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  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

 

Alternatively 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 2009 Biomarkers Summit, please see below...

“Congratulations on a great meeting. Excellent learning opportunities and fun networking”
Dr Herbert Fritsche, Professor, Laboratory Medicine & Chief, Clinical Chemistry Section, MD Anderson Cancer Centre – Delegate at SMi’s 2007 Biomarker Event
      
The pharmaceutical industry is facing high clinical development costs and declining drug discovery success rates. The importance of biomarkers is paramount when transforming drug discovery, molecular diagnostics and clinical development in the research and development process.


 

 
SMi’s Biomarkers Summit, the 2nd in the biomarkers series offers a unique opportunity to hear about the latest developments from industry leaders.  Bringing together knowledge and expertise, it’s designed to create the perfect setting for the exchange of ideas and networking opportunities.
Examine the latest developments in the biomarker research, and listen to case studies from the leading companies in the field. Discussions will include issues on the latest developments in biomarker research from discovery to validation to clinical issues.
 
 
 
 


 

 

 

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

 

 

 

 

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

  

  • Biomarkers in early clinical drug development
  • Biomarker validation
  • Protein biomarker discovery
  • Biomarkers as a diagnosis tool
  • Biomarker Assay Development
  • Imaging biomarkers
  • The implementation of pharmacogenomic biomarkers in clinical practice
  • Clinical Development in Alzheimer Disease and Multiple Sclerosis 
  • Biomarkers in Oncology Development
Vice Presidents, Heads, directors, scientists and Project Leaders of:
  • Drug and Safety Assessment
  • Biomarker Discovery/Validation
  • Diagnostics
  • Proteomics/Genomics/Metabolomics
  • Clinical Pharmacology
  • Toxicology/Toxicogenomics
  • Experimental Medicine
  • Early Clinical Development
  • Drug Metabolism/Pharmacokinetics
  • Clinical Pathology
  • Molecular and Cell Biology
  • Preclinical Development
  • Pharmacokinetics/Pharmacodynamics (PKPD)
Last 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

For Speaking opportunities please contact Rachel Francis at rfrancis@smi-online.co.uk

For Sponsorship opportunities please contact Alia Malick at amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Hartmut Heinzerling

Hartmut Heinzerling, Director Exploratory Medicine, Astellas Pharma Europe Ltd

9:10 THE USE AND USEFULNESS OF BIOMARKERS

Wil van den Hoven

Wil van den Hoven, Head Translational Sciences, Astellas Pharma Europe

  • What is it you want to address by use of a biomarker?
  • Efforts and costs required to establish the biomarker
  • “Fit for Purpose” - how critical is the biomarker for go / no go decision making?
  • Integration of biomarkers into a clinical development program
  • Feed back to Discovery – the Learn and Confirm strategy
  • 9:50 DISCOVERY AND EVALUATION OF PREDICTIVE BIOMARKERS IN EARLY DEVELOPMENT

    Hans Winkler

    Hans Winkler, Senior Director, Global Head Oncology Biomarker Research, Ortho Biotech Oncology Research & Development division of Janssen Pharmaceutica Johnson&Johnson

  • Importance of Biomarkers
  • Role of PD markers
  • Utility of predictive markers
  • Examples
  • Development path of predictive markers to companion diagnostic
  • 10:30 Morning Coffee

    10:50 HAIR BIOMARKERS - A NOVEL PLATFORM FOR CLINICAL TRIALS

    Lydia Meyer Turkson

    Lydia Meyer Turkson, Director, Biomarker Division, Epistem Ltd.

  • Single plucked hairs from patients offer an attractive, simple means of monitoring biological response in epithelial tissue
  • Epistem has a robust biomarker platform to monitor drug induced changes in mRNA expression from individual human scalp hairs
  • Epistem’s presentation will highlight the case to use hair as a  surrogate tissue for routine measurement of gene expression with case studies of preclinical and clinical models
  • 11:30 GENE EXPRESSION ANALYSIS OF BENIGN PROSTATIC HYPERTROPHY TISSUE FOR BIOMARKER DISCOVERY

    Herbert Fritsche

    Herbert Fritsche, Professor and Chief of Clinical Chemistry, MD Anderson Cancer Center, Houston Texas

    12:10 HIGH RESOLUTION AND SENSITIVITY PRE-CLINICAL IMAGING OF ISOTOPE LABELLED BIOMARKERS - BRIDGING GAPS AND ENABLING TRANSLATIONAL RESEARCH

