Sessions

Roundtable Discussions
Where Are We Now and Where Are We Heading? Cell and Gene Therapy in 2022

Roundtable Discussions

27 Jan 2022
09:30
Plenary Room
SPONSORED BY
Cook MyoSite
Fujifilm Irvine Scientific
Minaris Regenerative Medicine
Gemini Bio-Products
Time:Matters
Bioprocess Insider
Fresenius Kabi
L7 Informatics
MilliporeSigma

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

Speakers

Jo Anne Valentino
Chief Operating Officer
Minaris Regenerative Medicine
Dan Stanton
Founder and Editor
Bioprocess Insider