1. DIA Medical Writing SIAC All-SIAC Teleconference 06 January 2011 11:00-12:00 am EST DIAL: US: 1-877-746-4263 Int: (44)207-019-0492 Pass Code: 0207337# 2010 Accomplishments 2011 Plans 1

2. Agenda 1.Medical Writing SIAC Overview 2.2010 Accomplishments and 2011 Plans –Individual Positions –Core Committee –Programming Committee –Education Committee –Membership and Social Committee –Publications & Publication Planning Committee –ICH E3 Guidance Taskforce –Medical Writing Competency Model Project Team 2

3. SIAC Purpose: A Special Interest Area Community (SIAC) is a self- enabling forum by which a group of DIA members with one or more mutual areas of professional interest can share common experiences, learning and expertise, and develop a network of professional colleagues. SIAC Membership is a benefit of DIA Membership. Medical Writing SIAC Overview 3

4. SIAC Duties and Responsibilities: Develop a community of members for the purpose of networking, information exchange and working together to achieve common goals that foster the DIA mission and values and help meet objectives of DIA’s Strategic Plan. Identify topics of interest for programs and educational offerings and provide input to the DIA staff and Program Committees on the quality of the content for the event. Provide input to Program Committees for major annual meetings to ensure that the professional interests of SIAC members are addressed. Provide input for webinars and DIA publications and assistance/support for soliciting articles and speakers. Medical Writing SIAC Overview 4

5. Mission The MW SIAC provides a discipline-specific, global community where members can share common experiences and knowledge and connect with others in their particular field. Members will also find opportunities for leadership and networking. The MW SIAC's mission is to provide a professional, neutral forum for discussion of issues related to the development of medical writing (regulated and non-regulated documents) for the pharmaceutical and biotechnology industries. The mission is to both determine and address the educational needs of DIA members whose interest area is medical writing through such activities as designing and conducting courses and workshops under DIA auspices and contributing to the DIA Annual Meeting and EuroMeeting. The mission is also to publicize the medical writing field, to stimulate SIAC members to engage in the evaluation of writing issues, and to encourage dialogue between regulators, academic institutions, and industry. Medical Writing SIAC Overview 5

6. For newcomers… The MW SIAC provides a welcoming and friendly atmosphere! Questions – just ask! Want to get involved – just ask! Medical Writing SIAC Overview 6

7. Medical Writing SIAC is 1 of 25 SIACs Oversees DIA Organization (ANCP)(ACE) Regional Advisory Council (RAC) 7

8. Medical Writing SIAC Overview MW SIAC Individual Leadership Positions and Liaisons Programming Committee Education Committee Membership and Social Committee Publications & Publication Planning Committee ICH E3 Guidance Taskforce Medical Writing Competency Model Project Team Core Committee (and Auxiliary Core Committee) (leadership positions) DIA SIAC Workgroups 8

9. Individual Positions Name LastName FirstPosition ClemowDavidMW SIAC Chair ClemowDavidDIA ANCP Representative GawrylewskiHelleImmediate Past MW SIAC Chair HeckerSandraRegulatory SIAC Liaison MolzonJustinaFDA Liaison OssannaMelissaMW SIAC Communications Coordinator PrestonChristopherDIA ACE Representative Soul-LawtonJeanDIA Global Forum Publications Board TaiwoToluMedical Communications SIAC Liaison 9

10. Key Responsibilities Chair Organize and run SIAC; chair Core Committee Appoint committee membership Act as Regional Advisory Council (RAC) member Assure mission and goals are current and shared Maintain a global focus; develop activities in global regions Facilitate collaboration and information sharing among other SIACs Develop annual activity plan Review performance of committees and committee members DIA ANCP Representative (Regional Advisory Council) Represent SIAC at Advisory Council of North America (ANCP) meetings and keep ANCP up to date DIA ACE Representative Represent SIAC at Advisory Council of Europe (ACE) meetings and keep ACE up to date 10

11. Immediate Past Chair Help onboard and mentor new chair Communications Coordinator Own SIAC communications, informing SIAC members of activities and important announcements Act as SIAC WebOffice administrator and keep site up to date Use communication to help coordinate and deliver on SIAC activities Regulatory SIAC Liaison Connect with Regulatory SIAC to see how we can collaborate and help each other meet membership needs and educational efforts Stay abreast of Regulatory SIAC's activities - note activities of interest to the MW SIAC Regulatory SIAC notifies MW SIAC of calls and we can participate 11 Key Responsibilities

