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SMi’s 3rd Annual Preclinical Models & Biomarkers - Bridging the gap in drug discovery:

With the huge costs involved in drug development it is absolutely crucial that the drug candidates that are taken forward into clinical trials have a good chance of making it through to the commercial market. SMi’s 3rd Annual Preclinical Models & Biomarkers event will investigate the latest technological advancements in drug discovery and innovations in observing toxicological and efficacy issues associated with development.

Several practical case studies will highlight preclinical issues from a global systems perspective and in-depth presentation will outline the process from modelling through to the quantified validation of markers at the clinical stage. Case studies will examine cancer drug targetting, translating biomarker discoveries in Alzherimers Disease and models in assessing cardiac toxicity.

Speakers for Preclinical Models & Biomarkers - Bridging the gap in drug discovery include:

  • Dr Harsukh Parmar, Executive Director, Global Experimental Medicine & Executive Director, Discovery Medicine, Respiratory & Inflammation, AstraZeneca
  • Dr Hans Winkler, Head, Functional Genomics, Johnson & Johnson
  • Dr Zorina Galis, Research Fellow, Atherosclerosis/Metabolic Syndrome Drug Hunting Team, Cardiovascular Discovery, Eli Lilly
  • Dr Jarko Kochan, Director Biomarkers, Metabolic & Vascular Diseases, F Hoffman-La Roche
  • Dr Oliver Politz, Group Leader, Biomarker Discovery, Schering
  • Professor Karol Sikora, Scientific Director, Medical Solutions, & Professor of Cancer Medicine, Imperial College London
  • Dr Daniel Chelsky, Chief Scientific Officer, Caprion

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Alan Lewis

Alan Lewis, President, Celgene

9:10 THE USE OF BIOMARKERS AND TARGET VALIDATION

Harsukh  Parmar

Harsukh Parmar, Executive Director, Global Director, Discovery Medicine, Respiratory & Inflammation, AstraZeneca

  • High quality target validation is critical to the choice and selection of targets
  • Translational science and biomarkers across the R&D spectrum are important for earlier validation
  • Key functional validation experiments in in vitro and in vivo can help prioritise targets
  • Use of small and large molecule therapeutics in humans can validate important biological pathways
  • Use of small and large molecule therapeutics in humans can validate important biological pathways
  • 9:50 BIOMARKER DISCOVERY AND DEVELOPMENT FOR THE HISTONE DEACETYLASE INHIBITOR MS-275

    Oliver Politz

    Oliver Politz, Research Scientist, Schering AG

  • MS-275: a short introduction
  • Analysis of kinetics of hyperacetylation in PBMCs and tumours
  • Investigation of treatment effects on the serum proteome of an animal model
  • Metabolomic analysis showing effects of MS-275 treatment in rat serum
  • 10:30 Morning Coffee

    11:00 LEARNING FROM THE CLINIC

    Zorina Galis

    Zorina Galis, Research Fellow, Atherosclerosis/Metabolic Syndrome Drug Hunting Team, Cardiovascular Discovery, Eli Lilly & Company

  • Criteria for model selection
  • Preclinical surrogates for clinical end-points
  • Designs/endpoints that translate across species
  • Disease models and biomarker models
  • Mechanistic intermediates and empirical validation
  • 11:40 BALANCING COMPOUND PROPERTIES FROM CONCEPT TO PRACTICE

    Matthew Segall

    Matthew Segall, Head, Admensa Business, Inpharmatica

  • Addressing the need to balance potency, safety and ADME properties from first principles
  • Intergrating in silico models and in vitro data into design and decision tools for discovery projects
  • Virtual lead optimisation: validation of methodologies through case history
  • Future trends
  • 12:20 Networking Lunch

    14:00 GLOBAL PROTEOMIC ANALYSIS OF PLASMA

    Daniel Chelsky

    Daniel Chelsky, Chief Scientific Officer, Caprion

  • Identifying biomarkers of disease, drug efficacy and toxicity in preclinical studies
  • Biomarkers of disease, disease progression and response to drug in Alzheimer’s patients
  • Proteins that correlate with drug response in a cross-sectional study of Hypertension
  • Discriminating drug effects within a class and between classes
  • Proteins that give insight into mechanism of action and off-target effects
  • 14:40 TRANSLATING DISEASE-BASED PROTEOMIC BIOMARKERS DISCOVERIES TO ASSAYS FOR IMPLENTATION IN CLINICAL TRIALS

