Welcome to the P&PM white paper mini-series

Kevin Whittlesey headshot

THE IMPORTANCE OF EFFECTIVE P&PM FOR SUCCESSFUL C&GT PRODUCT DEVELOPMENT

by former Dark Horse Kevin Whittlesey
“Effective project and program management will have a substantial positive impact on the quality, time, and cost of cell and gene therapy product development. Although the terms ‘program management’ and ‘project management’ are often used interchangeably…”

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Ryan Duffy Headshot

KEY CONSIDERATIONS FOR SUCCESSFUL TECHNOLOGY TRANSFER

by former Dark Horse Ryan Duffy
“The end goal of Knowledge and Technology Transfer activities associated with a manufacturing process and analytical assays is moving the production, testing, and release of a Drug Product from one manufacturing location to another, while…”

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Phil Bowles Headshot

CGT FACILITY (CAPITAL) PROJECTS

by former Dark Horse Phil Bowles
"Successful delivery of a new Cell and Gene Therapy (CGT) facility relies on effective project management throughout its lifecycle to meet quality, financial and schedule goals. CGT capital projects require significant investment of money, time and human capital to construct or modify a clinical or commercial manufacturing facility. The new or expanded manufacturing capacity delivered by the project will inevitably be..."

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Sara Masterson Headshot

PROJECT AND PROGRAM MANAGEMENT: NAVIGATING TIMELINES WITH EMPATHY, EXPERIENCE, AND INTENTION

by Sara Masterson, MBA
"Project management (PM) is a critical function in every organization, to drive preparation, execution, & completion of operational activities that support overarching corporate or strategic goals.  The most important, defined output from project management is typically on time delivery of appropriate quality within budget. This is accomplished..."

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upcoming additions to the mini-series will include:

Heather Todd Headshot


P&PM THROUGHOUT THE C&GT PRODUCT LIFECYCLE

by Heather Todd, M.S.

Michael Kinzie Headshot

DEVICE ENGINEERING

by Michael Kinzie