1:30pm Chair Introduction

Jeff Masten, Chief Operating Officer, Theragent

1:35pm 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

1:50pm Presentation: Interim in-house production, strategic path of a small biotech

• Choosing CDMO to shorten time from lab to clinic
• Designing products for commercialization
• Scalability and licensing readiness

Mathias Svahn, Chief Executive Officer, NextCell Pharma AB

2:05pm Presentation: Use of Microfluidic Technology to maximize Patient Sample Potential and Simplify Manufacturing

• Microfluidic approaches offer significantly and consistently improved recovery of naïve T cells with greater purity vs. centrifugal/density-based approaches
• In addition, microfluidic processing results in both improved transduction and superior T cell expansion
• Together, these benefits synergistically combine to create a significantly and consistently shorter manufacturing process (~4 days) reducing cost while increasing capacity

Tony Ward, Chief Technology Officer, Curate Biosciences

2:20pm 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

David Sourdive, Executive Vice President CMC and Manufacturing, Cellectis

2:35pm Closing Panel with Q&A

With all session participants, joined by: 

Julie G. Allickson, Director, Mayo Clinic Center for Regenerative Medicine & Associate Professor of Regenerative Medicine, Mayo Clinic