1. 1 Global Medical Communications

2. Insight into a Career in Scientific Writing: Career Opportunities in Global Medical Communications Keri Poi Eli Lilly and Company

3. 3 My Background: Keri Poi 1993-1997B.S. in Biology University of Michigan-Ann Arbor 1997-2002Ph.D. in Nutritional Sciences University of Illinois-Urbana-Champaign 2003-2004Post-doctoral Fellowship Institute of Inflammatory Bowel Disease University of Chicago 2003-presentSr. Scientific Communications Associate, Publications Eli Lilly & Company

4. 4 Goals for Presentation What is Scientific Communications? What is Scientific Communications at Lilly? Introduction to Eli Lilly and Company

5. 5 Where is Scientific Communications within the Drug Development Scene? 2-4 years 2-6 months 3-6 years 1-3 years Over Time Preclinical StudiesClinical Trials Chemistry Pharmacology IND Phase 1 Phase 2 Phase 3NDAPhase 4 Writing Responsibilities by Development Phase Protocols Study Reports Submission Clinical Investigator's Brochure (CIB) Protocols Final Reports Abstracts Articles Submission Updated CIB Package Insert Newsletters Training Modules Articles Slide Kits

6. 6 Scientific Communications at Lilly Mission: We combine scientific knowledge and communications expertise to plan, generate and deliver relevant medical communications that are meaningful to customers worldwide, advance the quality and transparency of Lilly research, and enhance patient care.

7. 7 Global Medical Communications: Who We Are

8. 8 Global Medical Communications: Job Titles Scientific Communications Associate Editing Assistant Team Leader Manager Publications Coordinator Publications Assistant Medical Information Associate

9. 9 Current Global Medical Communications Organization The GMC organization focuses on 3 areas of scientific communications... Regulatory –Global Scientific Information and Communications – Regulatory –primary audience: regulatory agencies (e.g., FDA) Commercialization –Global Scientific Information and Communications – Commercialization –primary audience: scientific and medical community Medical Information –Global Medical Information –primary audience: healthcare providers

10. 10 Global Scientific Communication and Information – Regulatory (GSIC-R) Regulatory staff members: Design, write, and review clinical registration and scientific documents Lead collaborative writing teams, which includes physicians, statisticians, and clinical researchers Manage timelines and resources for complex clinical documents Ensure the quality of scientific documents and compliance with regulatory guidelines Develop deep expertise in medical science in the pharmaceutical industry Facilitate the registration of new drugs in other countries

11. 11 Global Scientific Communication and Information – Regulatory (GSIC-R) Primary Deliverables Protocols Investigator's Brochures Clinical Study Reports (CSRs) Global Registration Documents Contribution to Statistical Analysis Plans Briefing Documents Safety Updates Preparation for Regulatory Meetings Regulatory Responses

12. 12 Lifecycle of Communication Data Generation Data Disclosure (Primary) Data Dissemination (Secondary) Data Public, Promotion (Tertiary) Clinical trials Discovery research Regulators Investigators Peer-reviewed Scientific community Affiliates (Lilly Offices) Healthcare Professionals Pricing and Reimbursement Patients Clinicians Investor Community Media Healthcare Professionals Channels Submissions Journals Scientific Congresses Channels Medical Liaisons Medical Information (GRD’s) Symposia Medical Education Channels Internet Sales Force Call Center DTC Press Releases

13. 13 Global Scientific Communication and Information – Commercialization (GSIC-C) Commercialization staff members: Actively participate in planning and implementing data dissemination strategy Plan, write, and manage manuscripts, abstracts and posters Monitor scientific literature to build therapeutic area expertise and for competitive intelligence Based on knowledge of clinical trial data, develop novel publication ideas and plan additional analyses in collaboration with physicians and statisticians Review and provide input to press releases and other “lay press” documents related to publications and clinical data to ensure accuracy

14. 14 Other Manuscripts Abstracts Posters & Slides For submission to scientific/medical conferences For professional scientific/medical audiences For publication in peer-reviewed scientific journals e.g., publication planning, press releases Global Scientific Communication and Information – Commercialization (GSIC-C) Publication Deliverables

15. 15 Lilly discloses publicly all medical research results that are significant to patients, health care providers, or payers — whether favorable or unfavorable to a Lilly product — in an accurate, objective, and balanced manner, in order for our customers to make more informed decisions about our products. Publications writers at Lilly are not “ghost authors,” nor do they condone “guest authorship”! Principles of Medical Research

16. 16 All three of the following criteria must be satisfied to warrant authorship: –Making substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data. –Drafting the article or revising it critically for important intellectual content. –Giving final approval of the version to be published. Authors get credit for and are responsible for the publication’s contents. If a writer does not meet authorship criteria, then his or her name and contributions are listed in the “Acknowledgments.” ICMJE “Uniform Requirements”

17. 17 Lifecycle of Communication Data Generation Data Disclosure (Primary) Data Dissemination (Secondary) Data Public, Promotion (Tertiary) Clinical trials Discovery research Regulators Investigators Peer-reviewed Scientific community Affiliates (Lilly Offices) Healthcare Professionals Pricing and Reimbursement Patients Clinicians Investor Community Media Healthcare Professionals Channels Submissions Journals Scientific Congresses Channels Medical Liaisons Medical Information (GRD’s) Symposia Medical Education Channels Internet Sales Force Call Center DTC Press Releases

