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Monday, June 27 • 10:45am - 12:00pm
#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development

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Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-596-L04-P; CME 1.25; IACET 1.25; RN 1.25

If studies have 90% power, why don’t 90% of studies have a successful outcome? This workshop will demonstrate how eliciting knowledge from experts and calculating the probability of success of a study or development program can leverage strategic decision-making.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the statistical concept of Assurance (a.k.a. Probability of Success or PoS) with respect to drug development strategy; Describe the benefits of quantifying current knowledge (prior elicitation) among product and disease experts; Quantify the probability of success of a future clinical trial by participating in a mock exercise to elicit a prior.

Chair

Colleen Russell, MS

Speaker

Facilitator
Sharon Cornell Murray, PhD

Facilitator
David A. Burt



Chair
avatar for Colleen Russell

Colleen Russell

Associate Director, Biostatistics, PAREXEL International
Over 25 years of experience in pharmaceutical, medical and industrial research has fueled my vision for improving efficiency of drug development and clinical trial conduct through innovative technology and statistical methods. I welcome opportunities to collaborate, solve problems and influence through leadership and effective communication.

Speakers
DB

David Burt

Director, Biostatistics, Trevena Inc
David received his PhD in Statistics from Virginia Tech in 2000 and has since been working in the pharmaceutical industry for a number of different companies. Currently he is serving as the Director of Biostatistics at Trevena Inc a biotech company based out of King of Prussia, Pennsylvania.
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics, PAREXEL International
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of North Carolina at Chapel Hill. She has over 20 years of experience supporting clinical trials and was previously employed by GlaxoSmithKline.


Monday June 27, 2016 10:45am - 12:00pm
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA