© 2015 Evidera. All Rights Reserved.

Karin Hawkinson, Scientific Director, Global Market Access Communications

Message communication vs. data dumpingHow to write effectively for your audience

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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’

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Getting started

Key questions to make sure your document is on track

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

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Consider your audience Internal pharma company affiliates,

who then use/revise for an external audience

External payers, decision makers, and clinical advisors

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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’

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What are our clients looking for?

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Provide the SO WHAT

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Getting your message across

Selecting and translating information

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Present what is relevant…

Focus on the value story What distinguishes the

product What is needed for each

topic for the audience Talk to your client

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Relevance is relative Consider whether the information is relevant

to your specific product

Consider relevance on a more global level

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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.

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Selecting and translating facilitates original writing

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

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Getting your message across

Making the format work for you

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The organization and structure should support your message

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

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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

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Getting your message across

Incorporating the ‘so what’

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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 itappropriately for your audience

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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.

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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

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Pharmacokinetics and statistics need context

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

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Explain the background

Trial Description

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]

ExplanationThe 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.

Make the connections

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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?