Home
overview

This conference has already taken place.  For information on our Personalised Medicine 2010 event, please click on the link below:

 Personalised Medicine 2010 conference

Personalised Medicine 2010

 


For information about the 2009 Biomarkers in Clinical Trials conference, please see below...

The use of biomarkers in drug development is becoming more common and many pharmaceutical companies are already integrating them in to clinical development. Although the potential benefits of utilising biomarkers have been documented extensively, many of the practicalities of using them have not yet been sufficiently explored.

With an exceptional line-up of speakers, SMi’s Biomarkers in Clinical Trials conference will demonstrate the way forward in designing phase I, II and III trials. Attend and gain valuable insights into the use of biomarkers as a way of accelerating the approval or withdrawal of a product. You will have the chance to network with industry associates and the opportunity to explore ways in which you can integrate biomarkers into your own drug development processes. This unique event is designed to help you identify the potential of your products in the most efficient way possible and is an essential addition to the calendar of all those working in the industry.

  • Understand the realities of biomarker application in late-stage drug development
  • Learn ways of adapting existing clinical trial models to integrate biomarkers
  • Hear about the potential financial benefits of using biomarkers
  • Determine what the most appropriate strategies are for your own development programmes
  • Network with industry associates and discuss various approaches to biomarker implementation

Vice Presidents, Heads, directors, scientists and Project Leaders of:

  • Research and Development
  • Drug and Safety Assessment
  • Biomarker Discovery/Validation
  • Diagnostics
  • Imaging
  • Clinical Pharmacology
  • Toxicology 
  • Experimental Medicine
  • Translational Medicine
  • Drug Metabolism
  • Pharmacokinetics
  • Clinical Pathology
  • Molecular and Cell Biology
  • Clinical Development

Conference programme

8:30 Registration &Coffee

9:00 Chairman's Opening Remarks

Joe Keenan

Joe Keenan, Head of Sales and Marketing, Argutus Medical

9:10 THE USE OF NOVEL KIDNEY BIOMARKERS IN CLINICAL TRIALS

Cormac Kilty

Cormac Kilty, Chief Executive Officer, Argutus Medical

  • Current kidney biomarkers and the shortfalls
  • What are the characteristics of new valuable kidney markers?
  • Validation process for new potential clinical biomarkers
  • What does the future hold?
  • 9:50 BIOMARKER USE IN EARLY CLINICAL DECISION-MAKING

    Stefan Sultana

    Stefan Sultana, Clinical Lead, A&R Therapeutic Area, Pfizer

  • The cost-effectiveness of biomarker use in clinical development
  • Pharmacology or mechanistic biomarkers vs. efficacy measures: Their place in clinical development
  • Biomarker utility in early clinical decision-making: examples from the genitourinary disease area
  • 10:30 BIOMARKERS COMING OF AGE: MOVING TOWARDS PERSONALIZED MEDICINE

    Paul de Koning

    Paul de Koning, Head of Exploratory Development Department, Astellas

  • The similarity of drivers behind use of biomarkers in the pharmaceutical industry and those for personalized medicine
  • The challenges for widespread adoption of biomarkers in clinical practice
  • Current examples of use of biomarkers in clinical practice
  • Relevant regulatory guidance
  • 11:10 Morning Coffee

    11:30 TOXICITY BIOMARKERS: TRANSLATION FROM PRECLINICAL SAFETY ASSESSMENT TO CLINICAL SAFETY MONITORING

    Patrick  Mueller

    Patrick Mueller, Project Leader for Safety Assessment, Novartis Institutes for BioMedical Research

  • Tissue-specific, non-invasive toxicity biomarkers for sensitive and specific target organ monitoring
  • Opportunities and limitations of these biomarkers with respect to their translation into human clinical trials
  • Current regulatory status in view of recent changes in regulatory acceptance by health authorities
  • Comprehensive overview on serum and urine-based toxicity biomarkers regarding assay availabilities and sampling regimens
  • 12:10 BIOMARKERS IN EARLY AND LATE STAGE CNS DRUG DEVELOPMENT

    Mette Jensen

    Mette Jensen, Translational Medicine Scientist, H. Lundbeck

  • Biomarkers in early stage development
  • Biomarkers in late stage development
  • Examples of how biomarkers can improve internal decision-making
  • Statistical considerations
  • 12:50 Networking Lunch

    14:00 TRANSLATING BIOMARKERS INTO COMPANION DIAGNOSTICS

    Carol Berry

    Carol Berry, Vice President, Pharmacogenomic Services, Asuragen

  • Drug and Diagnostic Co-Development – Key Drivers
  • Lessons learned in Companion Diagnostic Development
  • Companion Diagnostics Development models – IVD & Clinical Trial Assay
  • 14:40 DISCOVERY, VALIDATION AND SUPPORT OF BIOMARKERS FOR CLINICAL DRUG TRIALS

    Herbert Fritsche

    Herbert Fritsche, Chief of Clinical Chemistry, MD Anderson Cancer Center

  • Discovery of biomarkers for benign prostatic hyperplasia (BPH)  and prostate cancer
  • Their use as companion diagnostics in the assessment of drug therapy
  • Support of drug trials with multiplex assays of protein analytes
  • Use of the circulating tumour cell assay for validation of an early response to drug therapy
  • 15:20 Afternoon Tea

