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CAMP. Quality by Design: A Challenge to the Pharma Industry. CAMP Member Companies March 2002. Ageing population urgent need for new medicines & greater use of pharmaceuticals. BUT. Increasing healthcare pressure to reduce use costs (and price) of pharmaceuticals.

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camp member companies march 2002

CAMP

Quality by Design: A Challenge to the Pharma Industry

CAMP Member Companies March 2002

the changing healthcare scene impact on the pharmaceutical industry

Ageing population urgent need for new medicines & greater use of pharmaceuticals

BUT

Increasing healthcare pressure to reduce use

costs (and price) of pharmaceuticals

More informed payers greater need to demonstrate

& consumers health and economic value

The Changing Healthcare Scene &Impact on the Pharmaceutical Industry
pressure comes in many forms
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
supercompression of drug discovery

Cell & Molecular

Sciences

R

Robotics

Genetics

Combinatorial

Chemistry

Computer &

Inform. Technology

Informatics &

Databases

Supercompression of Drug Discovery

Biotechnology

are manufacturing costs significant
Are manufacturing costs significant?

Cost Distribution: Big Pharma (16 Companies)

  • Total sales > $ 300 Bn
  • Total costs ~ $ 250 Bn
  • COS > $ 90 Bn
where are the quality and financial opportunities
Where are the Quality and Financial Opportunities?

Manufacturing Costs:

Big Pharma

  • $45 Bn in materials
  • $22.5 Bn in personnel costs
  • $22.5 Bn in dep and operating

10%

15%

50%

25%

the result of today s manufacturing processes
The result of today’s manufacturing processes:
  • Large inefficient batch equipment
  • Low utilization 30 - 40 % on average
  • Capital and labor intensive
  • High inventories and excessive warehouse space
  • Elaborate HVAC and mechanical segregation
  • High transportation costs
  • High operating costs
  • Low product yields
  • Excessive amounts of product non-conformances
  • Long lead-times due to stage and final product testing
main points from this
Main points from this:
  • High tech in R & D
  • Relatively low tech in Manufacturing
  • It matters
    • Big Pharma manufacturing costs are $ 90 Bn
    • Significantly more than R&D
how can we make a difference
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
opportunities
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
slide16

R&D

The future vision pharmaceutical

business model

Marketing

Manufacturing

slide17

Commercial

MOLECULE

Devices

LABORATORY

SCALE PROCESS

PROCESS DESIGN &

ENGINEERING

MANUFACTURING

SCALE PROCESS

Engineering and Operational Excellence

PILOT PLANT

& CT MATERIAL

EQUIPMENT SELECTION

AND LAYOUT DESIGN

GLOBAL SOPs and

VALIDATION PROTOCOLS

Process for new products

Project Management

Registration process

Roll out to sites with turnkey package

today a challenge
Today: A challenge
  • Need a paradigm shift
  • Barriers are challenging
  • Environment is ready to improve quality, shorten time to market and reduce costs
  • Will we take the step???
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