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Life Cycle and Portfolio Management: Regulatory Agency and Pharmaceutical Company Approaches
Session Chair(s)
Mark Kryah, PMP
Executive Director, Program Team Leader, Program and Portfolio Management
Ultragenyx Pharmaceutical Inc., United States
Portfolio management and life cycle management are critical elements in pharmaceutical development, key to optimizing the value of an aggregate of assets and to optimizing the value of an individual asset. This session will provide regulatory agency and industry perspectives as well as examples of these important business processes.
Learning Objective : Explain how a program/portfolio level approach was applied to strategic and integrated life cycle management within Health Canada; Describe a portfolio management model implemented at FDA which was applied to the drug safety life cycle, including challenges and best practices; Discuss the process and decision making from recent research pipeline prioritization exercises conducted at two large pharmaceutical companies.
Speaker(s)
Life Cycle Management of the Pharmaceutical Program: The Approach and Lessons Learned - A Regulator's Perspective
Marilena Bassi, MA
Health Canada, Canada
Senior Executive Director, Therapeutic Products Directorate
An Innovative Approach to Drug Safety Life Cycle Management Using a Portfolio Management Business Model
Jill Bourdage, RPh, PMP
Food and Drug Administration Recruiting, United States
Director, Project Management; Associate Director Regulatory Affairs, OSE, CDER
Portfolio Rationalization: A Pharma Perspective
Mark Kryah, PMP
Ultragenyx Pharmaceutical Inc., United States
Executive Director, Program Team Leader, Program and Portfolio Management
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