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
Discovery Life Sciences
Charles River

Roundtable Discussion 1:

Battling Bottlenecks, The Capacity Question: Navigating the Shifting Demand and Supply Needs of Advanced Therapy Manufacturing

  • Beyond the anecdotes. How high is current demand for manufacturing capacity and what impact has had this on both the biotech sector and the CDMO industry?
  • The power of the pandemic: What effects – positive or negative – has COVID-19 had on the manufacturing landscape for CGTs, and how is this likely to evolve going forward?
  • What are the options for CGT firms to scale up manufacture? Case studies in opting for inhouse capabilities and/or working with outsourcing partners
  • How has the CDMO space stepped up to support demand, and what does the changing services landscape mean for end-users?

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 Michael Griffin, Product Manager, Global Commercial Development, Cook Myosite

Roundtable Discussion 4: Navigating the Unknown: Unique Challenges of Manufacturing Uncharted Technologies

This session will consider:

  • The unique challenges presented by cell and gene therapy manufacturing and how a contract development and manufacturing organization confronts those challenges
  • Considerations for manufacturing commercial cell and gene therapies

Hosted by Jo Anne Valentino, Chief Operating Officer, Minaris Regenerative Medicine

Roundtable Discussion 5: Choosing Between Templated and Bespoke Processes for Scalable Viral Vector Manufacturing

  • Comparison of accelerated process development using templates versus tailored, full process development
  • Manufacturing in your facility vs. contract development manufacturing organizations (CDMO): How make vs. buy impacts the process
    • Speed to market considerations of CDMO templates vs. legacy processes
    • Speed to market considerations when choosing a template
  • Production formats which are most and least amenable to templating
  • Regulatory risk mitigation and the inflection point where switching a process makes sense

Hosted by Jerry Keybl, Senior Director, Cell & Gene Therapy, Millipore Sigma

Roundtable Discussion 6: Successfully Connecting Patients With Their Personalized Therapies Through Resilient and Scalable End-to-End Supply Chains

With people forming the key links of the cell and gene therapy supply chain, close collaboration between all stakeholders within the CGT ecosystem is critical. The patient holds an especially important and central role in the CGT supply chain while also being the source of key raw material for autologous therapies.

As the personalized therapy changes hands through the supply chain, maintaining strict temperature controls, COI, and COC is paramount all within the short viability window of these products.

High performance logistics plays a vital part of the overall client experience through ensuring on-time and on-spec delivery to the patient all while remaining agile and responsive in a dynamic environment.

How can we successfully manage a global supply chain with such a high degree of inherent variability for each patient treatment?

Primary challenges to overcome: Ensure COI/COC, Scalability, Automation/Integrations, Complex Scheduling, Last-minute changes

  • How can we develop a highly personalized and patient-centric logistics process?
  • How can we scale highly customized processes and commercialize while keeping the patient front of mind?
  • As the CGT industry begins to mature, harmonization and standardization of processes is needed in order to bring these treatments to more patients around the globe. How can we come together to accomplish this challenge?

Hosted by Radmila Feldmann, Patient Centric Supply Chain Solutions for Cell and Gene Therapies, 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: Digitalisation – Implementing a Unified Platform to Enable Transformative Progress for Cell and Gene Therapy Timelines

Join this collaborative session with Matthew Hewitt, B.A., Ph.D., Executive Director, Scientific Services Cell and Gene Therapy, Charles River & Trent Carrier, Ph.D., MBA, Chief Operating Officer, L7 Informatics for a dynamic discussion offering multiple perspectives and strategies in approaching today’s CGT challenges. Topics covered include:

  • Data challenges with CG&T manufacturing (small batch, multi-product, multi-vendor equipment)
  • Integrating end-to-end visibility for the patient journey with manufacturing and analytical testing
  • Strategy for transitioning from traditional data systems to next-generation data systems for scaling
  • Digitalization approaches to balance the need for flexibility and change control in GMP environment

Hosted by Vasu Rangadass, President & Chief Executive Officer, L7 Informatics
&
Matthew M. Hewitt, Executive Director, Scientific Services Cell and Gene Therapy, Charles River Laboratories

Speakers

Jo Anne Valentino
Chief Operating Officer
Minaris Regenerative Medicine
Dan Stanton
Founder and Editor
Bioprocess Insider
Michael Griffin
Product Manager, Global Commercial Development
Cook MyoSite
Dominic Clarke
Chief Technology Officer
Discovery Life Sciences
Radmila Feldmann
Patient-Centric Supply Chain Solutions for Cell and Gene Therapies
Time:Matters
Chris Wegener
Director, Cell Therapy R&D
Fresenius Kabi
Vasu Rangadass
President & Chief Executive Officer
L7 Informatics
Matthew Hewitt
Senior Director, Scientific Services, Cell and Gene Therapy
Charles River