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Scientific Publications Strategy- Managing Reputation, Clinical Trial Results and Commercial Relevance Report Summary


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Over the past few years, scientific journals and government regulators have increased the scrutiny and expectations facing pharmaceutical companies looking to publish the results of their clinical trials. While picking and choosing favorable findings may have been acceptable a decade ago, it is now considered unethical and potentially illegal. As a result of these changing expectations and regulations, global publications leaders at pharmaceutical companies are carefully building strategies that ethically present all study findings while still driving brand strength. Scientific publications are an essential tool for both clinical and commercial purposes, as they are intended to influence the target audience by raising both awareness of the disease and awareness of a company’s product. In the changing world of publications, it is vital that companies produce publications that are not only compelling, but are also in compliance with new transparency guidelines. This report, “Scientific Publications Strategy: Managing Reputation, Clinical Trial Results, and Commercial Relevance,” provides directors and managers with the research and understanding to produce effective clinical publications that possess commercial relevance.
This study identifies trends and new ways of thinking in the ways in which pharmaceutical and biotechnology companies approach global publication activities and supplies benchmarks for plan delivery outsourcing, as well as key contributors to the development of strategy and planning and the effects of the changing publications industry on journal emphasis.

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Scientific Publications Strategy- Managing Reputation, Clinical Trial Results and Commercial Relevance Report Summary

