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Biomarkers in Clinical Trials
20 September - 21 September 2010
Biomarkers in Clinical Trials

SAE Media Group’s Biomarkers in Clinical Trials conference will present attendees with new concepts in biomarker application as well as a comprehensive review of recent developments. This unique event will bring together academics and industry professionals in order to provide a complete picture. There will be a strong focus on using biomarkers to bridge the gap between basic and applied research in drug development.

There will also be a half-day post-conference workshop on Commercialisation of Biomarkers for Personalised Medicine. This interactive event will use examples and case studies to present participants with the opportunity to deal with the problems that they face or expect to face when defining their own biomarker commercialisation strategies.

 

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    RNAi 3         

 

  • Mark Fidock, Associate Director, Pfizer
  • Shawnmarie Mayrand-Chung, National Institutes of Health Program Director, Biomarkers Consortium

 

 

Transcription CD ROM
SMi are pleased to announce our Transcription CD ROM
 
What does it include?
-       The latest presentations from each expert speaker
-       Carefully transcribed speaker documentation in PDF format
-       Convenience of having information in text for ease of reference
 
Please Note: If would prefer not to receive this service you can opt out by e-mailing cservices@smi-online.co.uk. A fee of £100 will be deducted from your purchase.
 
Collection CD ROM
 
Why not consider our collection CD ROM?
 
It will provide you with all the latest information as well as allow you to look back over the previous year's developments.
 
This collection includes:
-       Biomarkers in Clinical Trials (2010)
-       Biomarkers in Clinical Trials (2009)
-       Biomarkers Summit (2010)
-       Biomarkers Summit (2009) 
 
Purchase this collection and save nearly £900 in comparison to buying the individual CDROM’s.
 

Conference agenda

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8:30

Registration & coffee

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9:00

Introduction to biomarker commercialisation for personalised medicine

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9:15

Clinical and scientific validation of biomarkers

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10:15

Regulatory aspects

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10:45

Coffee

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11:15

Reimbursement strategies

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11:45

Case studies of successful biomarker commercialisations

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12:15

Group discussion and Q&A

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12:45

Close of workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Russell Petty

Russell Petty, Clinical Senior Lecturer in Medical Oncology, University of Aberdeen

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9:10

Translational Biomarkers

Mark Fidock

Mark Fidock, Associate Director, Pfizer

  • Preclinical Biomarker discovery and translation for clinical utility
  • Biomarker tool box – enabling PK/PD
  • Case studies in the area of inflammation and infectious diseases
  • Biomarker use for decision making in clinical studies
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    9:50

    Using Preclinical Data to Optimise the Value of Biomarkers in the Clinic

    Chris Harbron

    Chris Harbron, Technical Lead Statistician, Discovery Statistics, AstraZeneca

  • Using molecular biomarkers to identify patient populations
  • The use of preclinical data from in-vitro systems and samples from undosed volunteers
  • Increasing the likelihood of robust identification of patients who would benefit from treatment
  • Reproducibility, robustness, evaluability, translation and interpretability
  • Implications for clinical development processes
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    10:30

    Morning Coffee

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    10:50

    Delivering on the Promise of Personalised Healthcare – Lessons from AstraZeneca

    Ansar Jawaid

    Ansar Jawaid, Global Diagnostics Manager, AstraZeneca

  • Overview of personalised healthcare
  • Challenges across the value chain
  • Leanings from AstraZeneca case studies
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    11:30

    Translating Biomarkers into Companion Diagnostics

    Hannah Mamuszka

    Hannah Mamuszka, Strategic Business Development Manager, Asuragen

  • Drug and diagnostic co-development – key drivers
  • Lessons learned in companion diagnostic development
  • Companion diagnostic development models
  • IVD and clinical trial assays
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    12:10

    Using LNA™ technology to transform novel biomarker discovery into effective Companion Diagnostics

    Adam Baker

    Adam Baker, Director of Diagnostic Product Development, Exiqon

  • Using a Locked Nucleic Acid (LNA™) based miRNA detection technology we have developed a high throughput QPCR system
  • Validated system for the detection of miRNAs in clinical paraffin-embedded tissue as well as blood derived plasma or serum
  • Use of the LNA™ bases adds critical specificity and sensitivity
  • Robust system for more rapid assay development in the clinical and diagnostic assay development
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    12:50

    Networking Lunch

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    13:50

    Translating Lymphoma Gene Expression Signatures into Routine Clinical Biomarkers

    Alison Banham

    Alison Banham, Senior Scientist, Nuffield Department of Clinical Laboratory Sciences, University of Oxford

  • Identification of patients who are not responsive to current therapy
  • The need for co-development of biomarkers and novel therapies
  • Reassessment of biomarker utility in response to evolving gold standard therapy
  • The importance of reagents and techniques that enable specific and reproducible biomarker detection
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    14:30

    Use of Academic Laboratories in Clinical Trials to Foster Collaborative Biomarker Research

    Mike Lau

    Mike Lau, Principal Clinical Development Scientist, Oncology, GlaxoSmithKline

  • Use of biomarkers in clinical research
  • Outsourcing to commercial laboratories
  • Collaborations with academic laboratories in clinical research
  • Case study/example in oncology trials
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    15:10

    Automating Biomarker Discovery and Qualification – Capturing Hypothesis, Analysis and Intellectual Property

