Publication Planning:The Role of The Freelance Writer

Tania Dickson, PhDMedical 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) Scribe

b) Gap analysis article reviewer and writer

c) Intellectual contributor for significant portions of pub plan content

Driving Force Behind Publication Planning

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

Launch Patent Expiry

StrategyDevelopment

Strategyrefinementand tactical development

Tactical development and delivery with periodic

strategic re-evaluation

Publicationwind-down

Optimizing the Effectiveness of Publication Planning… It’s All About the Timing

Anatomy of a Publication Plan

Market ResearchGap analysis

Advisory BoardFindings

Situation Analysis

SWOT

Communication Imperatives

Communication Messages

Product StrengthsProduct Weaknesses

Treatment GuidelinesMessage Testing

Market OpportunitiesMarket Threats

WHAT ISSUES NEED TO BE ADDRESSED

MESSAGES TO ADDRESS THE ISSUES

CLINICAL DATA

Sample Table of Contents1.0 EXECUTIVE SUMMARY2.0 COMPETITOR PUBLICATION ANALYSIS (GAP) SUMMARY

2.1 Product2.2 Competitor A2.3 Competitor B

3.0 CLINICAL DEVELOPMENT PLAN FOR PRODUCT3.1 Introduction3.2 Completed Clinical Studies3.3 Ongoing Clinical Studies3.4 Planned Clinical Studies3.5 XXXX Proposed Clinical Studies

4.0 SWOT ANALYSIS FOR PRODUCT4.1 Strengths4.2 Weaknesses4.3 Opportunities4.4 Threats

5.0 TARGET AUDIENCES, JOURNALS, AND MEETINGS6.0 MARKET ANALYSIS 7.0 PRODUCT COMMUNICATION IMPERATIVES8.0 KEY COMMUNICATION MESSAGES FOR PRODUCT 9.0 PRODUCT STRATEGIES AND TACTICS

Gap Analysis

In-depth Gap Analyses….

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?

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: 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

Abstracts Primary manuscripts Post hoc analyses

Hypothesis testing Disease awareness Subpopulations

Reviews Scene-setting (pre launch) Product specific (pre and post launch)

Monographs Custom publications Advisory board/consensus meeting practical use

guidelines

Timing to citability

Reprint availability

Other distribution

Tier Timing

Journal Selection Process

Author influence

Regulatory

= Review articles= Supplements= Journal clubs= Reprint carriers

Budget

versus

Impact factor

Reach

Rejection rate

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