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You've Got Data #now what?
Session Chair(s)
Karla Childers, MS
Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States
The availability of clinical study results can have an immediate impact on a development program. Once these results are available, teams often need to react quickly. To enable swift execution, the team should think in advance about potential outcomes and create a plan prior to the availability of the results that considers the potential outcomes and those who will be impacted. In this session, we will use a case study to demonstrate the importance of planning and also help the audience develop a rubric for thinking through the various elements of a communication plan, including identifying key stakeholders and how to “right size” one’s plan depending on the nature of the event. We will also cover foundational concepts, such as materiality and blinding/unblinding, and how the development phase of a product can influence the impact of the results.
Learning Objective : Discuss the importance of thinking in advance about the impact of clinical study results; Recognize potential outcomes, identify key stakeholders, and formulate project plans, including a communication plan; Describe the key elements of a communication plan and how to “right size” your planning for a particular event.
Speaker(s)
Planning in Anticipation of the Availability of Key Clinical Study Results
Diane Rintzler Yen
Merck Research Laboratories, United States
Director, Project Management
You’ve Got Data: Now What’s Your Communication Strategy and Plan?
Danielle Neveles
Eli Lilly and Company, United States
Global Communications Manager, Lilly Immunology
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