Sorry! But this conference has already taken place.
To learn more about our latest event, Biomarkers Summit 2011, please click on the link below:
Biomarkers Summit 2011
Monday 31st January & Tuesday 1st February 2011
Crowne Plaza City, Central London, UK
Additionally for information on our Personalised Medicine 2010 event, please click on the link below:
Personalised Medicine 2010
For information about the 2010 Biomarkers Summit, please see below...
“Well organised with a good list of speakers from multiple areas relevant to biomarkers.”
Paul Atherfold, Senior Translational Scientist, UCB-Celltech
The pharmaceutical industry is facing uncertain times amidst the global recession and with clinical trial success rates sliding and costs rapidly increasing, more and more companies are turning to biomarkers to maximize their return on investment.
SAE Media Group’s third Biomarkers Summit brings together experts from all over the world to allow you to investigate the multitude of topics that surround the biomarkers field. It also provides an unsurpassed opportunity to interact with global industry leaders and facilitates a free flow of information between delegates by providing networking opportunities.
Covering a range of topics relating to biomarker discovery, validation and quantification, there will also be a strong focus on current, relevant case studies that deliver real world and useful information.
For sponsorship opportunities please email sponsorshipdept@SAE Media Group-online.co.uk
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By the end of the conference, you will walk away with novel techniques to aide discovery and commercialisation and a greater understanding of the licensing and regulatory issues facing the biomarker industry.
- Learn about the latest ground breaking biomarker discoveries
- Focus on discovery, validation and qualification
- Understand personalised medicine, clinical research & innovative strategies
- Case studies with real life data and a strong take home message
Karol Sikora
Medical Director
CancerPartnersUK
Kaïdre Bendjama
Biomarker Expert & Laboratory Head
FIRALIS SAS
Conference agenda
Drivers of Personalized Medicine
Introduction to Benchmarking Model
Consideration of Why Targeted Therapies Require Different Drivers
Explanation of Model Drivers
Introduction to Financial Metrics in Personalized Medicine
Consideration of Necessity of Differential Resource Requirements
Explanation of Financial Metrics
Chairman's Opening Remarks
Jack Schalken, Professor of Experimental Urology, Radboud University Nijmegen Medical Centre
MOLECULAR MARKERS FOR PROSTATE CANCER
Jack Schalken, Professor of Experimental Urology, Radboud University Nijmegen Medical Centre
The unmet clinical need for biomarkers in prostate cancer
PCA3 from discovery to clinical practise
TMPRSS2-erg gene fusions in prostate cancer
INTEGRATING DRUG AND DIAGNOSTIC DEVELOPMENT
Errin Lagow, Technical Communications Manager, Asuragen
Understanding timelines
When to engage a Diagnostic Partner
Single Biomarkers vs Gene signatures
Assessing risk and mitigating risk
ANTI-IFNa THERAPY IN RHEUMATIC DISEASES
Laura Richman, Vice President, R&D, Medimmune Inc
Translational science and its impact on drug development
Unveiling the common molecular signatures to dissect the involvement IFNα in disease pathogenesis of myositis
Case study: developing pharmacodynamic and potential diagnostic biomarkers for anti-IFNα therapy in SLE
SOMATIC MUTATIONS AS ONCOLOGY BIOMARKERS
Barbara Parsons, Research Microbiologist, National Center For Toxicological Research, US Food and Drug Administration
Allele-specific competitive blocker PCR (ACB-PCR) measurement of tumour-associated mutation
Use in assessing chemical carcinogenicity
Defining normal and pathological levels of K-RAS mutation in human tissues
Implications of "normal" levels of tumour-associated mutations in human tissues
Niklas Mattsson, MD, PhD-student, Institute of Neuroscience and Physiology The Sahlgrenska Academy at Sahlgren’s University Hospital
Translation from diagnosis to prevention and progression
Using cerebrospinal fluid proteins in research
Biomarkers to complement clinical diagnostics with disease-modifying drugs
Standardising assays across multiple study sites in order to optimise sensitivity and specificity
COMBINING OPEN PLATFORM AND TARGETED APPROACHES FOR PROTEIN BIOMARKER DISCOVERY AND DEVELOPMENT
Huw Davies, Business Development Director, Pronota
Analytical requirements for plasma protein biomarker discovery
Study design and technology considerations for discovery and verification stages
Bridging the gap between discovery and clinical implementation
Case study: Discovery and validation of novel biomarkers for the diagnosis of acute heart failure
TECHNOLOGIES FOR IDENTIFYING NOVEL TOXICITY BIOMARKERS IN UNEXPECTED ORGANS
Philip Hewitt, Head of Molecular Toxicology, Merck KGaA
Toxicity biomarkers in non-clinical assessment
Looking past immunohistochemistry, immunoblot, and RT-PCR analysis methods to define localisation and expression
Translating from animal to human models
Case study: Returning to materials from previously completed diagnostic procedures as a novel and effective biomarker discovery method
BIOMARKER DISCOVERY & VALIDATION
Janna Sand-Dejmek, Senior Scientist Biomarkers, Ortho Biotech, Oncology Research & Development
Introduction to biomarkers
Classifications, how biomarkers differ to drugs
Biomarkers in clinical trials: practical issues
Case study: Developing biomarker assays to improve cancer treatment
CAPTURE COMPOUND MASS SPECTROMETRY
Mathias Dreger, Head of Biology, caprotec bioanalytics GmbH
Unbiased discovery of protein targets of small molecules
Unravelling of MoA of small molecules in all relevant tissues
Uncovering key protein-players in drug action
BIOMARKERS OF CHEMICAL STRESS AND CELLULAR DAMAGE IN DRUG-INDUCED LIVER INJURY
Neil French, Senior Scientific Operations Manager, Liverpool University
Using paracetamol as a paradigm hepatotoxin to investigate the mechanisms of hepatotoxicity
Mechanisms and biomarkers of chemical stress and adaptation
Development of serum biomarkers to monitor necrosis, apoptosis and inflammation
REGULATORY BIOMARKER QUALIFICATION FROM AN INDUSTRY PERSPECTIVE
David Laurie, Regulatory Policy Expert, DRA Management, Novartis Pharma
What is Regulatory Biomarker Qualification and why do we need it?
