Van utopie tot realiteit Personalised Healthcare Hype o

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Gepersonaliseerde gezondheidszorgVan utopie tot
realiteitPersonalised HealthcareHype or
reality?

• Rob Geraerdts

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Personalised Healthcare (PHC)Is it more than a
media reality hype or will it truly develop ?

Personalised medicine may be our future
approachTargeted drugs The race is
onTargeted cancer drugs gain backersPersonalis
ed drugs draw biotech dollarsPersonalised
approach to cancerPersonalised medicine New
approach to staying wellTargeted drugs prove
powerful against forms of cancerFDA acts to
foster personalised drugs

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The Challenge of Personalised Healthcare What
the public came to expect of PHC are truly
individualised therapies something science and
industry may not be able to deliver for some time
Source JAMA. 20062961453-1454.
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Why a new approach to staying well is required ?
What's the challenge and promise of Personalised
Healthcare?
...different effects Variability of disease Drug
metabolism Drug-drug interactions Non-compliance
Same symptoms Same findings Same disease Same
Drug...
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Development towards A More Personalised
HealthcareUsing clinical differentiators to
achieve optimal pharmaceutical efficacy and
safety for the purpose of creating sustainable
clinical benefits

Increasingly, treatment will be tailored to
patient groups defined by their genetic disease
pattern
Still today, almost all patients are treated in a
few similar ways
Therapeutic stratification
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Personalised HealthcareNot a totally new concept
but an evolution
For more than 10, 000 years Diagnosis and
treatment based on what could be seen, smelled,
tasted, palpated or intuited
The last 100 years Diagnosis and treatment
expanded with knowledge about biochemistry and
cellular processes

• Today
• Diagnosis and treatment expanded with rapidly
  growing insights into molecular processes and
  variations in our genes

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• Challenges for the Healthcare system
• Technological development and evolution in
  Diagnostics
• Potential future role for the General Practioner

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Health Economic Value of Medical Devices
The outside world is changing
Payers
Cost control
Qualityof Life
Best medicalpractice
People
Providers
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• Challenges for the Healthcare system
• Technological development and evolution in
  Diagnostics
• Potential future role for the General Practioner

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Personalised Healthcare hype or
reality?Evolution in literature of definitions
for In Vitro Diagnostics

• In Vitro Diagnostics are Medical Devices which
  enable analysis of bodily fluids and tissues for
  determining disease conditions
• In Vitro Diagnostics are enabling technologies to
  structure tomorrow's health care processes based
  on medical evidence
• In Vitro diagnostics are a valuable tool for
  preventing illness, for early diagnosis and for
  optimising therapy through patient monitoring
  and/or stratification

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Personalised Healthcare hype or reality?The
need for health information as basis for medical
decisions

• Today

• Tests with blood, liquid and tissue

• Health information
• the right information in the right place at the
  right time
• individual patient treatment (i.e. test result,
  risk profile, treatment recommendation)
• transition of today's IVD products into specific
  biomarkers

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Re-engineeringMedical Processes with IVD

• - DRGs
• - Indication management
• - Personalised Health Care

Productivity
Total IVD infrastructure( Lab Network / IT )
- IT solutions -Hospital solution
Laboratroy Organisation
- Increase laboratory productivity
Systems
- System portfolio- Professional System Service
Reagents
- Reagent harmonization- Robustness
improvement - Result standardisation
investments
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Personalised Healthcare hype or
reality? Populating the laboratory health value
chain with tools and content to create
personalised healthcare
Therapy monitoring
Therapy decision
Diagnosis
Preventive measures
Predisposition screening
Targeted monitoring
toring
Tools
Instruments and Reagents
Instruments and Reagents
Instruments and Reagents
Portable Sensor Platform
TOOLS
Decision Algorithms
Decision Algorithms
Decision Algorithms
Risk profile analysis
CONTENT
Risk alerts
Risk Stratification Algorithms
Databases
Data Management Systems
Current Offering

Personalised Health Information
Supporting and Integrative Services
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Personalised Healthcare hype or reality?More
fundamental knowledge of the "system biology"
increases our understanding for underlying causes
for diseases
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Personalised Healthcare hype or reality?To
unveil the secrets of the "system biology" novel
technologies are to be developed used for
diagnostic purposes
DNA (gene)
Bioinformatics
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Personalised Healthcare hype or reality?To
understand "system biology", convergence of
novel technologies will provide the full
potential to understanding disease patterns
Ascher Shmulewitz et al, Nature Biotechnology
March 2006
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Personalised Healthcare hype or
reality? "Systems biology" transparency in
disease processes
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Creating PHC from an industrial
perspectiveDiagnostics input is key - from
discovery to market of pharmaceuticals
Research
Develop
Commercialise
Target Selection
LeadGeneration/Optimisation
Market
Phase 0
Phase I
Phase II
Phase III
Filing
Phase IV
Confirmatory Phase
DiscoveryPhase
PoC
Exploratory Phase
?
?
?
?
?
Dx launch/ Post-launch assessment
Biomarker development
Companion diagnosticfeasibility attractiveness
Tailored prescribing monitoring
Target identification
Patient selection
Research assay
Technically validated assay
Clinically validated IVD assay
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Personalised healthcare hype or
reality?Understanding of disease "genetic"
pattern will drive usage of new technologies in
Diagnostics Examples
Parameters (eg, Genes, Mutations)
1
10
100
1000
PCR
Linear Arrays
Microarrays
Point Mutations
Simple Gene Analysis
Complex Gene Analysis
Resequencing
Genotyping Examples

