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SMi’s sixth Annual Biomarkers conference unites advances in biomarker use for drug discovery and development, alongside biomarkers for cancer.  This two-day meeting showcases the best new opportunities and strategies to accelerate go/no-go decision making in early and clinical development.

Key academic, government and industry figures cover topics encompassing:

  • Case studies in idiopathic pulmonary fibrosis (IPF) and molecular characterisation of solid tumors
  • Interactive panel discussion focusing on current developments in personalised medicine via biomarkers
  • Latest advancements in molecular diagnostics and multi-centre clinical imaging studies
  • New developments in pharmacogenetic and pharmacogenomic statistical study design
  • Future direction and initiatives for safety biomarkers
  • Maximise the cost-effectiveness of your companion diagnostic for end-users

Key topics for 2013:

  • Gain funding for stratified medicine from UK government agencies
  • Maximise the cost-effectiveness of your companion diagnostic for end-users
  • Improve regulatory toxicology studies to support FIH and regulatory filings 
  • Strategically manage multi-centre clinical imaging studies 
  • Case studies in TLF-7 and anti-inflammatory drug development
  • Molecular diagnostics to aid stratified medicine
  • New developments in pharmacogenetic and pharmacogenomic statistical study design

Chief Executive Officers, Chief Scientific Officers, Chief Medical Officers, Managing Directors, Vice Presidents, Directors, Partners, Heads and Managers in:

  • Biomarkers
  • Pharmacogenetics/Pharmacogenomics
  • Stratified Medicine/Personalised Medicine
  • Translational Medicine
  • Imaging
  • Clinical Pharmacology
  • Diagnostics
  • Research & Development
  • Oncology/Cancer Cell Biology
  • Inflammatory Diseases
  • Toxicology
  • Preclinical safety
  • Immunogenicity
  • Strategic Alliances
  • Business Development
  • ADMET

 

Previous attendees included:

Amgen Ltd; Arizona Cancer Center; AstraZeneca; Bayer Schering Pharma AG; Bristol-Myers Squibb; BTG; Cancer Research Technology; Eli Lilly & Co. Ltd; Exiqon; FDA; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK R&D; Helsinn Healthcare; Hildebrand Pharma Consulting; HUKM; Huntingdon Life Sciences; Intomics; J & JPRD; Kings College London; King's College London; Lilly Research Centre; Lilly Research Centre Ltd; Loughborough University; Lundbeck H A / S; MedImmune; Merck Serono; MHRA; National Center for Toxicological Research; NHS Innovations London; Novartis International AG; Oxford Gene Technology; Pfizer; ROCHE DIAGNOSTICS GMBH; Roche Products; Takeda Global Research & Development; Takeda Pharmaceuticals Europe Ltd; TAKEDA Pharmaceuticals North America; Technology Strategy Board; Teva Pharmaceuticals Ltd; The University of Buckingham; Thomson Reuters; UCB Pharma; UCL Cancer Institute; University College Dublin; University Of Alberta; University of Westminster; Unversity of Cambridge / Cancer Research UK ;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Nicholas Buss

Nicholas Buss, Toxicology Project Leader, MedImmune

9:10 Biomarkers: discovery strategies and technologies

Peter Parker

Peter Parker, Deputy Director of the Integrated Cancer Centre and Head of the Division of Cancer Studies , Kings College

  • Strategies for providing truly personalised predictive biomarkers and drugs in use and in development
  • Review of some emerging new technologies for generating sophisticated readouts directly informative on drug action
  • Predictions of drug responsiveness
  • 9:45 Pharmacogenomic biomarkers- an update

    Mark Caulfield

    Mark Caulfield, Director of Institute, The William Harvey Research Institute, Barts and The London School of Medicine & Dentistry

  • Progress in identifying gene regions coding for drug targets
  • Results from genome-wide association studies
  • Meeting the technical challenges of stratified medicine and companion diagnostics
  • 10:20 How to do it: pharmacogenetics and biomarkers - clinical study and statistical design

    Aiden Flynn

    Aiden Flynn, Managing Director, Exploristics

  • Design considerations
  • Association analysis
  • Design options
  • Case studies and applications
  • 10:55 Morning Coffee

    11:25 CASE STUDY: Translational value of the bleomycin rat model for the treatment of patients with idiopathic pulmonary fibrosis (IPF)

