Live-Licensing & In-life testing: R&D Processes and Regulation for New Drugs, 2008-2020

Table of Contents

1 Executive Summary: R&D Processes and Regulation for New Drugs, 2008-2020

• 1.1 Aim of this Report
• 1.2 Pharmaceutical Development and Regulation are Continually Evolving
• 1.3 An Overview of the Report
• 1.4 Economic Pressures and Regulatory Uncertainty

2 The Global Pharmaceutical Market Has Entered a Crucial Phase - Where Threats and Opportunities Meet

• 2.1 The Pharmaceutical Sector is a Leading Technological Industry: However, It Faces Marked Economic Pressures
  • 2.1.1 Number of Blockbusters Has Increased Along With Competition
  • 2.1.2 Current Pressures on Industry - Blockbuster Business Model Under the Spotlight
• 2.2 The World Pharmaceutical Market Continues to Grow, But Faces Mounting Challenges
• 2.3 Pharmaceutical Development is a High Risk High Gain Business
  • 2.3.1 R&D Strategy is Crucial to Success
• 2.4 The Continuing Success of the Pharmaceutical Industry is Dependent upon Important Drivers and Restraints
• 2.5 Companies Are Gradually Changing Their Strategic Focus to Overcome Challenges in the Worldwide Market
• 2.6 Unmet Needs and Specialist Uses Will Continue To Drive Innovation
• 2.7 Patent Protection Strategies Form a Cornerstone of Lifecycle Management
  • 2.7.1 Falling Numbers of Drug Approvals are Accompanied by Fewer Patents Submitted
  • 2.7.2 Life Cycle Management Requires a Combination of Strategies
• 2.8 Drug Developers Face Increasingly Difficult Therapeutic Challenges
• 2.9 Increasing Developmental Times is a Serious Problem
• 2.10 Reducing Efficiencies in R&D Result in Concerns over Thinning Pipelines
  • 2.10.1 Is Innovation Declining in the Pharmaceutical Industry?
  • 2.10.2 Follow-on Products are Very Appealing to Companies
  • 2.10.3 Calls for a More-Collaborative Approach to Pharmaceutical Regulation
  • 2.10.4 Reform of Pharmaceutical Patenting Laws is Demanded
• 2.11 Healthcare Stakeholders Can Benefit from Radical Changes to Regulatory Processes
• 2.12 Greater Regulatory Co-operation
• 2.13 Biomarkers and Theranostics
  • 2.13.1 Pharmacogenomics is Increasingly Relevant to Pharmaceutical Development
  • 2.13.2 Proteomics Constitutes the "Next Step" After Genomics
  • 2.13.3 Personalised Medicine Will Rely Heavily Upon Theranostics
  • 2.13.4 The Completion of the Human Genome Project Has Been a Major Driver of Molecular Diagnostics and Personalised Medicine
  • 2.13.5 Personalised Medicine Supported by Theranostics Could Supersede the Existing Blockbuster Model, With Sustainable Revenue Flows Continuing
• 2.14 Mandatory Price Reductions Continue to Beset the Pharmaceutical Industry
  • 2.14.1 There Are Strong Downward Pressures on Pricing Strategies
  • 2.14.2 Pricing is a Key Issue - One that is Often Contentious
  • 2.14.3 In Europe Governments are Exerting a Growing Influence on Pharmaceutical Prices
  • 2.14.4 It Is Possible That Mandatory Cost-Controls in Germany Will Serve As a Precedent for Wider Governmental Controlling of Prices
  • 2.14.5 Governmental Price Controls Are an Established Part of the Japanese Pharmaceutical Market
• 2.15 Is the Blockbuster Business Model Sustainable?

