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Cellular Therapies: Enabling commercial viability through integrated automation, AusBio2008
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eddieosh
October 27, 2008
Technology
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66
Cellular Therapies: Enabling commercial viability through integrated automation, AusBio2008
Speaker's presentation at AusBiotech08, Melbourne, Australia. 27th October 2008
eddieosh
October 27, 2008
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Transcript
Devices & Drugs – the new marriage Cellular Therapies: Enabling
commercial viability through integrated automation Edmund O’Shaughnessy Manufacturing Innovation © 2008 Invetech Pty Ltd
Basic & Applied Research Business Creation Managing a going concern
‘From Science to Profits’ ‘From science project to profitable business’, © Richard G. Caro, 2004
‘You can’t get there from here sir!’
‘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 ?
‘The Process is the Product’ http://www.fda.gov/cder/biologics/qa.htm
What regulatory requirements must I meet? How can I scale
my process for volume production?
Fully automated clinical processing platform manipulating patient derived molecular materials
in single- use devices
Hold your horses!
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
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
Capacity Planning Market prediction Planned capacity Cumul capital Schedule Capital
Investment ($'000) Devices/month
Start early with your regulatory requirements
Risk-driven Design
Putting the pieces together
In Summary
Know your process
Be a parrot! ‘What are the risks, what are we
doing about them?’
The Regulator is not the enemy
Automation is your friend
Get the money!
People want you to succeed
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