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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 trials and onto the market. SMi’s Pre-clinical Models and Biomarkers event aims to determine what models and markers work most effectively at uncovering any toxicological or efficacy issue at the early stages of drug development, before the drug is put into human trials.

The event will include a series of case studies, representative of a range of significant therapeutic areas, assessing both successful and less successful attempts at assessing a candidates potential at this early stage. The Conference will evaluate how predictive these models really are and at what stage a decision about the candidates future should be made in order to best serve the companies commercial interest.

The recent FDA regulations surrounding biomarkers will also be discussed and the requirements for pre-clinical safety models.
A unique opportunity to learn from leading industry experts including:

  • Dr Cathy Waterfield, Head, Biochemical Pathology & Toxicology, GlaxoSmithKline
  • Dr Richard Scheyer, Director, CNS Clinical Discovery & Human Pharmacology, Aventis
  • Dr Lewis Kinter, Senior Director, AstraZeneca
  • Dr Brad Guild, Director, Protein Science, Millennium
  • Dr Russell Mortishire Smith, Senior Research Fellow, Drug Metabolism & Pharmacokinetics Group, Merck
  • Sharp & Dohme
  • Dr Alasdair Naylor, Group Director, Therapeutic Area Head, Sexual Health & Urology, Pfizer
  • Dr John Bolodeoku, Director, Medical Affairs & Health Economics, Yamanouchi
  • Dr Mike Tarbit, Senior Vice President, Inpharmatica
  • Dr Alan Lewis, President, Celgene


  • Hot topics to be covered at this event include:

  • BIOMARKER DISCOVERY: Profiling and integrating multiple biological levels via systems biology
  • PRECLINICAL EFFICACY MODELS: Selecting the right drug candidates based on efficacy in the right models
  • PREDICTING THE TOXICITY OF NEW DRUG CANDIDATES: Effectively 'weeding out' compounds that are likely to fail
  • DRUG SAFETY ASSESSMENT: The implications of understanding global systems biology via metabonomics
  • DECISION TOOLS FOR DISCOVERY PROJECTS: Interpreting in vitro, in vivo and in silico data
  • CASE STUDIES: Meet leaders in the field and learn from their mixed experiences
  • Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Alan Lewis

    Dr Alan Lewis, President, Celgene

    9:10 MODEL ORGANISMS FOR PHARMACEUTICAL DEVELOPMENT

    Dr Lewis Kinter

    Dr Lewis Kinter, Senior Director, AstraZeneca

  • Identification of models that accurately predict the efficacy and safety of new drugs when subsequently administered to humans has been the ‘Holy Grail’ of pharmaceutical scientists
  • Advances in pharmaceutical chemistry have exponentially expanded demand for biological testing and effective efficacy and safety models
  • As the cost of clinical development of new pharmaceuticals has increased, so has the imperative to select the ‘right’ candidate drug based upon efficacy in the ‘right’ models
  • This presentation will discuss historical, philosophical, strategic, and tactical aspects in the context of modern pharmaceutical development
  • 9:40 PRECLINICAL MODELS

    Dr Richard Scheyer

    Dr Richard Scheyer, Director, CNS Clinical Discovery & Human Pharmacology, Aventis

  • Clinical models for compound screening
  • Designs / endpoints that translate across species
  • Criteria for model selection
  • Mechanistic intermediates and empiric validation
  • 10:20 PREDICTIVE AND DECISION TOOLS IN COMPOUND OPTIMISATION

    Dr Mike Tarbit

    Dr Mike Tarbit, Senior Vice President, Inpharmatica

  • Addressing the need to balance potency, safety and ADME properties from first principles
  • Integrating 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
  • 11:00 Morning Coffee

    11:20 BIOMARKER ANALYSIS AND DECISION MAKING IN PHARMACEUTICAL R&D

    Dr Daniel Chelsky

    Dr Daniel Chelsky, Executive Vice President & Chief Scientific Officer, Caprion Pharmaceuticals

  • Quantitative global protein analysis
  • Use of protein profiles in discriminating health from disease
  • Examples of toxicity profiling for compound selection and optimisation
  • Insights into compound mechanism of action
  • Proteomics-based patient clustering
  • 12:00 PROFILING AND INTEGRATING MULTIPLE BIOLOGICAL LEVELS VIA SYSTEMS BIOLOGY

    Prof Jan van der Greef

    Prof Jan van der Greef, Scientific Director ‘TNO Systems Biology', TNO

  • Profiling of the proteome and metabolome by multiple analytical techniques
  • Data handling: normalization of multidimensional techniques
  • Supervised and unsupervised analysis based on pattern recognition
  • Biosystematics; pathways and system biomarker profiles related to disease and intervention
  • 12:40 Networking Lunch

    14:00 BIOMARKER DISCOVERY

    Dr Michael Natan

    Dr Michael Natan, Vice President, Business Development, SurroMed

  • Differential proteomics and metabolomics
  • Microvolume laser scanning cytometry
  • Data reduction and multi-component data analysis
  • 14:40 TECHNOLOGICAL ADVANCEMENT IN BIOMARKER VALIDATION

    Dr Cathy Waterfield

    Dr Cathy Waterfield, Head, Biochemical Pathology & Toxicology, GlaxoSmithKline

  • Using open and closed methods for identification of biomarkers
  • Combining technologies to support biomarker validation
  • Evaluation and validation beyond identification
  • Importance of confounding factors and dealing with them
  • 15:20 Afternoon Tea

