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Preclinical Models & Biomarkers
16 March - 17 March 2005
Preclinical Models & Biomarkers

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. SAE Media Group’s 2nd Annual Preclinical Models and Biomarkers event aims to determine what models and markers work most effectively at uncovering any toxicological or efficacy issues at the early stages of drug development, before the drug is put into human trials

The conference will provide case studies of preclinical issues from a global systems perspective. The conference will take the audience through the process from Modelling and investigation though to the validation of markers at the clinical stage. A formal discussion will cover the validation of assays of biomarkers as candidate surrogates. The event will seek to cover microbicidies for the prevention of sexual tranSAE Media Groupssion of HIV and other sexually tranSAE Media Grouptted diseases.

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Dr Harsukh  Parmar

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

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9:10

BIOMARKERS IN THE NEW ORDER

Dr Giles Campion

Dr Giles Campion, European Head, Exploratory Clinical Development, Novartis

  • Biomarkers – mapping the route from target to clinical proof of concept
  • Indication, target and molecule specific biomarkers
  • Exploring the interface between preclinical and clinical development
  • What blend of technology applications and strategies will speed up the candidate drug into human trials?
  • Evolution of preclinical biomarkers
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    9:50

    THE TRANSLATION OF PRECLINICAL MODELS AND BIOMARKERS TO THE CLINICAL SETTING AND BACK TO DISCOVERY

    Dr Harsukh  Parmar

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

  • Strong feedback loops need to be established to make both discovery and development more effective
  • More animal models need to be developed to reflect human disease
  • Higher quality, more reliable biomarkers need to be developed to reduce clinical attrition
  • Stronger preclinical and clinical integration is vital to address the productivity gaps in Industry
  • Examples will be provided about how this can be achieved
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    10:30

    Morning Coffee

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    11:00

    DEVELOPMENT, VALIDATION AND APPLICATION OF DRUG SIGNATURES FOR THE EARLY PREDICTION OF LONG TERM TOXICITY OF PRECLINICAL CANDIDATES USING A LARGE CHEMOGENOMIC DATABASE

    Dr Mark Fielden

    Dr Mark Fielden, Principal Scientist, Chemogenomics & Toxicology, Iconix Pharmaceuticals

  • To improve compound selection during drug development we have developed a large library of gene biomarkers, Drug Signatures™, for the diagnosis and prediction of compound toxicities and mechanism of action
  • These signatures are derived from a comprehensive chemogenomic reference database of ~13,000 microarray expression profiles derived from treating rats with over 580 drugs, this expression data is coupled to traditional clinical pathology, histopathology and pharmacology measurements
  • Using long-term low-dose drug-induced tubular nephrosis in the rat kidney as a model system, we demonstrate the utility of a reference database to identify Drug Signatures predictive of sub-chronic pathology after sub-acute test compound administration
  • This predictive signature identifies tubular nephrosis before clinical or histological evidence of tissue injury
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    11:40

    A PROTEOMICS INVESTIGATION IN DRUG INDUCED TOXICITY

    Dr Georgina Meneses-Lorente

    Dr Georgina Meneses-Lorente, Research Scientist, Merck Sharp & Dohme

  • Aim of the project was to investigate the use of proteomics in drug toxicity
  • Compound A failed due to hepatotoxicity during safety studies
  • The type of toxicity caused by compound A was steatosis
  • Protein changes were observed during severe toxicity and clinical manifestation
  • Protein changes were observed during early stages of steatosis and prior to clinical and chemical manifestation
  • Protein changes correlated with the in vivo toxicity manifested
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    12:20

    Networking Lunch

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    13:50

    INTEGRATION OF BIOMARKERS IN EARLY DRUG DEVELOPMENT

    Dr Georg Wensing

    Dr Georg Wensing, Head, Pharmacodynamics, Clinical Pharmacology, Bayer Healthcare

  • Definition of biomarkers
  • Role of clinical pharmacology in drug development
  • Use of biomarkers for decision making
  • Example of clinical biomarkers in phase 1 studies
  • Examples of laboratory biomarkers in phase 1 studies
  • Link between preclinical and clinical use of biomarkers
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    14:30

    HIGH-THROUGHPUT TECHNOLOGY IN BIOMARKER DISCOVERY

    Dr Dan Li

    Dr Dan Li, Senior Research Scientist, Eli Lilly

  • Identifying candidate biomarkers for drug activity by in vitro gene expression profiling
  • Analyzing public microrray data on primary cancer specimen
  • Integrative data analysis to identify in vivo biomarkers for drug activity
  • Computational approaches to stratify patients for drug responses
  • Successes and limitations
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    15:10

    Afternoon Tea

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    16:20

    METABOLOMIC APPLICATIONS IN BIOMARKER DISCOVERY

    Dr Chris  Beecher

    Dr Chris Beecher, Vice President, Biochemistry & Technology, Metabolon

  • Metabolomics
  • Technological and statistical overview
  • Case studies
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    17:00

