11:00am Chair Introduction

Sumit Verma, Senior Vice President, Global Strategic Manufacturing, Iovance Biotherapeutics

11:05am Presentation: Mayo Clinic’s Center for Regenerative Biotherapeutics Program Focused on Scaling for Successful Translation to Favor Commercialization

• Advancing practice priorities through project assessment. How to determine which projects allow investment for translation.
• Collaboration with industry for early phase clinical trials
• Facilitating biotherapeutics for rare and complex diseases through the appropriate ecosystem

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

11:20am Presentation: The Future is Scalable: Stable Lentiviral Cell Lines for Improved Access to Advanced Therapies

• Lentiviral (LV) vectors are important gene delivery tools for cell and gene therapies, but achieving scalable yields using plasmid-based manufacture remains an industry challenge and affects the accessibility of novel treatments
• Disruptive technologies, removing or reducing the use of plasmids, have the potential to address these challenges
• The development of LentiVEX™ stable packaging and producer cell lines, incorporating some or all of the genetic material required for viral vector production, will enable efficient production of LV vectors compared with transient technologies

 David Chang, Chief Executive Officer, WuXi Advanced Therapies and OXGENE

11:35am Presentation:

Eliminating Process Translation: How To Scale Up CGTs From R&D To Manufacturing Overnight!

• Bioreactor technologies and strategies for scale-up/down for cell and gene therapies and case studies
• Upstream process analytical technologies and strategies for scale-up/down for cell and gene therapies and case studies

James Kusena, Vice President – Bioprocessing and Applications , MicroFluidX

11:50am Presentation: Identifying and Overcoming CMC Risks for Advanced Therapies

• The three main levers for scaling up supply (yield, run rate, batch scale) each require different investments/considerations
• Early collaboration between Manufacturing, Quality, Supply Chain and Process Development are critical to minimizing clinical and commercial supply risks
• Using the long-range plan to develop an operational network strategy is a useful process to promote the necessary cross-functional discussions to identify/characterize key CMC risks across the organization

Chad Salisbury, Senior Vice President, Project Farma

12:05pm Closing Panel with Q&A

With all session participants