Process Optimization and Excellence for Cell Therapies

12pm Chair Introduction

Patrick Hanley, Chief & Director, Cellular Therapy Program, Interim Co-Director, CETI, Associate Professor of Pediatrics, Childrens National Hospital

12.05pm Presentation Title: Building Scalable Allogeneic Processes to meet Phase 1 and Beyond

• Identification of process and material hurdles to minimize comparability
• Designing processes to meet fast-to-clinic FIH requirements with agility toward Phase 2 scale
• Developing digital tools to assess process unit impact

Amy Shaw, Director, Process Development, Takeda

12.20pm Fireside Chat: Embracing Accelerated Digital Transformation through Standardized CGT Processes

• Advancing Economical Digitization in Scaling CGT Programs
• The role of automation and digitization in high-throughput manufacturing operations

Josh Ludwig, Global Director, Commercial Operations, ScaleReady

12.35pm Presentation: Solving for Accessibility to Cellular Therapies

• Discussion of expanding access to cell therapies within the organization
• Development of processes and educational content to teach all stakeholders
• What lessons were learned and how they can benefit industry

Robert Richards, Corporate Director of Cell Therapy & Transplantation, University of Pennsylvania

12.50pm Fireside Chat: Looking Ahead: Addressing Regulatory Challenges Early On

• What are the predominant regulatory pain points encountered when scaling up processes in CGT applications?
• What solutions can FUJIFILM Irvine Scientific provide to help customers overcome these challenges?
• What does the future regulatory landscape look like for advanced therapies or cell and gene therapy developers?

Marlin Frechette, Chief Quality & Compliance Officer, FUJIFILM Irvine Scientific

13.05pm Panel Discussion joined by Ben Weil, Director of Manufacturing, INmune Bio