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Biomarkers Summit
1 February - 2 February 2010
Biomarkers Summit

 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 conference

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

 


 

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

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8:30

Registration & Coffee

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9:00

Welcome & Introductions

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9:30

Drivers of Personalized Medicine

  • Introduction to Benchmarking Model
  • Consideration of Why Targeted Therapies Require Different Drivers
  • Explanation of Model Drivers
     
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    10:45

    Coffee Break

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    11:00

    Financial Metrics

  • Introduction to Financial Metrics in Personalized Medicine
  • Consideration of Necessity of Differential Resource Requirements
  • Explanation of Financial Metrics
     
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    12:15

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Jack Schalken

    Jack Schalken, Professor of Experimental Urology, Radboud University Nijmegen Medical Centre

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    9:10

    MOLECULAR MARKERS FOR PROSTATE CANCER

    Jack Schalken

    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
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    9:45

    INTEGRATING DRUG AND DIAGNOSTIC DEVELOPMENT

    Errin Lagow

    Errin Lagow, Technical Communications Manager, Asuragen

  • Understanding timelines
  • When to engage a Diagnostic Partner
  • Single Biomarkers vs Gene signatures
  • Assessing risk and mitigating risk
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    10:25

    Morning Coffee

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    10:55

    ANTI-IFNa THERAPY IN RHEUMATIC DISEASES

    Laura Richman

    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
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    11:25

    SOMATIC MUTATIONS AS ONCOLOGY BIOMARKERS

    Barbara Parsons

    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
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    12:05

    Networking Lunch

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    13:05

    UNLOCKING ALZHEIMER’S

    Niklas Mattsson

    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
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    13:40

    COMBINING OPEN PLATFORM AND TARGETED APPROACHES FOR PROTEIN BIOMARKER DISCOVERY AND DEVELOPMENT

    Huw Davies

    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
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    14:15

    TECHNOLOGIES FOR IDENTIFYING NOVEL TOXICITY BIOMARKERS IN UNEXPECTED ORGANS

    Philip Hewitt

    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
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    14:50

    BIOMARKER DISCOVERY & VALIDATION

    Janna Sand-Dejmek

    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
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    15:25

    Afternoon Tea

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    15:55

    CAPTURE COMPOUND MASS SPECTROMETRY

    Mathias Dreger

    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
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    16:30

    BIOMARKERS OF CHEMICAL STRESS AND CELLULAR DAMAGE IN DRUG-INDUCED LIVER INJURY

    Neil French

    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
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    17:05

    REGULATORY BIOMARKER QUALIFICATION FROM AN INDUSTRY PERSPECTIVE

    David Laurie

    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
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    17:45

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Mark Fidock

    Mark Fidock, Associate Director, Head of Molecular Biomarkers, Experimental Biological Sciences, Pfizer

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    9:10

    SAFE-T CONSORTIUM & BIOMARKER QUALIFICATION

    Kaïdre Bendjama

    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
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    9:50

    DEVELOPING PROOF-OF-PHARMACOLOGY BIOMARKERS

    Mark Fidock

    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
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    10:30

    Morning Coffee

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    11:00

    PREDICTIVE ONCOLOGY BIOMARKERS

    Miro Venturi

    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
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    11:40

    TISSUE-BASED IMAGING IN CANCER

    William Gallagher

    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
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    12:20

    Networking Lunch

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    13:30

    QUALITY ASPECTS IN BIOMARKER EVALUATION BY IMAGE ANALYSIS

    Andreas Edelmann

    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
     
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    14:10

    DATA INTERPRETATION AND VALIDATION OF IMMUNOHISTOCHEMISTRY ASSAYS FOR USE IN CLINICAL TRIALS

    Gregory Stella

    Gregory Stella, Director, Translational Diagnostics, Ventana Medical Systems Inc

  • Observer variation
  • Data types and scoring algorithms
  • Analytical validation
  • Assessing effects of pre-analytical variables
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    14:50

    BIOMARKER USES AND THE FUTURE

    Karol Sikora

    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
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    15:30

    Afternoon Tea

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    16:00

    BIOMARKER USES IN DETERMINING TOXICITY AND ASSAY DEVELOPMENT IN NEPHROLOGY

    Thomas Herget

    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
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    16:40

    PREDICTIVE BIOMARKERS FOR MENTAL HEALTH CONDITIONS

    Franco Di Cesare

    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
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    17:20

    Chairman’s Closing Remarks and Close of Day Two

    Workshops

    The Drivers and Financial Benchmarks of Personalized Medicine

    The Drivers and Financial Benchmarks of Personalized Medicine

    Crowne Plaza Hotel - St James
    3 February 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James


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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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