Sessions

Arriving at your Cell & Gene Therapy Destination: Navigating the Many Journeys Within the Journey
Standardising Raw Materials to Reduce Outcome Variability
Building an Effective Supply Chain/Temperature-Controlled Therapeutics
Collection Centers of the Future: Standardisation and Optimising Apheresis for Quality Control
Patient-Centric Development – Supporting Improved Patient Outcomes

Arriving at your Cell & Gene Therapy Destination: Navigating the Many Journeys Within the Journey

27 Jan 2022
11:00
SPONSORED BY
Charles River

Attendees will learn from industry experts about:

  • Current & future state of the cell and gene therapy development and manufacturing
  • Comprehensive thinking and approaches central to success
  • Potential bottlenecks and pre-emptive  solutions
  • Critical considerations in facility design
  • Evolving regulatory landscape and the dynamics specific to cell and gene therapies

11:00 Chairperson’s Opening
Matthew Hewitt, Executive Director, Scientific Services, Cell and Gene Therapy Charles River

11:05 Best Practices and Standards – Road Maps for the Cell Therapy Journey

  • The rationale for best practices and standards in Cell Therapy Manufacturing
  • Project A-Cell
  • Current examples of standardization efforts

Michael Lehmicke, Senior Director, Science and Industry Affairs, Alliance for Regenerative Medicine

11:20 Tissue Specific Delivery and Expression of Viral Vectors

  • Evaluating novel gene therapy treatment modalities for rare disease
  • Overcoming the manufacturing bottleneck and streamlining the regulatory path
  • Developing a business model with rare disease in mind

Farzin Farzaneh, Chief Scientific Officer, ViroCell Biologics

11:35 The Facility Evolution of Small-Scale Cell Therapy

  • Overview on the evolution of autologous facility design: the history, what’s happening right now, and what’s next
  • Effective and efficient design considerations for scaling out autologous cell therapy
  • Facility strategies to save on square footage and cost

Peter Walters, Director, Advanced Therapies, CRB

11.50 Strategic Planning to Successfully Navigate the Challenges

  • Program awareness of challenges with multi-focused programs
    • Objectives of autologous vs. allogeneic programs and associated concerns
    • Target disease indications
    • Multi-use facility design and process flow
  • Streamlining process optimizations & changes with integration of QbD & internal process controls
    • CMC expectations
    • Effective comparability studies

Donna Rill, Chief Technology Officer, Triumvira Immunologics, USA Inc

12:05 Speaker Q&A and Panel Discussion

Speakers

Matthew Hewitt
Senior Director, Scientific Services, Cell and Gene Therapy
Charles River
Michael Lehmicke
Senior Director, Science and Industry Affairs
Alliance for Regenerative Medicine
Farzin Farzaneh
Chief Scientific Officer & Co-Founder
ViroCell Biologics
Donna Rill
Chief Technology Officer
Triumvira Immunologics