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IXI(CO): Progressing a scientific GRID project to an end-to-end solution

Thomas Hartkens, CTO. IXI(CO): Progressing a scientific GRID project to an end-to-end solution. Overview. A brief history of “IXI” From the idea to a business plan Challenges in the first two years GCP Maintaining an audit trail and FDA 21 CFR part11

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IXI(CO): Progressing a scientific GRID project to an end-to-end solution

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  1. Thomas Hartkens, CTO IXI(CO): Progressing a scientific GRID project to an end-to-end solution

  2. Overview • A brief history of “IXI” • From the idea to a business plan • Challenges in the first two years • GCP • Maintaining an audit trail and FDA 21 CFR part11 • Quality Management System / ISO 9001:2000 • Software validation • Conclusion

  3. Why using Grid in Automated Medical Image Analysis? • Huge volume of image data • hospitals typically produce several tera bytes per year • results of automated image analysis can be few times larger • Computationally demanding algorithms • - sophisticated image analysis of one single image can take several hours (or even days)‏ • Multiple processing steps (Workflows)‏ • - one solution consists often out of many single applications • Collaboration of different insitutions • - is often required in clinical trials or research studies

  4. Grid Demonstrator:A Dynamic Brain Atlas (2001-2002)‏ DB query Computational expensive ! Atlas Image database Patient scan registration create atlas transformation

  5. Opening of the National e-Science Centre (NeSC), April 2002

  6. Grid-enabled image registration and segmentation for medical research: • to assess scalability of Dynamic Brain Atlas • to extend to data from outside the brain • to build an application interface 3 year project funded by e-science core programme • GSK, Philips Medical Systems, Dunhill Charitable Trust

  7. IXI components Available Services Aggregations of MICL SDEs IXI Portal GT3 Index Service Service Provider #1 IXI Core Service Compute Resources Workflow submission IXIWorkflow service GridFTP Service Provider #2 Medical Image Database Result management Invocations & Notifications IXI insertion Service IXI Core Service Compute Resources

  8. IXI components Available Services Aggregations of MICL SDEs IXI Portal GT3 Index Service Service Provider #1 IXI Core Service Compute Resources Workflow submission IXIWorkflow service GridFTP Service Provider #2 Medical Image Database Result management Invocations & Notifications IXI insertion Service IXI Core Service Compute Resources • Algorithms wrapped as grid services for medical image analysis, e.g. • image segmentation • image registration • non-rigid registration: • run-time on single CPU between 10 minutes and 24 hours

  9. IXI components Available Services Aggregations of MICL SDEs IXI Portal GT3 Index Service Service Provider #1 IXI Core Service Compute Resources Workflow submission IXIWorkflow service GridFTP Service Provider #2 Medical Image Database Result management Invocations & Notifications IXI insertion Service IXI Core Service Compute Resources • Workflow engine • Workflow language to combine image analysis services • XML workflow file

  10. IXI components Available Services Aggregations of MICL SDEs IXI Portal GT3 Index Service Service Provider #1 IXI Core Service Compute Resources Workflow submission IXIWorkflow service GridFTP Service Provider #2 Medical Image Database Result management Invocations & Notifications IXI insertion Service IXI Core Service Compute Resources • Web interface to launch workflows • Grid applications to design workflows and to control the execution

  11. IXI components Available Services Aggregations of MICL SDEs IXI Portal GT3 Index Service Service Provider #1 IXI Core Service Compute Resources Workflow submission IXIWorkflow service GridFTP Service Provider #2 Medical Image Database Result management Invocations & Notifications IXI insertion Service IXI Core Service Compute Resources • large data set of MRI brains • ~550 normal volunteers • age range 20-80 years • T1, duel echo (proton density and T2 weighted) • acquired at 3 different sites • publicly available to research community

  12. Application: Automatic delineation of bones Rigid + non-rigid registration Elastic Transformation Apply transformation calcaneus Reference image Subject image Computed boundary of calcaneus Manual segmentation

  13. Business idea 3 months later 6 months later 9 months later Baseline • Automated image analysis for the Drug Development Process • Measurement in Rheumatoid Arthritis: eg. grade of bone erosion Start of treatment using drug candidate

  14. From the idea to a business plan ... Founders of IXICO: Prof. Daniel Rueckert Prof. David Hawkes Prof. Jo Hajnal Prof. Derek Hill

  15. Ixico Presentation Business plan • The Market • The industry • Product & Unique Selling Preposition • Sustainable advantage • The team • Intellectual Property • Finance (forecast, funding requirements)‏ • Exit strategy

  16. Ixico Presentation A crisis in drug discovery & development • Imaging can help… “Imaging is a key technology for assessing, accelerating the development of, and guiding the use of new therapeutic options” George Mills, FDA “It is estimated that between $10m and $30m could be saved per drug program through the use of advanced imaging technologies which could guide go/no go decisions.” Business Insights Journal, May 2006

  17. Ixico Presentation The Market • The customers are the pharmaceutical and biotech companies • What does an “imaging biomarker” product look like?

