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Following the success of SMi’s 2003 Conference, this event will address the continuing difficulties Biopharmaceutical companies are experiencing in getting biological products to the market place and will look at how the industry should cope with the recent slow down and the pressures to keep pipelines full.

This contentious area is highly regulated with different standards and expectations in different parts of the globe. The event will evaluate today’s regulations including current best practice, consequences of non-compliance, validation programmes and an update on regulation in the industry, including the FDA’s view on risk assessment and risk management.

The difficulties companies are experiencing in preclinical and clinical development will be discussed with an emphasis on overcoming the hurdles of immunogenicity testing and discussion on why clinical development times in this sector have slowed.

In general there is currently a huge bottleneck in production with companies having to choose between contracting out or going it alone. This event will feature an update on disposable technology in the manufacture of biologics, as well address the difficulties associated with manufacturing capacity and the challenges of scale-up in the biopharmaceutical industry.

This is a unique opportunity to learn from leading industry experts including:
Dr Mark Ratcliffe, Director, European Health Outcomes Research, Eli Lilly
Phil Sarocco, Director, Health Outcomes, Aventis
Dr Cristina Espinosa, Head, Health Economics & Outcomes Research, Novartis
Dr Sanjay Gupta, Senior Director & Head, Global Health Outcomes, Millennium
Peter Conway, Head, Health Economics, Wyeth
Jim Brown, Value Demonstration Leader, AstraZeneca
Dr Rick Berzon, Director, Corporate Market Access, Pricing & Outcomes Research, Boehringer Ingelheim
John Hutton, Vice President, European Operations, MEDTAP International

and is the essential event on:

THE GLOBAL ENVIRONMENT FOR PHARMACOECONOMIC ANALYSIS: Establish the future impact of changing market dynamics on pharmacoeconomics in the global arena
GOVERNMENT ASSESSMENT IN THE UK: An insight into the requirements of National Institute for Clinical Excellence (NICE) for pharmacoeconomic analysis
INCORPORATING OUTCOMES RESEARCH INTO MARKETING & PRICING STRATEGIES: Discover how to successfully translate pharmacoeconomics into commercial strategies
ENSURING THE VALIDITY OF PHARMACOECONOMIC DATA: Learn how to handle and present pharmacoeconomic information more accurately
HOW TO ACHIEVE COST EFFECTIVENESS: Understand the importance of economic evaluation and therefore cost effectiveness in all areas

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Richard Wyse

Dr Richard Wyse, Medical Director / Chairman, Celsus Research / Economic Healthcare Associates

9:10 PHARMACOECONOMICS IN THE GLOBAL ARENA

Brian Lovatt

Brian Lovatt, Managing Director & Chief Executive, Vision International Healthcare

  • Europe: a case of set standards
  • The effect of health technology assessment
  • The USA: altering the cost relative to the potential impact of the drug
  • Pharmacoeconomics in Canada
  • The view of pharmacoeconomics in Australia
  • 9:40 CHANGING MARKET DYNAMICS…

    Prof Nick Bosanquet

    Prof Nick Bosanquet, Professor of Health Policy, Imperial College

  • The ageing population: recent figures
  • The rising cost of R&D and the increase in clinical trials
  • Mean time approval for new drugs
  • Pressure from payers - Managed care - Government
  • Consumer expectations
  • The use of generic drugs
    Major implications for the future
  • 10:20 THE RELATIONSHIP BETWEEN OUTCOMES RESEARCH AND DRUG PRICING

    Dr Rick Berzon

    Dr Rick Berzon, Director, Corporate Market Access, Pricing & Outcomes Research, Boehringer Ingelheim

  • The need for healthcare resource data
  • The role of economic modelling
  • The place of quality of life data
  • The development of the product value dossier
  • 11:00 Morning Coffee

    11:20 PHARMACOECONOMICS AND PRODUCT DEVELOPMENT

    Dr Anthony Lockett

    Dr Anthony Lockett, Business Leader, Healthcare Practice, Henley Incubator

  • The nature of development product economics
  • The use of pharmacoeconomic information in decisions of selecting candidates
  • The impact of the current reimbursement and pricing strategies on development strategy
  • 12:00 PHARMACOECONOMICS: WHAT WILL BE NEXT?

