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The in vitro diagnostics is an expanding market estimated to be worth more than $38 billion globally in 2007.  In vitro diagnostics are thought to influence around 60% of all clinical decisions, yet IVD sales represent only around 2% of the total healthcare expenditure in Europe.  With clinicians under increasing pressure for better clinical outcomes, in vitro diagnostics may provide the tools needed for the critical early detection of diseases.

SMi’s conference aims to bring together the market leaders in this area allowing for discussion about the various aspects of this growing market.  Looking at the regulatory challenges and the needs of medical practitioners, consumers and drug developers this event intends to provide unique and valuable insight into the world of in vitro diagnostics.

 
IDENTIFY key areas for development within this growing market
CONSIDER new strategies for IVD development
EXAMINE regulatory challenges and how they can be overcome
HEAR from industry experts with experience in this field
REVIEW the future for the IVD market

This event is targeted at the decision makers developing, marketing and using in vitro diagnostics, including the following job titles:

  • CSOs
  • CTOs
  • Directors/Heads/VPs of Diagnostic Reasearch & Development
  • Directors/Heads/VPs of In Vitro Diagnostics
  • Clinical Scientists
  • Physicians
  • Pharmacists
  • Directors/Heads/VPs of Business Development
  • Hospital CEOs, CFOs, CIOs
  • Pathologist
  • Policy Makers

  Representatives at last years Point of Care Diagnostics and Molecular Diagnostics events included:

  • Abbott Point of Care
  • Genzyme Diagnostics
  • Roche Diagnostics
  • ALK Abello A/S
  • Biokit SA
  • Nanogen
  • Irish Medicines Board
  • Diasys Diagnostic Systems
  • Institute of Biomedical Science
  • Securetec Detektions-Systeme AG
  • Health Protection Agency
  • Cytyc Development & Corporation
  • Orion Diagnostica Phadia AB
  • DiagnOx
  • Johnson & Johnson/ McNeil Consumer Healthcare
  • Capio Diagnostics UK
  • Department of Health
  • Radiometer Medical APS
  • Connector
  • Meretek Diagnostics Inc
  • Tyco Healthcare Group LP
  • Nolato Medical
  • Biomerieux
  • Medifiq
  • Orion Corporation
  • Noiro
  • Biosurfit
  • Horiba ABX
  • Perlos Corporation
  • Laboritories Leti SL
  • TriVirix

 
This conference is an unmissable opportunity to raise the profile of your company amongst the market leaders in this area.
For speaker opportunities please contact Rachel Francis on +44 (0)20 7827 6056 or email rfrancis@smi-online.co.uk
For sponsorship opportunities please contact Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.uk

Representatives at last years Point of Care Diagnostics and Molecular Diagnostics events included:

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

David Huckle

David Huckle, Chief Executive, Adams Business Associates

9:10 OVERVIEW

David Huckle

David Huckle, Chief Executive, Adams Business Associates

  • In vitro diagnostics market drivers
  • Current market trends in molecular diagnostics
  • Current market thresholds & dynamics
  • 9:50 NANODIAGNOSTICS: SINGLE CELLS. PROTEOMICS AND SINGLE MOLECULE DETECTION

    Jon Cooper

    Jon Cooper, Professor of Bioelectronics and Bioengineering, University of Glasgow

  • Lab-on-a-chip methods to isolate single cells
  • Single cell platforms for exploring drug efficacy
  • Future look: nanoplasmonics and enhanced Raman to observe single molecules
  • 10:30 Morning Coffee

    11:00 FROM BIOMARKER DISCOVERY TO THERAPEUTIC PRACTICE

    Simon Read

    Simon Read, Leader of Biomarkers and Experimental Medicine, Roche Products

  • Introduction - the application of biomarkers in drug development
  • Addressing the challenge of biomarker selection - focus on utility
  • Feasibility of PHC -  A case study
  • Significance of diagnostic innovation - impacting therapeutic practice
  • 11:40 PHOSPHODIESTERASES IN PROSTATE CANCER

    Ralf Hoffmann

    Ralf Hoffmann, Principal Scientist - Molecular Biology, Philips Research Eindhoven

  • cAMP signaling in cellular function
  • Phosphodiesterases as regulatory elements of cAMP
  • Phosphodiesterases in prostate cancer
  • 12:20 Networking Lunch

    13:50 REGULATORY CHALLENGES FOR IN VITRO DIAGNOSTICS IN THE UNITED STATES

    Alberto Gutierrez

    Alberto Gutierrez, Deputy Director of OIVD, Office of In Vitro Diagnostic Device Evaluation and Safety, FDA

  • FDA regulation is science based and involves an overlapping series of well defined but flexible premarket and postmarket controls
  • New molecular test and the advent of personalized medicine have placed the diagnostic in center stage, since the safety and effectiveness of therapeutic decisions are dependent on a single diagnostic
  • The regulatory challenges presented by this prominent role will be discussed
  • 14:30 INDUSTRY & REGULATORY DEVELOPMENT FOR AUTO-IDENTIFICATION & TRACEABILITY

