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

 

Facts

 - 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

 

Traditional medicine

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Personalized medicine

 
 

 

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