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

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Definitions<br />2<br />

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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 />

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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)

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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 />

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6<br />Efficiencies from Overall Process Standards<br /><ul><li>Individual processes can be automated & standardized

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Point automation can provide small-scale efficiencies

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Rework to differing Standards can negatively impact overall efficiency

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

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Becoming more Efficient involves Automation using Overall Standards

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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

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

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Has become the de facto global submission standard

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Has a Definition on Wikipedia: “After USA, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.” *

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Significantly superior to different Dossiers for every country</li></ul>* Source: en.wikipedia.org/wiki/Common_Technical_Document<br />

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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

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

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

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Largely reduces the harmonization of data between sites in a single Trial and across Trials</li></li></ul><li>9<br />Continuous Improvement<br />

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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 />

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11<br />Standards Challenges: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Has been improved (How?)

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

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Primary agencies have actively supported this Standard

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

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Already built into tools and processes

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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?)

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

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One agency has actively supported this Standard

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Built into most tools and some processes

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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

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Still not the de facto submission standard within original three markets

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Shift to eCTD has been more challenging than anticipated

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Shift in use of technology is large

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Standards specification lacks certain detail, causing issues

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Interoperability issues causing tools not to work the same

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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

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Only used by one agency

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

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Built into tools and processes where applies

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

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Single agency has started to use in other domains (e.g. NDC Codes, Establishment Registration)</li></li></ul><li>15<br />Continuous Improvement<br />

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16<br />Addressing Challenges: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Expand use in same Domain: Biologics, Vaccines

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

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Get additional agencies to actively support it

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

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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

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

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

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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)

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Reduce existing challenges:

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Use should be more like use of Web than specialty applications

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Specifications need to include additional detail

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Implementation of tools with a Standard View is needed

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

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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

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Harmonized with other standards (e.g. PIM)

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

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Expand use of larger Standard

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

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Use different terms for different processes – even if using basically the same standard</li></li></ul><li>20<br />Continuous Improvement<br />

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21<br />Re-Focus on Process: CTD & CDISC Standards<br />Common Technical Document (CTD)<br /><ul><li>Technology has been focused on Final Documents

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EDM Systems for hand-off from Authoring to Submission construction

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

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Need to Shift Focus to Global Authoring process

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Collaborative Authoring

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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

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

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Used more as a point solution than an Overall Standard

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

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Interconnection of systems will be needed

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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

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EDM Systems for hand-off from Authoring to Submission construction

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eCTD Construction of a single submission and application

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Improve Standard for Process use

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Implementation of tools with a Standard View is needed

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

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Need appropriate use of metadata for Content

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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

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Harmonized with other standards (e.g. PIM)

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Need to address Content in multiple languages

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Global Core Data Sheet consists of Data and Content

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Content (Small Topics) need appropriate translations

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Global Small Topics need to be authored for Global translations

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Strong Combination of Data and Content for SPL and PIM

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Manage Data as part of Documents </li></li></ul><li>25<br />Continuous Improvement<br />

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26<br />Data to Documents<br />General Trends<br /><ul><li>Shift Focus from single application / submission to multiple Global applications

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

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Need to address authoring content for global translations

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

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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

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

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Manage Documents as Data

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

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Data is being incorporated into Documents

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Content pieces (Small Topics) become more like Data

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Need Data Management techniques for Content Management</li></li></ul><li>28<br />Continuous Improvement<br />

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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 />

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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 />

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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 />

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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 />

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