    Yasmina Bauer

    Yasmina Bauer, Senior Lab Head, Translational Science Biology, Actelion Pharmaceuticals

  • Whole-genome data collected from an IPF animal model time-course experiment
  • Comparison of animal model data from IPF patient-derived lung biopsies
  • New possibilities to evaluate efficacy of novel therapeutics in preclinical models and human clinical trials
  • 12:00 Translational biomarkers in drug development

    Mark Fidock

    Mark Fidock, Group Director, Biomarkers & Translational Sciences, Strategic Development, Huntingdon Life Sciences

  • Challenges and risk management in the development of new medicines
  • Strategic development and use of biomarkers in translational medicine
  • Case study: the TLR7 drug development programme
  • 12:35 Renal safety biomarkers

    Yi Yang

    Yi Yang, Research Investigator, Abbott Laboratories

  • Overview challenges and opportunities
  • Urinary biomarker qualification efforts
  • Current regulatory status
  • Validation and implementation of urinary biomarkers
  • 13:10 Networking Lunch

    14:10 On setting the first dose in man: quantitating biotherapeutic drug-target binding through pharmacokinetic and pharmacodynamic models

    Andrew Warren

    Andrew Warren, Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma

  • Delivering safe starting and therapeutically relevant escalation doses for human studies
  • Target-mediated drug disposition
  • Assaying captured drug-target complexes
  • 14:45 Safety biomarkers for risk assessment of investigative drugs entering first-in-human studies

    Nicholas Buss

    Nicholas Buss, Toxicology Project Leader, MedImmune

  • The principles of biomarkers for both safety and efficacy in regulatory toxicology studies
  • Classical and emerging biomarkers used in regulatory toxicology studies to support FIH studies.
  • Future direction and initiatives for safety biomarkers
  • 15:20 Afternoon Tea

    15:50 Understanding the mechanisms involved in immune responses to therapeutic proteins

    Matthew Baker

    Matthew Baker, Chief Scientific Officer, Antitope

  • Development of immune responses directed against protein therapeutics
  • Antigen presentation and T-dependent responses
  • Models for predicting immunogenicity
  • Reducing immunogenicity by design
  • 16:25 Panel discussion: Personalised medicine via biomarkers- where are we and what are the prospects for the future?

    Topics discussed will include recent advances in multiple omics technologies with the help of bioinformatics and biostatistics to improve the discovery and development of robust biomarkers for complex chronic diseases. Developing a consistent framework for the validation, acceptance and qualification of biomarkers for regulatory use and clinical phases of drug development will also be discussed.  The panel will comprise a selection of the day’s speakers.

    Aiden Flynn

    Aiden Flynn, Managing Director, Exploristics

    Yasmina Bauer

    Yasmina Bauer, Senior Lab Head, Translational Science Biology, Actelion Pharmaceuticals

    Yi Yang

    Yi Yang, Research Investigator, Abbott Laboratories

    Balazs Sarkadi

    Balazs Sarkadi, Head, Membrane Biology Research Group, Hungarian Academy of Sciences

    17:00 Chairman’s Closing Remarks and Close of Day One

    Andrew Warren

    Andrew Warren, Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Jill Walker

    Jill Walker, Diagnostics Director, AstraZeneca

    9:10 The challenges of translating biomarkers into clinical diagnostics

    Jill Walker

    Jill Walker, Diagnostics Director, AstraZeneca

  • Identifying patient subpopulations with improved response
  • Adapting development strategies to deliver companion diagnostics
  • Ensuring access to diagnostics
  •  

    9:50 Membrane proteins as personalised biomarkers

    Balazs Sarkadi

    Balazs Sarkadi, Head, Membrane Biology Research Group, Hungarian Academy of Sciences

    10:30 Morning Coffee

    11:00 Novel clinical trial design in the era of high-density biomarker data

    Yu Shyr

    Yu Shyr, Director of the Vanderbilt Center for Quantitative Sciences, Vanderbilt University Medical Center

  • Understanding high-density biomarker data
  • Repeatability and reproducibility of the pre-clinical high-density biomarker data
  • Intra & inter-tumor/subject variability
  • Pathway of drug development based on high-density biomarker data
  • 11:40 Opportunities for the development of stratified medicine in the UK

