Where Are We Now and Where Are We Heading? Cell and Gene Therapy in 2022
Roundtable Discussion 1
Hosted by Dan Stanton, Founder and Editor, BioProcess Insider
Roundtable Discussion 2: Understanding of the Principles of Cryopreservation and How They Impact Cell & Gene Therapy Development and Subsequent Manufacturability
Discuss key components to cryopreservation process from source materials to cell banks to final product
- Areas for optimization
- Reagent quality and relevant regulations
- Steps towards standardization
Hosted by Dominic Clarke, Chief Technical Officer, for Cell & Gene Therapies at Discovery Life Sciences
Roundtable Discussion 3: Treatment Development Paradigm for Quality of Life conditions: Regulatory Considerations & Collaborative Ecosystem
- “Just” QOL – call to re-examine the attention and nomenclature towards life-altering conditions.
- Fast track/accelerated approval standards for life-altering vs. life-threatening conditions – how can we build a path to ensure equitable considerations?
- Potential impact to future investments for the development of treatments for life-altering conditions in current regulatory landscape.
- Getting started – how can conferences like this also promote a “Collaborative Ecosystem” for life-altering disorders?
Hosted by Ryan Pruchnic, Managing Vice President, Cook Myosite
Roundtable Discussion 4
Hosted by Jo Anne Valentino, Chief Operating Officer, Minaris Regenerative Medicine
Roundtable Discussion 5
Hosted by Millipore Sigma
Roundtable Discussion 6: Patient Centricity And The Improvement Of The Entire End-To-End Supply Chain
Hosted by Time:Matters
Roundtable Discussion 7: Exploring Bedside Autologous CGT Manufacturing
- Allogeneic therapies (in concept) have a huge economic advantage over autologous therapies. What does the future of autologous therapies need to look like in order to make economic sense?
- What portions of the manufacturing workflow are amenable to be done at the point of collection?
- What technology gaps need to be overcome to enable more/all of the CGT workflow to occur at the point of collection? At the bedside?
- What biology gaps need to be overcome to enable more/all of the CGT workflow to occur at the point of collection? At the bedside?
- What are the limitations of bedside QC release? Does this change if you view the therapy as a procedure instead of a single-dose drug?
Hosted by Chris Wegener, Director, Cell Therapy R&D, Fresenius Kabi
Roundtable Discussion 8
Hosted by L7 Informatics