Download - CAMP Member Companies March 2002
![Page 1: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/1.jpg)
1
Quality by Design: A Challenge to the Pharma Industry
CAMP Member Companies March 2002
CAMP
![Page 2: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/2.jpg)
2
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
![Page 3: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/3.jpg)
3
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
![Page 4: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/4.jpg)
4
These pressures have driven innovation …
![Page 5: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/5.jpg)
5
Supercompression of Drug Discovery
R
Informatics &
Databases
Robotics
Biotechnology
Combinatorial
Chemistry
Genetics
Cell & Molecular
Sciences
Computer &
Inform. Technology
![Page 6: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/6.jpg)
6
The typical pharmaceutical business model
R&DR&D ManufacturingManufacturing MarketingMarketing
![Page 7: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/7.jpg)
7
V Blenders
![Page 8: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/8.jpg)
8
Slant Cone Blenders
![Page 9: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/9.jpg)
9
Granulators
![Page 10: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/10.jpg)
10
Are manufacturing costs significant?
41
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)
![Page 11: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/11.jpg)
11
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
![Page 12: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/12.jpg)
12
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
![Page 13: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/13.jpg)
13
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
![Page 14: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/14.jpg)
14
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
![Page 15: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/15.jpg)
15
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
![Page 16: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/16.jpg)
16
The future vision pharmaceutical business model
R&DR&D ManufacturingManufacturing MarketingMarketing
![Page 17: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/17.jpg)
17
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
![Page 18: CAMP Member Companies March 2002](https://reader036.vdocuments.mx/reader036/viewer/2022062410/56815ad0550346895dc8a3e2/html5/thumbnails/18.jpg)
18
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???