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2017 02-22 Oxford Global Biomarker Congress, Manchester, Alain van Gool

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Outline of various technology infrastructures (in Radboudumc, Netherlands, European) aiming at filing innovation gaps in personalized medicine and health research.

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2017 02-22 Oxford Global Biomarker Congress, Manchester, Alain van Gool

  1. 1. Infrastructures for personalized medicine and health research Prof Alain van Gool
  2. 2. 2 Alain’s path 1989-now • Basis in molecular biology • Academia, pharma, medical center, applied research institutes • Biomarkers / Omics / technologies • Mechanisms of disease • Translational medicine • Personalized healthcare Senior Scientist Integrator Biomarkers Scientific lead DTL-Technologies Chair EATRIS Biomarker Platform Professor of Personalized Healthcare Head Radboud Center for Proteomics, Glycomics & Metabolomics Coordinator Radboud Technology Centers Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  3. 3. Alain’s path 1989-now • Basis in molecular biology • Academia, pharma, medical center, applied research institutes • Biomarkers / Omics / technologies • Mechanisms of disease • Translational medicine • Personalized healthcare Senior Scientist Integrator Biomarkers Scientific lead DTL-Technologies Head EATRIS Biomarker Platform Professor of Personalized Healthcare Head Radboud Center for Proteomics, Glycomics & Metabolomics Coordinator Radboud Technology Centers 3 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  4. 4. Exponential technology developments in laboratories • Next generation sequencing • DNA, RNA • Risk analysis and therapy selection • Mass spectrometry • Proteins, metabolites • Monitoring of disease and treatment effects • Imaging • Non invasive images, real time • Spatial view of intact organs and organisms 500 1000 1500 2000 m/z 5 10 15 20 25 30 35 40 Time [min] 4 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  5. 5. Advances in mass spectrometry • Mass spectrometry analysis of glycoproteins in human plasma • 1/20 microliter analysis: detection of 1.000.000 signals in one scan (1,4 Gb) • ~40.000 peptides of which >80% contain sugar modification • Potential to screen patients and identify new biomarkers? 500 1000 1500 2000 m/z 5 10 15 20 25 30 35 40 Time [min] Proof of principle study: Biomarkers !? 5 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  6. 6. Serum N-glycopeptide profiling as biomarker discovery Comprehensive QC analytics
  7. 7. New diagnostic glycoprotein biomarker • Glycoprofile of intact transferrin protein (80 kDa) • Identified through combination glycoproteomics and exome sequencing • Is linked to specific glycosylation disorders (rare metabolic diseases) • Implemented now in clinical care as diagnostic mass spec test 7 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  8. 8. 8 New data ! (generators, owners) 8 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  9. 9. 9 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  10. 10. Exciting next steps: translate laboratory to society • Point-of-care analysis of few biomarkers • 1.000.000 signals per proteomics analysis 11 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  11. 11. implementation innovation research 12 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  12. 12. Irreproducibility of data {Freedman et al, PLOS Biology, 2015} {2012} {2011} {2013} {2008}{2012} 13 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  13. 13. Categories of errors leading to irreproducibility {Freedman et al, PLOS Biology, 2015} 14 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  14. 14. Biomarker innovation gaps ! Discovery Clinical validation/confirmation Diagnostic test Number of biomarkers Gap 1 Gap 2 • Too much biomarker discovery • Too little development to application 15 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  15. 15. Biomarker innovation gaps: some numbers ~ 5 biomarkers/ working day 1 biomarker/ 1-3 years 1 biomarker/ 2-10 years Eg Biomarkers in time: Prostate cancer May 2011: 2,231 biomarkers Nov 2012: 6,562 biomarkers Oct 2013: 8,358 biomarkers Nov 2014: 10,350 biomarkers Oct 2015: 11,856 biomarkers Nov 2016: 14,481 biomarkers Discovery Clinical validation/confirmation Diagnostic test Number of biomarkers Gap 1 Gap 2 16 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  16. 16. Choice for biomarker scientists: discover or confirm? 17 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  17. 17. Biomarkers for personalized medicine and health time for quality, not quantity 18 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  18. 18. Way forward Quote Freedman paper: {Freedman et al, PLOS Biology, 2015} 19 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  19. 19. Introducing 5 infrastructure communities (local) (European) (Netherlands) 20 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  20. 20. www.radboudumc.nl/research/technologycenters Genomics Bioinformatics Animal studies Stem cells Translational neuroscience Image-guided treatment Imaging Microscopy Biobank Health economics Mass Spectrometry Radboudumc Technology Centers Investigational products Clinical studies EHR data analysis Statistics Human performance Data stewardship Molecule Flow cytometry 3D lab 21
