1. Publication Planning: The Role of The Freelance Writer Tania Dickson, PhD Medical Director Carus Clinical Communications, an Elsevier business

2. 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

3. 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

4. Strategic Approach Consider both clinical and marketing initiatives Product life cycle Market and competitor activity Content and process

5. LaunchPatent Expiry Strategy Development Strategy refinement and tactical development Tactical development and delivery with periodic strategic re-evaluation Publication wind-down Optimizing the Effectiveness of Publication Planning… It’s All About the Timing

6. Anatomy of a Publication Plan Market Research Gap analysis Advisory Board Findings Situation Analysis SWOT Communication Imperatives Communication Messages Product Strengths Product Weaknesses Treatment Guidelines Message Testing Market Opportunities Market Threats WHAT ISSUES NEED TO BE ADDRESSED MESSAGES TO ADDRESS THE ISSUES CLINICAL DATA

7. 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

8. Gap Analysis

9. 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

10. 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

11. 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?

12. 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?

13. 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

14. 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

15. Clinical Development Plan

16. Tips for Preparing the Clinical Development Plan Repository of clinical data available for dissemination Sources:  Client  Product website  www.clinicaltrials.gov www.clinicaltrials.gov  World Health Organization Clinical Trial registry http://www.who.int/trialsearch/Default.aspx http://www.who.int/trialsearch/Default.aspx  Current Controlled Trials registry http://www.controlled-trials.comhttp://www.controlled-trials.com  International Federation of Pharmaceutical Manufacturers and Associations clinical trial registry http://clinicaltrials-dev.ifpma.orghttp://clinicaltrials-dev.ifpma.org

17. Key Communication Messages

18. 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

19. 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

20. 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

21. Tactical Recommendations

22. 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

23. Timing to citability Reprint availability Other distribution TierTiming Journal Selection Process Author influence Regulatory = Review articles = Supplements = Journal clubs = Reprint carriers Budget versus Impact factor Reach Rejection rate

24. Summary

25. 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