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bio.logis GIMS.pharma - pharmacogenomics for point of care
- 1. bio.logis Genetic Information Management GmbH Home of the Clinical Interpretome bio.logis Genetic Information Management GmbH Altenhöferallee 3 60438 Frankfurt info@biologis.com
- 2. • founded 2013 • located at Frankfurt Innovation Center Germany • 30 highly qualified team players with background in • Software Development • Bioinformatics • Human Genetics Who we are
- 3. aim: Develop IT-tools for management, curation and delivery of clinically relevant interpretations of genetic variants Support translation of genetic test results into actionable clinical insights Creation of a virtual space for a human “Interpretome”
- 4. Sequencing Bioinformatics Analysis& Interpretation ReportGeneration Delivery Genetic Laboratory Referring Physicians Referring Physicians Genetic Diagnostic: Workflow Genetic Information Management Suite
- 5. GIMS®: Genetic Information Management Suite bio.logis GIMS® • Efficient management of diagnostic content • Automated production of diagnostic reports • Structured documentation and sharing of assessments, decisions and reference information • Delivery and presentation of genetic test results through web-based applications at Point of Care Sequencing Bioinformatic Analysis Reporting Delivery Variant Analysis
- 6. Genetic Information Management Suite Standardized DX report production • efficient management of clinical content • automated production of diagnostic reports Seamless, secure access to results and insights • delivery and presentation of results via web-based applications GIMS.DRM GIMS.DM certified as medical device Modules Closes gap between interpretation and reports • structured documentation of variant annotation • sharing of decisions, clinical insights and other report content GIMS.KMM available soon
- 7. GIMS Integration LIMS Sequencing Bioinformatics Analysis& Interpretation Reporting Delivery Genetic Laboratory Referring Physicians Referring Physicians Secure VPN-connection customer-specific, locked GIMS-entity hosted on high security certified healthcare data centers of Deutsche Telekom
- 8. GIMS®: Genetic Information Management Suite
- 9. Complete workflow solutions for targeted clinical questions
- 10. • EU-funded project within the Horizon 2020 program • Aiming to support implementation of pharmacogenomics in clinical practice • bio.logis GIM responsible for implementing GIMS at 7 selected hospitals across Europe
- 11. Dosing recommendations for: 76 drugs based on: 44 variants in: 12 genes available: 7 languages Project Sites Leiden LjubljanaPatrasGranadaAvianoViennaLiverpool Patients
- 12. 12 Target genes • CYP2B6 • CYP2C9 • CYP2C19 • CYP2D6 • CYP3A5 • DPYD • F5 • HLA-B*57:01 • SLCO1B1 • TPMT • UGT1A1 • VKORC1 44 variants
- 13. 76 Index drugs (alphabetical) • Abacavir • Acenocoumarol • Amiodarone • Amitriptyline • Aripiprazole • Atenolol • Atomoxetine • Atorvastatin • Azathioprine • Bisoprolol • Capecitabine • Carvedilol • Citalopram • Clomipramine • Clonidine • Clopidrogrel • Clozapine • Codeine • Dexmethylphenidate • Disopyramide • Doxepin • Duloxetine • Efavirenz • Eliglustat • Escitalopram • Esomeprazole • Flecainide • Flucloxacillin • Fluorouracil • Fluoxetine • Flupentixol • Fluphenazine • Fluvastatin • Fluvoxamine • Gefitinib • Glibenclamide • Gliclazide • Glimepiride • Haloperidol • Imipramine • Irinotecan • Kinidine • Lansoprazole • Mercaptopurine • Methylphenidate • Metoprolol • Mirtazapine • Moclobemide • Nortriptyline • Contraceptives • Olanzapine • Omeprazole • Oxycodone • Pantoprazole • Paroxetine • Phenprocoumon • Phenytoin • Pimozide • Prasugrel • Propafenone • Quetiapine • Rabeprazole • Risperidone • Sertraline • Simvastatin • Soltalol • Tacrolimus • Tamoxifen • Tegafur • Ticagrelor • Tioguanine • Tolbutamide • Tramadol • Venlafaxine • Voriconazole • Warfarin • Zuclopenthixol
