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SMi Group is proud to announce their 4th annual Biomarkers Summit...

It is now clear that the use of biomarkers is an integral part in the future of medicine. With rising development costs and a declining rate of new drug discovery, pharmaceutical companies are now incorporating biomarker strategies into all new R&D processes.

With the industry currently realising the benefits to be had from joint R&D projects and key collaborations, it is now estimated that the Biomarker market value will reach over $12.8 Billion dollars by 2012.

Likewise the level of innovation in Biomarker applications and translational science is seeing increasingly rapid growth. With new discoveries being made in every therapeutic category, Biomarkers are promising to drive forward new drug discovery, companion diagnostics, and to wholly improve patient outcomes.
 

 

 
Keen to see the detailed programme? Click here.
Want to download the brochure?  Click here.
Want to register your place? Click here.

  

Why not attend the associated workshop as well?

Associated with the conference there will be a half-day workshop on "Fit for Purpose Biomarkers: From Bench to Bedside", taking place on the 2nd February.
 
This highly interactive workshop will highlight the nature and requirements of the different classes of biomarkers, the technologies most suited to developing biomarkers, and discuss case studies of biomarker development and implementation which will help illuminate the key issues which can arrive during the journey from bench to bedside.
 
This will be led by Eric Culbert, the Executive Director of BioScience Innovations Ltd. To see more information about the workshop, please see the workshop page
 

 

 

 

Conference highlights include;

  • Two distinct presentation streams covering Oncology, and also Immunology & CNS
  • 27 expert speakers providing key insights into current Biomarker R&D
  • New developments in Biomarker Discovery, Validation, and Qualification
  • Stratification Biomarkers in Personalised Medicine
  • Pharmacology Biomarkers and PK/PD modelling  
  • The application of informatics to Biomarker development

 

 

 
You should attend this event if you are involved in;
  • Biomarker Discovery, Validation, and Qualification
  • Cancer, Immunology, or CNS Biomarker R&D
  • Discovery Biomarkers
  • Translational Science
  • Proteomics/Genomics/Metabolomics
  • Clinical Pharmacology
  • Experimental Medicine
  • Biostatistics and Bioinformatics
  • Early Clinical Development
  • Preclinical Development
  • Drug Metabolism
  • Pharmacokinetics/Pharmacodynamics (PK/PD)
  • Personalised Medicine
  • Drug and Safety Assessment
 
 
 
Previous year’s attendees included representatives from the following companies:
  • Roche Diagnostics
  • Genzyme
  • Astellas
  • Merck Serono
  • UCB-Group
  • Amgen
  • Cancer Research UK
  • Bayer Schering
  • Pfizer
  • Johnson & Johnson
  • Millennium Pharmaceuticals
  • Eisai
  • Plus many other delegates from CROs, CTOs, biotechs and academia

 

Conference programme

8:30 Registration & Coffee

9:00 Click here to expand programme

 

STREAM ONE

BIOMARKERS IN ONCOLOGY

 

 

STREAM TWO

BIOMARKERS IN IMMUNOLOGY AND CNS

 

9.00  Chairman's opening remarks

Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson

          9.00  Chairman's opening remarks

Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer

 

 9.10     APPLICATION OF PHARMACODYNAMIC MARKERS OF NEDD8 PATHWAY INHIBITION TO ASSESS MLN4924 ACTIVITY IN PHASE I TRIALS

  • MLN4924 is a first-in-class small molecule inhibitor of NEDD8 activating enzyme that has shown potent antitumor activity in pre-clinical models
  • A panel of pharmacodynimc markers have been developed to assess NEDD8 pathway activity in blood, skin and tumours of patients
  • MLN4924 has demonstrated pharmcodynamic inhibition of NEDD8 pathway in patients at well tolerated doses in Phase I testing

    Peter Smith, Senior Scientist II, Oncology, Millennium Pharmaceuticals

  •  

     9.10     IDENTIFICATION AND CHARACTERISATION OF CANDIDATE BIOMARKERS FOR A NOVEL KINASE INHIBITOR FOR TREATMENT OF AUTOIMMUNE DISEASES

  • Approaches taken to identify novel candidate markers for a kinase inhibitor in autoimmune disease
  • Profiling of markers in model systems
  • Characterisation of markers in ex vivo-treated healthy and diseased human tissue samples
  • Future plans

