1. © 2015 Evidera. All Rights Reserved. Karin Hawkinson, Scientific Director, Global Market Access Communications Message communication vs. data dumping How to write effectively for your audience

2. Today’s discussion  Getting started –Key questions to make sure your document is on track  Getting your message across –Selecting and translating information –Making the format work for you –Incorporating the ‘so what’ 2

3. Getting started 3 Key questions to make sure your document is on track

4. Focus on your goal  What is the goal of a value dossier? –Compelling value story –Best available evidence  Includes the key components of the value story 4

5. Consider your audience  Internal pharma company affiliates, who then use/revise for an external audience  External payers, decision makers, and clinical advisors 5

6. The risk of data dumping  Forgetting your goal and audience can lead to a data dump: –Is a collection of facts without context or perspective –Does not incorporate what the information means or why it is relevant –Lacks the ‘so what’ 6

7. What are our clients looking for? 7

8. Provide the SO WHAT 8

9. Getting your message across 9 Selecting and translating information

10. Present what is relevant… 10  Focus on the value story  What distinguishes the product  What is needed for each topic for the audience  Talk to your client

11. Relevance is relative  Consider whether the information is relevant to your specific product  Consider relevance on a more global level 11

12. Translate the information Original DLQI scores: At 16 weeks, the mean change in DLQI was −6.9 for the 5-mg dose and −8.9 for the 10- mg dose versus 1.3 for placebo. Revised DLQI scores: Patients treated with [drug] 5 mg and 10 mg reported greater improvement in the DLQI score than patients treated with placebo. At 16 weeks, the mean DLQI improved by 6.9 points for the 5-mg dose and by 8.9 points for the 10-mg dose, and worsened by 1.3 points with placebo. 12

13. Selecting and translating facilitates original writing 13  Presenting information with selecting for relevance and without translating can lead to lifting text from a source  Our clients hire us for our writing skills and expect original writing that accurately reflects the source  Ways to ensure translation –What is relevant –List key points and rework from there –Pretend you need to cut the text in half and rework –Present the information differently –Acquire the necessary knowledge

14. Getting your message across 14 Making the format work for you

15. The organization and structure should support your message 15  Does your structure: –Segment the information into appropriate chunks? –Do the segments follow a logical order? –Do you show the relationships among segments? –Provide a home for all relevant information?  Have a place for everything that is relevant  If something doesn’t seem to fit the flow, that may be a clue it should not be there

16. Some organization strategies  Group similar information in a table, where the data can be compared  Move more detailed information to an appendix  Consider adding section summaries 16

17. Getting your message across 17 Incorporating the ‘so what’

18. Provide the ‘SO WHAT’  The most important technique to develop an effective dossier that is not merely a data repository –Helps winnow down the information to what is relevant –Forces you to translate the information and provide the perspective that supports your value messages  Provide it appropriately for your audience 18

19. Describe the consequences Original [Drug] 5 mg and [Drug] 10 mg were superior to placebo in achieving NAPSI 75 and resulted in greater improvements in DLQI and ISI. Revised [Drug] 5 mg and [Drug] 10 mg were superior to placebo in achieving NAPSI 75, reflecting a significant reduction in the symptoms of nail psoriasis, and in improving ISI scores, reflecting a reduction in itching. Both doses also improved DLQI scores, providing improvements in dermatologic and health-related quality of life. 19

20. Provide the context  Study design information Study 1 included patients with moderate to severe COPD (excluded GOLD IV patients). Patients who had previously been on a long-acting bronchodilator (LABA) or a LABA/inhaled corticosteroid fixed-dose combination (LABA/ICS FDC) had to cease therapy before the run-in period.  The ‘so what’ By excluding LABAs and LABA/ICS FDCs and not covering GOLD IV patients, the efficacy of [Drug] was tested in a patient population that does not represent “real-life” patients; the included population is also likely to lead to better lung function responses 20

21. Pharmacokinetics and statistics need context 21  Pharmacokinetic data are frequently presented without any context –Make sure any PK value you provide is relevant –Translate what each PK value means in terms of what happens to the drug and the consequences  Statistics and analysis populations usually need explained –Explanations can help bolster the credibility of the results and provide context

22. Explain the background TrialDescription Study 1 Comparison of the PK and PD profiles of [New Insulin] vs US-approved [Insulin Z] Study 2 Comparison of the PK and PD profiles of [New Insulin] vs EU-approved [Insulin Z] 22 Explanation The comparator used throughout the clinical development program, [Insulin Z] has been approved and marketed in both the US and the EU. While the US- approved and EU-approved products are not known to differ with respect to their clinical pharmacologic properties, the possibility of any such differences was taken into consideration in the clinical program. Separate phase 1 PK/PD trials were conducted to compare [New Insulin] to each [Insulin Z] product independently. In addition, a phase 1 PK/PD trial was conducted to compare the US-approved and EU-approved [Insulin Z] products to each other.

23. Make the connections 23

24. In closing  Providing the context and perspective that will help your readers understand why the information is important and what it means is THE most important technique you can use to develop an effective dossier that is not merely a data repository  Remind yourself of the goal and audience  Ask yourself: What information is relevant and how can I translate it for my audience? Is it presented in a fashion that is helpful to a reader and supports the overall story? What does it mean? 24