12. Medical Communications SIAC Liaison Connect with MC SIAC to see how we can collaborate and help each other meet membership needs and educational efforts Stay abreast of MC SIAC's activities - note activities of interest to the MW SIAC FDA Liaison Help MW SIAC liaise with FDA on medical writing oriented topics DIA Global Forum Publications Board Member Help SIAC liaise with DIA publication groups, keeping SIAC aware of opportunities Other In past MW SIAC has had representatives in Documents and Records Management(DRM) and Electronic Regulatory Submissions SIACs working on EDM model, content reuse, and other projects 12 Key Responsibilities

13. Core Committee Name LastName FirstCompany ClemowDavidEli Lilly and Company EdgrenAlthaCerexa, Inc. FosterMichelleCTD Quality Consulting GawrylewskiHelleJohnson & Johnson Pharmaceuticals R&D MolzonJustinaFDA OssannaMelissaEli Lilly and Company PrestonChristopherF. Hoffmann-La Roche Ltd StewartMaryH. Lundbeck A/S StoltenborgJanetAstraZeneca Clinical Development WilsonSueShire Pharmaceuticals WoodLindaMedWrite, Inc. WoolleyKarenProScribe Medical Communications PindNoelleNovo Nordisk A/S Auxiliary Core Committee Name LastName FirstCompany BoePeggyWarner Chilcott HeckerSandraHecker & Associates, LLC KammBarbaraAllergan Inc. KatzNancyIllyria Consulting Group, Inc Soul-LawtonJeanGlaxoSmithKline R&D 13

14. Key Accomplishments 2010 Grew membership and engagement Organized and held monthly All-SIAC teleconferences Provided input to DIA on SIAC and Programming activities Provided input to ANCP and ACE Oversaw activities of Programming Committee, ICH E3 Task Force, MW Comp Model Developed Education Committee, Membership & Social Committee, and Publication & Publication Planning Committee 14

15. Key Goals 2011 Set direction for the SIAC and guide SIAC activities, providing input as needed Foster networking, educational content development, and information exchange Solicit feedback from SIAC members to better meet needs Oversee SIAC committees – ensure action items are developed, assigned, and related goals are met 15

16. Programming Committee Name LastName FirstCompany StewartMaryH. Lundbeck A/S StoltenborgJanetAstraZeneca Clinical Development * Core Committee reviews output from program chairs. 16

17. Key Accomplishments 2010 Influenced DIA 2011 Annual Meeting track development: outcome = MW + MC Track Managed the development of the 2011 Medical Writing and Communications Track o 12 sessions with 44 abstracts: 4 MC, 6 MW, 1 MC/MW, 1 publications 17

18. Key Goals 2011 Contribute to DIA Clinical Forum Manage the development of the 2012 Medical Writing and Communications Track 18

19. Education Committee Name LastName FirstCompany BenauDanUniversity of Sciences (Chair) GirtenEileeni3 Statprobe SternerJacquelineRoche VélezLiliTowson University BoePeggyWarner Chilcott RieblingPeterPTC Therapeutics TaiwoToluHospira Vintilla-FriedmanSusanVintilla Communications LLC 19

20. Key Accomplishments 2010 8 well-attended All SIAC teleconferences for shared learning and discussion on medical writing topics Hot Topics in Medical Writing Overview of Briefing Documents Overview of Component-based Authoring Submissions to Asian Countries CDISC: An Introduction and Update to the Clinical Trial Registry and Results (CTR&R) Model in HL7/CDISC Patient-Reported Outcome Measures: Highlights of Final FDA Guidance Virtual Medical Writing Teams – How to Create a Great Workplace when There is No Workplace Danger Ahead - Warning Signs that You are about to Employ or Have Employed a Mediocre Medical Writer 20

21. Key Accomplishments 2010 6 published articles in DIA Forum The Value and Benefit s of the ICH to Regulators – The CTD as a Common Regulatory Language – Justina A. Molzon The eCTD: A Primer and Beyond for Regulatory Writers – Nancy R. Katz Development and Practical Use of an International Medical Writer Competency Model – Karen Woolley and David Clemow Manners and More! Importance of cultural sensitivity when medical writers work with authors from the Asia-Pacific region – Julie Ely, Rebecca Lew, and Karen Woolley Involving and Informing Patients – The Ultimate Customer – Jean Soul-Lawton (also Section Editor) Profile – Dr Robert Temple – Interview by Jean Soul-Lawton Established formal committee to start in 2011 21

