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Following a series of very well-received Conferences run specifically for the Diagnostics industry, SMi are delighted to continue the series with their 2nd annual event on Opportunities & Technology Trends in Global Diagnostic Testing Markets. The event will endeavour to provide a competitive assessment of the important diagnostic markets, looking at the new trends and drivers and evaluating the directions that the industry is likely to follow over the next few years. The event will investigate the benefits and drawbacks of company alliances and collaborations and will include an update of the regulatory issues impacting the industry, with a focus on the EU and US.

This year’s Conference will include a series of case studies from experts in their field as to the latest technology trends shaping the industry, providing a platform for discussion which will spark new product ideas, allow you to assess your current R & D investments and select where to focus your future business efforts.

A unique opportunity to learn from leading industry experts including:

· Dr Mara Aspinall, President, Genzyme Diagnostics
· Prof Christopher Price, Vice President, Clinical Research, Diagnostic Division, Bayer HealthCare
· Dr Kenneth Aron, Vice President, Research & Development, Abaxis
· Ian McLellan, Director, Projects, Business Development, Amersham Health
· Dr Ian Gilham, Group Managing Director, Laboratory Division, Axis-Shield
· Dr Howard Grey, Global Business Director, Clinical & Molecular Diagnostics, Perkin Elmer
· John Curtis, President, Diagnostics, Provalis
· Dr Glen Hortin, Chief, Clinical Chemistry, Department of Laboratory Medicine, National Institutes of Health

The essential event on:
· KEY SECTORS IN THE MARKET: Gain an insight into the latest developments in the key diagnostic sectors: glucose monitoring, cancer, drugs of abuse and point of care
· BUSINESS & COMMERCIAL TRENDS: Discover the opportunities that arise from strategic alliances and collaborations
· AN UPDATE ON REGULATIONS: Understand how recent regulations will impact you and your company
· CRITICAL TECHNOLOGY TRENDS: An update on the latest technologies in the pipeline
· KEY INDUSTRY PERSONNEL: Meet the leaders in the field, learn from their experiences and make valuable contacts

"Excellent panel of speakers, very interesting range of topics."
Larry Hambleton, Innogenetics, SMi’s Diagnostic Conference June 2003

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Doris-Ann Williams

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

9:10 KEYNOTE ADDRESS

Mara Aspinall

Mara Aspinall, President, Genzyme Diagnostics

  • Current turnover snapshot
  • Market sectors: point of care, over the counter and molecular diagnostics and their current status
  • Major global trends – current and future: regulatory, governmental policy and industry announcements
  • Current technology trends: identifying which will have real impact on the industry
  • Prospective challenges to the industry
  • Market forecasts
  • 9:40 STRATEGIC ALLIANCES

    Dr Stephen Little

    Dr Stephen Little, Chief Executive Officer, DxS Ltd

  • What we look for in potential partners
  • Finding synergies between diagnostic tools and new and existing therapeutics
  • Creating successful partnerships
  • Understanding each other’s business models
  • Licensing deals: mutual benefits and pitfalls
  • Going forward
  • 10:20 PRICING AND REIMBURSMENT IN THE GLOBAL DIAGNOSTIC TESTING MARKET

    Paula Wittels

    Paula Wittels, Director, Operations, Quintiles

  • Understanding the reimbursement process
  • Disease management
  • Identification of payers and budget holders
  • Dealing with formal listings
  • The importance of HTA and informal guidelines
  • 11:00 Morning Coffee

    11:20 AN UPDATE ON REGULATORY AFFAIRS IN USA

    Thomas Soriano

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

  • Current FDA regulatory policies
  • Changes in the FDA’s policies
  • An update on FDA product review cycles and performances
  • Vile gossip
  • 12:00 THE POINT OF CARE DIAGNOSTIC PRODUCT MARKET

    Prof Christopher Price

    Prof Christopher Price, Vice President, Global Clinical Research, Diagnostics Division, Bayer HealthCare

  • Global point of care diagnostic testing market
  • Current changes in health care delivery
  • Opportunities for point of care testing
  • Benefits from point of care testing
  • The economics of point of care testing
    Regulatory requirements for point of care diagnostic products
  • Making a business case for point of care testing
  • 12:40 Networking Lunch

    13:40 CRITICAL ISSUES IN POINT OF CARE

    Dr Kenneth Aron

    Dr Kenneth Aron, Vice President, Research & Development, Abaxis

  • Ease of use for primary instrument (reader) and associated disposables
  • ‘Smart’ instrument capable of catching user errors
  • Wide selection of analytes available to span many common lab tests
  • Multi-analyte selection and configurations matched to laboratory needs
  • 14:20 ADVANCES IN A1C AT POINT OF CARE

    John Curtis

    John Curtis, Managing Director, Diagnostics, Provalis

  • Complimentary or competitive to glucose?
  • Major trends and issues
  • An analysis of major devices
  • Future trends in A1c testing
  • 15:00 NEW DEVELOPMENTS IN VIRAL DIAGNOSTICS

    Dr Bruce Phelps

    Dr Bruce Phelps, Vice President, Research & Development, Chiron

  • Improved detection of hepatitis B surface antigen
  • Development of new antigens for detection of HCV
  • Feasibility of an automated antigen/antibody combination assay to detect HIV
  • Assays for detection of antibodies against west nile virus
  • 15:40 Afternoon Tea