Case study: Using the VXDS process as a Pilot for renal safety Biomarker Qualification
New (pilot) processes at Regulatory agencies for Biomarker advice and data review
Regulatory Documentation for Biomarker Qualification
Chairman’s Closing Remarks and Close of Day One
Chairman's Opening Remarks
Mark Fidock, Associate Director, Head of Molecular Biomarkers, Experimental Biological Sciences, Pfizer
SAFE-T CONSORTIUM & BIOMARKER QUALIFICATION
Kaïdre Bendjama, Biomarker Expert & Laboratory Head, FIRALIS SAS
The SAFE-T Consortium of the Innovative Medicines Initiative
Qualification of kidney, liver and vascular biomarkers for clinical contexts
Challenges of clinical biomarker qualification and challenges to overcome them
DEVELOPING PROOF-OF-PHARMACOLOGY BIOMARKERS
Mark Fidock, Associate Director, Head of Molecular Biomarkers, Experimental Biological Sciences, Pfizer
Utilization of Biomarkers in early clinical drug development
Development of techniques to successfully identify Biomarkers linked to the therapeutic mechanism; enabling PK/PD
Case study of assays for immune modulation in pre/clinical species and in man
PREDICTIVE ONCOLOGY BIOMARKERS
Miro Venturi, Director Biomarker and Experimental Medicine, Roche Pharmaceuticals
Translating oncology biomarkers into clinical decisions
Using biomarkers to identify the appropriate target population: values and challenges of prospective vs. retrospective biomarker assessments
Co-development of drug and diagnostic: combining tools and drug-focussed biomarker approaches to implement an appropriate companion diagnostic strategy
Case study: TBC
TISSUE-BASED IMAGING IN CANCER
William Gallagher, Associate Professor of Cancer Biology, University College Dublin
Reducing 'omic' datasets to clinical utility
Looking into the future: Immunohistochemistry in clinical management
Advent of automated image analysis approaches in histopathology
Case studies in breast and lung cancer
QUALITY ASPECTS IN BIOMARKER EVALUATION BY IMAGE ANALYSIS
Andreas Edelmann, Pharma Development Quality Assurance (PDQA GCP Auditing), Roche
Validation procedures in image capture
Standardization of image analyzing procedures to cope with reader bias
Measures to improve data validity
Lessons learned from image analyzing service provider audits in academia and CROs
DATA INTERPRETATION AND VALIDATION OF IMMUNOHISTOCHEMISTRY ASSAYS FOR USE IN CLINICAL TRIALS
Gregory Stella, Director, Translational Diagnostics, Ventana Medical Systems Inc
Observer variation
Data types and scoring algorithms
Analytical validation
Assessing effects of pre-analytical variables
BIOMARKER USES AND THE FUTURE
Karol Sikora, Medical Director, CancerPartnersUK
Background and industry overview
Key opportunities in biomarker discovery, development and commercialisation
Development of biomarkers for drug safety and efficacy
Case study: Novel biomarker assay performance in challenging clinical conditions where traditional diagnostic tests are weak
BIOMARKER USES IN DETERMINING TOXICITY AND ASSAY DEVELOPMENT IN NEPHROLOGY
Thomas Herget, Senior Director R&D New Technology Evaluation Performance & Life Science Chemicals, Merck KGaA
Developing assays
Fitness for use & process validation
Case study: Nephrotoxicity
PREDICTIVE BIOMARKERS FOR MENTAL HEALTH CONDITIONS
Franco Di Cesare, Department of Psychiatric Sciences and Psychological Medicine, University Of Rome La Sapienza
Prediction of drug treatment outcome in MDD
Evidentiary standards, MDD disease model and surrogate endpoint qualification
Validated surrogate endpoints for treatment drug outcome in MDD
Case study: memory measures as surrogate endpoints in MDD drug clinical trials
Chairman’s Closing Remarks and Close of Day Two
Workshops
Crowne Plaza Hotel - St James
3 February 2010
London, United Kingdom
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