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Bridging Pharma Content Silos: Managing Content From Clinical Through Labeling and Marketing

Ann Rockley, CEO, The Rockley Group

@arockley www.rockley.com ©2015 The Rockley Group, Inc.

The Rockley Group

More than 15 years’ experience in Healthcare

Clinical

Labeling

Promotional

Industry experts

Structured content strategy

Content reuse

Structured content management systems

Content globalization strategy

Multichannel delivery

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Rockley customers

@arockley www.rockley.com ©2015 The Rockley Group, Inc.

Ann Rockley

Known as the “mother of content strategy”

Forefront of content strategy, reuse, structured content management, multichannel delivery (print, Web, eBook, mobile)

Passionately committed to defining and sharing industry best practices

Master of Information Science

Fellow of the Society for Technical Communication

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Disclaimer

This presentation is not a recommendation for your pharmaceutical content, only your regulatory group and other authorized personnel can specifically identify your requirements.

This presentation is designed to provide an understanding of how you can more effectively create and manage your content

The list of documents is a partial list and not intended to be all inclusive

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Produce more than just pharmaceuticals

• Produce content… and lots of it!

As molecules are discovered and formulated into deliverable forms

As compounds/products are tested for safety and efficacy

As applications for regulatory review and approval are created

As labeling is developed

As marketing, sales and training materials are created for approved products

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Many types of documents

Investigational New Drug Applications (eIND)

New Drug Applications (NDA)

Clinical Study Protocols

Clinical Study Reports

Common Technical Document (eCTD)

Formulary Dossier

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Documents (cont.)

Core Data Sheet

United States Package Insert (USPI)

Medication Guide

Summary of Product Characteristics (SmPC)

Patient Information Leaflet (PIL)

Carton and package/container label

Medical letters

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Documents (cont.)

“Fair Balance Statement”

Preparation and administration/Dosage and administration

Sell Sheets

Reimbursement guides

Presentations

Training

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In many areas

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From the CSR we can use:

Clinical trial summaries

Charts/tables

Dosages

Adverse reactions

Etc.

Into

CDS

Presentations

Medical letters

Etc.

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From the PI we can use:

Indications

Contraindications

Adverse reactions

Warnings and precautions

Storage and handling

Into

Fair Balance Statement

Dosage and Administration

Training

Medical letters

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Common content

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Share content

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Issues

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Issues

Content is stored in monolithic documents in multiple systems

The content is created, recreated and recreated over and over again for multiple documents

Content is copied and pasted, or copied and pasted and rewritten

Changes aren’t reflected across documents

The further the content gets from clinical, the greater the level of variation

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Manufacture our contentlike we manufacture our product

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Manufacturing consists of

Product Content

Component parts/ingredients Content components (text, graphics, tables)

Assembled in a defined way Consistently structured content and documents

Using repeatable processes

For a consistent outcome

With consistent quality Content is the same wherever it appears

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Good Manufacturing Processes

Product Content

Processes are clearly defined and controlled

Rigorous workflow

Any changes are evaluated Content that is reused is locked; changes must be approved. Not all documents will use/reuse the changed component(s).

Complete history of a batch can be traced Every component is versioned. A complete audit trail of changes/reviews/approvals is available.

Complaints and quality defects are investigated

Issues with content can be reviewed. Changes in one can be automatically reflected in all.

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Following content through documents

Content is often written a specific way for inclusion in a specific document. The content may not always apply in subsequent documents:

Too long/short

Different focus

Different Health Authority requirement

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Content can be identical

Refined

Package Insert

Fair Balance Statement

Standardized content

Statements

Regulatory content

Corporate information

Presentations/training

Refined content reformatted for display

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Identical vs. derivative

Identically reuse content where possible While identical content in all outputs is desirable it isn’t always

possible due to Health Authority feedback, different document purposes

Derivatively reuse content when necessary Content is reused then a variation on the source is created

(derivative) A relationship exists between source and derivative, when the

source changes the creator/owner of the derivative is notified of the change

The creator/owner can choose to incorporate the changes or not Complete audit trail of changes and derivatives Authors can only reuse source not derivatives unless the derivative

is promoted to alternate source (e.g., common regions)

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Assess variations (derivatives)

When authors write in isolation content varies

When authors work together, common content that does not compromise the quality or the message of the content can be created more often than you think

When a derivative is necessary, create the derivative then reuse it as much as possible

Fair Balance Statement

Presentation versions of content

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Where/how to start

Pick a content area:

Clinical

Labeling

Promotional

Create good content processes

Create consistently structured and written reusable components

Define standardized document structures

Manage the content through rigorous workflow

Manage change

When the first area is under control expand control into another area, merging content sources into a unified whole over time

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Summary

Pharmaceutical organizations:

Create massive amounts of content in multiple areas and stored in multiple systems

Content is recreated and recreated, or copied and pasted into diverging content streams

Manufacture content like you do product

Consistently written and structured content for reuse

Rigorously controlled for quality and consistency

Choose an area to control first then select another area to incorporate based on content that is reused from area to area

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Additional resources

Whitepaper: Challenges in Creating, Managing, and Delivering Pharmaceutical Content (moreinfo@rockley.com)

Whitepaper: Addressing the Challenges of Pharmaceutical Content (coming soon, moreinfo@rockley.com)

Book: Managing Enterprise Content: A Unified Content Strategy (Amazon, Barnes & Noble)

You can watch this webinar with Ann Rockley on the BrightTalk Channel at:

https://www.brighttalk.com/webcast/9273/146095