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This event will provide you with a competitive assessment of the key diagnostic testing markets, including updates in major market trends and forecasts and the chance to hear case studies exploring key clinical applications. Discussing an invaluable and up-to-date overview of the global diagnostics testing market, hear key leaders from the European Patent Office and the Department of Health pinpoint recent regulatory policies and pricing and reimbursement practices. With examples of successful product developments and mergers and acquisitions, listen to the latest commercial issues and the opportunities that exist for diagnostic companies of the future.

Hear international case studies and expert perspectives from leaders in the field, including:

  • Dr David Horwitz, World-Wide Vice President, Medical & Clinical Affairs, LifeScan, Johnson & Johnson
  • Luis Gonzalez-Vaque, Advisor, European Commission
  • Dr Ioannis Theodoropoulos, Director, European Patent Office (EPO)
  • Dr Linda Surh, Director, Regulatory Affairs, Neurology & Pharmacogenetics, GlaxoSmithKline
  • Dr Howard Grey, Director, Molecular Diagnostics, Perkin Elmer Life & Analytical Sciences
  • Dr Kevin Daish, Global Marketing Director, Gene Expression, GE Healthcare
  • Dr Mark Chang, Technical Director, Research Biostatistics, Millennium Pharmaceuticals
  • Thomas Soriano, President & Chief Executive Officer, Diagnostic Oncology CRO

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Stephen Little

Stephen Little, Chief Executive Officer, DxS

9:10 GLOBAL FOCUS: KEY DRIVERS OF CHANGE

Linda Surh

Linda Surh, Director, Regulatory Affairs UK, Neurology and Pharmacogenetics, GlaxoSmithKline

  • Markets representing large opportunity
  • A statistical representation of geographical hot spots
  • Sales by business area
  • Market leader analysis in all key regions
  • Examination of new products driving growth in each segment – world-wide vs US market
  • Rapid globalisation of markets
  • What are the new technology developments?
  • Information technology and the internet
  • Increased pressure on funding
  • 9:50 DIAGNOSTICS: PROVIDING HEALTHCARE SOLUTIONS

    Howard Grey

    Howard Grey, Director, Molecular Diagnostics, Perkin Elmer Life & Analytical Sciences

  • Creating and expanding markets
  • Market trends – US vs ROW
  • Sustainable business growth – margins outpacing competitors for a strong market position
  • New and emerging markets and technology
  • Pharmacogenomics and biomarker advances
  • Biomarker research
  • Disease management programmes
  • 10:30 Morning Coffee

    11:00 CHANGES IN HEALTHCARE PROMPTED BY THE INCREASING USE OF POCT

    11:40 CASE STUDY: POINT OF CARE

    12:20 Networking Lunch

    13:50 PANEL DISCUSSION: MERGERS AND ACQUISITIONS

  • Detailed examination of the key drivers and issues that are shaping the business environment
  • What are the sources of value in the diagnostics industry? How do we create value?
  • The due diligence checklist – what, how, when?
  • Linda Surh

    Linda Surh, Director, Regulatory Affairs UK, Neurology and Pharmacogenetics, GlaxoSmithKline

    Roger Edwards

    Roger Edwards, Managing Consultant, PA Consulting

    Kevin Daish

    Kevin Daish, Global Marketing Director, Gene Expresson, GE Healthcare

    14:30 PRICING AND REIMBURESEMENT ISSUES

    Luis Gonzalez Vaque

    Luis Gonzalez Vaque, Advisor, European Commission

  • Reimbursement structure: the legal framework in the European Union
  • The ECJ's case law: how to apply it?
  • The impact of different pricing and reimbursement systems
  • The future of the European regulations on this matter
  • 15:10 Afternoon Tea

    15:40 UPDATE ON REGULATORY AFFAIRS IN USA

    Thomas Soriano

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

  • Current FDA regulatory policies
  • Changes in FDA’s policies
  • Update on FDA product review cycles and performances
  • Vile gossip
  • 16:20 PATENTING ISSUES

    Ioannis  Theodoropoulos

    Ioannis Theodoropoulos, Director, European Patent Office

  • Exclusion from patentability by means of a legal fiction
  • Proper construction of the terms "diagnostic methods" and "practised on the human or animal body"
  • Review of the role of the medical and veterinary practitioner
  • Essential features of a diagnostic method
  • Requirements for a diagnostic method to be regarded as being practised on the human or animal body
  • Implications regarding surgery and therapy
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    David Horwitz

