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May 12, 2008 23:11 ET

Focus on the Live-Licensing and In-Life Testing: R and D Processes and Regulation for New Drugs, 2008-2020

LONDON, UNITED KINGDOM--(Marketwire - May 12, 2008) - Reportlinker.com announces that a new market research report related to the Pharmaceutical industry industry is available in its catalogue.

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

http://www.reportlinker.com/p089491/Live-Licensing-and-In-life-testing-R-and-D-Processes-and-Regulation-for-New-Drugs-2008-2020.html

Visiongain predict that the current phase I to IV clinical testing process will eventually be selectively or wholly replaced by a system known as "in-life" testing or "live" licensing. Those proposals involve cumulative testing of the drug throughout its lifecycle. The industry would continually test drugs with smaller, more focused clinical trials. If a trial shows efficacy and safety, a live license would be given, allowing the company to market the drug in a limited manner. Already, the FDA and the EMEA have shown favourable interest in such developments

- amongst other amendments to current practice.

In particular, R&D Processes and Regulation for New Drugs, 2008-2020, concentrates on the following essential aspects of the market:

- Forward-looking development of R&D methods and regulatory policies in theory and practice

- Discussion of the relevant technology and methods, including accompanying diagnostic tests (theranostics/companion diagnostics)

- Discussion of un-met/under-met therapeutic needs and relative advantages of emerging developmental methods and regulatory policy

- Discussion of the current global pharmaceutical market and where it is heading

- Drivers and restraints facing new drug development from 2008-2020

- Opportunities and threats facing drug development from 2008-2020, with SWOT analysis

- Detailed interviews with leading experts in regulatory affairs in academia and industry

Why you should buy this report:

- To receive a comprehensive analysis of the prospects for new drug development from 2008-2020

- The views of leading experts in regulatory affairs concerning present and future issues in new drug development and regulatory trends

- To discover the most important existing and potential future regulatory developments

- Predictions for key developmental metrics that can be improved via the new methods and regulatory initiatives

To determine the forces that influence new drug development:

- Competitive characteristics

- Drivers

- Restraints

- Strengths, weaknesses, opportunities and threats

To find out where pharmaceutical R&D is heading - both technologically and commercially, with emphasis on all healthcare stakeholders.

Further clinical testing during the marketing of the drug could allow the marketing restrictions to be gradually lifted, providing access to greater numbers of patients, including an expansion of indications. This proposed testing system has the advantage of allowing companies to gain revenues from the drug candidate earlier, while benefiting patients earlier as well. The tests combined with treatment could also cut developmental costs significantly, since large-scale clinical testing is very costly and time consuming. This is a win-win situation for you and your company - you must be fully informed of it now.

Visiongain believes that in life testing/live licensing will be fully operative next decade.

The future of current and potential blockbusters is therefore vitally important to all companies in the pharmaceutical sector, especially in this period of economic pressures and regulatory uncertainty. This report concentrates on arguably the most exciting challenge facing the industry and regulators: how to adapt medicine to patient sub-populations and emerging regulatory demands, improving safety and efficacy markedly. No pharmaceutical company can afford to ignore those issues.

Please Note: Reports are sold based on the user licenses indicated. The Publisher delivers the report in Flash format via the publisher website, allowing viewing and printing capabilities only. Within one to two business days after placing the order, the Publisher will email the client with information on accessing their purchase. Prior to initiating fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.



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

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

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