isa 2nd process analytical technology conference
TRANSCRIPT
ISA’s Food and Pharmaceutical Division 2nd Process Analytical
Technology Conference
May 16, 2006
Standards
Certification
Education & Training
Publishing
Conferences & Exhibits By Mike Nager
Source: ISA Roster
ISA’s Food and Pharmaceutical Division – Key Benefits
Over 1600 automation professionals in the Pharmaceutical, Food, and Packaged Consumer Products fields.
Key issues of validation, PAT, packaging safety, aseptic processing, clean rooms, cGMPs. Also:
• Peer and Business Networking• Education and Professional Development
Spain, 13
Canada, 11
China, 7
Mexico, 6
Japan, 56
USA, 233
Germany, 29France, 27UK, 19Italy, 18
Source 2/2005 Scrip Magazine
$608B World Pharmaceutical Market
75% → Pharma revenue to face generic competition (Datamonitor)
70% → Drugs that won’t recoup development costs (PHRMA)
40% → Equipment Utilization Rate (FDA)
25% → Manufacturing costs as part of revenue (FDA)
18% → Pharma profit margin vs 4.5% for CPG (FDA)
15% → Utilization level of manufacturing cap. (FDA)
5-15% → Scrap Rate(IQPC) @ $3.5M/batch(AMR)
Pharmaceutical IndustryWhere are we today?
(IBM)
Room to Improve
0 2 4 6 8 10
Cox-2 Inhibitors 1999
Invirase 1995
Rocombinate 1992
Difulcan 1990
Mevacor 1987
AZT 1987
Seldane 1985
Prozac 1985
Capoten 1980
Tagemet 1977
Inderal 1968
Top Line Pressure from Competition & Generics – End of the Blockbuster
(PWC Consulting)
$49B → 2004 R&D Spending (PHRMA)
$25B → ’00-’04 Lost Revenue Patent expiration (Forrester)
$15B → 2005 Lost Revenue Patent expiration (Forrester)
$30B → Lost Revenue due counterfeiting (WHO)
$16B → 2005 Free Samples (PHRMA)
1.2B → Average number of records per company (IMS)
Bottom Line ErosionProfits under Pressure
0
1000
2000
3000
4000
5000
6000
7000
8000
90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05
Just one added cost:Pharma Direct to Consumer Advertising
Business Insights
200 → Days of inventory in pharma supply chain (AMR Research)
60 → Days of inventory in CPG supply chain (AMR Research)
25 → Average number of transfer points in supply chain between manufacturer and consumer (IMS)
Pharmaceutical IndustryNumbers
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2σ 3σ 4σ 5σ 6σ
Yield
Cost of Quality
Quality and the Cost of Quality
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2σ 3σ 4σ 5σ SEMI 6σ
Yield
Cost of Quality
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2σ PHARMA 3σ 4σ 5σ SEMI 6σ
Yield
Cost of Quality
(PWC Consulting)
74% → Execs who believe the need to improve operational excellence is paramount (MBT Magazine)
$12.5M → Amount a $5B pharma company will save by reducing manufacturing costs 1%( MBT Magazine)
$4.6B → Savings of top 10 pharma companies if improved from 2.5 Sigma to 5.5 Sigma (faster to market,
faster inventory turns and capital cost reductions) ( Phillipe Cini, Tunnell Consulting)
$10B → Savings top 30 companies would save by achieving 4.5 Sigma (IBM)
Savings Potentials
Manufacturing Defects
Cost more than just lost batches!
It’s been done before!
(IBM)
It’s a system to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
Source: FDA
Why Process Analytical Technology?
ISA has the expertise to help pharmaceutical and biotech companies increase manufacturing efficiencies to meet today’s market challenges of increasing costs and downward pressure on sales.
Conclusion
• Process Analyzers and sensors to provide process ‘signatures’
• Process Control used to ‘steer’ final products towards their desirable end-points
• Multivariate mathematical tools for simulation, statistical design, pattern recognition
• Knowledge Management for continuous process improvement
The Four Tools of P.A.T.Now Alex Habib will introduce P.A.T.