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This year's major international molecular diagnostics Conference highlights two key areas. It will show you how to:
  • Identify the emerging market opportunities for diagnostic products, and
  • Take advantage of the latest technological developments shaping these markets.
The Conference is split into 16 main sessions. Including the discusion of:
  1. Regulation: compliance strategies to address the impact of new regulations in the US and Europe
  2. Rx/Dx: how to achieve success in the development of therapeutic and diagnostic combinations
  3. Clinical Applications: the latest technical developments in oligonucleotides, cancer diagnostics, pharmacodiagnostics, testing, predictive markers and nanotech
  4. Research & Development: innovations in genetic testing, microarrays, personalised medicine and sample preparation
  5. Commerical Issues: pricing and reimbursement strategies for diagnostics products

This event is a unique opportuntiy to hear from the market leaders. We have structured the programme with lots of informal breaks between the sessions. Giving you a great opportunity to put your questions to the heads of all the major diagnostics programmes at:
  • Johnson & Johnson
  • Hoffmann LaRoche
  • Abbott
  • Bayer
  • GE Healthcare
  • Roche Diagnostics
  • and many, many more.

Plus,
  • Bottom-line numbers
  • what is the real value of incorporating diagnostics? early? or post-approval?
  • What are the best strategies for managing collaborative Rx/Dx programmes
  • Latest FDA regulations' have an impact on the diagnostics market
  • New EU regulations update
  • how will they affect your business
  • How can you develop combinations to their full potential?
  • What is happening in translational medicine and how can you assess it's impact?
  • How can you get your diagnostics out into the open pharma marketplace

Plus, back by popular demand, our in depth Workshop on Personalised Medicine, led by the worlds leading authority on the subject, Prof. KK Jain.
Last years Workshop sold out, so remember to register early to avoid disappointment. The format is a step-by-step roadmap in the development of Personalised Medicine. It is only being held once this year, and the interactive format means that places are strictly limited, so book now to secure your place.

Who will you meet at this important Conference? Previous delegates include: AstraZeneca, Bayer HealthCare LLC, BD (Becton Dickinson), British In Vitro Diagnostics Association, BTG, Diagnostic Oncology CRO Inc, DSTL, Eragen Biosciences, European Diagnostics Manufacturing Association, EXACT Sciences Corp., F Hoffman La Roche, Genzyme SA, GR Micro Ltd, Health Protection Agency, Health Protection Agency, Integragen, Inveresk Research Group Ltd, Invitrogen, Jain PharmaBiotech, Laval University, Medical College of Wisconsin, Millennium Pharmaceuticals, MLT Research Ltd

Conference programme

8:30 Registration & Coffee

9:00 Chairperson's Opening Remarks

Dr Stephen Little

Dr Stephen Little, Chief Executive Officer, DxS Ltd

9:10 THE EVOLVING ROLE OF REGULATIONS IN MOLECULAR DIAGNOSTICS

Thomas Soriano

Thomas Soriano, President & Chief Executive Officer, Diagnostic Oncology CRO

  • An overview of the US market - FDA regulated products vs analyte specific reagents/ home brews
  • Regulations and guidance documents of interest - ASR’s, molecular tests, multiplex tests
  • The impact of regulations on the industry - examples of regulatory impact of commercialisation plans
  • How do you comply?
  • Documentation - registration, listing with FDA
  • Future policies and regulations - current debate and possible outcomes
  • 9:50 A EUROPEAN OUTLOOK ON REGULATION

    Karen Howes

    Karen Howes, Regulatory Affairs Director, The European Diagnostic Manufacturers Association (EDMA

  • Current European legislation
  • Defining what legislation is applicable to your product
  • Key elements in the compliance process
  • European legislation in a global context
  • Forthcoming initiatives and their impact on your business
  • What does the future hold?
  • 10:30 Morning Coffee

    10:50 COMPANION DIAGNOSTICS: CO-DEVELOPMENT OF TESTS AND DRUGS

    Thomas Metcalfe

    Thomas Metcalfe, Head, Biomarker Programme & Senior Vice, F. Hoffmann – La Roche

  • Strategies for clinical development of therapeutic and diagnostic combinations
  • Developing molecular diagnostics to support research and development portfolios
  • Developing molecular diagnostics as commercial agents
  • Portfolio impacts of joint therapeutic/diagnostic products
  • Market overview
  • Relation of molecular diagnostics to other technologies
  • 11:30 TRANSLATIONAL MEDICINE: IMPACT ON THERAPEUTIC DEVELOPMENT AND COMPANION DIAGNOSTICS

    Anne Bailey

    Anne Bailey, Vice President & General Manager, Genomics, Tapestry Pharmaceuticals

  • Uses in therapeutic development
  • Will it change therapeutic development?
  • Influence on the growth of companion diagnostics
  • Current technology limitations
  • Economic impact on healthcare
  • Emerging opportunities
  • 12:10 Networking Lunch

    13:40 DELIVERING COMMERCIAL COMPANION DIAGNOSTICS TO THE OPEN PHARMA MARKETPLACE

    Angus Hastie

    Angus Hastie, Director, Marketing & Business Development, Roche Molecular Diagnostics

