Precision medicine 2014
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Precision medicine 2014

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Precision Medicine & Big Data analytics constitute the next disruption in health care. However, the implementation of these concepts requires a concerted effort of converging expertise. Precision ...

Precision Medicine & Big Data analytics constitute the next disruption in health care. However, the implementation of these concepts requires a concerted effort of converging expertise. Precision Medicine will eventually be enabled by the convergence of multi-omics technologies with diagnostics and mobile ICT allowing delivery of integrated medical services 24/7 anywhere.

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Precision medicine 2014 Precision medicine 2014 Presentation Transcript

  • Precision Medicine Foundations for a new ecosystem to deliver future health care services Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease Committee on a Framework for Development a New Taxonomy of Disease; National Research Councile http://www.ucsf.edu/sites/default/files/documents/new-taxonomy.pdf Preparing for Precision Medicine World Economic Forum November 2012 http://www3.weforum.org/docs/WEF_GAC_PreparingPrecisionMedicine_2012.pdf Precision Medicine © Dr. Thomas Wilckens, InnVentis
  • Precision Medicine: an attempt of a definition Precision Medicine is an approach:  to discover and develop medicines, vaccines or routes of intervention (behavior, nutrition, etc.) that enable disease prevention and deliver superior therapeutic outcomes for patients, by integrating “Big DATA”, clinical, molecular (multi-omics including epigenetics), environmental and behavioral information to understand the biological basis of disease.  This effort leads to better selection of disease targets and identification of patient populations that demonstrate improved clinical outcomes to novel preventive and therapeutic approaches.  In order to achieve this goal novel data architectures/analytics and mobile ICT technologies are instrumental to enable implementation and delivery of Precision Medicine 24/7 anywhere anytime worldwide Precision Medicine © Dr. Thomas Wilckens 2
  • The changing landscape of R&D and beyond: Big-Data analytics will disrupt current R&D processes requiring new paradigms and data architectures Erich Schadt; The changing privacy landscape in the era of big data Mol Syst Biol. 2012; 8: 612. 3
  • The route to precision medicine (adopted from Clayton Christensen): mobile information,-communication technologies (mICT), new mobile diagnostics (mDx) & Big Data as game changers of existing products/services and business models Available data sets Symptom -based (Trial & Error) Patternbased Algorithm -based *omics mobile ICT Big-data Intuition Medicine Evidencebased Medicine Yesterday & emerging markets Today Action Precision Medicine Tomorrow With the advent of mobile ICT enabled solutions, emerging markets will leapfrog western world today‘s medicine and create new business models
  • Integrated health care 24/7 anywhere: A vision Successful commercial strategies require the creation of a new ecosystem to deliver future services Key elements: • Fast real-time access to databases • Algorithms • Reliable and validated reference databases on customers requirements & health status • Interface to enable new „sticky services“ (third parties) Precision Medicine © Dr. Thomas Wilckens 5
  • Convergence of diagnostics with Big-Data and algorithms: Multi-omics individual molecular fingerprints Algorithms & intelligent, real time assistance Genome 25.000 genes Molecular imaging Proteome 1 million Molecular fingerprint Metabolome > 6000 SM Precision Medicine Other BigDATA other omics Precision Medicine © Dr. Thomas Wilckens 6
  • mobile ICT enables Precision Medicine 24/7 anywhere: Application of rules, algorithms and reference databases : diabetes care as a role model Rules & Algorithms Create Application जेम्स, कृपया फिर से ईधन दे ना आपक रक्त में े शकरा कम है क 60 Algorithms & Avatar MDs: Advise insulin quantity and nutrition from historic patient data, current blood metabolic status, physical activity etc. Precision Medicine © Dr. Thomas Wilckens
  • POC for longitudinal, intra-individual multi-omics profiling’s value proposition Exponential value growth by the generation of content from data Personal omics profile (iPOP), an analysis that combines genomic, proteomic, metabolomic, and autoantibody profiles from a single individual can be used to interpret healthy and diseased states by connecting genomic information with additional dynamic omics activity. Cell 148 , 1293–1307, March 16, 2012 The biggest value growth in health care resides in the generation of proprietary “biomarkers”, actionable information and a knowledge base for algorithm-based Precision Medicine Precision Medicine © Dr. Thomas Wilckens 8
  • A paradigm shift in R&D: Intraindividual multi-omics analysis replaces population based medicine Intra-individual, long-term Big-DATA analytics generates new insight in human biology and pathologies Precision Medicine © Dr. Thomas Wilckens 9
  • Multi-omics and Big Data analysis: Biological dynamics and complexities require new data architectures and analytics Data analytics challenges: • up to 100 terabyte per patient measurement (i.e. 50 samples over time) • nonlinear dynamics Precision Medicine © Dr. Thomas Wilckens 10
  • Real-time analytics requires new data architecture and analytics capacities Complex biology follows chaos rather linear mathematics ICT Challenges: • in-memory reference databases • Safe, secure encrypted data transmission, storage & back-ups • Patient lifetime data storage • New algorithms including quality control … • adopted from Mias and Snyder, Clinical Pharmacology & Therapeutics 2013, 93/1: 29-32 Precision Medicine © Dr. Thomas Wilckens 11