    Graham Bell

    Graham Bell, Lead Technologist, Stratified Medicine, Technology Strategy Board

  • Description of the Technology Strategy Board’s Stratified Medicine Innovation Platform
  • Joining up academia, diagnostic and therapeutic development and driving product uptake
  • Encouraging wide collaboration from biomarker discovery to product launch
  • Current and future focus for public funding
  • 12:20 Networking Lunch

    13:40 Evaluating the cost-effectiveness of diagnostics: the NICE diagnostics assessment programme

    Nick  Crabb

    Nick Crabb , Associate Director - Diagnostics Assessment Programme, National Institute for Health and Clinical Excellence

  • Explaining the structure and purpose of the diagnostics assessment programme
  • Evaluating the cost-effectiveness of a diagnostic test
  • Explaining how the diagnostics industry can engage with the programme
  • 14:20 CASE STUDY: Molecular characterisation of solid tumours to aid stratified medicine

    Lisa Thompson

    Lisa Thompson, Laboratory Manager and Clinical Scientist, The Royal Marsden NHS Foundation Trust

  • Improving diagnostic strategies to facilitate personalised therapeutic interventions
  • BRAF V600 mutation testing for malignant melanoma
  • KRAS mutation testing for patients with colorectal cancer
  • 15:00 Afternoon Tea

    15:30 Multi-centre imaging in the context of clinical trials

    Veronique Bragulat

    Veronique Bragulat, Clinical Imaging Manager, GSK

  • Managing multi-centre clinical trials and their associated challenges in oncology
  • Examples of best practice in imaging models
  • Notable trends gleaned from such studies
  • 16:10 Imaging biomarkers of cancer progression

    Simon Walker-Samuel

    Simon Walker-Samuel, Senior Research Associate, Centre for Advanced Biomedical Imaging, UCL

  • Noninvasive Measurement of tumor blood flow and interstitial fluid pressure
  • Tumor adaptations to ensure nutrient delivery
  • Assessing metatstatic potential
  • 16:50 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andrew Warren

    Andrew Warren

    Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma
    Graham Bell

    Graham Bell

    Lead Technologist, Stratified Medicine, Technology Strategy Board
    Nicholas Buss

    Nicholas Buss

    Toxicology Project Leader, MedImmune
    Nick  Crabb

    Nick Crabb

    Associate Director - Diagnostics Assessment Programme, National Institute for Health and Clinical Excellence

    Aiden Flynn

    Managing Director, Exploristics
    Aiden Flynn

    Andrew Warren

    Director, PK/PD/Immunogenicity Bioanalysis, Novartis Pharma
    Andrew Warren

    Balazs Sarkadi

    Head, Membrane Biology Research Group, Hungarian Academy of Sciences
    Balazs Sarkadi

    Graham Bell

    Lead Technologist, Stratified Medicine, Technology Strategy Board
    Graham Bell

    Jill Walker

    Diagnostics Director, AstraZeneca
    Jill Walker

    Lisa Thompson

    Laboratory Manager and Clinical Scientist, The Royal Marsden NHS Foundation Trust
    Lisa Thompson

    Mark Caulfield

    Director of Institute, The William Harvey Research Institute, Barts and The London School of Medicine & Dentistry
    Mark Caulfield

    Mark Fidock

    Group Director, Biomarkers & Translational Sciences, Strategic Development, Huntingdon Life Sciences
    Mark Fidock

    Matthew Baker

    Chief Scientific Officer, Antitope
    Matthew Baker

    Nicholas Buss

    Toxicology Project Leader, MedImmune
    Nicholas Buss

    Nick Crabb

    Associate Director - Diagnostics Assessment Programme, National Institute for Health and Clinical Excellence
    Nick  Crabb

    Peter Parker

    Deputy Director of the Integrated Cancer Centre and Head of the Division of Cancer Studies , Kings College
    Peter Parker

    Simon Walker-Samuel

    Senior Research Associate, Centre for Advanced Biomedical Imaging, UCL
    Simon Walker-Samuel

    Veronique Bragulat

    Clinical Imaging Manager, GSK
    Veronique Bragulat

    Yasmina Bauer

    Senior Lab Head, Translational Science Biology, Actelion Pharmaceuticals
    Yasmina Bauer

    Yi Yang

    Research Investigator, Abbott Laboratories
    Yi Yang

    Yu Shyr

    Director of the Vanderbilt Center for Quantitative Sciences, Vanderbilt University Medical Center
    Yu Shyr

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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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