January 27, 2021
11:00 am - 11:30 am
EST
CAR-T Clinical Trial Design and Efficacy
Peter Marks MD, PhD -
Director, Center for Biologics Evaluation and Research (CBER),
Food and Drug Administration (FDA)
We have adaptive design, but what else can be considered in diverse approaches to treat cancer? What have we learned about what else might be considered to augment real world evidence and other data sets, that could be valuable to understand the safety and effectiveness of new car t therapies?
Peter Marks MD, PhD
Director, Center for Biologics Evaluation and Research (CBER)Food and Drug Administration (FDA)
11:30 am - 11:45 am
EST
Q&A Session
11:45 am - 12:00 pm
EST
Overcoming Obstacles to Clinical Trial Enrollment, Engagement and Retention for Car-T Therapies
Andrew Brown PhD -
Strategy & Architecture Manager,
ZS Associates
Break down barriers to clinical trial enrollment from risk-benefit assessment for patients and clinicians, informed consent, to cultural and logistical challenges. Develop patient engagement and retention strategies to ensure the successful completion of your clinical trial on time and on budget. What are the most impactful considerations to be made to reduce patient burden and ensure an enhanced clinical trial experienced patients?
12:15 pm - 12:20 pm
EST
Q&A Session
12:20 pm - 1:00 pm
EST
Lunch & Refreshment Break
1:00 pm - 1:30 pm
EST
Advancements in Manufacturing, GMP & Global Supply Chain Strategies
John Balchunus -
Workforce Director,
National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Dan Bright - Director Of Manufacturing Operations, Cellectis
John Tomtishen - Director of Manufacturing, Technical Operations, Legend Biotech
Sean Werner - President, Sexton Biotechnologies
How can innovations achieve the cost reductions, accelerated results, reduced risk, and increased safety that they need to make car t cell therapies practical
Adopt strategies for transitioning from a good lab process to a good clinical process to overcome significant challenges. How can challenges in scale-up and scale-out be overcome to implement fundamentally solid, repeatable, foundational process development from preclinical, to clinical, and beyond? Explore novel technologies and innovations to secure the necessary level of quality, control and certainty to inject GMP throughout the phases of drug development for Car-T therapies
John Balchunus
Workforce DirectorNational Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
1:30 pm - 1:45 pm
EST
Q&A Session
1:45 pm - 2:00 pm
EST
Implementing a Suspension System in Viral Vector Manufacturing for Cell Therapy
Ken Warrington -
Sr. Director, Business Development,
GenScript ProBio
Since two CAR-T products entered into market in 2017, and three gene therapy products marketed from 2017, gene and cell therapy has made great breakthroughs in recent years. The attention to manufacturing of viral vectors is particularly focused on overcoming challenges in developing stable and scalable manufacturing process. Listen to a presentation around robust viral vector manufacturing processes using both adherent culture and suspension culture processes.