3 Clinical Development and Approval of Pharmaceuticals in 2007

• 3.1 A Brief History of Clinical Trials
  • 3.1.1 The Nuremberg Code and the Declaration of Helsinki
  • 3.1.2 Establishing Standards for Good Clinical Practice and the International Conference on Harmonisation (ICH)
• 3.2 Stages of Clinical Testing
  • 3.2.1 Clinical Testing Follows a Rigorous Internationally-Recognised Code
  • 3.2.2 Phase I Trials
  • 3.2.3 Phase II Trials
  • 3.2.4 Phase III Trials
  • 3.2.5 Phase IV Trials (Post-Marketing Surveillance)
  • 3.2.6 Further Division of Clinical Trials
• 3.3 Market Pressures are Driving the Need for Rationalisation of Clinical Testing
• 3.4 The FDA - Gatekeepers to the Largest Pharmaceutical Market in the World
  • 3.4.1 The FDA is the Most Important Pharmaceutical Regulatory Body in the World
  • 3.4.2 The CDER Oversees Drug Safety in the US
  • 3.4.3 The FDA Is Under Pressure to Tighten-Up Drug Approval Procedures
  • 3.4.4 Changes to Regulation of Off-Label Prescribing
• 3.5 The European Medicines Agency (EMEA) Controls a Diverse Range of Countries
  • 3.5.1 The EMEA Combines and Harnesses National Medical Expertise
  • 3.5.2 The EMEA Makes the European Market More Accessible to Companies - a Win-Win Situation
  • 3.5.3 Structure of the EMEA
  • 3.5.4 Approval Process of the EMEA and the EC
  • 3.5.5 New Pharma Legislation in the EC
  • 3.5.6 The EU Clinical Trials Directive
  • 3.5.7 Provision for Joint Scientific Advice from the EMEA and FDA
  • 3.5.8 Consultation Paper on Future of Healthcare in EU
• 3.6 Japan Has a High Level of Regulation
  • 3.6.1 Approval of Foreign Pharmaceuticals in Japan was Traditionally a Daunting Process
  • 3.6.2 Japan has Rigorous Post-Marketing Drug Regulation
  • 3.6.3 The Japanese System Accommodates Re-Evaluation of Drugs
• 3.7 Safety and Speed Are Now Pressing Issues for Regulatory Authorities
• 3.8 The Use of phase IV Clinical Trials Is Set to Increase Significantly
  • 3.8.1 Post Marketing Surveillance is High on the Agenda Worldwide
  • 3.8.2 Post Marketing Surveillance Can Benefit the Marketing of Products
  • 3.8.3 Safety is Driving Phase IV Studies
  • 3.8.4 Growth in Fast-Track Applications will also Stimulate Developments in Post Marketing Studies
  • 3.8.5 Self-Monitoring of Patients Will Become More Established
  • 3.8.6 The UK Yellow Card System Is a Long-Established Example of Post-Approval Monitoring
• 3.9 Stringent Assessment of Risk Will Require More Patients and Better Indicators of Risk
• 3.10 Education Is a Key Issue
  • 3.10.1 Public Mistrust of the Pharmaceutical Industry is a Serious Problem
  • 3.10.2 Problems with Vioxx and Other COX-2 Inhibitors Had a Major Impact
  • 3.10.3 Open and Trustworthy Communication from both Companies and Regulators is Vital
• 3.11 Changes in the Way Drugs Are Regulated Will Change the Nature of Clinical Trials
• 3.12 Pharmacogenomics and Molecular Profiling Will Change Pharma
  • 3.12.1 Pharmacogenomics Has the Potential to Revolutionise the Pharmaceutical Industry
  • 3.12.2 The Progress of Pharmacogenomics Has Been Slow
  • 3.12.3 Identification of Expression Profiles in Pre-Clinical Models
  • 3.12.4 A More Iterative Approach will Result in Greater Synergies in R&D
• 3.13 The Organisation of Clinical Testing is Changing
  • 3.13.1 Phase I and II Clinical Trials Will Incorporate More Complex Screening Techniques
  • 3.13.2 Post-Regulatory Approval will Become More Prominent
• 3.14 Safety Concerns and Development Pressures Will Change the Structure of Clinical Trials

