Highlights from ExL Pharma's 2nd Leveraging Global eCTD Effciencies Conference

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Highlights from ExL Pharma's 2nd Leveraging Global eCTD Effciencies Conference

  1. 1. ExLPharma’s 2nd Leveraging Global eCTDEffciencies Conference Highlights<br />January 11-12, 2010<br />Washington, D.C.<br />
  2. 2. Definitions<br />2<br />
  3. 3. Definitions<br />eCTD<br />Non-eCTD Electronic Submission (NeeS)<br />eCTD is specific for CTD format!!<br />EU – MAAs only<br />No harmonised format for clinical trials<br />3<br />
  4. 4. 4<br />Supports<br />Provides<br />Agency Review Tools<br />The review environment for theagency - allows lifecycle management<br />Style sheet<br />A way to view, at a simple level, the information in the submission<br />Main Components of the eCTD<br />Leaf Document<br />The file with the information for review<br />mostly PDF files<br />data files where required (notably USA)<br />Directory Structure<br />Somewhere to put all the files<br /><ul><li>XML Backbone (Metadata)
  5. 5. A way of managing all of the information about the submission and the files in the submission & relationships between file</li></li></ul><li>Moving from Data to Documents:The Next Stage for Global Submission Standards?<br />
  6. 6. 6<br />Efficiencies from Overall Process Standards<br /><ul><li>Individual processes can be automated & standardized
  7. 7. Point automation can provide small-scale efficiencies
  8. 8. Rework to differing Standards can negatively impact overall efficiency
  9. 9. Larger efficiencies can be made through end-to-end standardization
  10. 10. Becoming more Efficient involves Automation using Overall Standards
  11. 11. Standards that cross multiple handoffs are more efficient</li></li></ul><li>7<br />Pertinent Examples:CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Developed by the International Conference on Harmonisation (ICH) started April 1990
  12. 12. Has been a tremendous 19-year activity harmonising 3 major markets
  13. 13. Has become the de facto global submission standard
  14. 14. Has a Definition on Wikipedia: “After USA, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.” *
  15. 15. Significantly superior to different Dossiers for every country</li></ul>* Source: en.wikipedia.org/wiki/Common_Technical_Document<br />
  16. 16. 8<br />Pertinent Examples:CTD & CDISC Standards<br />Clinical Data Interchange Standards Consortium (CDISC)<br /><ul><li>Developed by the Clinical Data Interchange Standards Consortium (CDISC) started Feb. 2000
  17. 17. Has been a monumental 10-year activity standardizing Clinical Data including use in Submissions
  18. 18. Is gaining organization, partner, and global standard status, through agreements with HL-7
  19. 19. Largely reduces the harmonization of data between sites in a single Trial and across Trials</li></li></ul><li>9<br />Continuous Improvement<br />
  20. 20. 10<br />Standards Challenges: CTD & CDISC Standards<br />Challenges for a Standard<br />Make improvements to Standard<br />Especially needed early in use<br />Bring Standard into General Use<br />Use across organization, partners, and agencies<br />Build Standard into processes<br />Build/Buy tools that use Standard<br />Automate using Standard<br />Expand use of Standard into other domains<br />
  21. 21. 11<br />Standards Challenges: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Has been improved (How?)
  22. 22. Has become Best Practice across organizations, partners, and agencies (How?)
  23. 23. Primary agencies have actively supported this Standard
  24. 24. Has started to be used by other agencies (e.g. Canada, Australia)
  25. 25. Already built into tools and processes
  26. 26. Will not be expanded to other Domains (e.g. Devices, Veterinary)</li></li></ul><li>12<br />Standards Challenges: CTD & CDISC Standards<br />Clinical Data Interchange Standards Consortium (CDISC)<br /><ul><li>Has been improved (How?)
  27. 27. Is gaining organization, partner, and global standard status (How?)