22. Key Goals 2011 Organize and oversee monthly All SIAC teleconferences Work to get articles submitted to DIA publications Develop new DIA educational outputs (eg, webinars, courses, etc) Further develop medical writing links on SIAC WebOffice Contribute to DIA’s emerging professionals efforts 22

23. Membership and Social Committee Name LastName FirstCompany KammBarbaraAllergan Inc. (Chair) QuinnKathrynAstraZeneca BairdRossH. Lundbeck A/S WilsonSueShire Pharmaceuticals KojimaYukoEli Lilly Japan K.K. 23

24. Key Accomplishments 2010 32 new and onboarded MW SIAC members since June 2010 143 current, up-to-date-status members (as of September 2010) 19 new members contributing to SIAC committees not previously involved Established formal committee to start in 2011 24

25. Key Goals 2011 Recruit members to DIA MW SIAC Onboard new members Engage new and existing members Organize social events and networking activities Partner experienced members with new members at DIA meetings 25

26. Publications & Publication Planning Committee Name LastName FirstCompany EdgrenAlthaCerexa, Inc. (Chair) GertelArtBeardsworth Consulting Group WeberEricEastern Michigan University SimonsenJulia (Síle)Lundbeck A/S WoolleyKarenProScribe Medical Communications GarrityMaureenAstellas Pharma OssannaMelissaEli Lilly and Company GossenRodHealthcare Info Tech Global Consulting TokayBarbaraPopulation Council GatchalianChristineAmgen 26

27. Key Accomplishments 2010 Established committee to start in 2011 27

28. Key Goals 2011 Work to meet member needs and interests in regard to the publication side of medical writing Contribute to programming activities Contribute to educational activities Liaison with other publication professional groups 28

29. ICH E3 Guidance Task Force Name LastName FirstCompany BlountAprileFDA ChazinHowardFDA ConnellySarahFDA ElyJulieProscribe GawrylewskiHelleJohnson & Johnson Pharmaceuticals R&D GensingerGaryFDA HeckerSandraHecker & Associates, LLC KammBarbaraAllergan Inc. KatzNancyIllyria Consulting Group, Inc (Chair) MolzonJustinaFDA PrestonChristopherF. Hoffmann-La Roche Ltd Soul-LawtonJeanGlaxoSmithKline R&D StewartMaryH. Lundbeck A/S TempleRobertFDA UngerEllisFDA WhiteMarkNovo Nordisk WilsonSueShire Pharmaceuticals WoodLindaMedWrite, Inc. 29

30. Key Accomplishments 2010 Developed 48-item ICHE3 Problems & Solutions document Held several telecons with FDA to identify issues Presented Problems & Solutions document and proposed Q&A document to FDA for comment (gained support) Introduced idea of a Q & A to E3 at the Regulators Forum of the November ICH meeting in Japan Will request, at June 2011 meeting of ICH, that ICH implement a Q&A document to E3 30

31. Key Goals 2011 Address FDA feedback Work with Pharmaceutical Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA) to introduce Q & A concept to ICH Formally introduce a request for a Q & A to E3 at the June 2011 meeting in Cincinnati 31

32. Medical Writing Competency Model Project Team 32 Name LastName FirstCompany AndoSatomiNovarits BaldwinHelenSciNopsis BoePeggyImage Solutions BrownDavidAstrazeneca BrysonSusanCovance Bunting-EarlyTracyTracy Bunting ClemowDavidLilly USA (Chair) CooperJuliaParexel GawrylewskiHelleJ&J HeckerSandyHecker HodoshEllenAstellas HubbardFrankAstrazeneca KatzNancyIllyria KojimaYukoLilly Japan MaxemowDawnForest PrestonChrisRoche RyerHelenWyeth SamulackDonEditage StoltenborgJanetAstraZeneca Clinical Development TokayBarbaraPopulation Council WilsonSueShire WoolleyKarenProScribe Medical Communications ZuckerJanetQuintiles

33. Key Accomplishments 2010 Presented applications of MW Comp Model at DIA Annual Meeting Presented applications of MW Comp Model at AMWA Annual Meeting 33

34. Key Goals 2011 Update document 34

35. Questions & Comments 35