Session Details

Q&O Session 7: Impact of achieving clinical and commercial demand on GMP manufacturing practices in the lab
Saturday, May 30, 2020 03:15 PM - 04:30 PM
Quality & Operations
A surge in clinical trials for cell and gene therapies over the past 5 years is predicted to be impacted by a bottleneck in available capacity for post approval manufacturing.

This panel session will outline the main challenges being faced and discuss areas to be addressed to resolve production bottlenecks:

- Cost effective and timely GMP manufacture for commercialization
- Coordinating and streamlining your manufacturing with accelerated approval pathways
- Importance of facility design
- Securing your manufacturing process
- Leveraging partnerships to timely facilitate translation to the clinic

GMP manufacturing considerations for fast-track development of Cell and Gene Therapies
Angela Osborne, PhD, eXmoor pharma concepts ltd (UK)

The talk will focus on GMP manufacturing considerations to enable the fast-track development of cell and gene therapies in particular:
- Importance of process development and cost considerations.
- EU vs US: don’t get tripped up by the differences in facility GMP requirements and inspection approach
- Modular GMP construction as an option to ensure that design and implementation fits challenging timelines

Working with industry partners, specifically small start up companies choosing academic centers vs CMOs for manufacturing
Linda Kelley, PhD, Moffitt Cancer Center (US)

This talk will focus on leveraging partnerships to facilitate timely delivery to the clinic, both within and external to your institution:
- Industry sponsored projects within academic centers
- Elements of a contracting agreement, including manufacture, quality and technology transfer
- Responsibility for regulatory applications and licensing
- Outsourcing manufacture to CMOs vs academic centers