    Huw Davies

    Huw Davies, Manager, European Biomarker Centre, Ciphergen

  • Multi-institutional study design and sample handling considerations
  • Proteomic interrogation of clinical samples to mine for novel biomarkers
  • Univariate and multivariate data analysis techniques
  • Biomarkers of disease severity as potential surrogates for monitoring drug efficacy
  • Assay development and implementation in preclinical models and clinical trials
  • 15:20 METABOLIC APPLICATIONS OF BIOMARKERS

    Jarko Kochan

    Jarko Kochan, Director, Biomarkers, Metabolic & Vascular Diseases, F. Hoffmann-La Roche

  • What types of metabolic biomarkers are available?
  • Strategies for metabolic biomarker discovery
  • Development of assays for metabolic biomarkers
  • Applying metabolic biomarkers in research and early clinical studies
  • 16:00 Chairman’s Closing Remarks

    16:10 Networking Drinks Reception Sponsored by Siemens Medical Imaging

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Harsukh  Parmar

    Harsukh Parmar, Executive Director, Global Director, Discovery Medicine, Respiratory & Inflammation, AstraZeneca

    9:10 VALIDATION FOR SUCCESSFUL BIOMARKER MEASUREMENT

    John Allinson

    John Allinson, Laboratory Director, Veeda Clinical Research

  • An overview of the recently published paper of the AAPS LBABFG Biomarker Committee
  • The history behind the committee’s formation, it’s members and proceedings, summarising the outcomes covered in the paper and how the major recommendations were conceived
  • All aspects of assay validation, including how and why some validation experiments differ from both PK and diagnostic assays
  • Potential pitfalls in biomarker analysis
  • Case studies
  • 9:50 TRANSLATIONAL RESEARCH AT THE MOLECULAR LEVEL

    Anders  Aberg

    Anders Aberg, Chief Scientific Officer, Sidec Technologies AB

  • Coupling model systems to human biology
  • In vitro studies to experiments in vivo
  • Developing more predictable assays
  • Improving confidence in project selection
  • 10:30 Morning Coffee

    11:00 IMAGING BIOMARKERS

    Daniel Bradley

    Daniel Bradley, Senior Research Scientist, AstraZeneca

  • In vivo MRI techniques as translational possibilities
  • Imaging to explore novel clinically relevant read-outs
  • Impact of drug discovery – preclinical examples
  • MRI techniques as translational possibilities
  • Imaging to explore novel clinically relevant read-outs
  • Impact of drug discovery – preclinical examples
  • 11:40 THE DISCOVERY OF MOLECULAR IMAGING AGENTS

    Hartmuth  Kolb

    Hartmuth Kolb, Vice President, Biomarker Solutions, Siemens Molecular Imaging

  • Target-guided in situ click chemistry approach
  • Novel cyclooxgenase-2 (COX-2) and carbonic anhydrase II (CA-II) imaging agents
  • Results obtained by microPET imaging of mice
  • 12:20 Networking Lunch

    14:00 EGFR AS A CANCER DRUG TARGET

    Karol Sikora

    Karol Sikora, Professor, Cancer Medicine , Imperial College London & Medical Solutions

  • Over 50 small molecule kinase inhibitors or monoclonal antibodies to this target are currently in clinical development for cancer and three are now on the market
  • Downstream biomarker identification and quantitation enables logical decision-making and downstream comparisons of efficacy
  • Molecular signatures that predict response are essential to personalise therapy
  • Phosphoprotein mapping by immunohistochemistry and proteomics are likely to uncover novel biomarkers that can be used as response surrogates
  • The use of biomarkers and surrogates will enhance of EGFR inhibitor development, speed to market, life-cycle management through identification of likely target diseases
  • 14:40 CYTOMETRIC EVALUATION OF CELL-BASED BIOMARKERS

    John Ferbas

    John Ferbas, Principle Scientist, Clinical Immunology, Amgen

  • Utility of cytometric platforms for biomarker discovery and application in clinical studies
  • Fit-for-purpose validation and benchmarking
  • What types of biomarkers are best measured by flow cytometry/laser scanning cytometry ?
  • Case studies
  • 15:20 PREDICTIVE BIOMARKERS AND USEFUL MODELS TO ASSESS CARDIAC TOXICITY

    Laurie Iciek

    Laurie Iciek, Senior Research Toxicologist, Abbott Laboratories

  • Review of serum biomarkers for cardiac toxicity
  • Review of gene microarray databases for cardiac toxicity
  • Useful models to assess cardiac toxicity
  • Presentation of case study
  • 16:00 Chairman’s Closing Remarks Followed by Afternoon Tea

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    Workshops

    Project Management for Drug Discovery
    Workshop

    Project Management for Drug Discovery

    Millennium Gloucester Hotel
    17th March 2006
    London, United Kingdom

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    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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