    Robin Munro

    Robin Munro, Principal Consultant, IDBS

  • Solutions to empower scientists to seamlessly use and integrate clinical, genomic and image data
  • Automatically annotating genomic data using internal, public and third party sources
  • Using E-WorkBook: steps and decision points of the experimental set-up, data capture and analysis
  • Reports can be automatically generated and the burden of validation reduced
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    15:50

    Afternoon Tea

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    16:10

    Multimodality Cancer Biomarker Discovery and Development: Optimising the use of Biospecimens and Patients

    Russell Petty

    Russell Petty, Clinical Senior Lecturer in Medical Oncology, University of Aberdeen

  • Complex clinical phenotypes in cancer patients
  • Combining clinical, imaging and tissue biomarkers
  • Combined hypothesis generating and hypothesis driven approaches
  • Clinical implementation of combined biomarker modality approaches
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    16:50

    Biomarkers in Muscular Disease: A Turning Point for Innovative Therapy Monitoring

    Alessandra Ferlini

    Alessandra Ferlini, Associate Professor, University of Ferrara

  • Muscular dystrophies
  • Molecular therapies
  • OMIC biomarkers
  • Biomarkers discovery by selecting sub-phenotypes
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    17:30

    Chairman's Closing Remarks & Close of Day One

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    8:30

    Re-registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Dominic Williams

    Dominic Williams, Senior Lecturer, MRC Centre for Drug Safety Science, University of Liverpool

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    9:10

    The Advantages of Efficacy Biomarkers in Exploratory Development

    Shethah Morgan

    Shethah Morgan, Senior Research Clinical Scientist, Oncology Clinical Biomarker Group, AstraZeneca

  • Determining which efficacy biomarkers are appropriate
  • Validation of Phase I efficacy biomarkers
  • Assessing whether a drug is on target
  • Regulatory authorities and efficacy biomarkers
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    9:50

    Translational Biomarkers in Drug Induced Liver Injury

    Dominic Williams

    Dominic Williams, Senior Lecturer, MRC Centre for Drug Safety Science, University of Liverpool

  • Role of metabolism in drug-induced liver injury
  • Mechanistic biomarkers of cell damage
  • Involvement of the innate immune system during hepatic stress
  • A chronic infusion model of paracetamol hepatotoxicity
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    10:30

    An Overview of Next-Generation Sequencing Technologies

    David Dow

    David Dow, Group Leader, Molecular and Cellular Technologies, GlaxoSmithKline

  • Technology overview
  • Recent advances
  • Potential applications in biomarker research
  • Future developments
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    11:10

    Morning Coffee

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    11:30

    MicroRNA as Biomarkers of Disease and Drug Efficacy

    Sterghios Moschos

    Sterghios Moschos, Principle Scientist, Pfizer

  • Introduction to microRNAs
  • Approaches and considerations in microRNA profiling for biomarker discovery
  • Clinical progress of microRNA biomarker assays
  • Emerging evidence on invasive and non-invasive microRNA signature utility in diagnostics and theranostics
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    12:10

    Miniaturised Multiplexed Immunoassays

    Thomas Joos

    Thomas Joos, Head of Biochemistry, Natural and Medical Sciences Institute, Universitat Tubingen

  • Technologies and applications
  • Capabilities and limitations of multiplexed immunoassays
  • Multiplexed immunoassays for biomarker discovery
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    12:50

    Networking Lunch

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    14:00

    Innovative and New Ways of Conducting Clinical Trials in Biomarkers

    Shawnmarie Mayrand-Chung

    Shawnmarie Mayrand-Chung, NIH Director for the Biomarkers Consortium, National Institutes of Health

  • Navigating the landscape to design and conduct effective, efficient and regulatory acceptable trials
  • Biomarkers and adaptive trial designs: shortening the time it takes to discover and prove that a new drug or medical procedure is effective
  • Modelling and monitoring the effectiveness of personalised treatment in real time
  • Safety biomarkers: collaborative efforts for moving forward at a faster pace
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    14:40

    Applications of Nanoparticles for Biomarker Harvesting and Sensing

    Alan Dalton

    Alan Dalton, Senior Lecturer, Faculty of Engineering and Physical Sciences, University of Surrey

  • Engineering strategies to tailor nanoparticles for selective sequestering of biomarkers
  • High sensitivity proteomic tests
  • Competing with existing “state of the art” technology
  • Novel lab-on-a-chip type detection platforms
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    15:20

    Afternoon Tea

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    15:40

    Cancer Genetics-Guided Discovery of Serum Biomarkers

    Ralph Schiess

    Ralph Schiess, Co-Founder, ProteoMediX

  • Quantitative proteomics based biomarker discovery using model systems
  • Biomarker validation by highly sensitive targeted proteomics
  • PTEN tumor suppressor gene inactivation in prostate cancer
  • Protein biomarker for prostate cancer patient stratification
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    16:20

    Epigenetic Profiling for Patient Stratification

    Mark Eccleston

    Mark Eccleston, Managing Director, OncoLytika

  • Chromatin Structure and Gene Expression
  • Nucleosomics: Histone modification profiling
  • HyperGenomics: Nuclease accessible Site Profiling
  • Patient stratification and monitoring
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    17:00

    Chairman's Closing Remarks & Close of Conference

    Workshops

    Commercialisation of Biomarkers for Personalised Medicine

    Commercialisation of Biomarkers for Personalised Medicine

    Hilton London Kensington
    22 September 2010
    London, United Kingdom

    Hilton London Kensington

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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.

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    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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