4 How Pharmaceutical Development and Supporting Regulation Will Evolve from 2008 to 2020

• 4.1 Reducing Developmental Times and Late-Stage Failure are Crucial - Developments in Testing and Regulation Will Aid the Process
  • 4.1.1 Drugs Ineffectiveness in Sub-Populations is a Significant Obstacle to Current Drug Development
  • 4.1.2 There Are Steps that Can Reduce Developmental Times
  • 4.1.3 R&D Will Change Due to New Developmental Models Supported by Regulatory Reforms
  • 4.1.4 Leading Industry Figures Call for More Flexible Approach to Drug Approval
  • 4.1.5 Regulators Acknowledge the Need for Stratification of Treatment Populations
  • 4.1.6 Visiongain Predicts Stratification of Patient Populations Leading to Live-Licensing/In-Life Testing
  • 4.1.7 There Will Be Greater Co-Operation between Regulators and Pharmaceutical Developers from Now Onwards
  • 4.1.8 Uncertainties over Political and Legislative Will to Achieve Reform of Pharma Approval Processes
• 4.2 A SWOT Analysis for New Developments in the Pharmaceutical Market Framework
  • 4.2.1 SWOT Chart for Developmental and Regulatory Changes from 2008-2020
  • 4.2.2 Efficient Use of Resources is Essential to R&D in the Years Ahead
  • 4.2.3 Stratification of Patients is Key to More Personalised Medicine Sought by Developers and Increasingly Required by Regulators
  • 4.2.4 Traditional Clinical Development has a Significant Disadvantage - Better-Targeted Studies will Take Precedence
  • 4.2.5 Live Licensing/In-Life Testing is the Way Forward
  • 4.2.6 Regulatory Systems are Already Becoming Closer Together - But Global Convergence is Still Far from Certain
  • 4.2.7 Electronic Patient Records Will Be an Important Facilitating Tool of In-Life Testing
  • 4.2.8 Evidence-Based Medicine will Become Increasingly Demanded by Pharma Stakeholders
• 4.3 Adaptive Clinical Trial Design Will Facilitate Interaction with Regulators and Provide Increased Rationalisation of Drug Development
  • 4.3.1 Adaptive Clinical Trial Design Uses Accumulating Data
  • 4.3.2 Regulators Should be Involved in the Process
  • 4.3.3 Adaptive Trial Design will Gain Acceptance by Early Next Decade
  • 4.4 Personalised Medicine Driven by Theranostics and Live Licensing/In-Life Testing Will Become Established by 2020
  • 4.4.1 Drivers for Better-Targeted Medicine
  • 4.4.2 The Prospects for More-Personalised Medicine and Related Diagnostics are Good
  • 4.4.3 FDA Critical Path Initiative is a Progressive Move in the Right Direction
• 4.5 Personalised Medicine Aided by Regulatory Reform will also Face Significant Obstacles
  • 4.5.1 The Complex, Disparate Pharma Industry Will Prove Difficult to Reform, Especially in a Revolutionary Manner
  • 4.5.2 It is Unclear How Extensively New Clinical Testing Models and Supporting Regulation will be Applied
• 4.6 Calls for New Global Harmonization Effort from Influential Sources
  • 4.6.1 Calls for Greater Regulatory Consensus
  • 4.6.2 Agreements Between the FDA and EMEA are Already Taking Shape Encouragingly
  • 4.6.3 FDA-EC Co-Operation in Pharmacogenomics, Vaccines, Paediatric Medicine, Oncology, Counterfeiting and Pharmacovigilance
  • 4.6.4 Implementation Plan for Medicinal Products for Human Use and Other Transatlantic Developments
  • 4.6.5 Globalisation Facilitates Harmonisation of Pharmaceutical Regulations
  • 4.6.6 Design of a Supranational Regulatory Regime Should Protect National Interests
  • 4.6.7 Developing Nations Adopting ICH Guidelines
  • 4.6.8 Increasing Willingness for Regulators to Collaborate on a Global Scale - But No Sign of Global Regulatory Harmonisation
• 4.7 While Personalised Medicine and Better Targeted Clinical Trials are Emerging, Such Developments are Welcomed by the FDA and EMEA
  • 4.7.1 Emerging Developments are Welcomed by Pharma Stakeholders
  • 4.7.2 Cancer Drug Development Leads the Way in its Merging of Drug Development and Treatment of the Disease
  • 4.7.3 FDA' s Critical Path Initiative and Personalised Medicine
  • 4.7.4 Theranostic Solutions Will Aid the Development of Personalised Medicine and Improve Support from Regulators through Evidence-Based Medicine
• 4.8 Pricing of Personalised Medicine
  • 4.8.1 Personalised Medicine will Lead to Changes in Pricing and Reimbursement
  • 4.8.2 Onus is on Companies to Prove Benefits of their Drugs Including Comparative Cost-Benefits
  • 4.8.3 Biomarkers Can Create Value
  • 4.8.4 Non-Compliance is a Major Problem that Can be Ameliorated via More-Personalised Medicine
  • 4.8.5 The Developments are Complex and Systemic, Posing both Opportunities and Challenges for Healthcare Stakeholders
• 4.9 Evidence-Based Medicine and Pharmacoeconomic Analyses
  • 4.9.1 Comparative Testing is Prevalent
  • 4.9.2 Electronic Medical Records are a Major Priority for Leading Nations
  • 4.9.3 GSK Leads Way in Evidence-Based Medicine
  • 4.9.4 Personalised and Evidence-Based Medicine Will Require Time for Acceptance
• 4.10 Changes to Regulation Governing Paediatric Medicine
• 4.11 Visiongain Believes that the New Developments Will Cut Developmental Time and Provide Better Healthcare
  • 4.11.1 Shift from General to Personalised Healthcare is an Inevitable Trend with Significant Potential Gains for Industry and Society
  • 4.11.2 Increased Use of Conditional Acceptance Based upon Live Licensing and In-Life Testing Constitute a Logical Progression
  • 4.11.3 Pharmaceutical Developers Must Understand the Needs and Preferences of Other Healthcare Stakeholders

