1. Choosing the Right Writing Vendor(s) From the Perspective of the Pharma Company’s Medical Writing Manager

2. The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2www.diahome.orgDrug Information Association

3. Trends –Smaller in-house Medical Writing (MW) groups –More outsourcing of MW Driven by –Desire to decrease overhead (fixed costs) –Workload fluctuations The Rising Utilization of External Writing Vendors Drug Information Associationwww.diahome.org3

4. Determine what (writers) is needed & when Determine available inventory (writers & $) Determine gap b/ “Have” vs. “Need” Negotiate with management & project team –Headcount, outsourcing model, budget, time Research the market of writing vendors Go shopping Make the purchase Steps for Sourcing Medical Writers for a Project Drug Information Associationwww.diahome.org4

5. What Do You Need and When Do You Need It? Things to Consider Wish List Nice to Have Must Have Time Frame Drug Information Associationwww.diahome.org5

6. Considerations for writers for a project –How many writers? –When needed? –Exclusivity (% dedication to the project)? –What skill sets, background, & experience? –Personality and team fit? Do this in a “ideal world” scenario –Know what you want so you know what you can live with (really need) What’s Needed and When It’s Needed? Drug Information Associationwww.diahome.org6

7. Do You Already Have What You Need? Drug Information Associationwww.diahome.org7

8. Check the in-house MW group –Any writers on the project already? –Any writers who can be shifted to the project? –Check employees, temporary writers on-site and off-site, & any preferred providers –Check in other departments if needed/allowed Check the budget –Project budget –MW group/department budget Checking Inventory – What do you have already? Drug Information Associationwww.diahome.org8

9. Gap Analysis Gap = Want - Have Drug Information Associationwww.diahome.org9

10. In Writer Terms –If Have > or = Want, then Congratulations! –If Have < Want, then determine gap The Gap –How many more writers? When? –How much will this purchase cost (estimate)? –Does the budget cover the estimated cost? (If yes, congratulations & skip the next slide.) Determine Gap between “Have” and “Want” Drug Information Associationwww.diahome.org10

11. Management Negotiations Financing your Resource Purchase Drug Information Associationwww.diahome.org11

12. Reconcile Determination of Need and Gap with the Project Team –Speak with One Voice to Management Negotiate with Management for Budget –Know difference between Want and Need –Ask for budget to cover Want –Be willing to accept budget to cover Need –Be able to articulate consequences of not covering the Need Internal Negotiations Drug Information Associationwww.diahome.org12

13. Know the Marketplace Drug Information Associationwww.diahome.org13

14. Contract Research Organizations (CROs) Agencies Independent Writers These provider types may overlap or shade into each other. The Medical Writing Providers Market Drug Information Associationwww.diahome.org14

15. Full-service vs. Specialized/Functional Global vs. Regional Local vs. Off-Shore Service Model Billing Model Governance Model Contract Research Organizations (CROs) Drug Information Associationwww.diahome.org15

16. Full-Service CRO –Soup to nuts services –Large w/ many writers and global presence –May have bureaucracy –May not want small or partial projects Specialized CRO –Only medical writing &/or related services –Small and potentially nimble –May not have the resources for a large project CROs – Full-Service vs. Specialized Drug Information Associationwww.diahome.org16

17. Global presence –Time zone advantage –Larger pool of writers Local presence –Face time with writers & relationship building Off-shore –Potential for highly educated resources at relatively low cost CROs – Location Effect Drug Information Associationwww.diahome.org17

18. Project Management and Process –CRO vs. Sponsor What’s the Purchase? –Finished Product vs. Resouces (writers) Selection of writers –CRO employees vs. contractors –Sponsor approval needed? Allowed? CROs – Service Model Drug Information Associationwww.diahome.org18

19. Milestones –Payments based on finishing a particular task –Concerns: What is a “satisfactory draft”? May be prone to change orders / work stoppages Goods and Services –Payments based on time spent / pass-thru $ –Concerns: Very dependent on the person(s) doing the work CROs – Billing Model Drug Information Associationwww.diahome.org19