    Janice Kite

    Janice Kite, Traceability Director Healthcare, GS1

  • GS1 / GS1 healthcare / roadmap
  • Diverse regulatory requirements
  • Global initiatives
  • Pilot benchmarks
  • Why global standards?
  • 15:10 Afternoon Tea

    15:40 REGULATORY REQUIREMENTS FOR SELF-TESTING IN VITRO DIAGNOSTIC DEVICES

    Richard Saunders

    Richard Saunders, Regulatory Affairs Manager EMEA, Abbott Diabetes Care

  • CE marking approval process (IVD Directive requirements) 
  • Specific self-testing labelling requirements
  • ISO and EN standard requirements
  • Other directives e.g WEEE and Batteries Directives
  • 16:20 IVD MIA REGULATORY CASE STUDY

    Guido Brink

    Guido Brink, Director, Regulatory Affairs & Reimbursement, Agendia

  • Agendia BV obtained the first FDA clearance ever issued for an IVDMIA
  • Agendia is the first microarray laboratory to acquire an ISO 17025 accreditation
  • Hear discussion of the challenges and successes in obtaining and utilising this clearance
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    David Huckle

    David Huckle, Chief Executive, Adams Business Associates

    9:10 BREATH AS AN IN VIVO DIAGNOSTIC BIOMARKER IN MEDICINE

    Anil Modak

    Anil Modak, Associate Director, Medical Products Research & Development, Cambridge Isotope Laboratories Inc.

  • Detection of volatile organic compounds in human breath to identify oxidative stress caused by disease
    - NO breath test to detect and monitor asthma
    - Pentane breath test for heart transplant rejection
  • 13CO2 as a in vivo biomarker in human breath to diagnose enzyme deficiencies after ingestion of 13C substrates to help physicians personalize medication
    - Urea-13C breath test for diagnosing Helicobacter pylori infection
    - Uracil-13C breath test for detecting pyrimidine metabolic disorder prior to 5-Fluorouracil therapy
    - Dextromethorphan-13C breath test for evaluating CYP 2D6 enzyme activity
    - Pantoprazole-13C breath test for evaluating CYP 2C19 enzyme activity
  • 9:50 THE ROLE OF MOLECULAR DIAGNOSTICS IN PERSONALISED MEDICINE

    Eddie Blair

    Eddie Blair, Director, Integrated Medicines Ltd

  • Drug and diagnostic partnering in medicines development and marketing
  • The economic up-lift for drugs translated to value-based pricing of companion diagnostics
  • Extrapolation of valuation to a market opportunity and a guide to business relationships
  • The macroeconomics that support the case for companion diagnostic pricing and re-imbursement
  • 10:30 Morning Coffee

    11:00 MOLECULAR DIAGNOSTIC PLATFORMS FOR PERSONALISED MEDICINE

    Paul Weinberger

    Paul Weinberger, Director, Clinical Development, Enigma Diagnostics

  • The status quo for testing platforms
  • User perspectives
  • Two development paths
  • Platforms for the future
  • 11:40 POST MARKET SURVEILLANCE OF IVDS

    Elaine Mooney

    Elaine Mooney, Scientific Officer IVD’s, Irish Medicines Board

  • Vigilance MEDDEV
  • Market surveillance and auditing
  • Compliance with regulations: re-active and pro-active
  • 12:20 Networking Lunch

    13:20 CASE STUDY - DIRECT TO CONSUMER TESTING

    Gill Hart

    Gill Hart, Technical Director, Yorktest Laboratories

  • Benefits and disadvantages of testing at home
  • Regulatory issues for the market
  • Consequences of cutting out the health professionals
  • Applications of the technology
  • 14:00 DISCOVERY AND VERIFICATION OF NOVEL PLASMA PROTEIN BIOMARKERS FOR DIAGNOSTIC DEVELOPMENT

    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
  • 14:40 Afternoon Tea

    15:00 PERSONALISED MEDICINE AND PERSONALISED JUSTICE

    Steven How Yan  Wong

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

  • Emerging practice of PJ - using pharmacogenomics in assessing drug related behaviour/work performance in legal proceedings, and the "inevitable" chack and balance relationship of PM and PJ
  • PM and PJ drivers: patients, clinicians, legal communities, pharmas, in-vitro and molecular diagnostics and regulatory agencies
  • Illustrative cases including driving- and working- under the influence of drugs (DUID and WUID)
  • Expanding and emerging opportunities for in vitro diagnostics and for legal and health professionals
  • 15:40 LAB ON A CHIP TECHNOLOGIES FOR POINT-OF-CARE Testing

    Gert Blankenstein

    Gert Blankenstein, Head of Business Microfluids, Boehringer Ingelheim Microparts

  • New key technologies
  • Basic principles and applications
  • Market developments
  • Examples of microfluidic technology for POCT
  • Issues and implementation
  • Cost effectiveness of new technologies
  • 16:20 Chairman’s Closing Remarks and Close of Day One

    +

    Workshops

    Regulatory & Reimbursement Considerations for IVDMIA’s in the United States
    Workshop

    Regulatory & Reimbursement Considerations for IVDMIA’s in the United States

    Crowne Plaza Hotel - St James
    2nd June 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

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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.

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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@smi-online.co.uk

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