5 Emerging Technology Will Underpin Changes to Developmental Processes and Regulatory Policy

• 5.1 Personalised Medicine is a Prime Aim for Healthcare
  • 5.1.1 An Introduction to Pharmacogenomics
  • 5.1.2 The Aim of Pharmacogenomics
  • 5.1.3 Pharmacogenomic Drugs as Personalised Medicines
  • 5.1.4 The Economic Potential of Pharmacogenomics
• 5.2 The Advantages of Pharmacogenomics Drugs and Benefits to the Pharmaceutical Industry
  • 5.2.1 Pharmacogenomics is Attracting a Great Deal of Interest from Pharma Stakeholders
  • 5.2.2 Improved Drugs Through Better Targeting
  • 5.2.3 Reduced Deaths from Adverse Drug Reactions
  • 5.2.4 Personalised Drugs are More Likely to Work Safely and Efficaciously
  • 5.2.5 Advanced Screening for Disease Leading to Quicker Diagnoses
  • 5.2.6 Improved Vaccines
  • 5.2.7 Improvements in Drug Discovery and Reduced Cost of Clinical Trials
• 5.3 Adverse Drug Reactions are a Serious Problem
  • 5.3.1 Economic and Other Consequences of ADRs
  • 5.3.2 ADR and Genotype: Tacrine, a Case Study
• 5.4 The Human Genome Project (HGP) and its Influence on Pharmacogenomics
• 5.5 Barriers to the Growth of Pharmacogenomics
  • 5.5.1 The Complexity of Finding SNP Gene Variations that Affect Drug Responses
  • 5.5.2 Limited Therapeutic Alternatives
  • 5.5.3 Disincentives for Drug Companies to Develop and Produce Multiple Treatments for a Disease
  • 5.5.4 Educating Healthcare Providers
• 5.6 Advances in Computing and Electronic Communications Will Benefit Pharmaceutical R&D
  • 5.6.1 There are Prominent Examples of Electronic Solutions Benefiting Pharmaceutical Development
  • 5.6.2 Electronic Data Capture (EDC) Promises to Streamline Clinical Trials
  • 5.6.3 Training and Security are Barriers to EDC Conversion
  • 5.6.4 The Clinical Trials Industry Must Take the Initiative on EDC Standards
  • 5.6.5 Governments Working Hard to Establish e-Health Records
• 5.7 Electronic Submission of Post-Marketing Safety Data is Another Important Development
• 5.8 Proteomics Constitutes the "Next Step" After Genomics
• 5.9 Advanced Diagnostics Will Aid Personalised Medicine and In-Life Testing
  • 5.9.1 Theranostics - The Combination of Therapy and Diagnostics
  • 5.9.2 Exciting Developments in Molecular Biology Can Bring Two Healthcare Industries Closer Together
  • 5.9.3 Personalised Medicine Will Rely Heavily Upon Theranostics
  • 5.9.4 Theranostic Applications Will Exhibit Rapid Market Growth from 2007-2012
  • 5.9.5 Personalised Medicine Will Become More Prominent in Healthcare with Theranostics Benefiting as a Result
  • 5.9.6 The Completion of the Human Genome Project Has Been a Major Driver of Molecular Diagnostics
  • 5.9.7 Personalised Medicine Supported By Theranostics Could Supersede the Existing Blockbuster Model, With Sustainable Revenue Flows Continuing
  • 5.9.8 Theranostics will Benefit from FDA' s Guidance on Pharmacogenomic Data Submission
  • 5.9.9 Distinguishing Patients at a Greater Risk is Vital
  • 5.9.10 In Future Parallel Use of Markers and Drugs Will Become Prevalent
  • 5.9.11 The EDMA Cites Theranostics as a Medium-to-Long-Term Driver for Healthcare
  • 5.9.12 Personalised Medicine is a Strong Driver of the Theranostics Sector
  • 5.9.13 While Personalised Medicine Is Still a Goal for the Future, the Technology Is Already Emergent
  • 5.9.14 Identifying Suitable Biomarkers Remains a Significant Challenge
  • 5.9.15 Theranostics Bill Introduced in the US Senate During 2006
  • 5.9.16 Funding for Theranostics R&D Efforts May Be Limited by Low Reimbursement Rates
  • 5.9.17 Cancer Diagnostics is an Important Growth Area with Relevance to Theranostics
  • 5.9.18 Collaboration among Stakeholders is Essential
  • 5.9.19 Intra-Industry Collaboration is Important to Achievement of Innovation in the Years Ahead
  • 5.9.20 Nucleic Acid Testing Will Be Decisive in the Development of the Theranostics Market
  • 5.9.21 The Outlook for Theranostics