    Andrew Payne, Senior Group Leader, Cellular Sciences, UCB

  • 9.50     PRECLINICAL CANCER MODELS USED IN DRUG DISCOVERY AND TRANSLATIONAL ONCOLOGY
  • In vivo models in oncology
  • The merit of translating observations and end-points from pre-clinical models
  • Future models including primary explants and transgenics

    Robert Wilkinson, Principal Scientist II, AstraZeneca

     

  •  

     

    9.50     DEVELOPING PROOF-OF-PHARMACOLOGY BIOMARKERS 
     

  • Enabling early predictions using PK/PD
  • 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

    Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer

  •  10.30     SURVEYING SIGNALING NETWORKS AND POST-TRANSLATIONAL MODIFICATIONS IN CANCER BY PTMSCAN™ 

  • LC-MS/MS identification of disease associated Post-Translantional Modifications by PTMScan™
  •  
  • Investigation of signaling networks and kinase hierarchies in disease
  • Biomarker discovery in the Phosphoproteome

     John-David Herlihy, Product Specialist, Cell Signaling Technology

  •  

     

     

    10.30     BIOMARKERS FOR INHALED ANTI-INFLAMMATORY THERAPIES – SAMPLING THE LUNG 

  • Pre-clinical dose and duration of action prediction for inhaled anti-inflammatory therapies is challenging
  • There is a key strategic need to assess compound modulation of the target and subsequent anti-inflammatory efficacy early in clinical development
  • Various methods have been assessed for sampling the lung directly
  • Whole lung activity may also be assessed by methods such as spirometry and using imaging techniques
  • Examples of the above techniques will be discussed and challenges highlighted

     Iain Kilty, Director Allergy and Respiratory Research Unit, Pfizer

  •  

    11.10      Morning coffee

     

     

    11.10      Morning coffee

     

    11.30      LARGE-SCALE PROTEOME PROFILING OF BREAST AND COLORECTAL TUMOURS

  • Quantitative high-resolution mass spectrometry allows identification of new candidate biomarkers directly at protein level
  • Genome scale protein expression profiles may define new subtypes of cancer
  • Orthogonal validation methods confirm the results obtained by mass spectrometry while DNA arrays often show only weak correlation with protein abundance in micro dissected tumours

    Metodi Metodiev, Director of Proteomics Unit, University of Essex

  •  

     

    11.30      FINDING THE PATTERNS: EXECUTING AND INTERPRETING A BIOMARKER PROGRAM 

  • RBM’s consultative biomarker approach using its experience and database
  • Study design for maximum information at minimum cost
  • Biomarker and matrix selection for improved statistical outcome
  • Compare results to large database for increased study power
  • Strong data mining capabilities

    Emanuel Schwarz, Rules Based Medicine

  •  

    12.10      TRI-FUNCTIONAL CAPTURE COMPOUNDS: A NEW ROUTE IN FUNCTIONAL PROTEOMICS TO TARGET BIOMARKER-RELEVANT PROTEINS

  • Small molecule-protein-interaction based enrichment of functional subproteomes
  • Gain of sensitivity through photo-activated cross-link
  • Profiling of protein classes of whole cells
  • Targeting of receptors and ion channels
  • Drug mode of action and biomarker discovery applications possible

    Mathias Dreger, Head of Biochemistry, Caprotec

  •  

     

    12.10       TRANSLATIONAL BIOMARKERS IN THE DEVELOPMENT OF NOVEL ANALGESIC DRUGS

  • Attrition in analgesic drug development - Failures in forward or backward translation?
  • (Non-)overlapping realms of targets, biomarkers, models, symptoms and patients
  • Forward translation of an ion channel blocker - An example

    Ge Ruigt, Director Experimental Medicine, Merck

  • 12.50      Networking lunch

     

     

     

    12.50      Networking lunch

     

     

    1.50     DISCOVERY AND APPLICATION OF PREDICTIVE BIOMARKERS FOR MAGE-A3 CANCER IMMUNOTHERAPY

  • Biomarker discovery in early stage trials in cancer immunotherapy
  • Biological significance of predictive biomarkers in cancer immunotherapy
  • Challenges in clinical validation and application of predictive biomarkers

    Fernando Ulloa-Montoya, Head of Molecular Biology Technology Group, GlaxoSmithKline Biologicals

  •  

     