  28. 28. One agency has actively supported this Standard
  29. 29. Built into most tools and some processes
  30. 30. Now faces ‘competition’ in expanded domains – Electronic Health Records (EHR) standards that apply to a larger audience than Clinical Studies.</li></li></ul><li>13<br />Standards Challenges: eCTD and SPL Standards<br />electronic Common Technical Document (eCTD)<br /><ul><li>Has been a tenuous 7-year activity
  31. 31. Still not the de facto submission standard within original three markets
  32. 32. Shift to eCTD has been more challenging than anticipated
  33. 33. Shift in use of technology is large
  34. 34. Standards specification lacks certain detail, causing issues
  35. 35. Interoperability issues causing tools not to work the same
  36. 36. Only recently have major improvements started (NMV)</li></li></ul><li>14<br />Standards Challenges: eCTD and SPL Standards<br />Structured Product Labeling (SPL)<br /><ul><li>Has been an unsteady ~5 year activity
  37. 37. Only used by one agency
  38. 38. Other agencies considering other standards (e.g. PIM)
  39. 39. Built into tools and processes where applies
  40. 40. Has been improved (i.e. SPL R2 to R4)
  41. 41. Single agency has started to use in other domains (e.g. NDC Codes, Establishment Registration)</li></li></ul><li>15<br />Continuous Improvement<br />
  42. 42. 16<br />Addressing Challenges: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Expand use in same Domain: Biologics, Vaccines
  43. 43. Continue to be Best Practice across organizations, partners, and agencies
  44. 44. Get additional agencies to actively support it
  45. 45. Move toward becoming a recognized Global Standard (HL-7)
  46. 46. Expand use via different media (i.e. electronic)</li></li></ul><li>17<br />Addressing Challenges: CTD & CDISC Standards<br />Clinical Data Interchange Standards Consortium (CDISC)<br /><ul><li>Continue to gain organization, partner, and global standard status
  47. 47. Focus on primary use across organizations and partners – esp. Sponsors & CROs (rather than agencies)
  48. 48. Must Harmonize with expanded domain – Electronic Health Records (EHR)
  49. 49. Evolutionary Standard built into tools and processes through tool upgrades (not new tools)</li></li></ul><li>18<br />Addressing Challenges: eCTD and SPL Standards<br />electronic Common Technical Document (eCTD)<br /><ul><li>Needs a substantial update (NMV)
  50. 50. Reduce existing challenges:
  51. 51. Use should be more like use of Web than specialty applications
  52. 52. Specifications need to include additional detail
  53. 53. Implementation of tools with a Standard View is needed
  54. 54. Use of Standard in process needs more attention (on submission construction and reviewer sides)
  55. 55. Limits to Standard unless expanded significantly (RPS)</li></li></ul><li>19<br />Addressing Challenges: eCTD and SPL Standards<br />Structured Product Labeling (SPL)<br /><ul><li>Standard needs to be expanded to other agencies
  56. 56. Harmonized with other standards (e.g. PIM)
  57. 57. SPL is a sub-set of a larger Standard: Clinical Document Architecture (CDA)
  58. 58. Expand use of larger Standard
  59. 59. Additional uses need to be properly identified (SPL for non- ‘Content of Labeling’ use builds confusion)
  60. 60. Use different terms for different processes – even if using basically the same standard</li></li></ul><li>20<br />Continuous Improvement<br />
  61. 61. 21<br />Re-Focus on Process: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Technology has been focused on Final Documents
  62. 62. EDM Systems for hand-off from Authoring to Submission construction
  63. 63. Need to address multiple Global submissions rather than each submission / application separately
  64. 64. Need to Shift Focus to Global Authoring process
  65. 65. Collaborative Authoring
  66. 66. Determine appropriate global content pieces for core dossier (Small Topics – longest CTD heading levels)</li></li></ul><li>22<br />Re-Focus on Process: CTD & CDISC Standards<br />Clinical Data Interchange Standards Consortium (CDISC)<br /><ul><li>Industry has been waiting on Health Agencies
  67. 67. Compliance thinking over Efficiency thinking (reduce risk vs save money?)
