Publication Planning:
The Role of The Freelance
Writer
Tania Dickson, PhD
Medical Director
Carus Clinical Communications, an Elsevier business
Audience Questions
1.
Have you seen a completed pub plan?
2.
Have you developed a pub plan?
3.
What was your involvement?
a)
b)
c)
Scribe
Gap analysis article reviewer and writer
Intellectual contributor for significant portions of pub
plan content
Driving Force Behind Publication Planning

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Maximize dissemination of research data
Ensure research is clearly communicated and messages
are consistent
Differentiate product from competitors
Increase product market share
Single source describing all publication (non-CME)
activities
Strategic Approach

Consider both clinical and marketing initiatives

Product life cycle

Market and competitor activity

Content and process
Optimizing the Effectiveness of Publication
Planning… It’s All About the Timing
Launch
Strategy
Development
Strategy
refinement
and
tactical
development
Patent Expiry
Tactical development and
delivery with periodic
strategic re-evaluation
Publication
wind-down
Anatomy of a Publication Plan
Gap analysis
Message Testing
Advisory Board
Findings
Product Strengths
Product Weaknesses
CLINICAL DATA
Situation Analysis
Market Research
Treatment Guidelines
SWOT
Market Opportunities
Market Threats
Communication Imperatives
WHAT ISSUES
NEED TO BE
ADDRESSED
Communication Messages
MESSAGES TO
ADDRESS
THE ISSUES
Sample Table of Contents
1.0 EXECUTIVE SUMMARY
2.0 COMPETITOR PUBLICATION ANALYSIS (GAP) SUMMARY
2.1 Product
2.2 Competitor A
2.3 Competitor B
3.0 CLINICAL DEVELOPMENT PLAN FOR PRODUCT
3.1 Introduction
3.2 Completed Clinical Studies
3.3 Ongoing Clinical Studies
3.4 Planned Clinical Studies
3.5 XXXX Proposed Clinical Studies
4.0 SWOT ANALYSIS FOR PRODUCT
4.1 Strengths
4.2 Weaknesses
4.3 Opportunities
4.4 Threats
5.0 TARGET AUDIENCES, JOURNALS, AND MEETINGS
6.0 MARKET ANALYSIS
7.0 PRODUCT COMMUNICATION IMPERATIVES
8.0 KEY COMMUNICATION MESSAGES FOR PRODUCT
9.0 PRODUCT STRATEGIES AND TACTICS
Gap Analysis
In-depth Gap Analyses….

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Regular gap analyses are crucial for evaluating
strategy and tactics from early to late in a
product’s lifecycle
Identify areas where an increase in drug
publication activity is required
Measure the current publication performance of
a drug against it’s competitors
Evaluate gaps in a drug’s publication portfolio
Determine whether maximal publication use has
been made of available clinical data
Gap Analysis How To…

Rule #1— Are we all on the same page?
 Define
search strings
 Define timeframe
 Define competitors
 Define manuscript types
 Define patient populations
 Define study types
 Identify key messages for analysis
 Regroup, reassess, and confirm for consistency
Gap Analysis How To…
Audience Question
1. Primary study endpoint: time to doubling of
serum creatinine
2. Secondary study endpoint: time to first
cardiovascular morbidity or mortality event
3. Tertiary study endpoint: health economic
benefit of product X in this patient population

Primary or secondary or health economic
article?
Anatomy of a Gap Analysis

Number of pubs per year
Number of pubs by target audience
Number of pubs by article type
Number of pubs by journal
Number of pubs by message
Permutations of above
Journals used

What does this mean to product X?


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Tips for Gap Analyses

Communication is imperative
 Ask
lots of questions when you start
 Have they done these types of analyses before?
 Are there SOPs?
 What are the agency’s expectations for your
involvement
 Who is responsible for what deliverables
 Timing of deliverables
 Ask questions while you’re working through the
materials ASAP
Abstracts versus full manuscript review….

In Dr. T’s opinion….
 Review
articles MUST be reviewed in full
 Abstracts of review articles rarely cover all
messages included in the review article
 Clinical/data-driven
manuscripts
 Preference is to review full manuscript
Clinical Development Plan
Tips for Preparing the Clinical Development Plan

Repository of clinical data available for dissemination

Sources:


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
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
Client
Product website
www.clinicaltrials.gov
World Health Organization Clinical Trial registry
http://www.who.int/trialsearch/Default.aspx
Current Controlled Trials registry http://www.controlled-trials.com
International Federation of Pharmaceutical Manufacturers and
Associations clinical trial registry http://clinicaltrials-dev.ifpma.org
Key Communication
Messages
Key Communication Messages



MUST be based on clinical/scientific fact
Small number of core messages with more
detailed sub-messages as necessary
Messages should be consistent across
indications, formulations, and within franchises
Communicating the Right Messages to Ensure
Strategic Success



Define primary and secondary messages that
will promote strategic imperatives
Critically assess the data pool—align with
messages
Identify message gaps
 Messages
without supporting data
Type of messages:




Disease state/burden of disease
Mechanism of action
PK/PD/Metabolism/Drug-drug interactions
Efficacy
 Morbidity
 Mortality



Safety
Health economic
Quality of life
Tactical Recommendations
Types of Tactical Recommendations

Data-driven




Reviews




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Abstracts
Primary manuscripts
Post hoc analyses
 Hypothesis testing
 Disease awareness
 Subpopulations
Scene-setting (pre launch)
Product specific (pre and post launch)
Monographs
Custom publications
Advisory board/consensus meeting practical use
guidelines
Journal Selection Process
Tier
Impact factor
versus
Budget
Timing
Timing to citability
Reprint availability
Reach
Rejection rate
Regulatory
Author
influence
Other distribution
= Review articles
= Supplements
= Journal clubs
= Reprint carriers
Summary

Freelance writers are an important team
member and can support publication planning in
a variety of ways:
 Writing
support
 Review, analysis, and documentation support
 Strategic/tactical support

Communication is key to an effective working
relationship