    1.50      NON-FLUID BIOMARKERS

  • Animal models as preclinical biomarkers of target engagement, mechanism, and efficacy
  • The use of imaging to monitor disease progression and treatment efficacy
  • Benefits of integrating information from non-fluid and fluid biomarkers

    Karen Asin, Director, Translational Pharmacology, Takeda

  •  

    2.30       USE OF PROTEOMICS TO DISCOVER CELL SURFACE MARKERS OF APOPTOSIS

  • Omics approaches in the discovery of universal biomarkers of cell death
  • Applications in diseases
  • Transcriptional profiling - Proteomics, glycomics and metabolomics to identify biomarkers of cell death.
  • Subsequent biomarker validation

    Huseyin Mehmet, Director of Exploratory Biomarkers, Diabetes, Merck

  •  

     

    2.30     BIOMARKER RESEARCH IN DEPRESSION: PART I

  • Biobanking - Getting high quality samples from key populations
  • Using a hypothesis driven approach
  • Bioinformatics: Text mining to characterize potential biomarkers and the biologies to which they are linked

    Mette Jensen, Translational Medicine Scientist, Lundbeck

  •  

    3.10      Afternoon tea

     

     

    3.10      Afternoon tea

     

    3.40      APPLICATION OF BIOMARKERS IN EARLY DEVELOPMENT

  • Phase I trial design
  • PD markers for decision making at the phase II interface
  • Predictive markers for patient selection

    Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson

  •  

     

    3.40       BIOMARKER RESEARCH IN DEPRESSION: PART II 

  • Crossroads in depression
  • Gene expression profiling
  • Analysis tools: Mathematical modelling, algorithms and classifiers
  • Biological fingerprints for depression

    Jennifer Larsen, Translational Medicine Scientist, Lundbeck

  •  

    4.20      URINARY BIOMARKERS IN THE CLINICAL PROGNOSIS AND EARLY DETECTION OF ACUTE KIDNEY INJURY (AKI)

  • The SAFE-T project and Drug-Induced Kidney Injury (DIKI)
  • Case study - Novel urinary biomarkers
  • Urinary biomarkers may improve the ability to detect early AKI and determine the clinical prognosis of AKI at the time of diagnosis.

    Patrick Murray, Professor of Clinical Pharmacology, University College Dublin (UCD)

  •  

    4.10       EXPERIMENTAL NEUROSCIENCE - BETTER INTEGRATION OF NOVEL DISCOVERIES IN CLINICAL TRIALS 

  • Biomarkers in cognition
  • Disease targets in the brain
  • Molecular imaging of the human brain

    Jens Mikkelsen, Senior Scientist, Neurosearch A/S

  •  

    5.00  Chairman’s closing remarks and close of day one

     Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson

     

     

         4.50      Chairman’s closing remarks and close of day one

    Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer

       

     

     

    Hans Winkler

    Hans Winkler, Senior Director Translational Research, Oncology, Johnson and Johnson

    Mark Fidock

    Mark Fidock, Associate Director, Pfizer

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Huseyin  Mehmet

    Huseyin Mehmet, Director Exploratory Biomarkers, Merck Research Laboratories

    9:10 ISSUES IN STATISTICAL VALIDATION OF BIOMARKERS AS SURROGATE ENDPOINTS IN CLINICAL TRIALS

    Ziad Taib

    Ziad Taib, Statistical Science Director, AstraZeneca

  • The usefulness of biomarkers at various stages of clinical drug development
  • Biomarkers as surrogate endpoints
  • Issues in establishing the validity of a biomarker as a surrogate endpoint using statistical techniques
  • Improper validation can have severe consequences
  • Case study: Some examples related to cardiovascular diseases 
  • 9:50 CREATION OF BIOMARKER EVIDENCE MAPS TO ENABLE EXPLORATORY DEVELOPMENT

    Ann Hastings

    Ann Hastings, Translational Scientist, Astellas

  • Selection of biomarkers based on scientific qualification and method validation
  • Prioritisation of biomarkers and harnessing knowledge in a transparent way
  • Informed internal decision making in multidisciplinary development teams
  • 10:30 STRATIFICATION BIOMARKERS FOR DISEASE POPULATIONS IDENTIFY UNDERLYING MECHANISMS OF DISEASE

