measuring microRNAs in physiology and disease
- MicroRNAs: A novel group of key regulatory molecules
- MicroRNAs and Cancer
- Locked Nucleic Acids: Perfectly matched for microRNA detection
- Søren M. Echwald, Vice President, Business Development, Exiqon.
- 12.50 Networking Lunch
- 1.50 CONTEXTUAL THERAPEUTICS FOR CANCER
- From early discovery to phase I trials - a look at Chk1 inhibitors
- Molecular discovery and early preclinical results
- Methodologies, technologies and biochemical pathways
- Considerations when choosing preclinical models
- Phase I study design and patient recruitment
- Preparing for phase I - a phase 0 study
- Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals.
- 2.30 OBSTACLES IN DEVELOPING CLINICALLY USEFUL BIOMARKER TESTS
- Important considerations and practical approaches
- Which biomarker (or biomarkers) should be used?
- Designing a detection test with clinical value
- What tissue/fluid should be tested? - considering ease of collection,
- value, storage and efficacy
- Method of detection, ease of use and storage
- Clinical value versus cost
- Andrew Hughes, Director, Discovery Medicine, Cancer & Infection, AstraZeneca.
- 3.10 Afternoon Tea
- 3.30 RESPONSE PREDICTION AND COMPOUND DIFFERENTIATION IN KINASE DRUG DISCOVERY
- From Oncology Discovery to Early Development: varying responses to a multi-targeted tyrosine kinase inhibitor: EGFR/ Her family, VEGFR3/Flt4 and Src family kinase inhibitor
- Response prediction to the multi-targeted tyrosine kinase inhibitor, MTKI (an EGFR/ Her family, VEGFR3/Flt4 and Src family kinase inhibitor) using peptide arrays
- Matthias Versele, Scientist, Oncology Discovery & Early Development, Johnson & Johnson.
- 4.10 TISSUE ANALYSIS AND THE DEVELOPMENT OF PHARMACODYNAMIC END POINTS FOR NEW CANCER DRUGS
- Determination of the maximal effective dose is essential for targeted compounds
- New approaches using serial tumour biopsies are possible in phase I studies
- Novel quantitative multiplex digitised assays based on histochemistry are now available
- Determination of pharmacodynamic endpoint will speed up development times
- Similar strategies will be used to discover predictive biomarkers of response
- Karol Sikora, Scientific Director, Medical Solutions and Professor of Cancer Medicine, Medical Solutions Plc.
- 4.50 Chairman’s Closing Remarks and Close of Day One
- Day Two
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Bas van der Baan, Director, Business Development, Agendia BV.
- 9.10 MOLECULAR TESTS IN DISEASE MANAGEMENT - BEING MEANINGFUL IS WHAT COUNTS
- Patient benefit and economical value - current examples and future direction
- Testing for HER-2/neu
- Diagnostic implications for HIV patient management
- The promises of biomarkers
- Predictive medicine - why does It make sense in oncology?
- The theranostics approach
- Hans-Juergen Arens, Manager Medical & Scientific Development, Europe, Middle East & Africa, Abbott Gmb H.
- 9.50 THE USE OF CANCER BIOMARKERS IN THE DECISION MAKING PROCESSES IN CLINICAL TRIALS
- Important considerations the design of the trial
- Understanding variability
- - Human variation
- - Tumour variation
- Diagnostic development
- Recruiting the ‘right’ patients
- Peter Shaw, Director, Oncology, Merck & Co..
- 10.30 Morning Coffee
- 10.50 A NEW BIOMARKER SIGNATURE FOR PROSTATE CANCER
- Identifies clinically significant prostate cancer, AUC > 94%
- SVM/RFE pattern recognition tools were essential to discovery
- The beginning of the end for PSA?
- The future of cancer testing: multiple biomarker expression signatures
- Stephen Barnhill, Chairman & Chief Executive Officer, Health Discovery Corporation.
- 11.30 BIOMARKERS IN EARLY CLINICAL DEVELOPMENT OF NOVEL ANTICANCER THERAPEUTICS
- Goals of Biomarkers in Early Phase Clinical Trials (pharmacodynamic and safety biomarkers)
- Development of novel biomarker assays prior to starting Early Phase Clinical Trials
- Application of biomarkers during the Phase II clinical development
- Michael Lahn, Medical Advisor, Eli Lilly .