    York Haemisch

    York Haemisch, Vice President Imaging Technologies, Bioscan Europe

  • high resolution SPECT/CT and PET/CT enable to visualize and quantify biomarkers in rodents with the same accuracy as in humans
  • MMP™-SPECT and high sensitivity PET allow dynamic studies of biomarker distribution with seconds timing resolution
  • Ability to image I-125 labelled biomarkers with NanoSPECT/CT™ helps to bridge in-vitro to in-vivo gap
  • Imaging platform of NanoSPECT/CT™ and NanoPET/CT™ with common animal handling system and software represents versatile and high quality platform for biomarkers research
  • 12:50 Networking Lunch

    13:50 HIGH CONTENT IMMUNOASSAYS -- THE QUEST FOR MEANINGFUL BIOMARKER PATTERNS

    Sabine  Kuesters

    Sabine Kuesters, Director European Operations, Rules-Based Medicine Inc

  • Proteomics Using Known Biomarkers - rapid movement from discovery to the clinic
  • Quantitative and Reproducible - confidence in subtle changes across cohorts
  • Small Sample Volume - retrospective and prospective studies
  • 14:30 FROM DISCOVERY TO PHASE I CLINICAL TRIALS: MLN8054 and MLN8237, NOVEL, ORAL AURORA A KINASE INHIBITORS FOR THE TREATMENT OF CANCER

    Mark Manfredi

    Mark Manfredi, Associate Director, Oncology, Millennium Pharmaceuticals

  • Understanding the PK/PD/efficacy relationship in pre-clinical models
  • Investing in target, pathway and terminal outcome markers
  • Predicting an efficacious human dose/exposure
  • Translating pre-clinical markers to the clinical setting
  • 15:10 PERSONALIZED HEALTHCARE: BIOMARKERS AND DIAGNOSTIC CO-DEVELOPMENT FOR CANCER THERAPEUTICS

    Stefan Scherer

    Stefan Scherer, Senior Biomarker Program Leader ANGIOGENESIS, Roche Pharmaceuticals

  • BM strategies enable Translational Medicine, Target discovery and selection of compounds
  • Impact of BM on clinical development
  • Co-development of companion diagnostics
  • 15:50 Afternoon Tea

    16:20 IDENTIFICATION OF CANDIDATE BIOMARKERS USING MODELING AND SIMULATION

    Ananth Kadambi

    Ananth Kadambi, Senior Scientist, Entelos

  • Entelos has developed large-scale mathematical models of human pathophysiology (PhysioLabÒ platforms) to support collaborative research
  • PhysioLab platforms have been applied to identify novel candidate biomarkers of efficacy, safety, and prognosis in a number of key therapeutic areas
  • Methodologies for novel candidate biomarker identification
  • Specific case studies to illustrate the application of the methodology in the context of CV disease and rheumatoid arthritis
  • 17:00 GENERATING GENE SIGNATURES FROM A PAIR OF OLD SOCS

    Matthew Sleeman

    Matthew Sleeman, Director of Biology , Medimmune Ltd

  • Development of biomarkers using molecular biology
  • Generation of ex-vivo pharmacodynamic assays for antibody therapies
  • CASE study using SOCS3 to characterise the pharmacodynamics of CAM-3001, an antibody to the GM-CSF receptor
  • Use of Microarrays technology to identify gene signatures for antibody therapies
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Andreas Edelmann

    Andreas Edelmann, Pharma Development Quality Assurance (PDQA GCP Auditing), F. Hoffmann-LA Roche

    9:10 FROM BIOMARKERS TO COMPANION DIAGNOSTICS

    9:50 BIOMARKERS IN EARLY CLINICAL DEVELOPMENT IN THE CNS AREA

    Ellen Bech Christensen

    Ellen Bech Christensen, Specialist Clinical Pharmacology and Pharmacokinetics, Lundbeck Research DK

  • Due to the fragmentary knowledge of disease biology for CNS diseases, the preclinical models utilised in drug development can only partly reflect the clinical conditions the drugs are aimed to treat
  • In addition, many CNS diseases are multifactorial and not phenotypically well described, i.e. the diagnosis and measuring of treatment outcome is based on subjectivity
  • Parallel pre-clinical - and clinical data collection on functional biomarkers may support disease understanding and patient segmentation as well as development of more predictive animal models
  • The strategies behind this iterative process will be discussed and examples given
  • 10:30 Morning Coffee