    15:40 HIGH CONTENT IMMUNOASSAYS: THE QUEST FOR BIOMARKERS FOR EFFICACY AND SAFETY

    Sabine Kuesters

    Sabine Kuesters, Director, European Operations, Rules-Based Medicine

  • Proteomics Using Known Biomarkers – Rapid movement from discovery to the clinic
  • Quantitative and Reproducible – Confidence in subtle changes across cohorts
  • Small Sample Volume – Retrospective and prospective studies
  • TruCulture – a clinical trial in a tube
  • 16:00 MOLECULAR ANALYTE PROFILING (MAP) OF THE EARLY EVENTS FOLLOWING INTRAVESICAL BCG THERAPY IN PATIENTS WITH SUPERFICIAL BLADDER CANCER

    Matthew Albert

    Matthew Albert, Head, Laboratory of Dendritic Cell Immunobiology, Institut Pasteur

    16:20 COMBINING OPEN PLATFORM AND TARGETED APPROACHES FOR BIOMARKER DISCOVERY AND VERIFICATION

    Huw Davies

    Huw Davies, Business Development Director, Pronota

  • Analytical requirements for plasma protein biomarker discovery
  • Study design considerations for discovery and verification stages
  • Bridging the gap between discovery and clinical implementation
  • Acute heart failure biomarker discovery and verification case study
  • 17:00 BIOMARKER DISCOVERY TECHNIQUES FOR IDENTIFYING MOLECULAR SIGNATURES FREE OF INTELLECTUAL PROPERTY INFRINGEMENT ISSUES

    Stephen Barnhill

    Stephen Barnhill, Chairman and Chief Executive Officer, Health Discovery Corporation

  • Case-in-point: Introduction of new urine based molecular diagnostic test for clinically significant prostate cancer recently licensed by Abbott and Quest Diagnostics
  • Description of the biomarker discovery technique using SVM and SVM-RFE technology
  • Successful development of companion diagnostics for personalized medicine (using genomic and proteomic data as well as histologic and radiologic images)
  • Successful development of surrogate biomarkers for clinical trials
  • 17:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Stewart  Bates

    Stewart Bates, Director of Biomarker Discovery, GlaxoSmithKline

    9:10 BIOMARKERS IN CLINICAL TRIALS – A CENTRAL LABORATORY PERSPECTIVE

    Edwin  Janssen

    Edwin Janssen, Director Biomarkers and Biopharmaceuticals, Eurofins Medinet

  • Applications of biomarker analysis in clinical trials
  • Significance of fit-for-purpose biomarker assay validation
  • Benefits of integrating biomarker analysis in a routine central laboratory setting
  • Translating lessons learned
  • 9:50 BIOMARKER IDENTIFICATION, DEVELOPMENT AND UTILISATION

    Stewart  Bates

    Stewart Bates, Director of Biomarker Discovery, GlaxoSmithKline

  • The spectrum of utility for biomarkers
  • Biomarkers in translational research
  • Biomarkers and the delivery of personalised medicine
  • Future opportunities and possible limitations
  • 10:30 Morning Coffee

    11:00 FLOW CYTOMETRY: HIGHLY SOPHISTICATED TECHNOLOGY FOR CUSTOMISED BIOMARKER ASSAYS APPLIED IN CLINICAL TRIALS

    Alessandra Vitaliti

    Alessandra Vitaliti, Head of Cellular Biomarkers Group, Novartis

  • Standardisation of customised flow cytometry-based biomarker assays in multiple centre clinical studies
  • Measurement of rare events as cellular biomarkers
  • Cellular biomarkers in proof-of-mechanism clinical studies
  • Future challenges of biomarker assays
  • 11:40 LIMITATIONS IN BIOMARKER DISCOVERY AND APPLICATION

    Rudolf Oehler

    Rudolf Oehler, Senior Scientist, Surgical Research Laboratories, Medical University of Vienna

  • Discovery and application of high abundant vs. low abundant biomarkers
  • Disease-specificity of biomarkers
  • Discovery and application of cellular biomarkers
  • Obstacles and solutions in the application of biomarkers in the clinical routine
  • 12:20 Networking Lunch

    13:50 THE BIOMARKERS CONSORTIUM

    Shawnmarie Mayrand-Chung

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

  • Cross-sector biomarker partnerships for synergy, efficiency and economy
  • Early and continued input by scientists, regulators and industry
  • Discussion of several specific clinical  trial involving biomarker research
  • How to join and participate
  • 14:30 ASSESSING ATHEROMATOUS PLAQUE VULNERABILITY WITH MRI: DEVELOPING A SURROGATE BIOMARKER

    Jonathan Gillard

    Jonathan Gillard, Professor of Neuroradiology, University Of Cambridge

  • Exploring the limitations of conventional imaging – measurements of risk
  • Describing MR tools for assessing morphological risk measures
  • Describing functional MR tools quantifying inflammation and mechanical stress in plaque
  • Reviewing MR tools in the context of developing surrogate biomarkers of risk in clinical trials
  • 15:10 Afternoon Tea

    15:40 PET IN DRUG DEVELOPMENT

    Tony Gee

    Tony Gee, Director, PET & Radiotracer Development, GlaxoSmithKline

  • Use of PET in translational research
  • Assessing behavioural, therapeutic and toxic properties
  • PET tracer development for novel therapeutics
  • Developing a coherent approach
  • 16:20 PREDICTIVE BIOMARKERS IN CLINICAL DEVELOPMENT: AN INDUSTRY PERSPECTIVE

    Rose McCormack

    Rose McCormack, Clinical Biomarker Scientist, AstraZeneca

  • Choosing the right biomarkers, platform and assays
  • Making biomarker collection happen
  • Demonstrating clinical utility of biomarkers
  • Impact of biomarkers on diagnostic strategies
  • 17:00 Chairman’s Closing Remarks and Close of Conference

    +

    Workshops

    Protein Biomarkers in Clinical Development
    Workshop

    Protein Biomarkers in Clinical Development

    Crowne Plaza Hotel - St James
    22nd September 2009
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.