20. Setting the Sponsor-CRO Relationship Rules –Contracts and change orders –Communication process –Escalation of issues and disputes –Performance evaluation Key performance indicators Metrics Penalties and Rewards CROs - Governance Drug Information Associationwww.diahome.org20

21. Staff Augmentation –Purchase writers not finished documents Recruiters and Staffing Services –Find and screen writers (perm/temp) –May hire the writers as their employees –Pay writers a salary or by the hour Payroll Services –Hire writers as hourly contractors –Consolidates invoices from multiple writers Agencies Drug Information Associationwww.diahome.org21

22. aka Freelancers and Consultants Usually very experienced and confident Work from home most of the time Come into office on occasion Often have multiple clients simultaneously Generally paid by the hour May get paid directly by the pharma company or indirectly via CRO or Agency Independent Writers Drug Information Associationwww.diahome.org22

23. Pros –Multiple writers Replace sick writer or one that leaves Add more writers if project expands or needs help –Related services especially if full-service CRO Cons –“Employee” writers may be overworked –“Consultants” with workload conflicts –Bureaucracy adds costs & reduces flexibility –Personnel turnover Considerations for the Various Provider Types - CROs Drug Information Associationwww.diahome.org23

24. Pros –Multiple writers Replace sick writer or one that leaves Add more writers if project expands or needs help –Payroll services and invoice consolidation Cons –Limited experience with their writers –Add $ for finding writers and payroll services –“Temp” writers may leave for permanent jobs –“Consultant” writers with workload conflicts Considerations for the Various Provider Types - Agencies Drug Information Associationwww.diahome.org24

25. Pros –Lots of flexibility and no bureaucracy –Usually very experienced –Control their own workload Cons –No back-up in case of illness, etc. –1 contract, 1 set of invoices, & 1 set of checks per writer –Might need partial $ in case your project fails (negative results = no submission) Considerations for Using the Independent Writer Drug Information Associationwww.diahome.org25

26. Go Shopping (Finding the Suppliers) Drug Information Associationwww.diahome.org26 Who You Want Who Wants You

27. Preferred providers –Many companies have a list of preferred providers or agencies with contracts already in place. Providers you have experience with –Positive past experiences –Personal experience –Experience of others in in-house MW group –Experience of others in the pharma company Identifying Medical Writing Provider(s) – Who you want Drug Information Associationwww.diahome.org27

28. Contact potential providers –Check interest, availability, and capacity Send out Requests for Proposals –Formal document or casual conversation –Follow company processes –Involve contracting, legal, etc. as needed –More details the better Identifying Medical Writing Provider(s) – Who wants you Drug Information Associationwww.diahome.org28

29. Evaluate proposals –Who in your company reviews proposals? –Who has final decision-making authority? –Evaluation criteria Can be a gut feeling Can be objective with pre-defined criteria Can be both Determine who you really want and a back-up Suitability of Medical Writing Providers Drug Information Associationwww.diahome.org29

30. Make the Purchase (Contract Negotiations) Drug Information Associationwww.diahome.org30

31. Know thyself –Negotiate with 1 or more providers at a time –What do you want? –What must you get (non-negotiable)? –What are you willing to give up in negotiations? –What will make you walk away? Know your timeframe –If you don’t get a deal by, then you will go with another provider. Negotiating with the Potential Provider(s) Drug Information Associationwww.diahome.org31

32. Know the process on both sides Keep the decision makers informed Know the timeframe for review and approval of contracts and budgets Congratulations on resourcing your project! Sealing the Deal with the Medical Writing Provider Drug Information Associationwww.diahome.org32

33. Thank You Slide title paraphrased from a song from The Sound of Music. So Long, Farewell, I hate to leave this pretty sight… Drug Information Associationwww.diahome.org33