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Thursday, June 28 • 9:00am - 10:15am
#409: Emerging Best Practices and Challenges in Strategic Drug Development and Design Decision Making

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-692-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000232; RN 1.25

This session will present lessons learned and case examples from three different companies who have introduced change initiatives aimed at disrupting and improving strategy and design decision-making. Presentations will share common obstacles, change management pitfalls, critical success factors, and actions you can take now to improve design decision making in your company.

Learning Objectives

Compare and contrast traditional versus emerging strategic drug development and design decision-making practices; Recognize challenges often encountered when implementing new tools, data, processes, and approaches to strategic drug development and design decision-making and describe their impact; Define critical success factors for improving strategic drug development and design decision-making


Cara Willoughby, MS


Lessons Learned Translating Data to Meaningful Design Insights
Cara Willoughby, MS

Leveraging Big Data to Help Design Clinical Program Strategies
Kyle Holen, MD

Patient Engagement Strategies in Design
Florian Bieber, MD

avatar for Florian Bieber

Florian Bieber

Global Head, Clinical Development and Analytics, Novartis Pharma AG
Florian joined Novartis in 2014 as Clinical Development Head in Established Medicines. In 2016 he was promoted to Global Head of Clinical Development. Since then he also became responsible for Biostatistics and Pharmacometrics and since 2016 for Oncology Clinical Development. Prior... Read More →

Kyle Holen

Head, Development Design Center, AbbVie, Inc.
Kyle is a medical oncologist who started his career focusing on GI tumors at the University of Wisconsin Carbone Cancer Center. In 2009, he began working at AbbVie as a medical director, later as project leader, for a variety of oncology and hematology assets. His current role is... Read More →
avatar for Cara Willoughby

Cara Willoughby

Principal Scientific Advisor, IQVIA
Cara Willoughby leads an international team of design and data scientists at IQVIA who combine design thinking best practices with applied data, analytics and novel technologies to support planning and design trade-off decisions. She has 20 years of Pharma experience in clinical research... Read More →

Thursday June 28, 2018 9:00am - 10:15am EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  07: ProjMgt-StrategicPlanning, Session