    16:00 INFECTIOUS DISEASES

    Dr Patricia Garrett

    Dr Patricia Garrett, Senior Vice President, Science & Technology, Boston Biomedica

  • Who are the winners in the war between microbes and humans?
  • You can’t know if you don’t test
  • Emerging diseases as an engine for technology development
  • The clinical laboratory in the global village
  • 16:40 BUSINESS AND COMERCIAL ISSUES IN THE GLOBAL DIAGNOSTIC INDUSTRY

    Dr Malcom Luker

    Dr Malcom Luker, Managing Director, Hypoguard

  • The type II diabetic needs- a huge and growing market for blood glucose monitoring
  • What issues affect the self-testing of the diabetics at home
  • How the development of new monitoring system address these needs
  • How smart technology on the inside renders the product simple on the outside…and simplicity of use for the diabetic
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Stephen Little

    Dr Stephen Little, Chief Executive Officer, DxS Ltd

    9:10 CHANGES IN SUBSTANCE MISUSE TESTING

    Helen Vangikar

    Helen Vangikar, Toxicology Manager, Quest Diagnostics

  • Key changes in current and forthcoming legislation
  • Pros and cons of alternative biological samples
  • Current and future applications
  • Can you detect the cheats?
  • Future growth in the market
  • 9:40 CARDIAC MARKERS

    Dr Ian Gilham

    Dr Ian Gilham, Group Managing Director, Laboratory Division, Axis-Shield

  • A review of the available diagnostic markers for cardiac ischemia, antherosclerotic disease, heart failure and platelet function
  • Cardiac markers and the respective market size
  • Inherent shortcomings and limitations of diagnostic cardiac markers
  • The impact on the existing CV diagnostics and therapeutic markets
  • The future role of genetic analysis in shaping the cardiac diagnostic markers
  • 10:20 MOLECULAR DIAGNOSTICS

    Dr Howard Grey

    Dr Howard Grey, Global Business Director, Clinical & Molecular Diagnostics, Perkin Elmer

  • Where is MDx today?
  • What is driving MDx today?
  • What is and will emerge in MDx ?
  • What will the future bring in MDx?
  • 11:00 Morning Coffee

    11:20 GETTING TO THE GLOBAL MARKET

    Dr John Langmore

    Dr John Langmore, Co-Founder & Vice President, Commercial Development, Rubicon Genomics

  • Patient and physician needs for MDx
  • Physician and payer needs for specificity and sensitivity
  • Methods to increase specificity and sensitivity
  • How to fuse MDx with existing pathology practice
  • The small company problems: resources, approval, distribution, reimbursement
  • The large company problems: technology, content, approval, reimbursement
  • 12:00 EMERGING APPROACHES TO CANCER DIAGNOSTICS

    Dr Douglas Malinowski

    Dr Douglas Malinowski, Chief Scientific Officer & Vice President, Research, TriPath Oncology

  • A rapidly expanding and highly unreserved market?
  • Current technologies and approaches to an ever growing market
  • Novel technology platforms
  • A case study
  • Current product line
  • Business strategy, highlights and objectives
    Market trends and forecasts
  • 12:40 Networking Lunch

    14:00 THE CHANGING ROLE OF IN VIVO IMAGING IN MOLECULAR DIAGNOSTICS

    Ian McLellan

    Ian McLellan, Director, Projects, Business Development, Amersham Health

  • Why are in vivo imaging techniques so important?
  • How is the role of molecular diagnostic imaging changing ?
  • The importance of imaging in personalised diagnosis
  • How in vivo molecular diagnostics is able to enhance personalised medicine
  • In vivo and in vitro in personalised medicine: conflict or collaboration?
  • 14:40 CHOLESTEROL TESTING

    Dr Tom Worthy

    Dr Tom Worthy, Vice President, Development & Regulatory Affairs, Cholestech

  • Current status of cholesterol testing as a market segment
  • New guidelines for cholesterol testing: ATP III
  • The impact of expanding the cholesterol testing profile and changing of cut-points used in diagnostics
  • Current implications for in vitro diagnostics manufacturers
  • Processes and technologies
  • Future movements in the cholesterol testing market
  • 15:20 Afternoon Tea

    15:40 PHARMACOGENOMICS IN THE DIAGNOSTIC INDUSTRY AND CLINICAL LABORATORY

    Prof Steven Wong

    Prof Steven Wong, Director of Clinical Chemistry/Toxicology, Therapeutic Drug Monitoring, Pharmacogenomics & Proteomics / Scientific Director, Toxicology Department, Medical College of Wisconsin / Milwaukee County Medical Examiner’s Office

  • Pharmacogenomics as a biomarker for drug discovery
  • Current status of pharmacogenomics in diagnostics
  • The benefits and pitfalls of this emerging technology
  • Update on the development of regulatory policy
  • Clinical applications of pharmacogenomics
  • Status of reimbursement for pharmacogenomic testings
  • 16:20 USING PROTEOMICS IN DIAGNOSTICS

    Dr Glen Hortin

    Dr Glen Hortin, Chief, Clinical Chemistry, National Institutes of Health

  • Understanding the technologies
  • Roles of proteomic technologies in the diagnostic arena
  • Peptidomics: a new diagnostic frontier
  • Potential clinical applications
  • Results of clinical trials
  • Barriers to implementing proteomic tests in clinical labs
    Looking ahead
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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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