Cellular Therapies: Enabling commercial viability through integrated automation, AusBio2008

Transcript

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