1. 1 Clinical Supplies Discussion Group Winter Meeting, Oxford, UKNovember 19 th 2014

2. 2 Copyright 2014. Confidential – Distribution prohibited without permission Market leader ($489MM/year) Public Company (NASDAQ: LIOX) Global Scale spanning across 26 countries One of Forbes™ 100 Most-Trusted Companies Market leader ($489MM/year) Public Company (NASDAQ: LIOX) Global Scale spanning across 26 countries One of Forbes™ 100 Most-Trusted Companies 10,000+ Medical Resources (Regulatory SMEs, Translators, …) all tested and validated Tens of Thousands of “Label Projects” across 90+ languages completed in 2014 alone 10,000+ Medical Resources (Regulatory SMEs, Translators, …) all tested and validated Tens of Thousands of “Label Projects” across 90+ languages completed in 2014 alone Overall customer experience Lean Six Sigma Documented and Validated Focus on Total Quality (Continuous BPI) Overall customer experience Lean Six Sigma Documented and Validated Focus on Total Quality (Continuous BPI) About Lionbridge Life Sciences A Business Unit within Lionbridge Specialized in Life Sciences Excellence Is Our Standard Committed to your Success

3. Copyright 2014 Confidential – Distribution prohibited without permission Workshop

4. 4 Global labelling can be challenging “Delays” “Inconsistencies” “Translation Errors” “Confusing”

5. 5 Copyright 2014. Confidential – Distribution prohibited without permission Key Considerations when Creating Global Labels 3. Embracing Technology 2. Process Alignment 1. Getting Started

6. 6

7. 7 Copyright 2014. Confidential – Distribution prohibited without permission Clinical Labels are typically impacted by: Label Creation (English (Master) Type of study Therapeutic Area Type of label(s) Product use (hospital, home, …) Name of medicine (generic or brand) Application (Pharma, Device, …)

8. 8 Copyright 2014. Confidential – Distribution prohibited without permission Requirements explode when going Global!

9. 9 Copyright 2014. Confidential – Distribution prohibited without permission Create a “kick-off” requirements list

10. 10 2. Process Alignment

11. 11 Copyright 2014. Confidential – Distribution prohibited without permission Process, Roles & Responsibilities Start Cycle I Cycle II Analysis of Source Master Label TranslationTranslation SME Regulatory Validatio n SME Regulatory Validatio n Back Translation & Comparative Review Back Translation & Comparative Review Independent/Client Review Check and Implementation DTP (Formatting) & Finalization Final Delivery

12. 12 3. Embracing Technology

13. 13 Copyright 2014. Confidential – Distribution prohibited without permission Creating Phrase Libraries with Translation Memories (TM) Solutions? Directions: Take 1 tablet by mouth every 12 hours Keep out of reach of children Contains: 12 XYZ 150mg Tablets Directions: Take 1 tablet by mouth every 12 hours Keep out of reach and sight of children Contains: 12 Matching Placebo Tablets 100% match: identical to previous version Fuzzy match: similar but not identical to previous version. No match: No match found in TM

14. 14 Not all TM are created equal… Study 122 Study 444 Study 1221 Study 1231 TM1TM2TM3TM4TM5 TM2 TM3 TM4 TM5 24/7 Web access Shared TMs Hosted TM in the Cloud I n t e r n e t TM1 Centralized Glossary M7 TM8 TM9 TM10 Desktop TM Study 23

15. 15 Copyright 2014. Confidential – Distribution prohibited without permission Globalization Portal can help you: Manage access rights Initiate, track and manage translation projects (orders) Request, approve, reject quotes Review translated files Self-generate estimates Collaborate across global project teams Access linguistic assets (phrase libraries) Perform on-line review Run reports Monitor the status of all activities Simplify your day-to-day

16. Copyright 2014 Confidential – Distribution prohibited without permission Tips

17. 17 Copyright 2014. Confidential – Distribution prohibited without permission A few “high-level” parting tips  Establish a dialog between your vendors (“Translation” + CRO + CMO)  Work only with regulatory experts and highly specialized translators  Do not “skip” official/required languages  Do not combine different countries under a language (Spain is not Argentina)  Embrace technology when appropriate  Final Review and Sign-off are key

18. Copyright 2014 Confidential – Distribution prohibited without permission Q&A

19. 19 Thank You Eric Jacobs, Senior Director Head of Global Regulatory Solutions www.lionbridgelifesciences.com http://blog.lionbridge.com http://twitter.com/@Lionbridge http://www.facebook.com/L10nbridge Email:Eric.Jacobs@lionbridge.comEric.Jacobs@lionbridge.com Mobile: +1 917 297-7789 Danke Arigato Merci Gracias Grazie