STREAM ONE
BIOMARKERS IN ONCOLOGY
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STREAM TWO
BIOMARKERS IN IMMUNOLOGY AND CNS
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9.00 Chairman's opening remarks
Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson
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9.00 Chairman's opening remarks
Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer
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9.10 APPLICATION OF PHARMACODYNAMIC MARKERS OF NEDD8 PATHWAY INHIBITION TO ASSESS MLN4924 ACTIVITY IN PHASE I TRIALS
MLN4924 is a first-in-class small molecule inhibitor of NEDD8 activating enzyme that has shown potent antitumor activity in pre-clinical models
A panel of pharmacodynimc markers have been developed to assess NEDD8 pathway activity in blood, skin and tumours of patients
MLN4924 has demonstrated pharmcodynamic inhibition of NEDD8 pathway in patients at well tolerated doses in Phase I testing
Peter Smith, Senior Scientist II, Oncology, Millennium Pharmaceuticals
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9.10 IDENTIFICATION AND CHARACTERISATION OF CANDIDATE BIOMARKERS FOR A NOVEL KINASE INHIBITOR FOR TREATMENT OF AUTOIMMUNE DISEASES
Approaches taken to identify novel candidate markers for a kinase inhibitor in autoimmune disease
Profiling of markers in model systems
Characterisation of markers in ex vivo-treated healthy and diseased human tissue samples
Future plans
Andrew Payne, Senior Group Leader, Cellular Sciences, UCB
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9.50 PRECLINICAL CANCER MODELS USED IN DRUG DISCOVERY AND TRANSLATIONAL ONCOLOGY
In vivo models in oncology
The merit of translating observations and end-points from pre-clinical models
Future models including primary explants and transgenics
Robert Wilkinson, Principal Scientist II, AstraZeneca
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9.50 DEVELOPING PROOF-OF-PHARMACOLOGY BIOMARKERS
Enabling early predictions using PK/PD
Utilization of biomarkers in early clinical drug development
Development of techniques to successfully identify biomarkers linked to the therapeutic mechanism; enabling PK/PD
Case study of assays for immune modulation in pre/clinical species and in man
Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer
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10.30 SURVEYING SIGNALING NETWORKS AND POST-TRANSLATIONAL MODIFICATIONS IN CANCER BY PTMSCAN™
LC-MS/MS identification of disease associated Post-Translantional Modifications by PTMScan™
Investigation of signaling networks and kinase hierarchies in disease
Biomarker discovery in the Phosphoproteome
John-David Herlihy, Product Specialist, Cell Signaling Technology
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10.30 BIOMARKERS FOR INHALED ANTI-INFLAMMATORY THERAPIES – SAMPLING THE LUNG
Pre-clinical dose and duration of action prediction for inhaled anti-inflammatory therapies is challenging
There is a key strategic need to assess compound modulation of the target and subsequent anti-inflammatory efficacy early in clinical development
Various methods have been assessed for sampling the lung directly
Whole lung activity may also be assessed by methods such as spirometry and using imaging techniques
Examples of the above techniques will be discussed and challenges highlighted
Iain Kilty, Director Allergy and Respiratory Research Unit, Pfizer
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11.10 Morning coffee
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11.10 Morning coffee
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11.30 LARGE-SCALE PROTEOME PROFILING OF BREAST AND COLORECTAL TUMOURS
Quantitative high-resolution mass spectrometry allows identification of new candidate biomarkers directly at protein level
Genome scale protein expression profiles may define new subtypes of cancer
Orthogonal validation methods confirm the results obtained by mass spectrometry while DNA arrays often show only weak correlation with protein abundance in micro dissected tumours
Metodi Metodiev, Director of Proteomics Unit, University of Essex
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11.30 FINDING THE PATTERNS: EXECUTING AND INTERPRETING A BIOMARKER PROGRAM
RBM’s consultative biomarker approach using its experience and database
Study design for maximum information at minimum cost
Biomarker and matrix selection for improved statistical outcome
Compare results to large database for increased study power
Strong data mining capabilities
Emanuel Schwarz, Rules Based Medicine
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12.10 TRI-FUNCTIONAL CAPTURE COMPOUNDS: A NEW ROUTE IN FUNCTIONAL PROTEOMICS TO TARGET BIOMARKER-RELEVANT PROTEINS
Small molecule-protein-interaction based enrichment of functional subproteomes
Gain of sensitivity through photo-activated cross-link
Profiling of protein classes of whole cells
Targeting of receptors and ion channels
Drug mode of action and biomarker discovery applications possible
Mathias Dreger, Head of Biochemistry, Caprotec
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12.10 TRANSLATIONAL BIOMARKERS IN THE DEVELOPMENT OF NOVEL ANALGESIC DRUGS
Attrition in analgesic drug development - Failures in forward or backward translation?
