1. ExLPharma’s 2nd Leveraging Global eCTDEffciencies Conference Highlights January 11-12, 2010 Washington, D.C.

2. Definitions 2

3. Definitions eCTD Non-eCTD Electronic Submission (NeeS) eCTD is specific for CTD format!! EU – MAAs only No harmonised format for clinical trials 3

7. Point automation can provide small-scale efficiencies

8. Rework to differing Standards can negatively impact overall efficiency

9. Larger efficiencies can be made through end-to-end standardization

10. Becoming more Efficient involves Automation using Overall Standards

12. Has been a tremendous 19-year activity harmonising 3 major markets

13. Has become the de facto global submission standard

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. Significantly superior to different Dossiers for every country* Source: en.wikipedia.org/wiki/Common_Technical_Document

17. Has been a monumental 10-year activity standardizing Clinical Data including use in Submissions

18. Is gaining organization, partner, and global standard status, through agreements with HL-7

20. 10 Standards Challenges: CTD & CDISC Standards Challenges for a Standard Make improvements to Standard Especially needed early in use Bring Standard into General Use Use across organization, partners, and agencies Build Standard into processes Build/Buy tools that use Standard Automate using Standard Expand use of Standard into other domains

22. Has become Best Practice across organizations, partners, and agencies (How?)

23. Primary agencies have actively supported this Standard

24. Has started to be used by other agencies (e.g. Canada, Australia)

25. Already built into tools and processes

27. Is gaining organization, partner, and global standard status (How?)

28. One agency has actively supported this Standard

29. Built into most tools and some processes

31. Still not the de facto submission standard within original three markets

32. Shift to eCTD has been more challenging than anticipated

33. Shift in use of technology is large

34. Standards specification lacks certain detail, causing issues

35. Interoperability issues causing tools not to work the same

37. Only used by one agency

38. Other agencies considering other standards (e.g. PIM)

39. Built into tools and processes where applies

40. Has been improved (i.e. SPL R2 to R4)

43. Continue to be Best Practice across organizations, partners, and agencies

44. Get additional agencies to actively support it

45. Move toward becoming a recognized Global Standard (HL-7)

47. Focus on primary use across organizations and partners – esp. Sponsors & CROs (rather than agencies)

48. Must Harmonize with expanded domain – Electronic Health Records (EHR)

50. Reduce existing challenges:

51. Use should be more like use of Web than specialty applications

52. Specifications need to include additional detail

53. Implementation of tools with a Standard View is needed

54. Use of Standard in process needs more attention (on submission construction and reviewer sides)

56. Harmonized with other standards (e.g. PIM)

57. SPL is a sub-set of a larger Standard: Clinical Document Architecture (CDA)

58. Expand use of larger Standard

59. Additional uses need to be properly identified (SPL for non- ‘Content of Labeling’ use builds confusion)

62. EDM Systems for hand-off from Authoring to Submission construction

63. Need to address multiple Global submissions rather than each submission / application separately

64. Need to Shift Focus to Global Authoring process

65. Collaborative Authoring

67. Compliance thinking over Efficiency thinking (reduce risk vs save money?)

68. Used more as a point solution than an Overall Standard

69. Need to Shift Focus to larger domain – Electronic Health Records (EHR)

70. Interconnection of systems will be needed

72. EDM Systems for hand-off from Authoring to Submission construction

73. eCTD Construction of a single submission and application

74. Improve Standard for Process use

75. Implementation of tools with a Standard View is needed

76. Identify Construction and Review process needs (not just message transfer – as with RPS)

77. Need appropriate use of metadata for Content

79. Harmonized with other standards (e.g. PIM)

80. Need to address Content in multiple languages

81. Global Core Data Sheet consists of Data and Content

82. Content (Small Topics) need appropriate translations

83. Global Small Topics need to be authored for Global translations

84. Strong Combination of Data and Content for SPL and PIM

87. Need to break application content into basic units that can be used globally

88. Need to address authoring content for global translations

89. Shift Focus from Final formats to Processes using Standards for interim steps

91. Shift Focus from industry specific Standards to cross-industry standards (e.g. ISO, EHR via HL-7)

92. Manage Documents as Data

93. Data and Documents are becoming less distinct (e.g. SPL)

94. Data is being incorporated into Documents

95. Content pieces (Small Topics) become more like Data

97. 29 Summary Global Submission Standards is an ongoing process Shift Focus to Content over Final Documents Data and Documents are overlapping Harmonization with other Standards is important The really Large efficiencies can be made only through end-to-end standardization So we need to: Continually Improve this path

98. Why globalization Regulatory requirements (e-CTD, Asean CTD etc…) Emerging markets are becoming more strategic Slow down in the economy Refine process to be more efficient Reuse instead of re-invent Shift resources to “low cost” countries Reduce time from first to last submission Provide patients drug earlier Push from Generics Quality Oversee the submission process in all countries A quality issue in one country can affect the overall company Making sure that what is manufactured is what is registered Faster implementation of manufacturing changes 27 September 2010 Global Submission Management Slide no 30

99. Globalization : The new Buzz word Technology new web based publishing enable world wide access with limited constrains better communication tools enable faster and cheaper interactions between company employees rise of fast internet access enable remote work : Home, hotel, coffee shop… 27 September 2010 Global Submission Management Slide no 31

100. Globalization : The new Buzz word Change in mindset The sense of Headquarter is changing Organization VS location Global economy reaching conservative Pharma companies Pressure on revenue push towards efficiency and global vision Less major drug submissions enable more time to think and act more efficiently The next thing after e-CTD… 27 September 2010 Global Submission Management Slide no 32

101. Want to attend our next conference? For additional information on ExLPharma’s Leveraging Global eCTD Efficiencies Conferences, please visit www.exlpharma.com