How do you develop and manufacture a cell therapy that is deliverable? What does it take to make a cell therapy commercially viable? To do so, it must be transformative, have a robust manufacturing process, use the right business model, have an optimal cost of goods, be scalable, be logistically practical, be clinic-friendly and be reimbursable. With other experts from PCT, I will be discussing these and many other issues related to cell therapy manufacturing at two conferences later this month:
Terrapinn World Stem Cells Regenerative Medicine Conference
Business Design Centre, London
Scale to survive: The future of cell therapy
Wednesday, May 18, 2016, 14:50 – 15:15
Robert Preti, PhD, President
- When is the right time to consider scale during the development of cell therapies?
- Building clean room capacity: Your enemy or your friend?
- What is the relation of process optimization and automation to scale?
- How will scale and cost of goods impact your product’s commercial viability?
International Society for Cellular Therapy Annual Meeting
Suntec Convention and Exhibit Centre, Singapore
Innovation for Hire: Contract Development in Cell Therapy
Thursday, May 26, 2016, 07:30 – 08:30
Ian Gaudet, PhD, Director, Innovation & Engineering
- Understand the development pathway from an early phase process coming from academia to a mature, cGMP process in pivotal clinical trial manufacturing environment
- Appreciate the paradigm shift in going from fundamental scientific research to supporting the business needs of a fledgling cell therapy
- Build a forum for discussion of how academia and industry can more effectively collaborate and achieve mutually beneficial engagement
Panel: Managing Challenges to Achieve Optimal Cost of Goods
Friday, May 27, 2016, 07:30 – 08:30
Ian Gaudet, PhD, Director, Innovation & Engineering—Overcoming the Cost of Goods Challenge for Patient-Specific Cell Therapy Manufacturing
- The current state of cell therapy manufacturing leads to unsustainable direct COGs.
- Idle capacity in manufacturing facilities drives indirect COGs to unreasonable levels.
- A combination of the right business model and automation can realize true economies of scale and lead to industrialization of PSCT.
- Also speaking on this panel is Timothy Oldham, CEO at Cell Therapies Pty Ltd, discussing “COGS by design: a systems approach to achieving commercially viable cellular therapy products”
A case study on establishing a global commercial enterprise for cell therapy manufacturing
Friday, May 27, 2016, 10:45 - 12:15
George Goldberger, Vice President, Business Development
- PCT and Hitachi Chemical partnership to create a global commercial enterprise for cell therapy manufacturing with deep engineering expertise
- Licensing technology and know-how to launch Hitachi-PCT in Asia
- Aim to develop automated facilities with support from Hitachi Group
