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Personalized medicine: needs, challenges and considerations

Personalized medicine: needs, challenges and considerations. Montserrat Vendrell, CEO, Biocat. EPTA - “From genes to jeans: challenges on the road to personalized medicine ” . World’s population is ageing. Imperative for change : The few cost the most. % Population.

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Personalized medicine: needs, challenges and considerations

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  1. Personalized medicine: needs, challenges and considerations Montserrat Vendrell, CEO, Biocat EPTA - “From genes to jeans: challenges on the road to personalized medicine”

  2. World’spopulation is ageing

  3. Imperative for change: The few cost the most % Population % of Total Healthcare Expense Mean Annual Cost per Person 1% 29% $ 101,000 9% 39% $ 15,000 20% 21% $ 3,700 70% 11% $ 580

  4. Sustainability of Health Care Systems Total health expenditure as a share of GDP, 2009

  5. Ageingpopulationsdrivingneed for change in HC

  6. Disruptive innovation Elements of disruptive innovation Christensen CM, G.J. Hwang J (2009). The Innovator’s Prescription

  7. Technology trendstransforming HC • Wireless Sensors and Devices • Genomics • Social Networking • Mobile Connectivity and Bandwidth • Imaging • Health Information Systems • The Internet • Computing Power and the Data Universe (Big Data)

  8. Bilions of Data Points are Emerging Around Each Individual Epigenome TeleHealth Phenome Social Media 110101000 101010101 101010101 001000101 101010001 Na143K3,7 BP110/70 HCT32 BUN 12,9 Pulse 110 PLT150 110101000 101010101 101010101 001000101 101010101 110101000 101010101 101010101 001000101 101010000 Genome Transcriptome UUAGUG AUGCGUCU AGGCAUGC AUGCC GCGTAG ATGCGTAG GCATGCAT GCCATTATA GCTTCCA Single Cell Transactional Proteome iPS Cells arg-his-pro gly-leu-ser Thr-ala-trp fyt-val-met phe-asp-cys 110101000 101010101 101010101 001000101 101010001 110101000 101010101 101010101 001000101 101010001 110101000 101010101 101010101 001000101 101010001 Source: Institute for Systems Biology

  9. The Grand Challenge of the 21st Century in S & T is Complexity • Medicine as an informational science • Systems approaches allow one to understand wellness and disease – holist rather than atomistic • Emerging technologies will allow us to explore new dimensions of patient data space • Transforming analytic tools will allow us to decipher the billions of data points for the individual Single individual Single cell Single molecule Source: Institute for Systems Biology

  10. Digitalization of Biology and Medicine Will Transform Medicine • (P4) Medicine • Predictive, Personalized, Preventive and Participatory

  11. “We have, in truth, learned nothing from the genome other than probabilities. How does a 1 or 3 % increased risk for something translate into clinic? It is useless information.” J.Craig Venter, chairman of the J.Craig Venter Institute July 2010 Interview with Der Spiegel -----------------------------------------------------------------------------------------

  12. Current response to therapies • Deterioration of patient’s quality of life • Increase cost of healthcare

  13. Personalized medicine

  14. If we know more about how living beings work, this knowledge will help us correct body functions when they are not what we want.

  15. Location: Barcelona Science Park Fonder: Dr. Roger Gomis Focus: development of an assay to validate the capacity of its marker to predict future metastases to bone in cancer patients

  16. Pharma’s transition to bio-therapeutics Pharma annual sales trend Pharma business model is changing Medium efficency Traditional Pharmaceuticals Sales $17B High efficiency Bio-therapeutics Sales $23B

  17. Burrill & Company Biotech 2011 – Life Sciences 25 years looking back to see ahead

  18. "A thriving biotech ecosystem is crucial for the success of the pharmaceutical industry as a whole. Recent challenges in the economic environment have made it difficult for many emerging biotech companies.  We believe that supporting and nurturing these companies will be good for the entire industry." Our goal with Janssen Labs is to give novel technologies a greater opportunity to reach the patient by reducing some of the hurdles of early stage discovery." Diego Miralles, J&J Head, West Coast Research Center

  19. How to choosetherighttarget to ensureefficacy • Preclinicaltox. in human cells • Reprofiling of existingdrugs (bypass patent expiration) Budget 2012: 577 M$. Goal: shortenthepathtoclinics

  20. Imperativesforgenomic medicine • Making genomics-based diagnostics routine • Defining the genetic components of disease • Comprehensive characterization of cancer genomes • Practical systems for clinical genomics informatics • The role of human microbiome in health and disease

  21. Bioinformatics and computationalbiology • Data analysis • Data integration • Visualization • Computational tools and infrastructure • Training

  22. Education and training • Strengthening primary and secondary education • Conducting public outreach • Building HC providers’ genomic competences • Preparing the next generation genomic researchers

  23. Genomics and society • Psychosocial and ethical issues in genomics • (from research to medicine) • Legal and public policy issues • Broader societal issues

  24. Drivers • Patients - enabled by new technologies. Want safer more effective drugs. Want to take a more active role in their own HC • Payers - more certainty that the money spent generates medical benefit for the patient: cost-effective solution • Regulators - evidence that a drug that’s approved will work in the patients that receive it • Industry - cuts down development time and cost and increases their successrate

  25. Barriers • Scientific/technical - data management, storage and analysis • Regulation - need for clear guidelines (reimbursement processes are uncertain, difficult for molecular Dx companies to get paid for the value they provide) • Physicians • a structural barrier: incentives are not aligned to prioritize prevention versus treatment. • not trained to adopt it in their daily practice • (in US, 20% of MD received PM education in medical school) • Pharma and Dx companies working together Strategyneeded to implementgenomicsinto HC

  26. Incorporatinggenomicsinto HC systems • Translation of research into quality-assured care pathways • Developing a service delivery infrastructure (from commissioning initial tests to counseling patients and their families) • Bioinformatics platform (storing and managing data) • Training NHS workforce • Addressing legal and ethical issues • Raising public awareness

  27. Summary: challenges ahead • From data-collecting HC to data-driven HC • Development of a mid- & long-term strategy(at policy and clinical levels) • Linking technology to health outcomes. Monitor performance • Realignment of incentives: punish waste and reward quality and results • Innovation vs. Cost (Role of HTA) • LeanerR&Dapproaches. Variabilizationof fix costs (virtual companies) • The technology revolution is limited by economic, organizational and technology disparities among countries • Whole new range of competences: • Systemic thinking • Project management • Communication • Clinical + Genomics + IT $

  28. A continuously learning healthcare system

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