    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

    Dr Rakesh Dixit

    Dr Rakesh Dixit, Section Head, Toxicokinetics & Biomarkers, Merck

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    9:10

    SAFETY AND EFFICACY OF BIOMARKERS

    Dr Rakesh Dixit

    Dr Rakesh Dixit, Section Head, Toxicokinetics & Biomarkers, Merck

  • Safety and efficacy requirements - following a protocol
  • Safety and efficacy profile - key to understanding the potential of a compound
  • Ensuring accomplishment - steps taken to gain approval
  • Improving the precision and accuracy of biomarkers
  • Leading to rational, efficient and effective clinical development
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    9:50

    OPTIMIZATION OF EARLY COMPOUND SELECTION WITH PRECLINICAL SAFETY TESTS AND IN SILICO SAFETY APPROACHES

    Dr Lutz Mueller

    Dr Lutz Mueller, Non-Clinical Drug Safety, F. Hoffmann-La Roche

  • Testing strategy for ADME tests
  • Testing strategy for pre-GLP in vitro and in vivo toxicology
  • In silico approaches for predicting toxicity and safety pharmacology
  • A semi-quantitative method for predicting hERG channel interaction
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    10:30

    Morning Coffee

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    10:50

    IMAGING BIOMARKERS

    Prof Johan Luthman

    Prof Johan Luthman, Director, AstraZeneca

  • Imaging methods in either animals or man can provide essential links between PK and PD data
  • Molecular imaging with suitable ligands provides information on target occupancy that may be coupled to functional effects. Traditional in vitro autoradiography and in vivo binding in animals using long-lived isotopes can be used to predict for PET in primates and man as well as provide basic information on anatomical distribution, species differences and selectivity of drug binding
  • MR imaging offers opportunities for non-invasive measurements of treatment effects on structural pathology. Other MR techniques, such as functional MRI (fMRI), can be used to evaluate effects in various organs or anatomical sub-regions. MR spectra analysis presents possibilities to follow regional alterations in endogenous factors progression or drug treatment
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    12:20

    Networking Lunch

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    13:50

    PANEL DISCUSSION

    Dr Harsukh  Parmar

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

    Dr Lutz Mueller

    Dr Lutz Mueller, Non-Clinical Drug Safety, F. Hoffmann-La Roche

    Dr Walter Carney

    Dr Walter Carney, President, Oncogene Science, Oncogene Science, Bayer Healthcare

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    14:30

    CIRCULATING HER-2/NEU AS A BIOMARKER FOR MONITORING THERAPEUTIC RESPONSE OF HER-2/NEU POSITIVE BREAST TUMORS

    Dr Walter Carney

    Dr Walter Carney, President, Oncogene Science, Oncogene Science, Bayer Healthcare

  • Targeted anti-HER-2/neu therapies are directed to HER-2/neu positive tumors
  • HER-2/neu positive tumors are much more frequent than previously known and highly aggressive
  • Serum HER-2/neu testing can provide the real time HER-2/neu status of a breast cancer patient
  • Changes in serum HER-2/neu levels parallel the clinical course of disease
  • Studies show that breast cancer patients with continuously elevated (>15 ng/ml) serum HER-2/neu levels have a significantly poorer survival
  • Maintaining serum HER-2/neu levels <15 ng/ml may result in better clinical outcomes
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    15:10

    Afternoon Tea

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    15:40

    PREDICTIVE TOXICOLOGY

    Dr Vivek Kadambi

    Dr Vivek Kadambi, Associate Director, Oncology Safety Assessment, Millennium Pharmaceuticals

  • How predictive are our or animal models for toxicity?
  • Acute toxicology, HERG and QT and beyond
  • CNS
  • Case study
  • Liver toxicity
  • Issue management strategy
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    16:20

    INITIAL BIOMARKER AND CLINICAL DEVELOPMENT PLANS DURING PRECLINICAL DRUG DISCOVERY: FOCUS ON LOWER ATTRITION RATES

  • Choosing the target based on genetic (including human), animal model and clinical validation and understanding the relative risk of both novel first in class and "me too" best in class approaches
  • Establishing relationships with strategic marketing to help define the business case and understand the competitive landscape
  • Performing relevant preclinical efficacy models in concert with ADME scientists to establish PK/PD relationships that allow for prediction of human dose
  • Working closely with toxicologists to define potential for mechanism based toxicology, using tools such as gene knockouts, RNAi, and gene and protein expression data
  • Establishing biomarker approaches early that can be used both in preclinical toxicology to establish therapeutic index and later in clinical trials
  • Working closely with the clinical team to design proof of concept clinical trials during entry into man studies where feasible including experimental medicine approaches
  • Dr Rebecca Taub

    Dr Rebecca Taub, Vice President, Research & Metabolic Diseases, Hoffman-La Roche

    Jarko Karema

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

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    17:00

    Chairman’s Closing Remarks and Close of Conference

    Jurys Great Russell Street Hotel

    16-22 Great Russell Street
    London WC1B 3NN
    United Kingdom

    Jurys Great Russell Street 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, 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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