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2020 ISPE Annual Meeting & Expo

NA20CENOV1/SES207 - Agile Project Delivery for Cell & Gene Therapy Facilities

Nov 4, 2020 1:00pm ‐ Nov 4, 2020 2:30pm

Expiration Date: Nov 30, 2021


Agile Project Delivery for Cell & Gene Therapy Facilities | Pharmaceutical companies are now investing heavily in R&D to develop cell and gene therapies targeting previously incurable diseases, with the FDA anticipating more than 200 investigational new drug applications per year. Commercial growth in this sector will require substantial investment in new research and manufacturing facilities, with an emphasis on speed to market, flexibility, cost, and innovation. This session will review best practices in developing an agile engineering project delivery model to support these goals, focusing on the unique project management challenges in delivering projects for the cell and gene therapy sector. We will also discuss how innovations in robotics, engineering design, and modular construction can be leveraged to accelerate delivery and improve safety, quality, and reliability.

Key learning objectives:
-Understand the unique design differences and challenges in delivering cell and gene therapy facilities
-Apply critical project management processes and tools to drive performance and target value delivery
-Leverage innovative technologies in design and construction

Session Leader(s):


  • Scott Bertch, Exec. Director, Clinical Site Head, Tenaya Therapeutics

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