ISA 2nd process analytical technology conference
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Transcript of ISA 2nd process analytical technology conference
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ISA’s Food and Pharmaceutical Division 2nd Process Analytical
Technology Conference
May 16, 2006
Standards
Certification
Education & Training
Publishing
Conferences & Exhibits By Mike Nager
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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
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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
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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?
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(IBM)
Room to Improve
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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)
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$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
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0
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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
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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
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0%
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2σ 3σ 4σ 5σ 6σ
Yield
Cost of Quality
Quality and the Cost of Quality
0%
10%
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2σ 3σ 4σ 5σ SEMI 6σ
Yield
Cost of Quality
0%
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2σ PHARMA 3σ 4σ 5σ SEMI 6σ
Yield
Cost of Quality
(PWC Consulting)
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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
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Manufacturing Defects
Cost more than just lost batches!
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It’s been done before!
(IBM)
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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?
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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
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• 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.