  18. Ixico Presentation Image Analysis in clinical trials Image scoring and analysis Procedures Study set-up, regulatory charter, Site management (training, SOPs…)‏ Imaging supplier Data transfer metadata Results for database upload

  19. Ixico Presentation Potential revenue growth Potential Market compared to projected sales Total Market £161.9m 180 160 140 CNS & Oncology £124.6m 120 100 £m 80 60 40 IXICO £??m 20 0 2006 2007 2008 2009 2010 Years

  20. Ixico Presentation Image analysis suppliers • Dominated by small number of companies that specialise in traditional “radiological reading” • Fastest growth is in more sophisticated methods • Regulator push for methods that are less subjective • Industry need for more precise measures for better, faster, cheaper decision making

  21. Ixico Presentation Product • Advice on image acquisition parameters • Automated image analysis service • Quality control of analysis results • Quality Management System • Electronic audit trail • Site Management • Data logistics • Imaging charter for regulators (FDA)

  22. Ixico Presentation Product • Advice on image acquisition parameters • Automated image analysis service • Quality control of analysis results • Quality Management System • Electronic audit trail • Site Management • Data logistics • Imaging charter for regulators (FDA)

  23. Ixico Presentation USP Due diligence conducted by the Capital Fund identified unique combination of: + + Technology Know-how Quality system + Image acquisition Image analysis

  24. The team Prof. Derek Hill Dr. Thomas Hartkens Dr. Kate McLeish James Cameron Ian Alexander Richard Brooman

  25. IXICO's non executives • Peter Morgan – Chairman • Executive career with IBM and experience on several company boards • Formerly Director General of the Institute of Directors in London. • Prof. Sir Michael Brady • Track record of building successful entrepreneurial companies using academic technology (most recently Mirada, acquired by CTI) • Prof. Sir Colin Dollery • Clinical pharmacologist and leading authority on Clinical Trials • Senior consultant in GlaxoSmithKline (GSK): adviser to Dr Yamada the Chairman of Research and Development and member of the committees that review all protocols for human research, on the Development Investment Board and on the Global Safety Board • Peter Ellis • Executive Director of People in Health and previously senior partner in Ernst & Young's Global Consulting life sciences practice.

  26. Challenges in the first two years

  27. Good Clinical Practise (GCP)‏ Audit Trail Electronic audit trail compliant with FDA 21 CFR part 11 Quality Management System ISO 9001:2000 certification Software Validation e.g. V-model

  28. Audit trail produced by Workflow System Reference + Image data

  29. Task submission IWD 1 Coarse Registr. 2 Bias Correction 3 QC interface

  30. Task processing IWD 1 Coarse Registr. 2 Bias Correction 3 QC interface

  31. Automatic task Results & Audit trail information Image analysis application IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction 3 QC interface

  32. Task processing IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction 3 QC interface

  33. Task processing IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface

  34. Manual task Results & Audit trail information & Digital Signature Custom-made interface IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface Date:15.12.2006 9:45 Result:Comment Person:Kate McLeish Kate McLeish

  35. IXICO's Electronic Audit Trail Electronic Audit Trail Electronic Audit Trail Electronic Audit Trail IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface Date:15.12.2006 9:45 Result:Comment Person:Kate McLeish Kate McLeish Result images

  36. 21 CFR Part 11Electronic records; electronic signatures • Designed to provide FDA assurance that electronic records / signatures are • Trustworthy • Reliable • Equivalent to paper records and handwritten signatures • Applies to all FDA regulated industries

  37. 21 CFR part 11

  38. Requirements • Electronic records • Controls aimed at security and integrity of records • What information needs to be included with a signed electronic record • How the signature must be linked to the record • Electronic signatures • Unique to an identified individual • Components of an electronic signature (in general, 2)‏ • Security and integrity of ID codes and passwords • Software validation

  39. IXICO's Electronic Paper Trail Automatic Task Automatic Task Manual Task IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface Date:15.12.2006 9:45 Result:Comment Person:Kate McLeish Kate McLeish Derek Hill IXICO's Workflow System Report Analysis has shown that XY% of all cases .... IWD 1 Coarse Registr. 2 Bias Correction 3 QC interface IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction 3 QC interface IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface IWD 1 Coarse Registr. Date:11.12.2006 13:45 Result:Transformation Server:234.232.43.2 2 Bias Correction Date:13.12.2006 3:59 Result:Image Server:234.256.43.8 3 QC interface Date:15.12.2006 9:45 Result:Comment Person:Kate McLeish Kate McLeish

  40. ISO 9001:2000 based QMS

  41. ISO 9001:2000 • Does NOT say anything about the quality of the product. • BUT guarantees • a constant product quality or • an improvement of quality over time.

  42. “Idea” of QMS • Write down what you are doing. • Follow what you have written down. • Improve documentation in a “controlled” way. • Preserve and improve knowledge base

  43. ISO 9001:2000 certification • Does NOT certify a product • But • certifies that the company works according to the ISO 9001:2000 standard

  44. ISO 9001:2000 based QMS 4. Quality Management System 5. Management responsibilities 6. Resource management 7. Product realization 8. Measurement, analysis and improvement

  45. Written procedures System deployment procedure

  46. Software Transfer Control of documents Control of records Internal audit Issue tracking Control of Nonconformity, Corrective and Preventive Action Customer Feedback Document Review Document Version Control Training Recruitment Purchasing Risk Assessment IP Transfer Written procedures System deployment procedure Contract Agreement Contract Amendment Contract Processing Overview Site Management Site Training Protocol Optimization Adverse Findings Data Transfer Data Admission Data Export Data Delivery Software Design Workflow System Deployment Workflow design

  47. Document control

  48. Document server

  49. Documents and records

  50. Internal or external audit 1. 2. IXICO's QMS ISO 9001:2000

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