- 14. 76 Index drugs (therapeutical) PPIs: • Esomeprazole • Lansoprazole • Omeprazole • Pantoprazole • Rabeprazole beta Blockers: • Atenolol • Bisoprolol • Carvedilol • Metoprolol • Soltalol Anticoagulants: • Acenocoumarol • Clopidrogrel • Phenprocoumon • Prasugrel • Ticagrelor • Warfarin Cholesterol-lowering drugs: • Atorvastatin • Fluvastatin • Simvastatin Tumor therapy: • Capecitabine • Fluorouracil • Gefitinib • Irinotecan • Mercaptopurine • Tamoxifen • Tegafur • Tioguanine Immunotherapy: • Azathioprine • Tacrolimus Contraceptives: • Oestrogen containing drugs HIV therapy: • Abacavir • Efavirenz Analgetics: • Codeine • Oxycodone • Tramadol Antidepressants: • Moclobemide NARI • Atomoxetine SSRI • Citalopram • Duloxetine • Escitalopram • Fluoxetine • Fluvoxamine • Paroxetine • Sertraline • Venlafaxine TCA • Amitriptyline • Clomipramine • Doxepin • Imipramine • Mirtazapine • Nortriptyline Others: • Clonidine • Dexmethylphenidate • Eliglustat • Flucloxacillin • Methylphenidate • Phenytoin • Voriconazole Neuroleptics: • Aripiprazole • Clozapine • Flupentixol • Fluphenazine • Haloperidol • Olanzapine • Pimozide • Quetiapine • Risperidone • Zuclopenthixol Antiarrhythmic drugs: • Amiodarone • Disopyramide • Flecainide • Kinidine • Propafenone Antidiabetic drugs: • Glibenclamide • Gliclazide • Glimepiride • Tolbutamide
- 15. GIMS.pharma Official dosing recommendations PGx Laboratory Referring Physicians Referring Physicians Genotyping Platform LIMS / HIS Webportal Mobile App Safety-card Genetic Report Engine Content Management System Patient Data (anonymized)Genotypes PGx Report
- 16. Reports
- 17. QR-code provides automatic access to patient portal FAQs / Instructions Logotype Patient details Result summary Laboratory / Hospital contact Medication Safty Card
- 20. translating DNA into health bio.logis Genetic Information Management GmbH Olof-Palme-Straße 15 60439 Frankfurt info@biologis.com
- 21. Hosting All GIMS-modules are hosted in high security Healthcare Data Centers of Deutsche Telekom: DSI vCloud vCloud provides all security components required for hosting medical products according to European data protection laws, e. g. • infrastructure in secure T-Systems twin-core data centers • redundancy of all vCloud components • segregation of customers at level of • network • compute and • storage resources • robust protection for all external communication connections • external and internal security and quality checks • identity and access management • backup of virtual machines
- 22. GIMS hosting . . . • customer-specific, locked GIMS-entity • secure user access via VPN-connection • no third-party access to customer data • compliant with EU data protection regulations • easily integrated in every laboratory IT infrastructure @ Deutsche Telekom hold corporate certifications for following standards: • DIN EN ISO 9001: Quality management systems • ISO/IEC 20000: IT Service Management (ITILv3) • ISO/IEC 27001: Information technology security management systems • ISO 14001: Environmental management • OHSAS 18001: Certification for occupational health and safety • ISAE 3402: International standards on assurance engagements
- 23. Data protection compliance • Communication between client´s servers and client-specific GIMS entity within data centers of Deutsche Telekom (vCloud) protected by end-to-end encryption • Patient data which is processed in DRM entity at all times completely pseudonymized. Personal data which would allow identification of individuals are encrypted before leaving client´s server • DRM is certified as a Quality Product for Internet Medicine by the German association for Internet Medicine and carries CE-mark as a medical device class I. • bio.logis GIM GmbH provides data processing agreements according to the European General Data Protection Regulation for clients • bio.logis Genetic Information Management GmbH and Deutsche Telekom AG are acting as processors according to GDPR Art. 28. Collection, storage, and processing of client´s data is strictly limited to purpose of fulfilling the services described in service agreement between bio.logis and client. Collection, processing or usage of client´s data beyond this purpose and transfer of data to any third party are explicitly excluded