• State of the industry and market dynamics
• State of the industry
  • Figure 1: Pharma industry productivity decline (1995-2007)
  • Table 1: Major drug patent expiries: 2007-2009
• When do drugs fail?
  • Table 2: Failure rates at each stage of clinical drug development
• Why do drugs fail?
  • Figure 2: Reasons for attrition
• Report outline
• Black box warnings and withdrawals
• Introduction
  • Table 3: Drugs withdrawn from the market between 1998 and April 2008
  • Figure 3: Rate of safety-based drug withdrawal, 1971-2007
  • Table 4: Examples of black box warnings since 2006
  • Table 5: Drug withdrawals since 2006
• Case study 1: COX-2 inhibitors (Pain)
• The facts
  • Table 6: COX-2 inhibitors - Key facts
  • Table 7: Selectivity of the coxibs
• The fall-out
  • Table 8: Arcoxias FDA review
• The future
• Case study 2: Avandia (Diabetes)
• The facts
  • TTable 9: The glitazones - Key facts
• The fall-out/li>
• The future
• CCase study 3: Lotronex and Zelnorm (Irritable Bowel Syndrome)
• The facts
  • TTable 10: Lotronex and Zelnorm - Key facts
• The fall-out
  • Table 11: Post-marketing scenarios for Zelnorm and Lotronex
• The future
• Case study 4: Tysabri (Multiple Sclerosis)
• The facts
  • Table 12: Tysabri - Key facts
• The fall-out
• The future
• Case study 5: Iressa (Cancer)
• The facts
  • Table 13: EGFR inhibitors - Key facts
• The fall-out
• The future
• Consequences of drug withdrawals and black box warnings since 2004
• Introduction
  • Figure 4: Key issues arising from drug withdrawals and safety problems since 2004
• The Food and Drug Administration Amendments Act (FDAAA) of 2007
• Fast track drug development and accelerated approval in the US and surrogate endpoints
  • Figure 5: Statistics of fast track review (1998 - March 2007)
  • Figure 6: Results of the ENHANCE study with Vytorin (Merck/Schering-Plough)
• Monitoring the safety of marketed drugs
• Post-marketing commitments
  • Table 14: REMS negotiated with the FDA since March 2008
• Changes to direct-to-consumer advertising
• Differences in regulatory outcome: FDA vs EMEA
  • Table 15: EMEA vs FDA: differences in drug approvals
• The publics risk perception and communication of safety issues
• Litigation
• Conclusions
• Drug non-app rovals
• Introduction
  • Table 16: Percentage change in FDA drug decisions: 2006 vs 2007
• Examples of filing withdrawals, refusals to file and non-approval letters
  • Figure 7: Reasons for filing withdrawals, refusals to file and non-approval letters in US and EU in 2007 and 2008 (to September)
  • Table 17: Non-approval/refusal of marketing applications for new drugs (2007-2008)
  • Figure 8: Critical issues raised by the non-approval of new drugs
• Credibility of the FDA questioned
• FDA transparency
• FDA going against Advisory Committee recommendations
• Use of surrogate endpoints
• Requirement for relevant comparative efficacy data
• Conclusions
• Late-stage clinical failure and pipeline re-evaluation
• Introduction
  • Table 18: Phase 3 failure rates in the pharma and biotech industries (2006-2007)
• Examples of late-stage clinical project terminations
  • Table 19: Examples of late-stage clinical project terminations
• Case study: Inhaled Insulin
• The facts
  • Table 20: Inhaled insulin products - Key facts
  • Figure 9: Exuberas product timeline
• The fall-out
  • Table 21: Reasons for the market failure of Exubera
  • Table 22: Developmental inhaled insulin products
  • Figure 10: Inhaled insulin products from Eli Lilly, MannKind, Novo Nordisk and Pfizer
• The future
• Consequences of late-stage failure
  • Figure 11 Critical issues raised for pharma companies by the failure of late-stage development projects
• Consequences for the therapeutic area
  • Table 23: Final results of the ILLUMINATE trial of torcetrapib
• Job cuts in big pharma
  • Table 24: Examples of job cuts at big pharma in 2007
• Consequences for small pharma companies
• Pipeline re-evaluation
• Conclusions
• Discussion
• Introduction
• Getting the dose right
• Pharmacometrics and model-based drug design
  • Figure 12: Points in the drug development timeline that could be influenced by parmacometrics
• Table of Contents
  • Table 25: Role of pharmacometrics in regulatory review
  • Table 26: Importance of pharmacometric analysis in NDA submissions (2000-2004)
• Interaction with regulators
  • Figure 13: Opportunities for interaction with the FDA during drug development
• Real-world clinical trials
• New technologies and biomarkers
  • Figure 14: Types of biomarker and their uses in drug development and disease management
  • Table 27: Examples of biomarker projects under way as a result of the FDAs Critical Path Initiative
• Collaboration and open science
• Progress in translational medicine
  • Figure 15: The learn and confirm model of drug development
• Development of clinical study expertise
• Summary
• Acknowledgement
• Bibliography & Footnotes
• Endnotes

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