  • The bottom-line numbers - what is the value of incorporating diagnostic? If early? If post-approval?
  • Strategies for collaborative Rx/Dx programmes with pharma - avoiding the ‘submarine’ diagnostic
  • ‘Aligning the planets’ - creating proactive connections between all stakeholders in the implementation chain (from discovery to approvals)
  • Applying translational research from prototype assays to optimised, market-compatible tests
  • Incorporating optimised, scalable tests into pivotal regulatory trials
  • Gaining early market penetration with screening tests – pulling new drug choice through diagnostic metrics
  • 14:20 OLIGONUCLEOTIDES FOR THE MOLECULAR DIAGNOSTICS INDUSTRY

    Dr Patrick De Meyer

    Dr Patrick De Meyer, Director, International Marketing, Scandinavian Gene Synthesis

  • Current technologies
  • Process aspects
  • Regulatory aspects
  • Quality control considerations
  • Future developments
  • 15:00 Afternoon Tea

    15:20 CANCER MOLECULAR DIAGNOSTICS

    Dr David Atkins

    Dr David Atkins, General Manager, Molecular Diagnostics, Veridex, Johnson & Johnson

  • State of the industry
  • Barriers to growth
  • Future opportunities
  • 16:00 THE CHALLENGE OF PHARMACODIAGNOSTICS

    Dr Eva Pisa

    Dr Eva Pisa, Chief Executive Officer, Sangtec Molecular Diagnostics

  • Selection of suitable technology platforms
  • Generation of clinical relevant diagnostic target –trial designs
  • Impact on health economics
  • Business models for commercialisation
  • 16:40 MOLECULAR DIAGNOSIS OF COMPLEX DISEASES

    Dr Jan Mous

    Dr Jan Mous, Chief Executive Officer, IntegraGen

  • Rapid discovery of disease-associated genes
  • Epistatic interactions and susceptibility prediction
  • Genetic analysis and counselling service
  • Reimbursement challenges
  • Market opportunities
  • 17:20 Chairperson’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairperson's Opening Remarks

    Doris-Ann Williams

    Doris-Ann Williams, Director General, British In Vitro Diagnostics Association (BIVDA)

    9:10 OPPORTUNITIES AND TRENDS IN CLINICAL DIAGNOSTICS

    Dr Stephen Little

    Dr Stephen Little, Chief Executive Officer, DxS Ltd

  • Role in predisposition, early screening, prognostic, monitoring and pharmacogenetic testing
  • Integrated healthcare
  • Current technology limitations and opportunities
  • 9:50 THE FORESEEABLE IMPACT OF MOLECULAR DIAGNOSTICS ON TODAY’S THERAPIES

    Dr Christoph Petry

    Dr Christoph Petry, Head, Diagnostics Research, Bayer HealthCare

  • Current practice to select therapies
  • Molecular diagnostics to fine-tune the characterisation of disease
  • Developing molecular diagnostics to guide established therapies
  • Predictive markers and health economy
  • 10:30 Morning Coffee

    11:00 DEVELOPING PRACTICAL NANOTECH INNOVATION WITHIN MOLECULAR DIAGNOSTICS TESTING

    David Browning

    David Browning, Executive Vice President, Oxonica

  • Market requirements and drivers
  • The quest for ultra-sensitivity and robust multiplex
  • Oxonica’s answer to the market requirement challenge
  • Partnership strategies for global commercialisation success
  • 11:40 NUCLEIC ACID TESTING (NAT) VS IMMUNO ASSAYS

    Dr Hans-Jörg Grill

    Dr Hans-Jörg Grill, Chief Technology Officer, Business Area, Clinical Diagnostics, Tecan

  • Impact and potential of NAT in molecular diagnostics
  • The market: past, present and future
  • Automation of NAT: industry progress to date, impact on the market and problems encountered so far
  • Short-term and long-term opportunities
  • Outlook – market needs
  • NAT and preventive medicine
  • 12:20 Networking Lunch

    14:00 46 CHROMOSOMES, INFINITE POSSIBILITIES

    Dr Edward Chait

    Dr Edward Chait, Chief Executive Officer, Spectral Genomics

  • Principles of comparative genomic hybridisation CGH in detecting chromosomal changes with microarrays
  • Microarrays for detection of pre-natal/post-natal genetic defects
  • Detection of aneuploidy in cancer
  • Disease classification via chromosomal data
  • Detection of aneuploidy in cancer
  • Drug discovery applications of CGH microarrays
  • 14:40 PERSONALISED MEDICINE

    Dr Paul Cload

    Dr Paul Cload, Vice President, Global Marketing, Cardiology, GE Healthcare

  • Development of personalised medicine: predict, diagnose, inform, treat
  • Delivering the vision
  • How will it change the market and business models?
  • The role of imaging agents
  • Informatics
  • 15:20 MOLECULAR DIAGNOSTIC SAMPLE PREPARATION

    Noel Doheny

    Noel Doheny, Vice President, Preanalytical Solutions for Molecular Diagnostics, Qiagen

  • Blood viral formats
  • Genomic DNA approaches
  • Cancer requirements
  • Pathogens: respiratory form
  • 16:00 Chairperson’s Closing Remarks and Close of Conference

    +

    Workshops

    Personalised Medicine
    Workshop

    Personalised Medicine

    The Hatton, at etc. venues
    5th November 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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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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