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Isaiah Campbell
Landscape Changes


    DDMAC                                       OPDP
Key landscape questions
• What’s your approval process? Can you report against it, or take
  action?
• Who handles your marketing submissions today?
• More than just a name change?
• More compliance enforcement budget $ means more teeth?
• New hurdles for prescription and direct to consumer products?
• New rules for social media and internet?
• What does this mean for new product, indications or our legacy?
Current Landscape Intelligence

More enforcement and compliance info
 requests
 Do you have the process, workflows, and data
DAM a key part of your brand integrity strategy
 You’re probably doing this today with other tools
  such as Zinc
Position yourself to be successful
 Know what you’ll need to scale across current /
  future or acquired brands
Maturity – Detail View
                                                                                         Short Term
                                  • Centralized area with all graphics, video and other media.
                                  • Enable Search, Taxonomy, and Keywords.
        Asset Management          • Cost savings by sharing assets among brands and agencies.
                                  • Extended data attributes support better management of assets with insight into
   (Brand Management, Agencies)     expiration, royalties and license terms.
                                  • External collaboration between parties.



                                                                                        Intermediate
                                  • Standard workflow process for design, submission and approval of Marketing
        Marketing Material          Materials which contain a medical claim or other regulated messages.
   Review & Approval Workflow     • Each brand has its own workspace (SharePoint site collections)
                                  • Material can be PDF, Video, Graphic, etc.
   (Brand Management, Agencies,   • Work items for agencies are initiated in SharePoint or via InfoPath. Agencies
                                    work with brand to submit material for review/approval by participant who
        Medical Information)        verifies medical claims.


                                                                                          Long Term
                                  • Separate SharePoint Web Application > partitioned from rest of farm.
                                  • Approved materials moved via custom workflow action with select group of meta data,
       Compliance Archive           versions.
                                  • Searchable database of all approved marketing materials by product, graphics, etc.
        (Legal, Regulatory)       • Can be configured to assemble and push supporting materials to other systems
                                    including FDA.
                                  • Discoverable archive preserved for legal and regulatory purposes.
Maturity Model – Simple View
    Asset Management                            Review and Approval                     Compliance Datamart




•   Centralized assets (graphics, video, etc)   • Workflow for design, approval and      •   Approved materials tracker
•   Search, Taxonomy and Metadata                 internal approval of medical claims    •   Search and reports on datamart
•   Asset re-use and asset intelligence         • Brand workspaces (optional)            •   Push to 3rd parties (IE Zinc MAPS)
•   External collaboration                      • Agency collaboration throughout        •   Discoverable and traceable
                                                  lifecycle of work items
What makes you success
  Tracking of approved messages
   Cradle to grave
  Central repository for assets
   Used by agencies in the production of marketing
    materials
  Reduced spend on media licensing and royalties
   sharing already owned assets across agencies/brands
  Build framework to extend the value of assets
   management system for upstream and downstream
    business value including compliance
Where to start with ?

  Digital Asset management
  “quick hits”
   Single area to manage assets with brand
    management and agencies realizes immediate
    productivity gains.
   Assets shared among brands and agencies
    maximize marketing spend for asset licensing
    and approval.
   Taxonomy, keywords all support powerful
    Search capabilities.
   Extended attributes support both reporting on
    license terms and potential to automate asset
    retirement using workflow.
Why align with a larger strategy?

  Intermediate and long term value
   Standard process for working with
    agencies to produce and approve
    marketing material and digital assets.
   Collaborate in the same platform (browser,
    SharePoint)
   Continue to capture data about the
    lifecycle of assets by including in which
    material they are used.
   Build a compliance engine for submission
    of data to FDA; archive these submissions
    electronically for lower cost electronic
    discovery production.
SharePoint and Digital Asset Management


