scientific publication strategy

Scientific Publications Strategy: Managing Reputation, Clinical Trial Results and

Commercial Relevance

Best Practices, LLC Benchmarking Report

Page INTRODUCTION 4

• Project Methodology and Study Objective 5

SUMMARY OF KEY INSIGHTS 6-14 UNIVERSE 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 23

GLOBAL 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

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 41-43

PUBLICATION 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

Table of Contents

Page• Mix of Papers Appearing 65

MEASURING THE EFFECTIVENESS OF PUBLICATION STRATEGY ACTIVITIES 66 Performance Measures 67-68 Paper Acceptance Most Important Measure of Effectiveness 69Primary Journals Highly Important for Publishing Clinical Results 70

MANAGING 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 82

PUBLICATION BEST PRACTICES 83• Top Best Practices for Publication Effectiveness 84

• Top Challenges 85

• Best Practices for Implementing Successful Scientific Publication Strategy 86

Table of Contents

Copyright © Best Practices®, LLC 5

Project Methodology and Study Objectives

The study sought to identify best practices that publications groups use successfully today to build scientific credibility and commercial success.

Key study objectivesOptimal 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 marketplace

Global 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 both scientific credibility and commercial viability. This study investigates the impact of industry and corporate transparency policies on the operation of publication function at Pharma/Biotech Companies.

Summary of Key Insights


Key Findings (Samples)

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.

The following key findings and insights emerged from the field surveys, direct interviews and study verbatim.

Universe of Learning


List of Participating Companies

The benchmark class includes 17 participants from 16 companies across the pharmaceutical, biotech and medical device industries.

Abbott Amgen AstraZeneca Becton Dickinson

(formerly Merck) Biogen Idec BMS Eli Lilly and Company Genentech, Inc. GlaxoSmithKline Human Genome

Sciences, Inc. Merck NPS Pharmaceuticals Pfizer Shire Pharmaceuticals Vertex

Pharmaceuticals

2011 2009

Alkermes Astellas Pharma Global

Development Baxter BioScience BD Biosciences Boehringer Ingelheim Cephalon Inc Epigenomics Ethicon Inc. GlaxoSmithKline Human Genome

Sciences, Inc. Janssen Global

Services, LLC Lundbeck Inc. Novartis Vaccines and

Diagnostics Novo Nordisk Inc. Theravance, Inc. URL


Range of Career Levels Lend Insight

Research participants’ roles ranged from senior leaders to managers of medical affairs, Publications and Communications.

Director Head Global Publications Senior Medical Writer Medical Director Publications Manager Senior Director, Medical Communications VP, Strategic & Commercial Planning Medical Science Liaison Product Manager VP Associate Director Manager, Global Medical Affairs Director, Publications Medical Publications Lead Head Global Scientific Affairs Director, Medical Communications Director, Global Medical Affairs

Global Director, Publications Group Manager, Publication Planning Senior Product Manager, Strategic

Marketing Senior Director, Global Health Economics Manager, Global Commercial Strategy Associate Director, Medical Affairs Vice President, Scientific Publications Senior Product Manager, Global Medical

Publishing Director, Global Brand Strategy Senior Director, Medical Communications Team Leader, Scientific Communications Director, Publications Management Team Executive Director, Medical

Communications Director, Marketing Executive Director, Medical

Communications

2011 20092011


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.

47% 47%

41%

24% 24%

18%

12%

41%

CNS Immunology Oncology Cardio-vascular

Respiratory Diabetes Hema-tology

Others

N2011=17

• Women's health, wound closure, homeostasis, aesthetic surgery, ENT surgery, Pain medicine, GI, Anti-infective

• Infectious disease, critical care; inflammatory neuropathy, dermatology, urology, vaccines

Please specify the therapeutic area(s) you serve in the scientific publication department. (Check all that apply.)


Six 6 FTEs Work in Scientific Publications, on AverageThere is only slight variance between the mean and median FTEs that work within Scientific Publications, with a mean of 6 and a median of 5. One company said it had 15 FTEs within its Scientific Publications function in 2011.

15

8

65

21

Max 75thPercentile

Mean Median 25thPercentile

Min

How many FTEs work within your scientific Publications Function?

N2011=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.

Assistant Director, 6%

Other , 18%Director, 24%

Vice President,

53%

N2011=17

• Senior Director• Head Global Scientific

Affairs

Who oversees your Publications function?


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, LLC6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517

[email protected]

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