18. 18 Global Medical Information (GMI) GMI staff members: Plan, write, and edit Global Response Documents (medical letters) and unique responses to health care professionals’ questions Interface with scientific opinion leaders Participate in planning submission strategies and publication strategies, improving clinical document processes

19. 19 Lifecycle of Communication Data Generation Data Disclosure (Primary) Data Dissemination (Secondary) Data Public, Promotion (Tertiary) Clinical trials Discovery research Regulators Investigators Peer-reviewed Scientific community Affiliates (Lilly Offices) Healthcare Professionals Pricing and Reimbursement Patients Clinicians Investor Community Media Healthcare Professionals Channels Submissions Journals Scientific Congresses Channels Medical Liaisons Medical Information (GRD’s) Symposia Medical Education Channels Internet Sales Force Call Center DTC Press Releases

20. 20 Lilly GMC Writer Qualifications Graduate degrees preferred (bachelors degree required) Demonstrated writing experience or aptitude. Writing exercise is required as part of candidate evaluation process Excellent analytical, interpersonal, teamwork, project and self management, influence/negotiation, innovation/creativity, and leadership skills Excellent written and oral communication skills

21. 21 What is my life like as a Scientific Writer at Lilly? I enjoy writing and had experience writing scientific papers prior to Lilly. I am able to work in a project team, which means juggling multiple projects to meet deadlines. I am constantly learning new things and need to pay attention to the details. I was able to learn a particular therapeutic area (e.g. oncology, diabetes, neuroscience). I continually use my scientific training by interpreting complex data. I attend medical conferences that enable me to interact with physicians and learn more about clinical science. I have had the opportunity to work with the world leaders in the field of Diabetes. The science advancements that I have contributed, ultimately will help patients.

22. 22 Find out More from Professional Organizations American Medical Writers Association (AMWA) www.amwa.orgwww.amwa.org European Medical Writers Association (EMWA) www.emwa.orgwww.emwa.org Council of Science Editors (CSE) www.cbe.orgwww.cbe.org Drug Information Association (DIA) www.diahome.orgwww.diahome.org Society for Technical Communication (STC) www.stc.orgwww.stc.org The Board of Editors in the Life Sciences (BELS) www.bels.orgwww.bels.org Therapeutic-related organizations (ADA, APA, etc.)

23. 23 Primary Employer, According to a Survey by the American Medical Writer’s Association (AMWA) Source: AMWA Salary Survey, 2004 CRO Other Research or Education Health Care Org Communication or Advertising Co Journal or Publisher Association or Professional Society Pharmaceutical Company University or Medical School

24. 24 Field of Highest Degree, According to a Survey by the American Medical Writer’s Association (AMWA) Source: AMWA Salary Survey, 2004 Science (33.8%) English (14.4%) Journalism (5.3%) Pharmacy (5.1%) Medicine (4.8%) Communication (4.3%) Public Health (3.1%) Nursing (2.4%) Technical Writing (2.4%) Other (24.3%)

25. 25 Income by Primary Employer, According to a Survey by the American Medical Writer’s Association (AMWA) Source: AMWA Salary Survey, 2004 EmployernMeanMedianMode Pharmaceutical38687,41882,00072,000 Communication or advertising 13382,08480,00085,000 Clinical research organization 8971,19465,00075,000 Other13668,90366,50075,000

26. 26 Income by Employer (cont’d) Source: AMWA Salary Survey, 2004 EmployernMeanMedianMode Association or professional society 3861,21054,75646,000 University or medical school 10058,42353,50048,000 Research or education organization 5658,58452,00042,000 Journalism or publishing8557,77753,00028,000 Health care organization7560,32457,000

27. 27 Scientific Communications at Lilly is a Challenging and Rewarding Career Writing Medicine & Science Teamwork Managing Projects K

28. 28 Why Choose Lilly? Developing People Cross-functional teams and assignments Opportunities with global impact Many career path options Promotion from within Recognized by Harvard Business Review for Succession Management Process Work-Life Balance Flexible hours and work options On-site conveniences On-site child development centers Employee volunteer policy Business casual attire Global recognitions Employee clubs and activities

29. 29 Lilly at a Glance Founded in 1876 in Indianapolis, Indiana 129-year history of innovation $14B in sales 43,000 employees worldwide Clinical research in more than 60 countries and sell products in more than 143 countries Award winning culture: -FORTUNE magazine “100 Best Companies to Work For” -FORTUNE magazine "Global Most Admired Companies“ - MONEY magazine "America's Best Company Benefits" -Science magazine Best Companies for Scientists - IndustryWeek "100 Best-Managed Companies“ -Business Ethics magazine 100 Best Corporate Citizens -FORTUNE magazine "50 Best Companies for Minorities“ -Working Mother magazine “100 Best Companies for Working Mothers” www.lilly.com/careers

30. 30 Lilly’s Mission: We provide customers “Answers that Matter” through innovative medicines, information, and exceptional customer service to enable people to live longer, healthier, and more active lives. Integrity –Leadership by example –Honesty Respect for People –People are our greatest asset. Lilly is committed to communicating early and often about any changes that may occur. Excellence -We are pursuing only first-in-class/best-in-class products. -History of health care breakthroughs -Industry’s strongest late-stage pipeline Living examples of providing “Answers that Matter.” Lilly Mission and Values

31. 31 Who We’re Looking For People who embrace the Lilly values People with a strong desire to contribute to the world of health care Talented individuals who can help us solve problems and meet our growth goals People with a proven track record of leadership Individuals who show flexibility, adaptability, and ability to manage through uncertainty