CAR-T PRODUCTS: CONSIDERATIONS FOR CLINICAL, MANUFACTURING AND COMMERCIAL SUCCESS

The Evolution of Analytics in CAR-T Cell Therapy
Tariq Warsi, Senior Scientist, Process Development, Amgen, USA

A Forward Look at the Future of Cell Therapy Manufacturing
Donna Rill, Vice President of Manufacturing, Cell Medica Inc

New Analytical Technologies for Facilitating Qbd in Process Analytics
Junxia Wang, Director, Analytical Development, Mustang Bio Inc., USA

Implementation of an Affordable and Scalable Manufacturing Strategy
Jon Gunther, Associate Director Technology Strategy and Innovation, Juno Therapeutics, USA

T Lymphocyte Targeting Strategies: CAR-T and TCR-T Success Challenges and Path Forward
Miguel Forte, CEO, Zelluna Immunotherapy, Norway

Combination of Analytical Methods for Characterization of Viral Vectors
Gillian Payne, Director, Vector Analytics, bluebird bio, USA

What Academia are Looking for in a Development Partner
Olive J Sturtevant, Administrative Director of Connell & O’Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute

Current State of Play for the Cell Therapy Industry in the Clinic – Stats and Facts
Patricia Reilly, Head of Intelligence Alliances and Unification, Pharma Intelligence, Informa, USA

Leveraging Academic and Commercial Contract Manufacturing Organizations to Facilitate Accelerated FDA Approvals
Linda Kelley, Senior Member, Director Cell Therapy Facility, Moffitt Cancer Center, USA

The Economics of Closed Systems – Ensuring Reproducibility
Ohad Karnieli, CEO & Co-Founder, ATVIO Biotech, Israel

Ensuring Enough Supply and Magnitude in Terms of Patient and Dose Increases
Someet Narang, Senior Scientist, MedImmune, USA Wouter Van t’Hof, Cord Blood Bank Director, Cleveland Cord Blood Centre, USA

It Depends: Understanding the Science and History behind the Regulations
Nancy Markovitz, Assoc. Director, Regulatory Affairs CMC, Nantkwest, USA

Breakfast Surgery – FDA, EMA and PMDA Pinch Points

The Next Wave of Cell Therapy Product – Allogeneic Manufacturing Solutions
Yajin (Jenny) Ni, Associate Research Fellow, Director Manufacturing Process Development Lead, Allogene Therapeutics, Inc., USA

Delivering New Investigational Medicinal Products to the Clinic Through NextGeneration Allogeneic Cell Therapies
Bryan D. Utter, Procurement Manager, GMP Solutions, Cellectis Inc., USA

Developing a Commercially-Ready Process for Viral Vector Manufacturing
John Kerwin, Manufacturing Scientist, Gene Therapy, Biogen, USA

CASE STUDY: Adaptimmune – SPEAR T-cells
Dan Williams, VP Research and Technology Operations, Adaptimmune, UK

CASE STUDY: Key Success Factors for Planning and Building a Facility for Cell Therapies
Knut Niss, Chief Technology Officer, Mustang Bio, USA

CASE STUDY: Low Cost Automation to Drive Efficiency and Reproducibility
Shashi Murthy, Professor of Chemical Engineering,Northeastern University, USA

PANEL: What Can Be Learned from those Already Manufacturing at Commercial Scale

PANEL: What Can Cell Therapy Manufacturers Learn from MAbs to Save Time and Money on the Path to Commercial Scale Manufacturing
Trent Munro, Executive Director, Process Development, Amgen Inc., USA Lan Cao, Senior Director, Cell Therapy Head of Product Development and Clinical Manufacturing, Takeda Pharmaceuticals International Co., USA

PANEL: Driving Collaboration for Development In Cell and Gene Therapy

PANEL: CDMO Experts: How Do You Choose Your Development Partner?