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
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