    David Horwitz, World-Wide Vice President, Medical & Clinical Affairs, LifeScan, Johnson & Johnson

    9:10 CASE STUDY: LIFESCAN

    David Horwitz

    David Horwitz, World-Wide Vice President, Medical & Clinical Affairs, LifeScan, Johnson & Johnson

  • Sensor systems for diagnostic applications
  • Glucose measurements – frequent Monitoring advised
  • Different types of diabetes
  • Public health impact of diabetes
  • Diagnosis of diabetes
  • Hypoglycaemia
  • Glucose testing methods
  • Technology innovations - non invasive glucose testing meters
  • Factors affecting growth
  • Increasing number of diabetics
  • Scope of the undiagnosed diabetes market
  • Dr David Horwitz, World-Wide Vice President, Medical & Clinical
  • 9:50 RESPIRATORY DISEASE TESTING MARKET – A CASE STUDY

    Sue Hill

    Sue Hill, Chief Scientific Officer, Department of Health

  • Diagnostics and the current testing market
  • Patient safety and quality measures
  • Potential market entry barriers and risks
  • The future of the global respiratory testing markets
  • 10:30 Morning Coffee

    11:00 UTILISATION OF BIOMARKERS IN CLINICAL TRIALS

    Mark Chang

    Mark Chang, Technical Director, Research Biostatistics, Millennium Pharmaceuitcals

  • Impact of biomarkers on drug development
  • Challenges in validation of biomarkers
  • Impact of diagnostics in trial designs
  • Adaptive design using biomarkers
  • Ethical considerations
  • Case studies
  • 11:40 HIGH-GROWTH TESTING TRENDS

    David Huckle

    David Huckle, Chief Executive, Adams Business Associates

  • Quality measures
  • Moderators of growth
  • Diagnostics and the ageing population
  • Individualised medicine
  • Patient safety and quality measures
  • Genetic testing
  • Preventive medicine
  • Workforce issues
  • Rapid near patient testing in hospitals
  • Satellite facilities
  • Regionalization of laboratory care
  • Requirements for high-growth testing
  • Clinical Laboratory Improvement Act (CLIA)
  • 12:20 Networking Lunch

    13:50 PHARMACODIAGNOSTICS: EMERGING MARKETS

    Roger Edwards

    Roger Edwards, Managing Consultant, PA Consulting

  • An update on technology requirements for pharmacodiagnostics
  • Pharmacodiagnostic products on the market and in development
  • The business environment for pharmacodiagnostics
  • Market models for pharmacodiagnostics
  • What are the drivers of personalised medicine?
  • Pharmaceutical industry perspective
  • Diagnostic industry perspective
  • 14:30 MOLECULAR DIAGNOSTICS - DNA MICROCHIPS

    Kevin Daish

    Kevin Daish, Global Marketing Director, Gene Expresson, GE Healthcare

  • An introduction to aCGH
  • The aCGH market
  • BACS or Oligo arrays
  • The potential of aCGH
  • 15:10 Afternoon Tea

    15:40 PHARMACOGENETICS (Pgx)

    Stephen Little

    Stephen Little, Chief Executive Officer, DxS

  • How is Pgx applied?
  • Identifying genetic variations/polymorphism
  • PEST constraints
  • Political
  • Sociological
  • Economic
  • Technological
  • 16:20 PROMISES AND CHALLENGES OF CLINICAL GENOMICS

    Steven Wong

    Steven Wong, Professor of Pathology & Scientific Director, toxicology Department, Milwaukee County Examiners Office, Medical College of Wisconsin

  • Clinical genomics applications - prediction, detection and diagnosis
  • Determining risk of disease
  • Predicting response to drugs
  • Diagnosing and monitoring diseases
  • Detecting response to the environment
  • Identifying individuals: paternity and forensics testing
  • Genomic technologies for the clinic
  • DNA variation: detection and genotyping
  • Gene expression detection
  • Other technologies
  • Current applications of clinical genomics
  • Business and strategic issues
  • Key factors driving adoption
  • Cost evaluation of clinical genomics
  • Regulatory environment
  • Clinical genomics diagnostics market
  • Market outlook
  • Business opportunities

    Business opportunities

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

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    Workshops

    Changes in Diagnostic Practice - Commercial & Technical Impacts
    Workshop

    Changes in Diagnostic Practice - Commercial & Technical Impacts

    Park Street Training and Meeting Centre, at etc. venues
    13th June 2006
    London, United Kingdom

    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

    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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