  1. 1. Scientific Publications Strategy: Managing Reputation, Clinical Trial Results and Commercial Relevance Best Practices, LLC Benchmarking Report
  2. 2. Table of Contents PageINTRODUCTION 4• Project Methodology and Study Objective 5SUMMARY OF KEY INSIGHTS 6-14UNIVERSE OF LEARNING 15• List of Participating Companies 16• Range of Career Levels Lend Insight 17• Regional Representation 18• Functional Representation 19• Those Who Work for Publications Mostly Have Ph.D. 20• Respondents Serve Various Therapeutic Areas in Publication Function 21• Current Role With Regards To Publication 22• Mostly Vice President Oversee Publication Function 23GLOBAL PUBLICATION ORGANISATION 24• Publication Function Is A Part Of Medical Affairs Group 25• Publication Strategy Shifting To Hybrid Structure 26• Strategy Responsibility 27• Publications Planning Shifting To Hybrid Structure 28• Planning Responsibility 29• Centralized Structure Followed for Publications Plan Delivery 30• Plan Delivery Responsibility 31• Medical Directors Mainly Contribute to Strategy & Plan 32• Other Strategy Contributors 33• Successful Communication Tactics 34• Top Tactics Used to Communicate Publication Strategy 35
  3. 3. Table of Contents Page• Regional Empowerment 36• Alignment Between the Regional & Global Plans 37•Plan Delivery Outsourcing 38• FTEs in Publication Function 39• Percent Publications FTEs Outsourced 40• Tasks Outsourced by Publication Group 41-43PUBLICATION STRATEGIES BY PRODUCT 44• Most Effective Publication Vehicle in Early Development 45• Most Effective Publication Vehicle in Phase III-Submission 46• Most Effective Publication Vehicle in Launch-Post-Launch 47• Most Effective Content Type in Early Development 48• Most Effective Content Type in Phase III-Submission 49• Most Effective Content Type in Launch-Post-Launch 50• Most Important Target Audience in Early Development 51• Most Important Target Audience in Phase III-Submission 52• Most Important Target Audience in Launch-Post-Launch 53• Publications Outlet Focus 54-56• Development of Publishing Strategy 57• Stage of Publishing First Abstract & Manuscript 58• Last Stage When Publication Function is Active 59• Publication Produced 60• Abstracts Produced 61• Number of Manuscripts Planned, Produced & Published 62• Number of Publications Issued 63-64
  4. 4. Table of Contents Page• Mix of Papers Appearing 65MEASURING THE EFFECTIVENESS OF PUBLICATION STRATEGY ACTIVITIES 66 Performance Measures 67-68 Paper Acceptance Most Important Measure of Effectiveness 69 Primary Journals Highly Important for Publishing Clinical Results 70MANAGING WITHIN A CHANGING PUBLICATION ENVIRONMENT 71• Planning Neutral or Negative Results 72• Process for Publishing Neutral and Negative Results 73• Increased Emphasis on Regional-Peer Reviewed Journals 74• Emphasis on E-journals Will Decline 75• Increased Importance of Review Articles Over Next Three Years 76• Other Changes Implemented for Publication Excellence 77 PUBLICATION BUDGET 78• Budget Allocated 79• Allocation of Publication Budget in Various Activities 80• Medical Affairs Funds Publication Budget 81• Factors Affecting Publication Budget 82PUBLICATION BEST PRACTICES 83• Top Best Practices for Publication Effectiveness 84• Top Challenges 85• Best Practices for Implementing Successful Scientific Publication Strategy 86
  5. 5. Project Methodology and Study ObjectivesGlobal publications are under the microscope with calls for improved transparency and data disclosure.Due to this, global publications leaders find themselves in a balancing act—needing to ensure bothscientific credibility and commercial viability. This study investigates the impact of industry and corporatetransparency policies on the operation of publication function at Pharma/Biotech Companies. The study sought to identify best practices that publications groups use successfully today to build scientific credibility and commercial success. Key study objectives Optimal structure for the global publications function Transition of global pub function from commercial to clinical Key internal stakeholders who contribute to publications strategy Tactics for handling publication of neutral or negative clinical trial results Impact of transparency guidelines on publications, planning and delivery Strategy changes for the new marketplaceCopyright © Best Practices®, LLC 4
  6. 6. Summary of Key Insights
  7. 7. Key Findings (Samples) The following key findings and insights emerged from the field surveys, direct interviews and study verbatim. Global Peer-reviewed Publications Most Effective Publication Vehicle During Phase III & Post Launch: Relative to 2007, the rating of global peer- reviewed publication “as most effective vehicle” has dropped by 46%. Consequently, an equal 46% of benchmark partners consider global peer- reviewed publication as most effective during phase-III and post launch. Relative to 2007, during early product development phases 20% of respondents consider specialty journals as most effective vehicle, while during phase-III 27% lesser benchmark class partners deem specialty journals as most effective vehicle for publication. Benchmark Class Spilt on Structure of Publication Plan Delivery: Relative to 2007, 41% of benchmark class have a centralized structure for Publication Plan delivery in 2011. However, overall the benchmark class is split on the way Publication Plan Delivery is structured. Moreover, as compared to 2007, the responsibility of Global Publication Director has shifted to regional Publication Director for Plan Delivery. In fact, at 25% of Benchmarked organizations regional Publication Director has the ultimate responsibility for Plan Delivery.Copyright © Best Practices®, LLC 6
  8. 8. Universe of Learning
  9. 9. List of Participating CompaniesThe benchmark class includes 17 participants from 16 companies across thepharmaceutical, biotech and medical device industries. 2011 2009 Alkermes Abbott Astellas Pharma Global Amgen Development AstraZeneca Baxter BioScience Becton Dickinson BD Biosciences (formerly Merck) Boehringer Ingelheim Biogen Idec Cephalon Inc BMS Epigenomics Eli Lilly and Company Ethicon Inc. Genentech, Inc. GlaxoSmithKline GlaxoSmithKline Human Genome Human Genome Sciences, Inc. Sciences, Inc. Janssen Global Merck Services, LLC NPS Pharmaceuticals Lundbeck Inc. Pfizer Novartis Vaccines and Shire Pharmaceuticals Diagnostics Vertex Novo Nordisk Inc. Pharmaceuticals Theravance, Inc. URLCopyright © Best Practices®, LLC 8
  10. 10. Range of Career Levels Lend Insight Research participants’ roles ranged from senior leaders to managers of medical affairs, Publications and Communications. 2011 2009 Director Global Director, Publications Head Global Publications Group Manager, Publication Planning Senior Medical Writer Senior Product Manager, Strategic Medical Director Marketing Publications Manager Senior Director, Global Health Economics Senior Director, Medical Communications Manager, Global Commercial Strategy VP, Strategic & Commercial Planning Associate Director, Medical Affairs Medical Science Liaison Vice President, Scientific Publications Product Manager Senior Product Manager, Global Medical Publishing VP Director, Global Brand Strategy Associate Director Senior Director, Medical Communications Manager, Global Medical Affairs Team Leader, Scientific Communications Director, Publications Director, Publications Management Team Medical Publications Lead Executive Director, Medical Head Global Scientific Affairs Communications Director, Medical Communications Director, Marketing Director, Global Medical Affairs Executive Director, Medical CommunicationsCopyright © Best Practices®, LLC 9
  11. 11. Respondents Serve Various Therapeutic Areas Almost half of benchmark participants either served the therapeutic areas of central nervous system (CNS) or immunology. Another 41% work said they work with oncology groups. Please specify the therapeutic area(s) you serve in the scientific publication department. (Check all that apply.) • Womens health, wound closure, homeostasis, aesthetic surgery, ENT surgery, Pain medicine, GI, Anti-infective 47% 47% • Infectious disease, critical care; inflammatory 41% neuropathy, dermatology, urology, vaccines 41% 24% 24% 18% 12% CNS Immunology Oncology Cardio- Respiratory Diabetes Hema- Others N2011=17 vascular tologyCopyright © Best Practices®, LLC 10
  12. 12. Six 6 FTEs Work in Scientific Publications, onAverageThere is only slight variance between the mean and median FTEs that work withinScientific Publications, with a mean of 6 and a median of 5. One company said it had 15FTEs within its Scientific Publications function in 2011. How many FTEs work within your scientific Publications Function? 15 8 6 5 2 1 Max 75th Mean Median 25th Min Percentile Percentile N2011=13Copyright © Best Practices®, LLC 11
  13. 13. Vice President Oversees Publication Function Senior management is actively involved in overseeing publication function. Vice presidents oversee the publication function at 53% of the benchmark organizations. More than 75% of the vice presidents report to medical affairs group. Who oversees your Publications function? Assistant Director, 6% Director, Other , 18% 24% • Senior Director • Head Global Scientific Affairs Vice President, 53% N2011=17Copyright © Best Practices®, LLC 12
  14. 14. About Best Practices, LLC Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 © Best Practices®, LLC 13