Management of Life Science Promotional Material
Transcript of Management of Life Science Promotional Material
Promotional Materials - Business Process and Technology
Dirk K Beth
CEO, Mission3
October 10th – 8:30 – 10:00
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
2www.diahome.orgDrug Information Association
Promotional Material Defined
PromotionMeans any activity undertaken, organized or sponsored by a member company which is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all methods of communications, including the internet.
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IFPMA (International Federation of Pharmaceutical Manufacturers – Code of Practice
Consistency of Product InformationIt is understood that national laws and regulations usually dictate the format and content of the product information communicated on labeling, packaging, leaflets, data sheets and in all promotional material. Promotion should not be inconsistent with locally approved product information. Respecting the requirement that promotion should be consistent with the label and approved uses locally, healthcare professionals in developing countries should have access to similar data to those being communicated in developed countries.
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Accurate and Not MisleadingPromotional information should be clear, legible, accurate, balanced, fair, and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission or in any other way. Every effort should be made to avoid ambiguity. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. Descriptions such as “safe” and “no side effects” should generally be avoided and should always be adequately qualified.
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Substantiation Promotion should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry.
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The Challenge
Promotion is marketing
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Audio
Book
Carrier
Carton
Catalog
CD-ROM
Direct Mail
Drug Sample
Exhibit
File Card
Form Econ
Form Kit
Giveaway
House Organ
Kit
Monograph
Other
Press Release
Print Ad
Print Other
Promotional Labeling
Radio
Reply Card
Reprint
Sales Aid
Promotional Slides
Telephone
TV
Video News Release
Video
www-banner
www-ecomm
www-links
www-other
www-soc-med
www-website
www-video
www-mobile
Controlling the conversationStaying on message
– The marketing message – The “accurate product and therapeutic
benefit” message
Primarily when that message changes
38,000 pieces in 2000
79,000 pieces in 20101. Decrease in the number of sales
representatives pounding the pavement from an all-time high of 100,000+ in 2006
2. Proliferation of new communications channels
3. Significant shift in the way that people prefer to consume information.
Just hitting stride of social media
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Costs of promotional materials
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Processes and costs related to management of promotional materials
Technology and resources that can reduce time and cost of promotional materials management
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• “Medical is increasingly spending time reviewing promotional materials”– While spending less time on other activities vs
the previous yearBonk et al
Cost of managing promotional materials
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eCTD - Promotional Material Types
Audio
Book
Carrier
Carton
Catalog
CD-ROM
Direct Mail
Drug Sample
Exhibit
File Card
Form Econ
Form Kit
Giveaway
House Organ
Kit
Monograph
Other
Press Release
Print Ad
Print Other
Promotional Labeling
Radio
Reply Card
Reprint
Sales Aid
Promotional Slides
Telephone
TV
Video News Release
Video
www-banner
www-ecomm
www-links
www-other
www-soc-med
www-website
www-video
www-mobile
Document / Digital Asset Management
Media Production Software
Collaboration
Workflow
Claims Repository / Archive
eCTD Submission Management Solution
Regulatory Information Management Solution
Marketing and Sales Analytics
Website &Web Content Management
Project Management
Regulatory
Marketing (internal)
Marketing (external)
Sales
Medical
Legal
Executive Management
R&D
Health Authorities
Patients
Prescribers
10 1000s100s
100s
½ Million Review Touch Points
Millions of Records
10s of Millions of External Exposures
Review
Review
Review
Execution of process
Create
ReviewMedical
ReviewMarketing
ReviewRegulatory
Approve
Submit eCTD or Media
Organizational structure
• Campaign Oriented Projects– Product– Market– Release Date– Media format
Technology to Optimize Promotional Materials Management
Promotional Materials Management technology• Reduce time to reviewed and approved materials by tracking every
item through every step• Reduce costs associated with interactions with outside agencies,
such as courier costs• Improve quality and compliance by ensuring processes and
association of current supporting materials • Collect process metrics and improve the total process time through
application of business intelligence• Collaboration internally and externally ensures faster and fewer
cycles• Electronic submission enablement• Management of all media types
How does technology help
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Promotional Materials
Document Management Media
Production Software
Collaboration
Workflow
Claims RepositoryeCTD
Submission Management
Solution
Regulatory Information
Management Solution
Marketing and Sales Analytics
Project Management
Website and Web Content Management
Systems associated with Promotional Materials Management (not necessarily discreet systems)
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• Metadata management– Submission Required– Release dates– Media outlet targets– Budget
• Version control– Manage development
and approved versions– Manage change
• Workflow– Route – Review– Approve– Submit
• Where Used– Track one to many
uses of materials thus track back to claims etc
• Referential Integrity
Document Management Capabilities and Requirements
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• eCTD submission capability– Latest US regional
XML support (and support within the interface)
– Ability to support file types supported by the FDA
• Outside of the eCTD– Pieces must be
developed to adequately communicate to the reviewer
• See all sides of a 3D piece
• Be able to open video format
• Provide links directly to reference material
Submission Management Requirements
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Full eCTD and Non-eCTD submission support
• New FDA Module 1 supports Promotional Materials– Support for Audience
• Consumer• Professional
– Promotional Material DocType• Promotional 2253• Request For Advisory Launch• Request For Advisory Non-Launch• Presubmission Accelerated Launch• Presubmission Accelerated Non-launch• Promotional 503b
eCTD - Promotional Material Types
Audio
Book
Carrier
Carton
Catalog
CD-ROM
Direct Mail
Drug Sample
Exhibit
File Card
Form Econ
Form Kit
Giveaway
House Organ
Kit
Monograph
Other
Press Release
Print Ad
Print Other
Promotional Labeling
Radio
Reply Card
Reprint
Sales Aid
Promotional Slides
Telephone
TV
Video News Release
Video
www-banner
www-ecomm
www-links
www-other
www-soc-med
www-website
www-video
www-mobile
• MPEG-2-HD (High Definition Video)• WMV-HD (High Definition Video)• DVD-VR• DVD+VR• DVD-Video• Mini-DVD• CD-R and CD-RW• VHS
• Please Note: the following file formats are acceptable:– .iso files– Audio_ts/video_ts folders that include the following formats:
• .bup• .ifo• .vob
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Endpoints
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Released Source
Use locally
Instance Instance
Instance Instance
InstanceInstance
Instance
Use Locally
InstanceInstance
Instance
InstanceInstance
Instance
Use LocallyInstance Instance
Instance
Upstream• Review• Approval• Release
• Review• Approval• Release
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Dirk’s Contact Info
Drug Information Association www.diahome.org
Dirk Karsten Beth | Chief Executive Officer | Mission3, Inc.
@dirkbeth
@regtrack
Group: Registration Tracking
www.mission3.com