6 Interviews with Experts in Pharmaceutical Regulatory Affairs: Drug Development - Present and Future Trends

• 6.1 Respondent 1: US-Based Academic Specialising in US Pharmaceutical Regulation
  • 6.1.1 The Most Important Unmet Regulatory Needs
  • 6.1.2 What Changes are Going to Occur?
  • 6.1.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.1.4 Potential Resistance from Payers
  • 6.1.5 How Will Pharma R&D Benefit?
  • 6.1.6 The Obstacles to Regulatory Reform
• 6.2 Respondent 2: US-Based Academic Specialising in International Pharmaceutical Regulation
  • 6.2.1 The Most Important Unmet Regulatory Needs
  • 6.2.2 What Changes are Going to Occur?
  • 6.2.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.2.4 Potential Resistance from Payers
  • 6.2.5 How Will Pharma R&D Benefit?
  • 6.2.6 The Obstacles to Regulatory Reform
• 6.3 Respondent 3: Analyst from a European Pharmaceutical Industry Representative Group
  • 6.3.1 The Most Important Unmet Regulatory Needs
  • 6.3.2 What Changes are Going to Occur?
  • 6.3.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.3.4 Potential Resistance from Payers
  • 6.3.5 How Will Pharma R&D Benefit?
  • 6.3.6 The Obstacles to Regulatory Reform
• 6.4 Respondent 4: US-Based Academic Specialising in US and European Pharmaceutical Regulation
  • 6.4.1 The Most Important Unmet Regulatory Needs
  • 6.4.2 What Changes are Going to Occur?
  • 6.4.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.4.4 Potential Resistance from Payers
  • 6.4.5 How Will Pharma R&D Benefit?
  • 6.4.6 The Obstacles to Regulatory Reform
• 6.5 Respondent 5: Regulatory Affairs Analyst from an International Business Consultancy Specialising in the Pharmaceutical Industry
  • 6.5.1 The Most Important Unmet Regulatory Needs
  • 6.5.2 What Changes are Going to Occur?
  • 6.5.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.5.4 Potential Resistance from Payers
  • 6.5.5 How Will Pharma R&D Benefit?
  • 6.5.6 The Obstacles to Regulatory Reform
• 6.6 Respondent 6: Representative from Regulatory Affairs in an International Pharmaceutical Company
  • 6.6.1 The Most Important Unmet Regulatory Needs
  • 6.6.2 What Changes are Going to Occur?
  • 6.6.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.6.4 Potential Resistance from Payers
  • 6.6.5 How Will Pharma R&D Benefit?
  • 6.6.6 The Obstacles to Regulatory Reform
• 6.7 Respondent 7: Head of Regulatory Affairs in a Top-10 Pharmaceutical Company
  • 6.7.1 The Most Important Unmet Regulatory Needs
  • 6.7.2 What Changes are Going to Occur?
  • 6.7.3 Will the Changes Become Widespread, Geographically and in Disease Area?
  • 6.7.4 Potential Resistance from Payers
  • 6.7.5 How Will Pharma R&D Benefit?
  • 6.7.6 The Obstacles to Regulatory Reform

