Personalized medicine

The traditional consumer-driven health model is today supplemented and increasingly replaced by R&D-driven genomics and personalized medicine. We know that one size does not fit all and drugs will target smaller-niche patient populations.

BLOCK-BUSTERS

CHARACTERISTICS

  • „One-drug fits-all”
  • High volume, low price medications
  • narrow product portfolio
  • marketed for mass phenotype
  • focused on the disease state
  • economics of sale
  • manufactured in few ’large’ runs

CHARACTERISTICS

  • poor response rates (20-80%)
  • risk of SAEs (>1%)
  • long time to market
  • high healthcare and marketing costs

SEGMENT-BUSTERS

CHARACTERISTICS

  • for a selected number of patients
  • drug responses monitored for efficacy and SAEs
  • diagnostic-type tests used (CDx)

FACTS

  • 1% of marketed drugs have a CDx
  • 10% of marketed drugs recommend genetic testing for optimal treatment
  • under 50 pharmacogenomic biomarkers are included on FDA-approved drug labels
  • 30% of all treatments in late clinical developments rely on biomarker data
  • 50% of all treatments in early clinical developments rely on biomarker data
  • 60% of all treatments in preclinical clinical developments rely on biomarker data
  • 50% of all clinical trials collect DNA from patients to aid in biomarker development

NICHE-BUSTERS

CHARACTERISTICS

  • for targeted patients
  • determined by predictive tests (Mol Dx, PGx)
  • wide product portfolio
  • marketed for targeted genotype
  • focused on disease life cycle
  • economics of knowledge
  • manufactured in multiple „small” runs

FACTS

  • marker discoveries enable development of safer and effective drugs for a specific population
  • speedier clinical trials based on high responder population
  • due to improved clinical outcomes and better treatment adherence increased profitability is achievable
  • lower cost marketing to a more targeted audience
  • patient-drug stratification: drug toxic but not beneficial, drug toxic but beneficial, drug not toxic and not beneficial, drug not toxic and beneficial

CHALLENGES OF PERSONALIZED MEDICINE

  • Engaging medical community:
    • transfer knowledge to healthcare providers
    • medical education
  • Engaging industry:
    • sequencing technology and research tools
    • health information management
    • participation of private companies and investors
    • insurance coverage
  • Engaging public:
    • counsellors to interpret
    • foster understanding of the value and limitations of genomics
  • Engaging policy makers:
    • government rules and regulation
    • introduction into healthcare systems
    • ethic, legal and social implications