How Are We Developing Necessary Manufacturing Capacity for Advanced Therapies?

18 Jan 2023
New & Enabling Technologies Track
Curate Biosciences

1:00pm Chair Introduction

Jeff Masten, Chief Operating Officer, Theragent


1:05pm Presentation: TBC

Senior Representative, ATARA Biotherapeutics


1:20pm Presentation: In-House Production vs. CDMO: Meeting The Challenges of Commercializing Cell and Gene Therapies

  • In this presentation, expert Peter Walters evaluates what cell and gene therapy developers can do to plan for long-term commercial success while so much change is underway at the lab bench
  • In a recent report produced by CRB, drawing on survey data from over 500 industry experts, Walters will discuss facility strategies to consider when deciding to scale out, such as utilization of a CDMO or in-house production. He will touch on drivers such as adequate manufacturing capacity, availability of skilled workers and cost implications
  • Diving into the survey data and past project experience, he will evaluate different case studies while outlining the business case for in house production, utilizing a CDMO and a hybrid model

Peter Walters, Fellow in Advanced Therapies, CRB


1:35pm Presentation: How Are We Developing the Necessary Manufacturing Capacity for Advanced Therapies? 

  • Importance of integration of the Development, QC, MSAT, and Mfg Ops
  • Full control of supply chain and production scheduling is key
  • A purpose-built plant that speeds delivery of clinical supplies and is designed for commercial expandability

Steve Doares, Senior Vice President and Site Head, US Manufacturing, Cellectis


1:50pm Presentation: TBC

Senior Representative, Curate


2:05pm Closing Panel with Q&A

With all session participants


Jeff Masten
Chief Operating Officer
Peter Walters
Fellow, Advanced Therapies
Steve Doares
Senior Vice President US Manufacturing and Head of Raleigh Allogeneic CAR-T Facility