- 12.10 PET IMAGING IN CLINICAL TRIALS
- How far we have come, where we need to go
- Practical aspects of PET in Oncology Imaging
- Emerging Criteria for determination of response
- Challenges of obtaining reliable quantitative data
- Using PET/CT in Clinical Trials
- Design and Limitations of PET in Multi-center Trials
- Eric Perlman, Director, Molecular Imaging and Biomarkers, Radpharm.
- 12.50 Networking Lunch
- 1.50 IMAGING ENDPOINTS IN CLINICAL DEVELOPMENT
- Identifying and developing novel approaches and challenges to implementation
- An overview of currently accepted and standardised imaging methodologies
- A review of technical developments that can challenge standardised implementation
- A review of emerging technologies that can potentially inform drug development
- How do we develop and validate new techniques?
- Philip Murphy, Director, Clinical Research and Development, Pfizer.
- 3.10 Afternoon Tea
- 3.30 BIOMARKERS IN THE CLINICAL DEVELOPMENT OF HKI-272
- An irreversible-binding inhibitor of the ErbB receptor tyrosine kinases
- A brief description of the in vitro and in vivo preclinical activity of HKI-272
- Summary of preliminary phase I data
- Identification of predictive and efficacy biomarkers for clinical development
- Challenges faced in applying biomarker strategy, and opportunities for improvement
- Sridhar Rabindran, Associate Director, Oncology, Wyeth.
- 4.10 VALIDATING YOUR CANCER BIOMARKER
- Overcoming challenges in the efficacy testing of your cancer agent
- Ensuring specificity
- Dosages and side effects
- Janusz Jankowski, , University Of Oxford.
- 4.50 Chairman’s Closing Remarks and Close of Conference
AbstractEffective use of biomarkers at each stage of R&D can improve decision-making, increase clinical trial success rates and productivity and allow earlier stop/go decisions to be made, eliminating waste of resources, which can otherwise be re-deployed.
Companies taking advantage of and making best use of biomarkers in R&D are reaping the rewards of gaining the competitive edge.
Designed to focus specifically on oncology, The SMi Group's Cancer Biomarkers Conference is an excellent opportunity for you to learn from industry leaders about how they are applying biomarkers to expedite cancer detection, drug discovery and development.
Our excellent panel of speakers includes:
- Andreas Strauss, Head PDx Portfolio Management, Biomarker Program Oncology, Roche Diagnostics GmbH.
- Dr Stephen Barnhill, Chairman & Chief Executive Officer, Health Discovery Corporation
- Dr Herbert Fritsche, Professor, Laboratory Medicine and Chief, Clinical Chemistry Section, MD Anderson Cancer Center & Chairman, Scientific Advisory Board, Health Discovery Corporation
- Dr Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals
- Dr Hans Winkler, Senior Director, Functional Genomics, Johnson & Johnson
- Dr Peter Shaw, Senior Director, Clinical Oncology, Merck Research Laboratories
- Professor Andrew Hughes, Worldwide Clinical Director, Discovery Medicine, AstraZeneca Oncology
- Dr Philip Murphy, Director, Clinical Research & Development, Pfizer
- Dr Sridhar K Rabindran, Associate Director, Oncology Research, Wyeth
- Dr Paul McSheehy, Senior Research Investigator & Lab Head, Oncology Research, Novartis Pharma
- Dr Hans-Juergen Arens, Manager, Medical & Scientific Development, Europe, Middle East & Africa, Abbott
The programme will be led by a panel of international experts, including:
By attending, you will benefit from hearing about:
- UNRAVELLING the complexities of cancer
- PREDICTIVE response markers in oncology
- USING biomarkers as a novel tool in the diagnosis and treatment of cancer
- WHERE the bottle necks lie in technology applications
- TISSUE ANALYSIS and the development of pharmacodynamic end points for new cancer drugs
- OVERCOMING obstacles in developing clinically useful biomarker tests
- HOW cancer biomarkers can aid the decision-making process
- VALIDATING your cancer biomarker
- AND much more!
Get Full Details About This Report >>
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