  21. 21. About 280 dedicated people working in 19 Technology Centers, ~1800 users (internal, external), ~150 consortia www.radboudumc.nl/research/technologycenters/22 • Proteins • Metabolites • Drugs • PK-PD • Preclinical • Clinical • Behavioural • Preclinical • Animal facility • Systematic review • Cell analysis • Sorting • Pediatric • Adult • Phase 1, 2, 3, 4 • Vaccines • Pharmaceutics • Cyclotron • Radio-isotopes • Malaria parasites • Management • Analysis • Sharing • Cloud computing • DNA • RNA • Internal • External • Early HTA • Evidence- based surgery • Field lab • Statistics • Biological • Structural • Preclinical • Clinical • Economic viability • Decision analysis • Experimental design • Biostatistical advice • Electronic Health Records • Big Data • Best practice • In vivo • Functional diagnostic s • iPSC • Organoids • 3D imaging • 3D printing • Virtual reality
  22. 22. Link to European infrastructures 23 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  23. 23. 24EATRIS15/02/2017 Filling the gaps (1) GAP 1 Public increasingly funding early development, funding gap remains Public Funding Private Funding Moves away from early development Fundamental discovery Early Translational F.I.M Phase 1 Phase 2 Phase 3 GAP 1 24 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  24. 24. 25EATRIS15/02/2017 Filling the gaps (2) GAP 2 Outputs of publicly funded projects misaligned with privately financed requirements for further development Public Funding Technology push, publications Private Funding Product and patient focus, market pull Fundamental discovery Early Translational F.I.M Phase 1 Phase 2 Phase 3 GAP 2 25 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  25. 25. 26EATRIS15/02/2017 Participating countries : CZ, ES, FI, FR, IT, NO, EE, NL, LU, SI, SE (Host) Observer: LV 88 Academic & non-profit research institutions of excellence in translational medicine EATRIS map 26 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  26. 26. 27EATRIS15/02/2017 Client projects Infrastructure Funding Expertise GMP manufacturing Licenses Imaging facilities Biobanks Clinical trial units Patient groups Academia Research /charities SME/biotech Pharma Clinicians Latest technologies Project management Regulatory Partnering Nat’l governments Regional dev. Funds H2020 Venture capital Pharma partnering Landscape 5 Technology Platforms 27 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  27. 27. 28EATRIS15/02/2017 • Chair: Alain, van Gool, Radboudumc/TNO, the Netherlands • Operational manager: Florence Bietrix • 46 European advanced biomarker development centres • State-of-the-art technologies and expertise • Biobanks • Assay development and validation • Multi-centre clinical trials Biomarkers platform 28 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  28. 28. 29EATRIS15/02/2017 1. Matchmaking & services • Fast Matchmaking: clarify client’s need, identify relevant institutions, provide list to PI who contacts the institution(s) directly • Matchmaking: for researchers with funded projects: identify institution(s) for service delivery – full support of C&S to reach agreement. The institution delivers. Contract is between client and institution. 2. Improving pipeline productivity Collaborating across boundaries to design, validate and roll out novel: • Funding, operational and collaboration models  e.g. access to early regulatory dialogue • Tools, technologies and methodologies  e.g. enabling multi-centre, imaging-enabled clinical trials for mAbs & ADCs with 89Zr 29 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  29. 29. 30EATRIS15/02/2017 TRANSLATIONAL MEDICINE’17, September 24 – 26, Prague www.eatris.eu 30 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 www.EATRIS.eu
  30. 30. Introducing 5 infrastructure communities (local) (European) (Netherlands) 31 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  31. 31. Ongoing independent biomarker activities Europe USA {Asadullah et al, Nature Reviews Drug Discovery, Dec 2015} 32 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  32. 32. NL Biomarker Development Center Standardisation, harmonisation, knowledge sharing in: 1. Assay development 2. Clinical validation www.biomarkerdevelopmentcenter.nl NL Grant 4.3M Eur (2014) EU Grant 1M Eur (2016) 33 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017 BDC is part of:
