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CAMP. Quality by Design: A Challenge to the Pharma Industry. CAMP Member Companies March 2002. Ageing populationurgent need for new medicines & greater use of pharmaceuticals. BUT. Increasing healthcarepressure to reduce use costs(and price) of pharmaceuticals. - PowerPoint PPT Presentation
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Quality by Design: A Challenge to the Pharma Industry
CAMP Member Companies March 2002
CAMP
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BUTBUT
More informed payersMore informed payers greater need to demonstrategreater need to demonstrate& consumers& consumers health and economic valuehealth and economic value
Increasing healthcareIncreasing healthcare pressure to pressure to reducereduce use usecostscosts (and price) of pharmaceuticals(and price) of pharmaceuticals
Ageing populationAgeing population urgent need for new medicines urgent need for new medicines & greater use of pharmaceuticals& greater use of pharmaceuticals
The Changing Healthcare Scene &Impact on the Pharmaceutical Industry
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Pressure comes in many forms…External pressures
diseases shareholders special interest groups governmental agencies
Internal pressures pipeline speed to market cost of goods consolidation & merger savings continuity of supply
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These pressures have driven innovation …
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Supercompression of Drug Discovery
R
Informatics &
Databases
Robotics
Biotechnology
Combinatorial
Chemistry
Genetics
Cell & Molecular
Sciences
Computer &
Inform. Technology
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The typical pharmaceutical business model
R&DR&D ManufacturingManufacturing MarketingMarketing
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V Blenders
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Slant Cone Blenders
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Granulators
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Are manufacturing costs significant?
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36
16
7
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Taxes
R&D
Cost ofsales
S&GA
Total sales > $ 300 Bn
Total costs ~ $ 250 Bn
COS > $ 90 Bn
Cost Distribution: Big Pharma (16 Companies)
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Where are the Quality and Financial Opportunities?
$45 Bn in materials
$22.5 Bn in personnel costs
$22.5 Bn in dep and operating
MaterialEmploymentMaint & UtilDepreciation
50%
25%
15%
10%
Manufacturing Costs:Big Pharma
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The result of today’s manufacturing processes:
Large inefficient batch equipmentLow utilization 30 - 40 % on averageCapital and labor intensiveHigh inventories and excessive warehouse spaceElaborate HVAC and mechanical segregationHigh transportation costsHigh operating costsLow product yieldsExcessive amounts of product non-conformancesLong lead-times due to stage and final product testing
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Main points from this:
High tech in R & D
Relatively low tech in Manufacturing
It mattersBig Pharma manufacturing costs are $ 90 BnSignificantly more than R&D
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How can we make a difference?
Technology exists Near infra-red Laser induced fluorescence Continuous processing
On line monitoring and control to improve quality Minimize troubleshooting and investigation systems Prevent rather than repair
Financial drivers are strong 1% yield improvement = $400 million in savings
There are significant barriers Cultural Organizational Historical
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Opportunities
Closer links between R&D and Mfg.
Develop and design manufacturing scale processes … before registration
On line measurement and control
Continuous processing
Product plants … not component plants
Small dedicated facilities
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The future vision pharmaceutical business model
R&DR&D ManufacturingManufacturing MarketingMarketing
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PROCESS DESIGN &
ENGINEERING
PILOT PLANT
& CT MATERIAL
GLOBAL SOPs and
VALIDATION PROTOCOLS
EQUIPMENT SELECTION
AND LAYOUT DESIGN
MOLECULE
LABORATORY
SCALE PROCESS
Process for new products
Engineering and Operational Excellence
Commercial
Devices
Registration process
Roll out to sites with turnkey package
Pro
ject
Man
agem
ent MANUFACTURING
SCALE PROCESS
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Today: A challengeNeed a paradigm shift
Barriers are challenging
Environment is ready to improve quality, shorten time to market and reduce costs
Will we take the step???
