Upgrade to Pro
— share decks privately, control downloads, hide ads and more …
Speaker Deck
Features
Speaker Deck
PRO
Sign in
Sign up for free
Search
Search
Cellular Therapies: Enabling commercial viabili...
Search
eddieosh
October 27, 2008
Technology
0
77
Cellular Therapies: Enabling commercial viability through integrated automation, AusBio2008
Speaker's presentation at AusBiotech08, Melbourne, Australia. 27th October 2008
eddieosh
October 27, 2008
Tweet
Share
More Decks by eddieosh
See All by eddieosh
Melbourne Agile and Scrum User Group -- Agility Quiz
eddieosh
1
37
Agile Pop Quiz
eddieosh
0
270
Go forth and self-organise! | strategies & tactics for building great teams 1stConf
eddieosh
0
100
Go forth and self-organise! | strategies & tactics for building great teams
eddieosh
1
130
Go forth and self-organise! LAST2017 Canberra
eddieosh
0
700
Go Forth and Self-organise | Strategies & tactics for building great teams
eddieosh
0
270
Psychological Safety -- Foundation of Effective Collaboration. LAST Conference
eddieosh
0
42
Advancing Agility using Lean Coffee, LAST Conference 2016
eddieosh
0
120
My Agile Journey in Progressing an Agile Revolution, 1st Conference 2016-02-15
eddieosh
0
66
Other Decks in Technology
See All in Technology
Webブラウザ向け動画配信プレイヤーの 大規模リプレイスから得た知見と学び
yud0uhu
0
230
Webアプリケーションにオブザーバビリティを実装するRust入門ガイド
nwiizo
6
760
Snowflake Intelligenceにはこうやって立ち向かう!クラシルが考えるAI Readyなデータ基盤と活用のためのDataOps
gappy50
0
110
スマートファクトリーの第一歩 〜AWSマネージドサービスで 実現する予知保全と生成AI活用まで
ganota
1
210
20250910_障害注入から効率的復旧へ_カオスエンジニアリング_生成AIで考えるAWS障害対応.pdf
sh_fk2
3
230
Autonomous Database - Dedicated 技術詳細 / adb-d_technical_detail_jp
oracle4engineer
PRO
4
10k
なぜテストマネージャの視点が 必要なのか? 〜 一歩先へ進むために 〜
moritamasami
0
210
テストを軸にした生き残り術
kworkdev
PRO
0
190
ZOZOマッチのアーキテクチャと技術構成
zozotech
PRO
3
1.5k
RSCの時代にReactとフレームワークの境界を探る
uhyo
10
3.3k
バイブスに「型」を!Kent Beckに学ぶ、AI時代のテスト駆動開発
amixedcolor
2
530
Agile PBL at New Grads Trainings
kawaguti
PRO
1
400
Featured
See All Featured
ピンチをチャンスに:未来をつくるプロダクトロードマップ #pmconf2020
aki_iinuma
126
53k
Being A Developer After 40
akosma
90
590k
Optimising Largest Contentful Paint
csswizardry
37
3.4k
The Pragmatic Product Professional
lauravandoore
36
6.9k
For a Future-Friendly Web
brad_frost
180
9.9k
No one is an island. Learnings from fostering a developers community.
thoeni
21
3.4k
[RailsConf 2023 Opening Keynote] The Magic of Rails
eileencodes
30
9.7k
Code Reviewing Like a Champion
maltzj
525
40k
The Art of Delivering Value - GDevCon NA Keynote
reverentgeek
15
1.6k
[RailsConf 2023] Rails as a piece of cake
palkan
57
5.8k
Rebuilding a faster, lazier Slack
samanthasiow
83
9.2k
Navigating Team Friction
lara
189
15k
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