The Programme

Day One - Tuesday 2 December 2008

Registration

Opening remarks from the Chair

 EXAMINING CHALLENGES IN BIOMARKER DISCOVERY AND VALIDATION

Discussing critical issues in the validation of biomarkers – with a focus on preclinical and early phase I

• Examining difficulties in biomarker assay validation
• Identifying effective biomarker validation strategies
• How do you prove that the biomarker is a good predictor of outcomes?
• Deploying the best practices

 An automated multiplex assay system for biomarker evaluation of serum protein markers

• Evaluating various biomarkers to identify potential companion diagnostic marker(s)
• Assessing the systems to ensure high quality results
• Examining biomarker programmes - from early evaluation to the point of companion diagnostic development

Developing biomarkers for proof of pharmacology purposes

• Utilizing biomarkers in early clinical drug development
• Developing techniques to successfully identify molecules/processes that have changed
• Deploying techniques that provide accurate decision-making data
• Case study of assays for immune modulation in pre/clinical species and in man

Dr. Michael Shi
Director, Biomarker Project Leader of Exploratory Oncology Development
NOVARTIS

Biomarker applications in oncology clinical development

• Discussing the application of biomarkers to address key challenges and opportunities in developing novel cancer therapeutics
• Verifying the impact of novel drugs on targets/pathways by monitoring pharmacodynamic biomarkers
• Evaluating molecular response as an early clinical efficacy read-out
• Increasing drug development predictability using biomarkers

Epigenetic markers for diagnosis, prognosis and response prediction in gastrointestinal cancers

• Role of epigenetics in biology of GI cancers
• Methods for assessment of methylation in GI cancers
• Epigenetic markers in blood and tissue of cancer patients
• Epigenetic markers for early diagnosis and precancer lesions detection
• Epigenetics in assessment of prognosis
• Response prediction and selection of cancer treatment by epigenetic markers

Validation of biomarkers of breast cancer progression and therapeutic response via tissue microarray technology and automated image analysis

• Tissue microarrays and digital slides as translational research tools
• Bridging from -omic discovery to validation
• Manual and automated image analysis
• Case studies in breast cancer including retrospective analysis of clinical trial-derived samples

Gene networks represent robust transcriptional biomarkers

• How do gene networks as biomarkers differ from individual genes/proteins?
• How to derive gene networks from FFPE-derived microarray data?
• All shown on the example of a prostate cancer study

Jens Mikkelsen
PhD, Director, Translational Neurobiology
NEUROSEARCH

Examples on biomarkers for CNS drug discovery

• Identification and validation of new biomarkers in CNS
• Discussing recent developments
• Application of biomarkers to improve success rates in clinical trials

Qualification of neurochemical and imaging biomarkers for early detection, progression and endpoints in phase 2/3 trials in Alzheimer's disease

• Discussing neurochemical markers of Alzheimer's disease
• Presenting recent advances in MR- and PET-based imaging for early diagnosis, monitoring of disease progression and qualification
• Assessing treatment effects - academic, industry and regulatory perspectives
• Detecting essential features of the disease for early diagnosis

Quantitative tissue biomarker analysis – a CRO perspective
Specialisation and innovation: applications in discovery, pre-clinical R&D and clinical trials

• High throughput quantitative analysis of immunolabelled target molecules
• Case studies in inflammation (lungs, GI tract, CV system)
• Collaboration and optimisation: the CRO alternative

Day 2 - Wednesday 3 December, 2008

Registration

Opening remarks from the Chair

Lunch

Proteomic strategies for biomarker discovery – from differential expression to isoforms to pathways

• Psychiatric disorder biomarkers
• Mouse models
• Stable isotope metabolic labelling
• Quantitative mass spectrometry
• Pathway analysis

14:10

Linking biomarkers discovery and development with drug discovery

• Prioritising early biomarkers discovery to drive drug R&D productivity
• How to harmonise these two so they can be used to make informed decisions
• Using biomarkers discovery to aid the drug discovery process

UTILISING BIOMARKERS TO ACHIEVE TRULY PERSONALISED MEDICINE

The role of biomarkers in developing personalized medicine

• Using biomarkers as links between diagnostics and therapeutics
• Pharmacogenetic, pharmacogenomic and pharmacoproteomic biomarkers
• The role of biomarkers in developing safe and effective medicines

Afternoon refreshments

TOXICOLOGY BIOMARKERS IN DRUG DEVELOPMENT

Reviewing the current status of toxicology biomarkers in drug development

• Biomarkers as early predictors of adverse effects related to chronic drug exposures
• Discussing the clinical application of pharmacogenetics to predict and prevent adverse drug effects
• Identifying current barriers to the development of toxicology biomarkers
• Assessing technological approaches for developing more and better toxicology biomarkers

 THE ROLE OF BIOMARKERS IN THE DECISION MAKING PROCESS

Outlining a strategy to identify and make use of biomarkers in a drug discovery research and development of viral diseases

• Focusing on HCV and HIV biomarkers in drug development
• Setting up a strategy for successful implementation
• Tibitec BVBA case study

Closing remarks from the Chair and close of conference