7 Conclusions of this Study

• 7.1 The Prevailing Development of Pharmaceuticals is Under Increasing Commercial and Regulatory Pressure
• 7.2 Pharmaceutical Regulatory Authorities Play a Vital Role in Healthcare
• 7.3 Personalised Medicine and Rationalisation of the Developmental Process
• 7.4 Developmental Processes and Regulatory Policy Need to Accommodate Stratified Patient Populations
• 7.5 Visiongain Predicts Stratification of Patient Populations Leading to Live-Licensing/In-Life Testing
• 7.6 There Will Be Greater Co-Operation between Regulators and Pharmaceutical Developers
• 7.7 Uncertainties over Political and Legislative Will to Achieve Reform of Pharma Approval Processes
• 7.8 Greater Regulatory Co-Operation - However, No Sign of Global Harmonisation in Pharma in Sight
• 7.9 Theranostic Solutions Will Aid the Development of Personalised Medicine and Improve Support from Regulators through Evidence-Based Medicine
• 7.10 Increased Use of Conditional Acceptance Based upon Live Licensing and In-Life Testing Constitute a Logical Progression from 2008-2020

Appendix A: Glossary

Appendix B: About visiongain

Appendix C: visiongain report evaluation form

List of Tables

• Table 2.1 Major Drugs Losing Patent Expiry in Near Future
• Table 2.2 Revenue Generation ($bn) by the World Pharmaceutical Industry, 2000-2006
• Table 2.3 Forecast Revenue Generation ($bn) by the World Pharmaceutical Market, 2006-2012
• Table 3.1 Key Stages in the History of Clinical Trials
• Table 3.2 Drug Approvals Agencies within the EU
• Table 4.1 Greater Use of Disease Knowledge and Biomarkers Will Benefit Pharmaceutical Development
• Table 4.2 SWOT Chart for Developmental and Regulatory Changes, 2008-2020
• Table 4.3 Visiongain' s Predictions of How Changes to Pharma Development Will Benefit the Industry and Other Stakeholders, 2007-2020
• Table 5.1 Assessment of EDC Solutions
• Table 5.2 Share (%) of the World Molecular Diagnostics Market Held by Theranostics, 2006 & 2012

List of Figures

• Figure 2.1 Revenue Generation ($bn) by the World Pharmaceutical Industry, 2000-2006
• Figure 2.2 Forecast Revenue Generation ($bn) by the World Pharmaceutical Market, 2006-2012
• Figure 2.3 The Drug Development Process is Long, Complex and Costly
• Figure 2.4 Increasing Average Cost ($m) of NCE Development, 1976-2005
• Figure 4.1 The Current Framework for Drug Development
• Figure 4.2 How Pharmaceutical Development Will Evolve into a More Progressive System
• Figure 4.3 The Dynamic Integrated Regulatory System of the Future
• Figure 4.4 Systemic Changes to Pharmaceutical Regulation Involve all Healthcare Stakeholders
• Figure 5.1 Progressive Technological Developments in Medicine
• Figure 5.2 World Revenues ($m) for Theranostic Applications, 2006-2012

Companies Mentioned in this Report

• Abbott Laboratories
• Affymetrix
• Amgen
• AstraZeneca
• Bayer HealthCare
• Cambridge Antibody Technologies
• Chiron
• CyGene
• Dako
• Digene
• Eli Lilly
• EXACT Sciences
• First Horizon
• Genaissance Pharmaceuticals
• Genentech
• Genetic Vectors
• Gen-Probe
• Glaxo Wellcome
• GlaxoSmithKline
• Hoechst Marion Roussel
• Human Genome Sciences
• IGEN International
• Innogenetics
• Millennium Pharmaceuticals
• Myriad Genetics
• Organon
• Pfizer
• Roche
• Sanofi-Aventis
• Schering Plough
• Sequenom
• Teknika
• Tibotec-Virco
• Visible Genetics
• Vysis
• Warner Lambert
• Wyeth