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

ExL Pharma’s 2nd Leveraging Global eCTD Effciencies Conference HighlightsJanuary 11-12, 2010Washington, D.C.

Definitions

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DefinitionseCTDNon-eCTD Electronic Submission

(NeeS)

eCTD is specific for CTD format!!EU – MAAs only

◦No harmonised format for clinical trials

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Leaf Document◦ The file with the information for review

mostly PDF files data files where required (notably USA)

Directory Structure◦ Somewhere to put all the files

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Main Components of the eCTD

Style sheetA way to view, at a simple level, the information in the submission

Agency Review ToolsThe review environment for theagency - allows lifecycle management

• XML Backbone (Metadata)– A way of managing all of the information about the

submission and the files in the submission & relationships between file

Moving from Data to Documents:The Next Stage for Global Submission

Standards?

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Efficiencies from Overall Process Standards

Individual processes can be automated & standardized Point automation can provide small-scale efficiencies Rework to differing Standards can negatively impact

overall efficiency

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

Becoming more Efficient involves Automation using Overall Standards Standards that cross multiple handoffs are more

efficient

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Pertinent Examples:CTD & CDISC Standards

Common Technical Document (CTD)

Developed by the International Conference on Harmonisation (ICH) started April 1990

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

Has become the de facto global submission standard Has a Definition on Wikipedia: “After USA, European

Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.” *

Significantly superior to different Dossiers for every country

* Source: en.wikipedia.org/wiki/Common_Technical_Document

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Clinical Data Interchange Standards Consortium (CDISC)

Developed by the Clinical Data Interchange Standards Consortium (CDISC) started Feb. 2000

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

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

Largely reduces the harmonization of data between sites in a single Trial and across Trials

Pertinent Examples:CTD & CDISC Standards

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Continuous Improvement

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Challenges for a Standard

1. Make improvements to Standarda) Especially needed early in use

2. Bring Standard into General Usea) Use across organization, partners, and agenciesb) Build Standard into processesc) Build/Buy tools that use Standardd) Automate using Standard

3. Expand use of Standard into other domains

Standards Challenges: CTD & CDISC Standards

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Has been improved (How?)

Has become Best Practice across organizations, partners, and agencies (How?) Primary agencies have actively supported this

Standard Has started to be used by other agencies (e.g.

Canada, Australia)

Already built into tools and processes

Will not be expanded to other Domains (e.g. Devices, Veterinary)


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Has been improved (How?)

Is gaining organization, partner, and global standard status (How?) One agency has actively supported this Standard

Built into most tools and some processes

Now faces ‘competition’ in expanded domains – Electronic Health Records (EHR) standards that apply to a larger audience than Clinical Studies.


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electronic Common Technical Document (eCTD)

Has been a tenuous 7-year activity

Still not the de facto submission standard within original three markets

Shift to eCTD has been more challenging than anticipated Shift in use of technology is large Standards specification lacks certain detail, causing

issues Interoperability issues causing tools not to work the

same

Only recently have major improvements started (NMV)

Standards Challenges: eCTD and SPL Standards

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Structured Product Labeling (SPL)

Has been an unsteady ~5 year activity

Only used by one agency Other agencies considering other standards (e.g. PIM)

Built into tools and processes where applies

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

Single agency has started to use in other domains (e.g. NDC Codes, Establishment Registration)

Standards Challenges: eCTD and SPL Standards

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Expand use in same Domain: Biologics, Vaccines

Continue to be Best Practice across organizations, partners, and agencies Get additional agencies to actively support it Move toward becoming a recognized Global Standard

(HL-7)

Expand use via different media (i.e. electronic)

Addressing Challenges: CTD & CDISC Standards

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Continue to gain organization, partner, and global standard status Focus on primary use across organizations and

partners – esp. Sponsors & CROs (rather than agencies)

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

Evolutionary Standard built into tools and processes through tool upgrades (not new tools)

Addressing Challenges: CTD & CDISC Standards

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Needs a substantial update (NMV)

Reduce existing challenges: Use should be more like use of Web than specialty

applications

Specifications need to include additional detail

Implementation of tools with a Standard View is needed

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

Limits to Standard unless expanded significantly (RPS)

Addressing Challenges: eCTD and SPL Standards

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Standard needs to be expanded to other agencies Harmonized with other standards (e.g. PIM)

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

Additional uses need to be properly identified (SPL for non- ‘Content of Labeling’ use builds confusion) Use different terms for different processes – even if

using basically the same standard

Addressing Challenges: eCTD and SPL Standards

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Technology has been focused on Final Documents EDM Systems for hand-off from Authoring to

Submission construction

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

Need to Shift Focus to Global Authoring process Collaborative Authoring Determine appropriate global content pieces for core

dossier (Small Topics – longest CTD heading levels)

Re-Focus on Process: CTD & CDISC Standards

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Industry has been waiting on Health Agencies Compliance thinking over Efficiency thinking (reduce

risk vs save money?) Used more as a point solution than an Overall

Standard

Need to Shift Focus to larger domain – Electronic Health Records (EHR) Interconnection of systems will be needed Combining Data with Reports – Data with Documents

Re-Focus on Process: CTD & CDISC Standards

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Technology has been focused on Final Documents EDM Systems for hand-off from Authoring to

Submission construction eCTD Construction of a single submission and

application

Improve Standard for Process use Implementation of tools with a Standard View is

needed Identify Construction and Review process needs (not

just message transfer – as with RPS) Need appropriate use of metadata for Content

Need tools to process Global submissions

Re-Focus on Process: eCTD and SPL Standards

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Integration of Standard with other Agencies Harmonized with other standards (e.g. PIM)

Need to address Content in multiple languages Global Core Data Sheet consists of Data and Content Content (Small Topics) need appropriate translations Global Small Topics need to be authored for Global

translations

Strong Combination of Data and Content for SPL and PIM Manage Data as part of Documents

Re-Focus on Process: eCTD and SPL Standards

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General Trends

Shift Focus from single application / submission to multiple Global applications Need to break application content into basic units

that can be used globally Need to address authoring content for global

translations

Shift Focus from Final formats to Processes using Standards for interim steps Apply (and improve) Overall Standards to Authoring

Process

Data to Documents

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General Trends

Shift from Final formats to Processes with interim steps

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

Manage Documents as Data Data and Documents are becoming less distinct (e.g.

SPL) Data is being incorporated into Documents Content pieces (Small Topics) become more like Data Need Data Management techniques for Content

Management

Data to Documents

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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

April 11, 2023 Global Submission Management

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

Slide no 30


Globalization : The new Buzz wordTechnology

◦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…

Slide no 31


Globalization : The new Buzz wordChange 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… Slide no 32

Want to attend our next conference? For additional information on ExL Pharma’s Leveraging Global

eCTD Efficiencies Conferences, please visit www.exlpharma.com

http://www.exlpharma.com/

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

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