  33. 33. The Good Biomarker Practice initiative Join forces among Europe’s major academic infrastructures + industry to: 1. Establish “Good Biomarker Practice” guidelines - on translational research, biomarker technologies, biobanking, data stewardship. 2. Efficiently execute high quality biomarker projects - work together in clinical validation and development of probable biomarkers. {Nature Reviews Drug Discovery, accepted}34 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  34. 34. Introducing 5 infrastructure communities (local) (European) (Netherlands) 35 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  35. 35. Rich history of PPP in the Netherlands (Centre for Translational Molecular Medicine) (Top Institute Pharma) (BioMolecular Materials) Public-private collaboration on diagnosis, drugs, devices (2006-2015) 36 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  36. 36. PARTNERSHIP FOR DATA, TECHNOLOGIES & LEARNING
  37. 37. DUTCH TECHCENTER FOR LIFE SCIENCES NL platform enabling cross-disciplinary research
  38. 38. >100 EXPERT GROUPS INVOLVED SO FAR Nijmegen Amsterdam Wageningen Utrecht Rotterdam Eindhoven Maastricht Groningen Leiden Delft Enschede Zeist Hanze University University Groningen UMCG Hubrecht Institute UMCU Utrecht University Wageningen UR PRI TU Twente Radboudumc Radboud University Maastricht Univ. MUMC+ CTMM TUe ErasmusMC Generade LUMC Leiden University Naturalis TUDelft AMC AMOLF CWI NLeSC NKI SURFSARA University of Amsterdam VU University Amsterdam VUMC TNO 20 17 44 13 1 15 6 4 5 1 9 Technology & data hotels  Access to high-tech expertise & facilities  Wetlab & data facilities  Collections of biosamples/cohorts  Public and private labs  Training & education High-quality  experimental design  measuring  data stewardship 39 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  39. 39. FOCUS ON CRITICAL COMPONENT: THE DATA {Wilkinson et al, Nature Scientific Data, 2016} Prof Barend Mons Leiden University Medical Center Dutch Techcenter for Life Sciences Netherlands eScience Center  Data capture  Data stewardship (FAIR) 40 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  40. 40. DATA STEWARDSHIP: INTEROPERABILITY IS KEY If data are interoperable Data analytics provide new knowledge 41 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  41. 41. ELIXIR-NL Areas Data interoperability Data stewardship e-Infrastructure services FAIR data training & education Cross-RI collaboration  BBMRI-NL  EATRIS-NL  NL-Bioimaging  e-Infra’s Industry involvement ELIXIR links FAIR data … Expertise Resources (databases) Compute & storage Tools Standards Training NL-NODE IN ELIXIR (‘DATA FOR LIFE’) Technologies Data Learning 42 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  42. 42. FAIR EVOLVING RAPIDLY INTO A GLOBAL MOVEMENT Rapid acceptance and endorsement process  The conference  The Website  Research Data Alliance endorsement  DTL flagship project  FORCE11 international partner  Articles accepted in NATURE  NIH accepts FAIR compliance in Life Sciences Commons  DTL Data lead Prof. Barend Mons Chair High Level Expert Group EC  The Personal Health Train Initiative started  EC announces European Open Science Cloud with FAIR as leading principle World 2017 43 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  43. 43. ALSO THE G20 HAS RECENTLY ADOPTED FAIR! “We support appropriate efforts to promote open science and facilitate appropriate access to publicly funded research results on findable, accessible, interoperable and reusable (FAIR) principles.” (Statement 12) http://europa.eu/rapid/press-release_STATEMENT-16-2967_en.htm 44 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  44. 44. Further joining forces in Netherlands To drive personalized medicine & health research 46 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  45. 45. See Youtube – Health-RI 47 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017
  46. 46. 24-2-2017 48
  47. 47. Acknowledgements Hans Wessels Jolein Gloerich Roel Tans Esther Willems Maurice van Dael Jenneke Keizer Dirk Lefeber Monique van Scherpenzeel Leo Kluijtmans Ron Wevers Marcel Verbeek Lucien Engelen Jan Kremer Bas Bloem Nathalie Bovy Paul Smits the Radboudumc Technology Centers and many others www.radboudumc.nl/personalizedhealthcare www.radboudumc.nl/research/technologycenters www.radboudresearchfacilities.nl alain.vangool@tno.nl alain.vangool@radboudumc.nl www.linkedIn.com www.slideshare.net/alainvangool Many collaborators and funders Jan van der Greef Ben van Ommen Ivana Bobeldijk Hans Princen Lars Verschuren Marjan van Erk Suzan Wopereis Heleen Wortelboer Wessel Kraaij Ronald Mooi Peter van Dijken Cyrille Krul and many others CarTarDis Ruben Kok Barend Mons Jaap Heringa Merlijn van Rijswijk and many others Anton Ussi Florence Bietrix Laura Bermejo Andreas Scherer Sulev Koks Marian Hajduch Giovanni Migliaccio and many others 49 Alain van Gool, Oxford Global Biomarkers Conference, Manchester, 21 Feb 2017

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