Addressing Key Challenges in Drug Safety (Strategic Focus)

Table of Contents

• Overview
  • Catalyst
  • Summary
• Key Messages
  • Pressures to adhere to government regulations are driving the adoption of PV solutions
  • The pharma industry turns to drug safety solutions to ease financial woes
  • Signal detection in clinical research is a necessity to increase efficiency and reduce costs
  • In its nascent stages, companies have been reluctant to adopt PV technologies
  • There are no leading providers of PV solutions, and partnerships are essential
• Table of Contents
• Table of figures
• Market Opportunity
  • Growing drug safety issues are leading to enhanced pharmacovigilance activities
    • Technology is crucial in developing a comprehensive pharmacovigilance strategy
      • Post-market surveillance capabilities is essential for a robust PV system
  • Government regulations are driving the adoption of PV solutions
    • The FDA has a long standing history of drug safety regulations...and shortage of funds
      • The FDA becomes more proactive and enhances drug safety and its IT systems with PDUFA IV
      • FDA will demand more safety data and proactive pharmacovigilance from the industry
    • New reforms standardize the European PV system
      • The EMEA pharmacovigilance system is still developing
  • The pharma industry turns to drug safety solutions to ease financial woes
    • Safety warnings and drug withdrawals hurt companies' business portfolios
      • Unexpected litigation costs lower the overall bottom line of a company
    • Pharma companies will save millions of dollars with early detection of an unsafe drug
  • In its nascent stages, companies have been reluctant to adopt PV technologies
    • The pharma industry' s conservative nature impedes the adoption of PV systems
    • Companies relate new PV technologies with older, more cumbersome statistical tools
    • Implementation of PV solutions requires an overhaul of existing IT systems
• Customer Impact: Using PV Technologies to promote public health
  • Signal detection in clinical research is a necessity to increase efficiency and reduce costs
    • Clinical trials signal detection must provide an intuitive interface
      • A simple example of how clinical trials signal detection is used for proactive pharmacovigilance
    • Detection of safety signals during clinical trials can save pharma companies millions of dollars
  • Consumer knowledge and participation significantly affect pharmacovigilance activities
    • Consumers require more transparency into the pharmacovigilance process
  • Pressures to adhere to global regulations increases the uptake of PV solutions
    • More data and advanced IT tools mean better safety monitoring and reporting
      • PV technologies to support post-market surveillance are more important now then ever before
      • Signal detection is becoming increasingly important during clinical trials
• Technology evolution
  • Signal detection and management solutions are essential for proactive pharmacovigilance
    • Signal detection technologies must be user-friendly and accessible from global sites
  • Adverse event reporting systems are becoming increasingly important
  • In this nascent market, there are no clear leaders for PV solutions
    • Examples of vendors providing total PV solutions
      • Aris Global develops a data mining and signal detection application to add to its PV suite
      • Phase Forward acquires Lincoln Technologies to provide a powerful set of drug safety solutions
      • TCS, Oracle, and DrugLogic collaborate to deliver a comprehensive and integrated PV solution
• Go to market
  • PV technologies must streamline the pharmacovigilance workflow
  • IT vendors must educate the industry on the usefulness of signal detection technologies
  • In a highly fragmented market, partnerships are essential
    • Vendors that openly communicate with their clients and put their needs first will prosper
  • Changing regulations will require vendors to continuously update their solutions
    • Ensure that IT solutions meet government standards for electronic records
  • A close eye should be kept on emerging markets
• APPENDIX
  • Definitions and Abbreviations
  • Methodology
  • Further reading
  • Ask the analyst
  • Datamonitor consulting
  • Disclaimer
  • List of Figures
    • Figure 1: Balance between risks and benefits for drugs to be approved
    • Figure 2: A typical pharmacovigilance system utilizing technology and strategy
    • Figure 3: Sources of risk from a drug, leading to an adverse drug reaction
    • Figure 4: Key drug safety-related events in FDA history
    • Figure 5: Stock price for Merck on NYSE for 2004, US$
    • Figure 6: Stock price for GlaxoSmithKline on NYSE for 2007, US$
    • Figure 7: Drug discovery and development process
    • Figure 8: Challenges facing the pharmaceutical industry
    • Figure 9: Adverse event reporting systems in North America and Europe
    • Figure 10: An example of a complete PV system