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Drug Repositioning Strategies: Innovative strategies to boost pipeline productivity

CHAPTER 1: INTRODUCTION

  • Summary
  • Introduction
  • Why reposition?
  • The aims of repositioning
  • What has made repositioning possible?
  • Structure of the report

CHAPTER 2: REPOSITIONING FAILED COMPOUNDS

  • Summary
  • Introduction
  • Technology platforms for indications discovery
    • Gene Logic
    • Sosei
    • Melior Discovery and Melior Pharmaceuticals
    • KineMed
    • BrainCells Inc and Dynogen
  • Repositioning – the Synosis business model
  • Pharmacogenomics
  • Conclusions

CHAPTER 3: REPOSITIONING MARKETED COMPOUNDS

  • Summary
  • Introduction
  • Repositioning strategies
    • Indications discovery with new technologies
    • Bionaut Pharmaceuticals
    • DanioLabs and VASTox
    • Applying a therapeutic focus
    • Mining databases for new indications
    • Drug combinations
  • Repositioning in the public sector
    • Screening technologies
    • Molecular libraries
    • Repositioning based on advancing knowledge of disease
  • Conclusions

CHAPTER 4: DRUG REPOSITIONING THROUGH REFORMULATION

  • Summary
  • Introduction
  • Controlled delivery and chronotherapeutics
  • Non-invasive delivery routes
    • Inhaled delivery
    • Intranasal delivery
    • Transdermal delivery
  • Pro-drugs
  • Targeted delivery
    • nab TM technology
    • Dendrimers
    • BioSiliconTM
  • Conclusions

CHAPTER 5: INTELLECTUAL PROPERTY AND REGULATORY ISSUES

  • Summary
  • Introduction
  • Patent issues
  • Regulatory considerations
    • Filing routes
    • Other issues
  • Non-patent market exclusivity
  • The non-approval route
  • Pharmacogenomics
  • Conclusions

CHAPTER 6: CHALLENGES OF DRUG REPOSITIONING

  • Summary
  • Introduction
  • Challenges and obstacles to successful drug repositioning
    • Proof of concept clinical trials
    • New drug targets with novel mechanisms of action
    • Safety remains a key issue for early stage stalled drugs
    • Data and IP issues
    • Development of combination products
    • Indications discovery as part of a long-term lifecycle management program
    • Reformulation

CHAPTER 7: TRENDS AND OPPORTUNITIES

  • Summary
  • Introduction
  • The future for repositioning
    • Business models and the future
    • Repositioning marketed drugs
  • Market size estimates
    • Impact of repositioning on R&D
    • Future financial rewards of repositioning marketed drugs
    • Market potential of reformulated drugs
  • Conclusions
  • Bibliography