    Simon Holt

    Simon Holt, Vice President, Cambridge Pharma Consultancy

  • What will be the impact of the major changes and trends in the cost-containment/Pricing & Reimbursement environment?
  • What practical activities can an organisation do now to adapt and respond to cost-containment situation to help shape their environment to optimise revenue and profit levels?
  • 12:40 Networking Lunch

    14:00 HEALTH ECONOMICS UP TO PHASE IV TRIALS

    Keith Tolley

    Keith Tolley, Head, Health Economics, Ortho Biotech

  • Economic evaluation at each stage of the drug development cycle
  • Drug development at phase IV
  • Understanding local market needs for cost-effectiveness evidence
  • 14:40 PHARMACOECONOMICS AND OUTCOMES RESEARCH

    Dr Sanjay Gupta

    Dr Sanjay Gupta, Senior Director & Head, Global Health Outcomes, Millennium

  • Generation of product benefit messages
  • Pricing
  • Reimbursement & health policy issues
  • Promotion
  • 15:20 PROBLEMS RELATING PHARMACOECONOMIC DATA TO THE AUTHORITIES

    Dr Richard Wyse

    Dr Richard Wyse, Medical Director / Chairman, Celsus Research / Economic Healthcare Associates

    John Hutton

    John Hutton, Vice President, European Operations, MEDTAP International

    Phil Sarocco

    Phil Sarocco, Director, Health Outcomes, Aventis

    Jim Brown

    Jim Brown, Value Demonstration Leader, AstraZeneca

    Janice Haigh

    Janice Haigh, Consultant, IMS Global Consulting
    View Bio

    16:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Jim Brown

    Jim Brown, Value Demonstration Leader, AstraZeneca

    9:10 THE UK QUALITY AGENDA: NICE

    Prof Ron Akehurst

    Prof Ron Akehurst, Dean of School, School of Health & Related Research, University of Sheffield

  • NICE & the requirements for pharmacoeconomic analysis
  • Implementing clinical governance
  • Implications for the future
  • 9:40 RATIONALISING DEVELOPMENT COSTS

    Peter Conway

    Peter Conway, Head, Health Economics, Wyeth

  • Increased pressure from investors at the beginning of trials
  • Avoiding ‘dry holes’ (research without success)
  • Developing cost effectiveness internally
  • 10:20 HANDLING AND PRESENTING PHARMACOECONOMIC INFORMATION

    John Walt

    John Walt, Senior Manager, Global Health Outcomes, Allergan

  • How does the price of drugs compare to… - What US marketing departments want - What US Managed Care customers want - What US Publicity Relations (PR) firms want - What European pricing authorities want - What patients want
  • 11:00 Morning Coffee

    11:20 POST LAUNCH ECONOMICS AND OBSERVATIONAL RESEARCH

    Dr Mark Ratcliffe

    Dr Mark Ratcliffe, Director, European Health Outcomes Research, Eli Lilly

  • Observational studies: what are they?
  • Observational studies and how do they compare to RCT? - internal and external validity - types of bias - implementation
  • Conclusion
  • 12:00 COMMUNICATING AND REPORTING ECONOMIC INFORMATION

    John Hutton

    John Hutton, Vice President, European Operations, MEDTAP International

  • The challenges of reporting economic information
  • Responsive and proactive communication
  • Relevance of the message to the audience
  • New audiences and raised expectations
  • Enhancing the credibility of economic information
  • 12:40 Networking Lunch

    14:00 AN OUTCOMES RESEARCH (OR) AND HEALTH ECONOMICS (HE) UNIT IN EUROPE

    Dr Cristina Espinosa

    Dr Cristina Espinosa, Head, Health Economics & Outcomes Research, Novartis

  • Role of a local OR & HE Unit
  • Networking with other departments: some clues for success
  • Synergism with the global environment: same priorities at the same time?
  • Local results: do they represent an added value for the physicians, patients and stakeholders?
  • Communication of local results: where, when, how and whom
  • 14:40 PRODUCTIVITY ASSESSMENT IN PHARMACOECONOMIC STUDIES

    Dr Christopher Evans

    Dr Christopher Evans, Senior Project Director, Mapi Values

  • Selection and use of self-report questionnaires
  • Validity and reliability of assessments
  • International adaptation of productivity questionnaires
  • Problems in the valuation of productivity
  • Regulatory authority views of productivity assessments
  • 15:20 THE FUTURE FOR PHARMACOECONOMICS

    Dr Clive Pritchard

    Dr Clive Pritchard, Health Economist, Office of Health Economics UK

  • The changing role of NICE in the UK
  • The role of other UK HTA bodies
  • The commercial implications of more widespread use of pharmacoeconomics
  • A prediction for future changes to healthcare policy
  • 15:40 HOW TO INCORPORATE HEALTH OUTCOMES STRATEGY INTO OVERALL BRAND MARKETING STRATEGY

    Phil Sarocco

    Phil Sarocco, Director, Health Outcomes, Aventis

  • Knowing the outcomes needs of the healthcare decision-maker
  • Knowing the outcomes advantages of your product
  • Generating the outcomes information
  • Challenges to communicating with end users
  • 16:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    How to Use Pharmacoeconomics to Support Pricing & Reimbursement Strategies
    Workshop

    How to Use Pharmacoeconomics to Support Pricing & Reimbursement Strategies

    The Hatton, at etc. venues
    20th February 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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