    10:50 THE CHANGING ETHICAL ENVIRONMENT IN BIOMARKER SAMPLING WITHIN CLINICAL TRIALS

    Sola Sobowale

    Sola Sobowale, Global Biosamples Specialist , Roche Products

    • Operational considerations when defining a Biobank
    • Obstacles & solutions
    • Case studies
    • How the ethical environment determines sample collection success
    • Cultural influences
    • Country specific Biobanks

    11:30 BIOMARKER ASSESSMENT FROM A QUALITY ASSURANCE PERSPECTIVE

    Andreas Edelmann

    Andreas Edelmann, Pharma Development Quality Assurance (PDQA GCP Auditing), F. Hoffmann-LA Roche

  • Introduction and Categories of Specialized Laboratories
  • Audit Strategy
  • Quality Standards
  • Contractual Agreements
  • 12:10 Networking Lunch

    13:10 THE USE OF SUPPORT VECTOR MACHINE (SVM) TECHNOLOGY TO CREATE NEW MOLECULAR DIAGNOSTIC AND PROGNOSTIC TESTS

    Stephen Barnhill

    Stephen Barnhill, Chairman & Chief Executive Officer, Health Discovery Corporation

  • SVM-RFE  - A new type of pattern recognition technology for identifying "Biomarker Signatures" free of intellectual property rights.
  • Introducing a new molecular diagnostic test for prostate cancer
  • The use of SVM technology in diagnostic and prognostic development using flow cytometry data
  • Imaging analysis in both radiology (mammography) and anatomic pathology (Pap Smears, bone marrow, cervical cancer, ovarian cancer, endometrial cancer)
  • Development of surrogate biomarkers and companion diagnostics for Pharma clinical trials and commercialization of personalized medicine
  • 13:50 ENABLING PERSONALIZED MEDICINE FROM FFPE TISSUE

    Austin Tanney

    Austin Tanney, , Almac Diagnostics

    • Understanding the importance of working with FFPE and the associated challenges
    • Using microarrays for prognostic and predictive biomarker identification
    • Understanding and dealing with disease heterogeneity
    • Analytical issues in biomarker identification and validation
    • Regulatory Issues
    • Case study -- colorectal cancer

    14:30 IMPROVED DETECTION AND MONITORING OF RENAL EFFECTS BY THE USE OF CELL-SPECIFIC BIOMARKERS

    Martin Shaw

    Martin Shaw, Senior Scientific Officer, Argutus Medical

    • The need for the better monitoring of renal effects
    • The use of cell specific biomarkers in drug discovery and development
    • Validation of novel renal biomarkers

    15:10 Afternoon Tea

    15:30 EARLY DETECTION OF ADVERSE EFFECTS OF IMMUNOTHERAPEUTIC DRUG SUBSTANCES USING HUMAN ORGANOTYPIC CO-CULTURE SYSTEMS COMBINED WITH SYSTEMS BIOLOGY BASED PATHWAY ANALYSIS

    Thomas  Herget

    Thomas Herget, Director PLS R&D/New Technology Evaluation Performance & Life Science Chemicals, Merck Products

  • Co-culture system  using health epithelial – and blood cells mimicking the in vivo situation
  • Analysis of inter- and extracellular  interactions under the influence of drug candidates
  • Controlled and standardised conditions allowing reproducible results
  • In-depth bioinformatic analysis of the inter- and extracellular pathways contribute knowledge to both, applied and basic research
  • Co-culture system allows way to personalised medicine
  • 16:10 PROTEIN BIOMARKER PROFILING

    John Thompson

    John Thompson, Managing Director, Genovac GmbH

  • Generation of antibodies by genetic immunisation against known biomarkers
  • To develop multiparameter screening tests (e.g. prostate cancer)
  • Enabling the screening of various patient samples
  • The development of a catalogue of antibodies for protein profiling
  • 16:50 COMBINING OPEN PLATFORM AND TARGETED APPROACHES FOR PROTEIN BIOMARKER DEVELOPMENT

    Huw Davies

    Huw Davies, Business Development Director, Pronota

  • Analytical requirements for plasma protein biomarker discovery
  • Study design considerations for discovery and verification stages
  • Bridging the gap between discovery and clinical implementation             
  • Cardiac biomarker discovery and verification case study
  • 17:30 Chairman’s Closing Remarks and Close of Conference

    +

    Workshops

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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