Next generation sequencing technology in routine analysis in Belgian healthcare system
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1 Next generation sequencing technology in routine analysis in Belgian healthcare system Brussels, 25 Oktober 2016 Rue Juliette Wytsmanstraat Brussels Belgium T F belgiancancercentre@wiv-isp.be
2 Program Welcome Opening by Minister of Public Health Maggie De Block Introduction of Next-Generation-Sequencing technology in (hemato)-oncology in the Belgian healthcare system Lunch Genomics in oncology and hemato-oncology: opportunities & challenges PM Reception
3 NEXT GENERATION SEQUENCING GENE PANELS FOR TARGETED THERAPY IN ONCOLOGY AND HAEMATO-ONCOLOGY MARC VAN DEN BULCKE, LORENA SAN MIGUEL, ROBERTO SALGADO, ELS DE QUECKER, HARLINDE DE SCHUTTER, ANOUK WAEYTENS, PETER VAN DEN BERGHE, SABINE TEJPAR, JEROEN VAN HOUDT, STEVEN VAN LAERE, BRIGITTE MAES, FRANK HULSTAERT 19 March 2015
4 Big data Analysis Genomics in 21st century
5 Roadmap for NGS in routine analysis in oncology and heamato-oncology 1. Organisation: - Expert WG on clinical utility of somatic mutations in oncology/haemato-oncology - Linkage CTG-TGR (drugs Φ tests) 2. Quality: - NGS guidelines, checklist and NGS genepanel - Real-life pilot study Benchmarking test Real-life pilot study 3. Registration, monitoring, evaluation (incl. cost): - Data management (actionable mutations, reimbursement, register) 4. Ethics, Legal impact: - Informed Consent (ethical and legal concerns) 5. Education and training
6 Commission of Personalized Medicine Brussels,25 Oktober 2016 Symposium NGS in (hemato) oncology Marc Van den Bulcke WIV-Kankercentrum Rue Juliette Wytsmanstraat Brussels Belgium T F belgiancancercentre@wiv-isp.be
7 Commission on Personalized Medicine (December 2015)
8 Commission Personalized Medicine General aim: Advisory board on clinical utility of omics in oncology and haemato-oncology Principle tasks: Develop a methodology to assess the clinical utility of novel somatic mutations Assess novel somatic mutations to be retained in reimbursed NGS gene panels, including registration Assess novel omics technology for application in oncology Present evidence-based advise to officials
9 Organisation: - Secretariat: Cancer Centre (WIV-ISP) - Include representatives of all professional organisations directly involved in DNA profiling - Working groups by tumour type or research issue/topic - Regular face to face meetings - Seek international embedding
10 Organisation: general view - Cancer Centre (CC) - Management Board (MB) - Scientific board (SB) SB MB CC -
11 Management Board Main role: Define the key activities validate the outcomes Yearly planning key initiatives/scope Validation of outcomes/deliverables Online database 2 MB meetings /year Confidentiality and Conflict of interest statement
12 Management Board Members: Riziv Directie Farmaceutisch Beleid Riziv Medische Directie FOD-VVVL platform CDx CTG/TGR College voor Oncologie College voor Genetica Commissie Pathologische Anatomie Commissie Klinische Biologie Kenniscentrum (KCE) Stichting Kankerregister FAGG BELAC WIV-ISP afdeling Kwaliteit van de Medische Labotaroria WIV-ISP afdeling Healthdata
13 Scientific Board Who: Belgian professionals and experts in the field of (haemato) oncology (preferentially with direct involvement in personalized medicine ) Role of the SB: Provide advise on issues related to the clinical utility of somatic mutations in (haemato) oncology Confidentiality and Conflict of interest statement
14 Scientific Board How will we work? - Organized in working groups around specific themes/issues - Project-based approach (scope, methodology, standard report, SMART recommendations/measures) - Limited number of participants in each WG (CV-based selection) - Discussion on project progress/conclusions at regular plenary meetings
15 Commission Personalized Medicine Proces within ComPerMed Decision Bodies Secr. CC MB SB PLAN Proj 1 Proj 2 Proj 3 Proj 4
16 Workprogram 2016: NGS guidelines for (haemato) oncology (version 01 finalized) NGS genepanel for (haemato) oncology (at final stage for solid tumors) Support to NGS proficiency test (WIV-ISP Quality of Medical Labs and Kankercentrum) (invitation sent) Advise to /Interaction with CTG/TGR (ongoing) Establish mode of interaction with principal partners: Colleges of Oncology/Genetics, Commisisons of Pathology/Clinical Biology, KCE, Cancer Registry, IMA, FAGG, WIV, (ongoing) Develop methodology to assess clinical utility of somatic mutations in (haemato) oncology (ongoing) Guidelines/factsheets for the use of omics in clinical practice (oncology, pathology, clinical biology, genetics) (started)
17 Hospital Networks Decision Bodies... Advise Consultation Off patent application Literature Registries ComPerMed Advise Platform CTG-TGR Off Label Use Targeted Therapy - CDx Clinical Guidelines
18 THANK YOU
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