  • The integrated diagnostics/monitoring technology & value map Structure, competences, plattforms, up-scaling & value added services in a lean pilot project User- and administration interface Value added services (VAS) and APPs , Algorithm-based Medicine Data management, Personal health records Dada Mining, Expert System, Therapy, Context matching Monitoring, Analytics, distributed, secure data storage and „HealthSecurity“ Data transport, near field communication, mobil and fix Horizontal cross sectional functions Pilot implementation in selected target marktes CASE-specific: User interface, Data representation, Alarm, Parameters Mobile und portable vital data measurement, Preprocessig and control (non) invasive Frontend tech sensors Non invarsive Sensoric Lab on a chip Technologies Central platform functionalities with general application features; i.e.: • • • • • • Secure data collection, storage, managment and extraction/analysis Monitoring and alarm Personalised health records Expertsystems for datamining, epidemiologic analysis, therapeutic decisions etc. Datatransmission via operator Care management Target case specific diagnostics/sensor and actuator at the frontend • Single point measurement • Repeated measurement (chronic monitoring) • Continuous measurement and monitoring Still missing: IT-platforms, validated front end data, reference databases, Precision Medicine © Dr. Thomas Wilckens algorithms and business models
  • The route to precision medicine What pharma and nutraceuticals need:  Biomarkers for patient stratification  To increase efficacy and/or safety  To increase success rate in drug/product development  To increase clinical utility / value of marketed drugs i.e. anti-TNF  To rescue failed drugs  Integrated services for fast decision making  Biomarkers for monitoring of clinical efficacy  Novel therapeutic targets/concepts  IT solution to enable Big-Data management & Precision Medicine  *omics insight; what do the data mean; i.e. actionable information  Reliable and valid data to create new products and services Precision Medicine © Dr. Thomas Wilckens 13
  • The route to precision medicine What the diagnostics companies need:  Access to novel, emerging markets  Concepts to secure established markets  Concepts to create value from Big-Data  IT-solutions to enable integrated diagnostics & disease management  Novel concepts on value-added services alongside current business  Reliable and valid data to create new products and services Precision Medicine © Dr. Thomas Wilckens 14
  • The route to precision medicine What the health care industries needs:  Products and services to limit health care expenditures  Product and services enabling disease prevention  Products and services to compare clinical efficacy of competing concepts  IT-solutions to enable large scale Big data analysis (including costs)  Intelligent diagnostics support systems (data flodding reduction)  Novel concepts on value-added services alongside current business  Reliable and valid data to create new products and services Precision Medicine © Dr. Thomas Wilckens 15
  • New data and standardized processes (SOP) are essential for success: Establishing data bases and algorithms for Precision Medicine requires highest validity and reliability Nature 03 April 2013 If a job is worth doing, it is worth doing twice Researchers and funding agencies need to put a premium on ensuring that results are reproducible A lack of standardized procedures, well documented patient collectives and reproducible results is the key problem in biomarker and drug discovery Precision Medicine © Dr. Thomas Wilckens 16
  • Standards and SOPs on the horizon to secure value today? The case for vertically integrated pilot projects Problems with scientific research How science goes wrong Scientific research has changed the world. Now it needs to change itself 10/2013 Launch of a Transformative Health Care Initiative: The National Biomarker Development Alliance (NBDA) 1/2014 A sea of standards for omics data: sink or swim? JD Tenenbaum et. al. Am Med Inform Assoc, 09/2013 Precision Medicine © Dr. Thomas Wilckens 17
  • Implementing Symbiotic Innovation to ensures scientific leadership A project’s specific tasks are orchestrated science and technology leaders Big-data, IT-platform, pattern-recognition, algorithms Proteomics Metabolomics Other omics Successful PoC Biomarkers IT Plattform for Precision medicine Logistics/QM/SOPs Genomics Sequencing Clinical Chemistry Antibody Analytics Science Google Ontologies Project specific management teams, will orchestrate the virtual R&D process securing quality control CROs to become part of a value chain and the ROI by participating in the project solving a task Participation anticipates acceptance of a master-contract a priori, which eliminates endless negotiations Precision Medicine © Dr. Thomas Wilckens 18
  • Implementation in a vertically integrated, scalable pilot project: R&D approaches lack of standardized, integrated SOPs and a coherent analytics architecture 1. TRAPS Patient selection • • • • Anti-TNF 2. Inflammation Sample • • • Arthritis 3. 4. 5. Metabolomics Antibody analysis Clinical chemistry Other *omics Big-DATA Format … Data intergration • • Proteomics Collection & logistics Processing Storage Data • • Genomics Disease duration Treatment regimen Drug … Validation …. Analytics & Algorithms Clinical data Ontologies Literature Biomarkers Proprietary reference database Services Precision Medicine © Dr. Thomas Wilckens 19
  • InnVentis’ products enable new product/services development Exponential value growth by serving growth poised industries needs Biomarkers Compagnien Dx Drugs/Nutraceuticals Services Stratification Monitoring Database Precision Medicine © Dr. Thomas Wilckens 20
  • InnVentis reduces risks, costs, time and increases the chance for success Successful commercial strategies require sustainable proactive industry engagement in innovating health care P. Talaga in Drug Discovery Today 9/2009, Share or die!: ‘It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change’ Charles Darwin The best way to predict the future is to invent it Alan Curtis Kay Precision Medicine © Dr. Thomas Wilckens 21