Cellular Therapies: Enabling commercial viability through integrated automation, AusBio2008

Speaker's presentation at AusBiotech08, Melbourne, Australia. 27th October 2008

1. Devices & Drugs – the new marriage Cellular Therapies: Enabling commercial viability through integrated automation Edmund O’Shaughnessy Manufacturing Innovation © 2008 Invetech Pty Ltd
2. Basic & Applied Research Business Creation Managing a going concern ‘From Science to Profits’ ‘From science project to profitable business’, © Richard G. Caro, 2004
3. ‘You can’t get there from here sir!’
4. ‘The Innovation Continuum’ ‘From science project to profitable business’, © Richard G. Caro, 2004 Basic research Directed research Product research Product development Market adoption Discovery Stage Business Creation Stage ?
5. ‘The Process is the Product’ http://www.fda.gov/cder/biologics/qa.htm
6. What regulatory requirements must I meet? How can I scale my process for volume production?
7. Fully automated clinical processing platform manipulating patient derived molecular materials in single- use devices
8. Hold your horses!
9. A Cost Model can help direct development priorities and generate investment scenarios Design concept estimates Patient volumes Process timings Market projections Scale-up timelines Capital Investment Scenarios Staffing levels Cost Of Tests Cost Of Goods Manual/Automation cross-over Breakeven points
10. Justifying Automation 0 50 100 200 400 800 1,600 3,200 5,000 7,000 10,000 Patients per year processed Cost per patient Manual Semi Automated Fully Automated
11. Capacity Planning Market prediction Planned capacity Cumul capital Schedule Capital Investment ($'000) Devices/month
12. Start early with your regulatory requirements
13. Risk-driven Design
14. Putting the pieces together
15. In Summary
16. Know your process
17. Be a parrot! ‘What are the risks, what are we doing about them?’
18. The Regulator is not the enemy
19. Automation is your friend
20. Get the money!
21. People want you to succeed
22. Thank you for your attention Any questions? Edmund O’Shaughnessy Manufacturing Innovation Images used in this presentation from iStockphoto.com, not for reuse or resale