Research such as the Cell and Gene Therapy Catapult's GMP manufacturing report continues to paint a picture of an industry that is growing in size and capability.
As the industry moves towards commercial realisation, there are a number of areas in which companies must focus, including:
- Preparing for a successful audit
- Quality control
- Data handling
The theme for this years workshop is practical considerations for commercial realisation. The objective is to challenge delegates to think carefully about the about the commercial product, market and process from the outset when developing a cell or gene therapy.
Following the two-day workshop delegates should be able to use this information to inform their process development and manufacturing strategy for clinical trials and routine manufacturing.
Register here
Agenda day 1
| 12:00-12:30 | Registration and lunch |
| 12:30-12:40 |
Welcome Julie Kerby, Director of Industrialisation, CGT Catapult |
| 12:40 - 13:00 |
Industry update and future predictions Dr Stephen Ward, Chief Manufacturing Officer, CGT Catapult |
| 13:00 - 13:30 |
Preparing for a successful audit Liz Allanson, ExPharmaceutical Inspectors Consortium |
| 13:30 - 14:40 |
Data integrity Kasia Averal, Head of Quality Assurance, CGT Catapult |
| 14:40 - 15:00 | Coffee break |
| 15:00 - 15:30 |
Validating disinfection regimes Dr Daria Popova, Lead Technical Scientist, CGT Catapult |
| 15:30 - 15:45 |
Skills and training Dr Kate Barclay, Consultant |
| 15:45 - 16:15 |
Why move to a Grade C background? Seb Hodgkin, VP Quality, Cell Medica |
| 16:15 - 16:40 |
Automation Dr Stephen Shapka, Process Development Automation Engineer, CGT Catapult |
| 16:40 - 17:15 |
PLENARY: Allo PSC based immunotherapy Dr Pete Mitchell, Group Leader, Adaptimmune |
Agenda day 2
| 08:30 - 09:00 | Registration and breakfast |
| 09:00 - 09:10 |
Recap of day one Julie Kerby, Director of Industrialisation, CGT Catapult |
| 09:10 - 09:40 |
PLENARY: Affordability and Innovative Reimbursement Models for Commercial Success Omar Ali, Visiting Lecturer Value Based Pricing University of Portsmouth & Former Adviser to NICE |
| 09:40 - 10:50 |
Quality control TBC |
| 10:50 - 11:15 |
Scheduling materials Nick Page, Chief Operating Officer, Oxford Biomedica |
| 11:15 - 11:35 | Coffee break |
| 11:35 - 12:00 |
In-line technology Dr John Churchwell, Senior Scientist - Industrialisation, CGT Catapult |
| 12:00 - 12:25 |
Data handling Dr Markus Gershater, Chief Scientific Officer, Synthace |
| 12:25 - 12:50 |
Next-generation products Dr Edward Samuel, VP Manufacturing, Achillies Therapeutics |
| 12:50 - 13:50 | Lunch |
| 13:50 - 14:15 |
Viral vector manufacturing Dr Fernanda Masri, Technology Expert for Regenerative Medicine, Sartorius Stedim |
| 14:15 - 14:40 |
AAV next-generation quality control Dr Tony Bou Kheir, Senior Analytical Development Scientist, CGT Catapult |
| 14:40 - 15:05 |
Gene therapy manufacturing Tim Hillyer, Director of GMP Operations, Freeline Therapeutics |
| 15:05 - 15:25 | Coffee break |
| 15:25 - 15:50 |
Downstream processing Dr Quentin Bazot, Viral Vector Scientist, CGT Catapult |
| 15:50 - 16:15 |
CRISPR TBC |
| 16:15 - 16:30 | Wrap up and close |