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.

Drug Information Association www.diahome.org 4

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.


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.


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.


The Challenge

Promotion is marketing


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


Costs of promotional materials



Processes and costs related to management of promotional materials

Technology and resources that can reduce time and cost of promotional materials management

Drug Information Associationwww.diahome.org 13

• “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


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


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


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)


• 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


• 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


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


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


Endpoints


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

27

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

[email protected]

Date post:	06-May-2015
Category:	Business
Upload:	dirkbeth
View:	1,913 times
Download:	1 times