• CF Linear Array (US)

• AmpliChip CYP450Test (CE-IVD)

• AmpliChip p53

• CYP450 2C9
• Factor II/V

Expression Examples
Single parameter Expression
Complex Expression

• Leukemia
• Breast Cancer
• Cardiovascular Disease

• Taqman HIV Monitor
• Taqman HCV Monitor

under development
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Personalised Healthcare in the market
todayCurrent examples in oncology

• Implementing biomarker strategy for all pipeline
  drugs
• Distribution of K-RAS and EGFR Cancer Mutation
  Tests
• Tests identify genetic mutations that can affect
  patient response to certain cancer drugs

• Identifying patients who have an improved
  response to launched drugs
• e.g. Tarceva in 1st line maintenance NSCLC /
  SATURN trial

• Assessing opportunities for companion diagnostics
• Pertuzumab/HER dimerization inhibitors
  Expression of HER 2
• MDM2 Active only in p53 wild-type patients
• PLX4032 Presence of BRAF V600E gene mutation

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Personalised Healthcare today in the
marketCurrent examples in virology

• Detecting Hepatitis C virus subtype and
  monitoring viral load/ Pegasys response
• Determine length of treatment by strain of virus
• Monitor viral load to determine likelihood of
  response and aid in compliance

• Determining genotype 16 and 18 of Human Papilloma
  Virus
• Reduce risk of cervical cancer by closer
  monitoring
• Support Roche Pharma studies on therapeutic
  vaccines

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Personalised Healthcare in the market
todayIAT-Beispielliste
Oncology
CNS
Virology/Infectious Diseases
Phenytoin Venlafaxine Modafinil Resperidone Atomox
etine Thioridazine Levodopa Tasmar Aripiprazole
CYP2C9 CYP2D6 CYP2D6 CYP2D6 CYP2D6 CYP2D6 COMT COM
T CYP2D6
Tamoxifen Tamoxifen Tamoxifen Tamoxifen Chemothera
py Arimidex Herceptin Xeloda 6-Mercaptopurine Gle
evec (CML) Gleevec (GIST) Dasatinib Iressa Tarceva
Irinotecan Erbitux Retinoic acid MabThera Tykerb
ER/PR Status BRCA1 BRCA2 CYP2D6 Oncotype Dx ER/PR
status HER2 assay Enzyme activity TPMT BCR-ABL C-K
it BCR-ABL EGFR Status EGFR/HER1 UGT1A1 EGFR
status PML/RAR gene CD20 EGFR status
HCV Genotyping Viral Load Viral Load Viral
Genotyping Viral Genotyping NAT Influenza A/B
test HCV EVL HCV EVL
Pegasys/Copegus HIV Prot. Inh. (1st to mkt)1 HIV
Prot. Inh. (2nd to mkt)2 HIV Prot. Inh. (1st to
mkt)1 HIV Prot. Inh. (2nd to mkt)2 Isoniazid Tamif
lu PegintronA Roferon
Respiratory
Metabolic and Vascular Disease
Fosamax Somatropin Insulin Simvastatin
Prolastin Theophylline
PiZZ, PiZ Pi CYP2D6
P1NP Chr 15 HbA1c Lipid profiles
GIT
Omeprazole Proton pump inh. and Antibiotics
CYP2C19 H Pylori
Haematology
Warfarin Warfarin Heparin EPO
CYP2C9 VKORC1 APTT CBC
Autoimmune and Transplant
Cardiovascular
Cellcept Azathioprine Neoral (Cyclosporine) Progra
f (Tacrolimus) Rapamune (Sirolimus) Mabthera
IA TPMT IAs for CsA IA IA RA profiles
Ethnicity NAT NAT Troponin Troponin
BiDiL Hydralazine Procainamide GPIIb/IIIa Streptok
inase
Anaesthesia
Succinylcholine
Pseudochol- Inesterase levels
1. Invirase 2. Crixivan
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• Challenges for the Healthcare system
• Technological development and evolution in
  Diagnostics
• Potential future role for the General Practioner

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Personalised Healthcare hype or realityThe
proven promise of personalised health care is to
further improve effectiveness of treatment

• Effectiveness of treatment can be improved
• 20-75 of patients do not receive effective
  treatment1
• gt100.000 deaths/yr from adverse drug reactions in
  US2

by tailoring treatments to selected patient
groups defined by biomarkers
1 Spears et al., Trends Mol Med, 20012 Lazarou
et al., JAMA, 1998
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New testing algorithms A new paradigm shift in
"how to treat" patients Earlier, better diagnosis
allowing for better and cost effective treatment
Early patient stratification
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Personalised healthcare hype or reality Role of
the treating physician across the healthcare
value chain
Risk Assessment
Screening/ Diagnosis
Prognostic
Predictive
Monitoring
Predisposition for developing disease
Early detection
Predict probable disease course
Predict likely response to a drug
Monitor efficacy/ recurrence
Patient Stratification / Therapy Selection
Therapy adaptation
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Personalised Healthcare hype or reality?
Benefits for patients and healthcare system