  68. 68. Used more as a point solution than an Overall Standard
  69. 69. Need to Shift Focus to larger domain – Electronic Health Records (EHR)
  70. 70. Interconnection of systems will be needed
  71. 71. Combining Data with Reports – Data with Documents</li></li></ul><li>23<br />Re-Focus on Process: eCTD and SPL Standards<br />electronic Common Technical Document (eCTD)<br /><ul><li>Technology has been focused on Final Documents
  72. 72. EDM Systems for hand-off from Authoring to Submission construction
  73. 73. eCTD Construction of a single submission and application
  74. 74. Improve Standard for Process use
  75. 75. Implementation of tools with a Standard View is needed
  76. 76. Identify Construction and Review process needs (not just message transfer – as with RPS)
  77. 77. Need appropriate use of metadata for Content
  78. 78. Need tools to process Global submissions</li></li></ul><li>24<br />Re-Focus on Process: eCTD and SPL Standards<br />Structured Product Labeling (SPL)<br /><ul><li>Integration of Standard with other Agencies
  79. 79. Harmonized with other standards (e.g. PIM)
  80. 80. Need to address Content in multiple languages
  81. 81. Global Core Data Sheet consists of Data and Content
  82. 82. Content (Small Topics) need appropriate translations
  83. 83. Global Small Topics need to be authored for Global translations
  84. 84. Strong Combination of Data and Content for SPL and PIM
  85. 85. Manage Data as part of Documents </li></li></ul><li>25<br />Continuous Improvement<br />
  86. 86. 26<br />Data to Documents<br />General Trends<br /><ul><li>Shift Focus from single application / submission to multiple Global applications
  87. 87. Need to break application content into basic units that can be used globally
  88. 88. Need to address authoring content for global translations
  89. 89. Shift Focus from Final formats to Processes using Standards for interim steps
  90. 90. Apply (and improve) Overall Standards to Authoring Process</li></li></ul><li>27<br />Data to Documents<br />General Trends<br /><ul><li>Shift from Final formats to Processes with interim steps
  91. 91. Shift Focus from industry specific Standards to cross-industry standards (e.g. ISO, EHR via HL-7)
  92. 92. Manage Documents as Data
  93. 93. Data and Documents are becoming less distinct (e.g. SPL)
  94. 94. Data is being incorporated into Documents
  95. 95. Content pieces (Small Topics) become more like Data
  96. 96. Need Data Management techniques for Content Management</li></li></ul><li>28<br />Continuous Improvement<br />
  97. 97. 29<br />Summary<br />Global Submission Standards is an ongoing process<br />Shift Focus to Content over Final Documents<br />Data and Documents are overlapping<br />Harmonization with other Standards is important<br />The really Large efficiencies can be made only through end-to-end standardization<br />So we need to:<br /> Continually Improve this path<br />
  98. 98. Why globalization<br />Regulatory requirements (e-CTD, Asean CTD etc…)<br />Emerging markets are becoming more strategic<br />Slow down in the economy<br />Refine process to be more efficient<br />Reuse instead of re-invent<br />Shift resources to “low cost” countries<br />Reduce time from first to last submission<br />Provide patients drug earlier<br />Push from Generics<br />Quality<br />Oversee the submission process in all countries<br />A quality issue in one country can affect the overall company<br />Making sure that what is manufactured is what is registered<br />Faster implementation of manufacturing changes<br />27 September 2010<br />Global Submission Management<br />Slide no 30<br />
  99. 99. Globalization : The new Buzz word<br />Technology<br />new web based publishing enable world wide access with limited constrains<br />better communication tools enable faster and cheaper interactions between company employees<br />rise of fast internet access enable remote work : Home, hotel, coffee shop…<br />27 September 2010<br />Global Submission Management<br />Slide no 31<br />
  100. 100. Globalization : The new Buzz word<br />Change in mindset<br />The sense of Headquarter is changing<br />Organization VS location<br />Global economy reaching conservative Pharma companies<br />Pressure on revenue push towards efficiency and global vision<br />Less major drug submissions enable more time to think and act more efficiently<br />The next thing after e-CTD…<br />27 September 2010<br />Global Submission Management<br />Slide no 32<br />
  101. 101. Want to attend our next conference? For additional information on ExLPharma’s Leveraging Global eCTD Efficiencies Conferences, please visit www.exlpharma.com<br />

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