    Renee Kenney

    Renee Kenney, Senior Scientific Director, Selventa

  • Specific Patient-derived Interactive Disease Relevant (SPIDR) models using patient data and innovative analytics
  • SPIDR models are interactive, dynamic and reusable and are designed to address key scientific challenges
  • Identifying biomarker panels for patient stratification based on underlying mechanisms driving the disease
  • A mechanistic understanding of individual patient’s disease, and simulated portfolio outcomes
  • Value includes; Evidence-driven identification and validation of mechanisms linked to specific disease outcomes, combination therapies to maximize response, and stratification biomarker panels
  • 11:10 Morning Coffee

    11:30 THE APPLICATION OF INFORMATICS TO BIOMARKER DEVELOPMENT

    Hugh Salter

    Hugh Salter, Principal Scientist, AstraZeneca

  • Background to biomedical informatics in clinical drug development
  • Biomarkers for personalised healthcare
  • Integrating modelling and simulation into translational programs
  • Support for biomarker discovery, development and validation via data mining
  • Case studies for both efficacy and safety
  • 12:10 BIOSTATISTICS CHALLENGES OF BIOMARKER IDENTIFICATION FOR PERSONALISED MEDICINE

    Andreas Schuppert

    Andreas Schuppert, Director, Applied Sciences, Bayer Technology Services

  • Impacts of biodiversity and heterogeneous protocols on predictivity of complex biomarkers noise suppression by genome-scale analysis of expression patterns from micro-arrays
  • Quantification of the stability of biomarker performance by genome-scale pattern analysis
  • Concepts for the identification of tumour biomarkers to support
  • Translational medicine using retrospective data sources
  • 12:50 Networking Lunch

    13:50 PERSONALISED MEDICINES: TURNING PROMISE INTO REALITY

    Louise Leong

    Louise Leong, Head of R&D, Association of the British Pharmaceutical Industry (APBI)

  • Challenges for developing personalised medicine approaches
  • Opportunities in the UK
  • Implementing a unified UK strategy
  • 14:30 RAPID BIOMARKER VALIDATION AND DEVELOPMENT IN TRANSLATIONAL RESEARCH

    Hayley Whitaker

    Hayley Whitaker, Research Associate, University of Cambridge / Cancer Research UK

  • Development of a robust pipeline within an academic research environment
  • Using high throughput immunohistochemstry on human tissue as a biomarker validation tool
  • Developing urine-based ELISA’s for clinical use
  • Making the most of collaborations between academia the NHS, biotech and pharma
  • 15:10 BIOMARKERS FOR CHRONIC HCV - PREDICTING RESPONSE TO THERAPY

    Matthew Albert

    Matthew Albert, Director of Immunology, Institut Pasteur

  • New biomarkers for response to therapy in patients with Chronic HCV
  • In vitro assays to mimic the mechanism of action of in vivo therapeutics
  • Novel insight into disease pathogenesis and the immune dysregulation that occurs during chronic inflammation
  • 15:50 Afternoon Tea

    16:10 NEW AND INNOVATIVE AND WAYS OF CONDUCTING BIOMARKER R&D

    Shawnmarie Mayrand-Chung

    Shawnmarie Mayrand-Chung, Program Director, Biomarkers Consortium, National Institutes of Health (NIH)

  • Improving the rate of new biomarker drug discovery
  • Modelling and monitoring the effectiveness of personalised treatment in real time
  • Safety biomarkers: Collaborative efforts for moving forward at a faster pace
  • 16:50 STRATIFICATION BIOMARKERS IN PERSONALISED MEDICINE

    Jean-Luc Sanne

    Jean-Luc Sanne, Scientific Officer, European Commission

  • The development of stratification biomarkers is a vital concept
  • Biomarkers should be referenced in clinical guidelines
  • Need to improve disease knowledge and apply appropriate technology to increase biomarkers specificity and sensitivity of the companion diagnostic tests
  • Validation and qualification of biomarkers and clinical and laboratory procedures are fundamental issues for the development of proper companion diagnostic tests
  • Interaction between all stakeholders is necessary at early stages of drug development
  • Stratification biomarkers should be identified and qualified at early stages of drug development
  • 17:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Fit for Purpose Biomarkers: From Bench to Bedside
    Workshop

    Fit for Purpose Biomarkers: From Bench to Bedside

    Crowne Plaza - The City
    2nd February 2011
    London, United Kingdom

    Crowne Plaza - The City

    19 New Bridge Road
    London EC4V 6DB
    United Kingdom

    Crowne Plaza - The City

    HOTEL BOOKING FORM

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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, SMI 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@smi-online.co.uk

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