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Wednesday, June 27 • 10:30am - 11:45am
#338: You've Got Data #now what?

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-647-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000227; RN 1.25

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 Objectives

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.


Karla Childers, MS


Planning in Anticipation of the Availability of Key Clinical Study Results
Diane Rintzler Yen

You’ve Got Data: Now What’s Your Communication Strategy and Plan?
Danielle Neveles

avatar for Karla Childers

Karla Childers

Head, Bioethics-based Science & Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Danielle Neveles

Global Communications Manager, Lilly Immunology, Eli Lilly and Company
Danielle Neveles is a global communications manager at Eli Lilly and Company, where she leads media relations and communications strategy for product milestones, issues, brand initiatives and key scientific data disclosures and environment shaping activities for the immunology franchise... Read More →

Diane Yen

Director, Project Management, Merck Research Laboratories
Diane joined Merck in 1998 in the Chemical Engineering R&D group where she was responsible for manufacturing and scaleup of Drug Substance to support clinical studies. In 2003 she joined the Global Project Management group where she has managed early and late stage programs within... Read More →

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 157AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjMgt-StrategicPlanning, Session
  • Level Advanced
  • format json
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Session