    15:40 DEVELOPMENT AND VALIDATION OF A POTENTIAL BIOMARKER IN CANCER IN PRACTISE

    Dr John Bolodeoku

    Dr John Bolodeoku, Director, Medical Affairs & Health Economics, Yamanouchi

  • Introduction
  • Materials and methods
  • Cell culture work
  • Human tissue work (immunohistochemistry, Western blot, RNA)
  • Human serum samples
  • Conclusion
  • 16:20 PROTEIN BIOMARKERS IN RHEUMATOID ARTHRITIS

    Dr Brad Guild

    Dr Brad Guild, Director, Protein Science, Millennium

  • Discovery media for the identification of new biomarkers in rheumatoid arthritis
  • Mass spectrometry: a powerful tool for differential protein analysis
  • Fractionation and enrichment strategies using multidimensional chromatography
  • Biochemically processed samples are trypsinized and further fractionated using online 2D/LC methods prior to analysis by ion trap mass spectrometry
  • Cataloguing the protein composition of each sample
  • Assessing prospective candidates markers in serum using multiple reaction monitoring to provide a semi-quantitative measure
  • Discovery and quantification of protein biomarkers of disease using mass spectrometry
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Alan Lewis

    Dr Alan Lewis, President, Celgene

    9:10 ORGAN AND TISSUE SPECIFIC BIOMARKERS IN DRUG DEVELOPMENT

    Martin Shaw

    Martin Shaw, Senior Product Manager, Biotrin

  • The value of specific biomarkers in the area of:
  • Preclinical toxicity
  • Lead optimisation
  • Diabetes
  • Hepatitis C
  • 9:40 DEVELOPING A GENE EXPRESSION DATABASE FOR PREDICTING TOXIC RESPONSES IN DRUG DISCOVERY

    Dr Jeff Waring

    Dr Jeff Waring, Research Investigator, Abbott Laboratories

  • Identification of predictive genes for hepatotoxicity
  • Building a compendium of expression profiles for toxicity
  • Statistical tools for data analysis
  • Application of toxicogenomics database in drug discovery
  • 10:20 BIOMARKERS FOR PREDICTING THE TOXICITY AND MECHANISM OF NEW DRUG CANDIDATES

    Dr Kurt Jarnagin

    Dr Kurt Jarnagin, Vice President, Biology & Chemogenomics, Iconix Pharmaceuticals

  • ‘Weeding out’ compounds that are likely to fail, and identifying novel benefits of new candidates for modern drug discovery
  • DrugMatrix TM - a contextual database comprised of new experimental findings uses the detection sensitivity and resolution of gene expression profiling linked with traditional end-points to achieve high predictive power
  • Mining for unique biomarker patterns through extensive mathematical analyses
  • These signatures are highly accurate predictions of toxicology and mechanism
  • Defining biomarker derivation methods and case studies using gene expression data to improve clinical
  • 11:00 Morning Coffee

    11:20 THE IMPORTANCE OF PRECLINICAL MARKERS OF IMMUNE FUNCTION IN BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

    Dr Paul Chamberlain

    Dr Paul Chamberlain, Director, Biopharmaceuticals, Drug Development Programs, MDS Pharma Services

  • Opportunities for measuring B and T cell responses during preclinical development
  • Considering the limitations for measuring immune responses during preclinical studies
  • Appraisal of the relevance of preclinical observations of immunogenicity to highly conserved sequences
  • Predicting the clinical safety of therapeutic proteins
  • 12:00 PROTEIN BIOMARKERS IN REGULATORY BIOANALYSIS

    David Gordon

    David Gordon, Team Leader, Immunoassays, Quintiles

  • Use of immunoassays in regulatory studies
  • Endogenous biomarkers and problems in assay validation
  • Commercial assays – help or hindrance?
  • Future prospects
  • 12:40 Networking Lunch

    14:00 APPLYING PHARMACOGENOMIC BIOMARKERS TO PRE-HUMAN TOXICITY & EFFICACY

    Dr Sandra Kirkwood

    Dr Sandra Kirkwood, Senior Statistical Geneticist, Eli Lilly

  • Applications of PGx biomarkers to the preclinical world
  • Efficacy
  • Toxicology
  • Phenotype considerations
  • Statistical methods
  • Power considerations
  • 15:20 Afternoon Tea

    15:40 APPLICATIONS OF METABONOMICS IN DRUG SAFETY ASSESSMENT

    Dr Russell Mortishire Smith

    Dr Russell Mortishire Smith, Senior Research Fellow, Drug Metabolism & Pharmacokinetics Group, Merck Sharp & Dohme

  • Successful application of metabonomics to characterise an otherwise ill-defined mechanism of drug toxicity
  • Use of biomarkers and carrying out metabonomic analysis
  • Multivariate statistical analysis of metabonomic data
  • Subsequent in vitro experiments to confirm results
  • Practicalities of the approach for resolving toxicity issues for drugs in discovery and development
  • 16:20 PRECLINICAL AND CLINICAL APPLICATIONS OF HIGH PRECISION GENE EXPRESSION BIOMARKERS

    Dr Michael Bevilacqua

    Dr Michael Bevilacqua, Chief Executive Officer & Chief Scientific Officer, Source Precision Medicine

  • Source has developed an integrated molecular medicine system called TheraTrax, which is based on high-precision gene expression analysis, growing disease and drug response datasets, and interpretive algorithms
  • Optimised in vitro models (including whole blood) and clinical trial applications provide quantitative measures of efficacy, dose response and comparative benchmarking
  • Previous studies include inflammatory diseases such as rheumatoid arthritis, lupus and psoriasis, as well as infectious disease and cancer
  • The Source Client Laboratory is guided by strict standard operating procedures (SOPs) and has performed more than 50 projects for a variety of clients, including large pharmaceutical companies, biotech companies and natural products companies
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Pharmacogenomic Biomarkers
    Workshop

    Pharmacogenomic Biomarkers

    The Hatton, at etc. venues
    21st January 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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