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

• Centralized area with all graphics, video and other media.

• Enable Search, Taxonomy, and Keywords.

• Cost savings by sharing assets among brands and agencies.

• Extended data attributes support better management of assets with insight into expiration, royalties and license terms.

• External collaboration between parties.

Asset Management

(Brand Management, Agencies)

•Standard workflow process for design, submission and approval of Marketing Materials which contain a medical claim or other regulated messages.

•Each brand has its own workspace (SharePoint site collections)

•Material can be PDF, Video, Graphic, etc.

•Work items for agencies are initiated in SharePoint or via InfoPath. Agencies work with brand to submit material for review/approval by participant who verifies medical claims.

Marketing Material

Review & Approval Workflow

(Brand Management, Agencies,

Medical Information)

• Separate SharePoint Web Application > partitioned from rest of farm.

• Approved materials moved via custom workflow action with select group of meta data, versions.

• Searchable database of all approved marketing materials by product, graphics, etc.

• Can be configured to assemble and push supporting materials to other systems including FDA.

• Discoverable archive preserved for legal and regulatory purposes.

Compliance Archive

(Legal, Regulatory)

Short Term

Intermediate

Long Term

Maturity Model – Simple View

Asset Management Review and Approval Compliance Datamart

• Centralized assets (graphics, video, etc)

• Search, Taxonomy and Metadata

• Asset re-use and asset intelligence

• External collaboration

• Workflow for design, approval and

internal approval of medical claims

• Brand workspaces (optional)

• Agency collaboration throughout

lifecycle of work items

• Approved materials tracker

• Search and reports on datamart

• Push to 3rd parties (IE Zinc MAPS)

• Discoverable and traceable

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)