Personalized medicine

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

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

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