(Non-)overlapping realms of targets, biomarkers, models, symptoms and patients
Forward translation of an ion channel blocker - An example
Ge Ruigt, Director Experimental Medicine, Merck
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12.50 Networking lunch
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12.50 Networking lunch
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1.50 DISCOVERY AND APPLICATION OF PREDICTIVE BIOMARKERS FOR MAGE-A3 CANCER IMMUNOTHERAPY
Biomarker discovery in early stage trials in cancer immunotherapy
Biological significance of predictive biomarkers in cancer immunotherapy
Challenges in clinical validation and application of predictive biomarkers
Fernando Ulloa-Montoya, Head of Molecular Biology Technology Group, GlaxoSmithKline Biologicals
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1.50 NON-FLUID BIOMARKERS
Animal models as preclinical biomarkers of target engagement, mechanism, and efficacy
The use of imaging to monitor disease progression and treatment efficacy
Benefits of integrating information from non-fluid and fluid biomarkers
Karen Asin, Director, Translational Pharmacology, Takeda
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2.30 USE OF PROTEOMICS TO DISCOVER CELL SURFACE MARKERS OF APOPTOSIS
Omics approaches in the discovery of universal biomarkers of cell death
Applications in diseases
Transcriptional profiling - Proteomics, glycomics and metabolomics to identify biomarkers of cell death.
Subsequent biomarker validation
Huseyin Mehmet, Director of Exploratory Biomarkers, Diabetes, Merck
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2.30 BIOMARKER RESEARCH IN DEPRESSION: PART I
Biobanking - Getting high quality samples from key populations
Using a hypothesis driven approach
Bioinformatics: Text mining to characterize potential biomarkers and the biologies to which they are linked
Mette Jensen, Translational Medicine Scientist, Lundbeck
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3.10 Afternoon tea
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3.10 Afternoon tea
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3.40 APPLICATION OF BIOMARKERS IN EARLY DEVELOPMENT
Phase I trial design
PD markers for decision making at the phase II interface
Predictive markers for patient selection
Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson
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3.40 BIOMARKER RESEARCH IN DEPRESSION: PART II
Crossroads in depression
Gene expression profiling
Analysis tools: Mathematical modelling, algorithms and classifiers
Biological fingerprints for depression
Jennifer Larsen, Translational Medicine Scientist, Lundbeck
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4.20 URINARY BIOMARKERS IN THE CLINICAL PROGNOSIS AND EARLY DETECTION OF ACUTE KIDNEY INJURY (AKI)
The SAFE-T project and Drug-Induced Kidney Injury (DIKI)
Case study - Novel urinary biomarkers
Urinary biomarkers may improve the ability to detect early AKI and determine the clinical prognosis of AKI at the time of diagnosis.
Patrick Murray, Professor of Clinical Pharmacology, University College Dublin (UCD)
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4.10 EXPERIMENTAL NEUROSCIENCE - BETTER INTEGRATION OF NOVEL DISCOVERIES IN CLINICAL TRIALS
Biomarkers in cognition
Disease targets in the brain
Molecular imaging of the human brain
Jens Mikkelsen, Senior Scientist, Neurosearch A/S
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5.00 Chairman’s closing remarks and close of day one
Hans Winkler, Senior Director and Global Head, Oncology Biomarkers, Johnson & Johnson
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4.50 Chairman’s closing remarks and close of day one
Mark Fidock, Associate Research Fellow, Head of Quantitative Biomarkers, Pfizer
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