  Life sciences has widely adopted SharePoint
    SharePoint widely used in pharma (you own licenses today).
    Rapid application development on platform lowers complexity.
    Use search for ease of access, finding the right assets.
    Extended asset attribute data is natively supported and aides
     development of lifecycle management tools and workflow.
    Secure external access to collaborate with agencies is
     supported.
    Can be a validated solution.
    Ease of access using web browser, Microsoft Office and Adobe.
    Integration other platforms & systems (Zinc)

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Digital Asset Management in Pharma

  • 2. Landscape Changes DDMAC OPDP Key landscape questions • What’s your approval process? Can you report against it, or take action? • Who handles your marketing submissions today? • More than just a name change? • More compliance enforcement budget $ means more teeth? • New hurdles for prescription and direct to consumer products? • New rules for social media and internet? • What does this mean for new product, indications or our legacy?
  • 3. Current Landscape Intelligence More enforcement and compliance info requests Do you have the process, workflows, and data DAM a key part of your brand integrity strategy You’re probably doing this today with other tools such as Zinc Position yourself to be successful Know what you’ll need to scale across current / future or acquired brands
  • 4. Maturity – Detail View Short Term • Centralized area with all graphics, video and other media. • Enable Search, Taxonomy, and Keywords. Asset Management • Cost savings by sharing assets among brands and agencies. • Extended data attributes support better management of assets with insight into (Brand Management, Agencies) expiration, royalties and license terms. • External collaboration between parties. Intermediate • Standard workflow process for design, submission and approval of Marketing Marketing Material Materials which contain a medical claim or other regulated messages. Review & Approval Workflow • Each brand has its own workspace (SharePoint site collections) • Material can be PDF, Video, Graphic, etc. (Brand Management, Agencies, • Work items for agencies are initiated in SharePoint or via InfoPath. Agencies work with brand to submit material for review/approval by participant who Medical Information) verifies medical claims. Long Term • Separate SharePoint Web Application > partitioned from rest of farm. • Approved materials moved via custom workflow action with select group of meta data, Compliance Archive versions. • Searchable database of all approved marketing materials by product, graphics, etc. (Legal, Regulatory) • Can be configured to assemble and push supporting materials to other systems including FDA. • Discoverable archive preserved for legal and regulatory purposes.
  • 5. Maturity Model – Simple View Asset Management Review and Approval Compliance Datamart • Centralized assets (graphics, video, etc) • Workflow for design, approval and • Approved materials tracker • Search, Taxonomy and Metadata internal approval of medical claims • Search and reports on datamart • Asset re-use and asset intelligence • Brand workspaces (optional) • Push to 3rd parties (IE Zinc MAPS) • External collaboration • Agency collaboration throughout • Discoverable and traceable lifecycle of work items
  • 6. What makes you success Tracking of approved messages Cradle to grave Central repository for assets Used by agencies in the production of marketing materials Reduced spend on media licensing and royalties sharing already owned assets across agencies/brands Build framework to extend the value of assets management system for upstream and downstream business value including compliance
  • 7. Where to start with ?  Digital Asset management “quick hits”  Single area to manage assets with brand management and agencies realizes immediate productivity gains.  Assets shared among brands and agencies maximize marketing spend for asset licensing and approval.  Taxonomy, keywords all support powerful Search capabilities.  Extended attributes support both reporting on license terms and potential to automate asset retirement using workflow.
  • 8. Why align with a larger strategy?  Intermediate and long term value  Standard process for working with agencies to produce and approve marketing material and digital assets.  Collaborate in the same platform (browser, SharePoint)  Continue to capture data about the lifecycle of assets by including in which material they are used.  Build a compliance engine for submission of data to FDA; archive these submissions electronically for lower cost electronic discovery production.
  • 9. SharePoint and Digital Asset Management  Life sciences has widely adopted SharePoint  SharePoint widely used in pharma (you own licenses today).  Rapid application development on platform lowers complexity.  Use search for ease of access, finding the right assets.  Extended asset attribute data is natively supported and aides development of lifecycle management tools and workflow.  Secure external access to collaborate with agencies is supported.  Can be a validated solution.  Ease of access using web browser, Microsoft Office and Adobe.  Integration other platforms & systems (Zinc)