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Gepersonaliseerde gezondheidszorg Van utopie tot realiteit Personalised Healthcare Hype or reality? Rob Geraerdts Personalised Healthcare (PHC) Is it more than a media reality – hype – or will it truly develop ? Personalised medicine may be our future approach Targeted drugs: The race is on Targeted cancer drugs gain backers Personalised drugs draw biotech dollars Personalised approach to cancer Personalised medicine: New approach to staying well ‘Targeted‘ drugs prove powerful against forms of cancer FDA acts to foster ‘personalised drugs` 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. 2006;296:1453-1454. Why a new approach to staying well is required ? What's the challenge and promise of Personalised Healthcare? Same symptoms Same findings Same disease Same Drug... ...different effects Variability of disease Drug metabolism Drug-drug interactions Non-compliance Development towards A More Personalised Healthcare Using 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 Personalised Healthcare Not 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 Challenges for the Healthcare system Technological development and evolution in Diagnostics Potential future role for the General Practioner Health Economic Value of Medical Devices The outside world is changing Cost pressure Aging population Payers Cost control Empowered people with increased health consciousness and demands to the system Payers controlling providers and redistributing costs to people Borderless world IT revolution Medical innovation Providers forced by people and payers to change the way they perform medical practice Involvement of all players in the creation of health networks that form strong health care brands. Challenges for the Healthcare system Technological development and evolution in Diagnostics Potential future role for the General Practioner 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 Personalised Healthcare: hype or reality? The need for health information as basis for medical decisions Result Standardisation Today: • Tests with blood, liquid and tissue Tomorrow: Improved Information Novel Content • 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 Personalised Healthcare: hype or reality? How did technological development in IVD testing contribute to creating value in the laboratory ? Productivity Re-engineering Medical Processes with IVD Total IVD infrastructure ( Lab Network / IT ) - DRG’s - Indication management - Personalised Health Care - IT solutions -Hospital solution Laboratroy Organisation - Increase laboratory productivity Systems Reagents - System portfolio - Professional System Service - Reagent harmonization - Robustness improvement - Result standardisation investments Personalised Healthcare: hype or reality? Populating the laboratory health value chain with tools and content to create personalised healthcare Targeted monitoring Preventive measures Diagnosis Tools CONTENT TOOLS Predisposition screening + Therapy decision Therapy monitoring toring Personalised Healthcare: hype or reality? More fundamental knowledge of the "system biology" increases our understanding for underlying causes for diseases 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) mRNA (transcript) genome transcriptome genomics transcriptomics Bioinformatics protein proteome proteomics 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 Personalised Healthcare: hype or reality? "Systems biology" transparency in disease processes Creating PHC from an industrial perspective Diagnostics input is key - from discovery to market of pharmaceuticals Research Develop Lead Target Generation/ Phase 0 Selectio Optimisatio n n Discover Exploratory Phase y Phase Biomarker development Target identification Research assay Phase I Commercialise Phase II Phase III Filing Market Phase IV PoC Companion diagnostic feasibility & attractiveness Patient selection Technically validated assay Confirmatory Phase Dx launch/ Post-launch assessment Tailored prescribing & monitoring Clinically validated IVD assay Personalised healthcare: hype or reality? Understanding of disease "genetic" pattern will drive usage of new technologies in Diagnostics Examples Parameters (eg, Genes, Mutations) 1 PCR Point Mutations; 10 Linear Arrays 100 1000 Microarrays Simple Gene Analysis Complex Gene Analysis Resequencing Genotyping Examples: • CYP450 2C9 • Factor II/V • CF Linear Array (US) • AmpliChip CYP450 Test (CE-IVD) • AmpliChip p53* Expression Examples: Single parameter “Expression”: Complex Expression: • Taqman HIV Monitor • Taqman HCV Monitor • Leukemia* • Breast Cancer • Cardiovascular Disease * under development Personalised Healthcare in the market today Current 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 Personalised Healthcare today in the market Current 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 Personalised Healthcare in the market today IAT-Beispielliste Oncology Tamoxifen Tamoxifen Tamoxifen Tamoxifen Chemotherapy Arimidex Herceptin Xeloda 6-Mercaptopurine Gleevec (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-Kit BCR-ABL EGFR Status EGFR/HER1 UGT1A1 EGFR status PML/RAR gene CD20 EGFR status 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 Tamiflu PegintronA Roferon Azathioprine Neoral (Cyclosporine) Prograf (Tacrolimus) Rapamune (Sirolimus) Mabthera 1. Invirase; 2. Crixivan IA TPMT IA’s for CsA IA IA RA profiles HCV Genotyping Viral Load Viral Load Viral Genotyping Viral Genotyping NAT Influenza A/B test HCV EVL HCV EVL Respiratory Prolastin Theophylline PiZZ, PiZ Pi CYP2D6 GIT Omeprazole Proton pump inh. and Antibiotics Autoimmune and Transplant Cellcept CNS Virology/Infectious Diseases Ethnicity NAT NAT Troponin Troponin CYP2C9 CYP2D6 CYP2D6 CYP2D6 CYP2D6 CYP2D6 COMT COMT CYP2D6 Metabolic and Vascular Disease Fosamax Somatropin Insulin Simvastatin CYP2C19 H Pylori Cardiovascular BiDiL Hydralazine Procainamide GPIIb/IIIa Streptokinase Phenytoin Venlafaxine Modafinil Resperidone Atomoxetine Thioridazine Levodopa Tasmar Aripiprazole P1NP Chr 15 HbA1c Lipid profiles Haematology Warfarin Warfarin Heparin EPO CYP2C9 VKORC1 APTT CBC Anaesthesia Succinylcholine PseudocholInesterase levels Challenges for the Healthcare system Technological development and evolution in Diagnostics Potential future role for the General Practioner Personalised Healthcare: hype or reality The 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 • >100.000 deaths/yr from adverse drug reactions in US2 …by tailoring treatments to selected patient groups defined by biomarkers 1 2 Spears et al., Trends Mol Med, 2001 Lazarou et al., JAMA, 1998 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 Today Today diagnostics often addresses end stages of diseases. Here (e.g. late cancer phase) treatment is expensive and may not cure the patient. for the individual patient Likelihood of treatment success lower higher New markers for the disease onset change this picture dramatically. Health care cost go down and treatment success improves. lower Future Patient Status asymptomatic symptomatic higher This is were marker identification programs like proteomics and genomics come in. Personalised healthcare: hype or reality Role of the treating physician across the healthcare value chain Healthy Risk Assessment Predisposition for developing disease Asymptomati c disease Symptomatic disease Chronic disease Cured Screening/ Diagnosis Prognostic Predictive Monitoring Early detection Predict probable disease course Predict likely response to a drug Monitor efficacy/ recurrence Patient Stratification / Therapy Selection Therapy adaptation Personalised Healthcare: hype or reality? Benefits for patients and healthcare system Patients Best treatment Regulators & Policy Makers Physicians & Providers Increased efficacy & safety Reduced healthcare costs Maximum benefit, minimum toxicity Payers & Reimbursers Efficient use of healthcare budgets