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Published by: SMI Publishing, Ltd
Published: Jun. 14, 2006
Table of Contents
- Day 1
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr Stephen Little, Chief Executive Officer, DxS .
- 9.10 GLOBAL FOCUS: KEY DRIVERS OF CHANGE
- Evaluating growth potential
- 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
- Dr Linda Surh, Director, Regulatory Affairs UK, Neurology and Pharmacogenetics, GlaxoSmithKline.
- 9.50 DIAGNOSTICS: PROVIDING HEALTHCARE SOLUTIONS
- Bringing diagnostics and pharmaceuticals closer together
- 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
- Dr Howard Grey, Director, Molecular Diagnostics, Perkin Elmer Life & Analytical Sciences.
- 10.30 Morning Coffee
- 11.00 CHANGES IN HEALTHCARE PROMPTED BY THE INCREASING USE OF POCT
- Concerns in development?
- POCT and decentralised laboratory services
- Impact on patient care
- Implementation challenges
- Clinical governance and QA
- Commercial considerations
- 11.40 CASE STUDY: POINT OF CARE
- Important technology considerations
- Indication of the type and number of tests conducted by private practices and hospitals per country
- Market size by product segment
- Market shares by product segment
- Market growth and forecasts by product segment and country
- Indication of data management/software storage requirements in hospitals by country
- The future of data management software requirements in hospital
- Trends regarding decentralised healthcare services (policlinics, hospital outpatients)
- 12.20 Networking Lunch
- 1.50 PANEL DISCUSSION: MERGERS AND ACQUISITIONS
- Growing pace of pharmaceutical 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?
- Dr Linda Surh, Director, Regulatory Affairs UK, Neurology and Pharmacogenetics, GlaxoSmithKline.
- Dr Roger Edwards, Managing Consultant, PA Consulting.
- Dr Kevin Daish, Global Marketing Director, Gene Expresson, GE Healthcare.
- 2.30 PRICING AND REIMBURESEMENT ISSUES
- How does pricing and reimbursement affect the internal market?
- 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
- Mr Luis Gonzalez Vaque, Advisor, European Commission.
- 3.10 Afternoon Tea
- 3.40 UPDATE ON REGULATORY AFFAIRS IN USA
- What’s the latest from the FDA?
- Current FDA regulatory policies
- Changes in FDA’s policies
- Update on FDA product review cycles and performances
- Vile gossip
- Mr Thomas Soriano, President & Chief Executive Officer, Diagnostic Oncology CRO Inc.
- 4.20 PATENTING ISSUES
- Diagnostic methods under Article 52 (4) EPC
- 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
- Dr Ioannis Theodoropoulos, Director, European Patent Office.
- 5.00 Chairman’s Closing Remarks and Close of Day One
- Day 2
- 8.30 Registration & Coffee
- 9.00 Chairman's Opening Remarks
- Dr David Horwitz, World-Wide Vice President, Medical & Clinical Affairs, LifeScan, Johnson & Johnson.
- 9.10 CASE STUDY: LIFESCAN
- Glucose monitoring - the new paradigm
- 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
- Dr David Horwitz, World-Wide Vice President, Medical & Clinical Affairs, LifeScan, Johnson & Johnson.
- 9.50 RESPIRATORY DISEASE TESTING MARKET - A CASE STUDY
- Technological, epidemiological and etiological considerations
- 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
- Professor Sue Hill, Chief Scientific Officer, Department of Health.
- 10.30 Morning Coffee
- 11.00 UTILISATION OF BIOMARKERS IN CLINICAL TRIALS
- 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
- Dr Mark Chang, Technical Director, Research Biostatistics, Millennium Pharmaceuitcals.
- 11.40 HIGH-GROWTH TESTING TRENDS
- What does the future hold for genetic testing?
- 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)
- Dr David Huckle, Chief Executive, Adams Business Associates.
- 12.20 Networking Lunch
- 1.50 PHARMACODIAGNOSTICS: EMERGING MARKETS
- Technologies, competition and market models
- 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
- Dr Roger Edwards, Managing Consultant, PA Consulting.
- 2.30 MOLECULAR DIAGNOSTICS - DNA MICROCHIPS
- The future of aCGH
- An introduction to aCGH
- The aCGH market
- BACS or Oligo arrays
- The potential of aCGH
- Dr Kevin Daish, Global Marketing Director, Gene Expresson, GE Healthcare.
- 3.10 Afternoon Tea
- 3.40 PHARMACOGENETICS (Pgx)
- The evolving environment
- How is Pgx applied?
- Identifying genetic variations/polymorphism
- PEST constraints
- Political
- Sociological
- Economic
- Technological
- Dr Stephen Little, Chief Executive Officer, DxS .
- 4.20 PROMISES AND CHALLENGES OF CLINICAL GENOMICS
- PEST factors
- 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
- Professor Steven Wong, Professor of Pathology & Scientific Director, toxicology Department, Milwaukee County Examiners Office, Medical College of Wisconsin.
- 5.00 Chairman’s Closing Remarks and Close of Day One
AbstractThis 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
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