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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 l.jpg

CAMP

Quality by Design: A Challenge to the Pharma Industry

CAMP Member Companies March 2002


The changing healthcare scene impact on the pharmaceutical industry l.jpg

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 l.jpg
Pressure comes in many forms… use of pharmaceuticals

  • 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 l.jpg

Cell & Molecular use of pharmaceuticals

Sciences

R

Robotics

Genetics

Combinatorial

Chemistry

Computer &

Inform. Technology

Informatics &

Databases

Supercompression of Drug Discovery

Biotechnology


The typical pharmaceutical business model l.jpg

R&D use of pharmaceuticals

The typical pharmaceutical business model

Marketing

Manufacturing


V blenders l.jpg
V Blenders use of pharmaceuticals


Slant cone blenders l.jpg
Slant Cone Blenders use of pharmaceuticals


Granulators l.jpg
Granulators use of pharmaceuticals


Are manufacturing costs significant l.jpg
Are manufacturing costs significant? use of pharmaceuticals

Cost Distribution: Big Pharma (16 Companies)

  • Total sales > $ 300 Bn

  • Total costs ~ $ 250 Bn

  • COS > $ 90 Bn


Where are the quality and financial opportunities l.jpg
Where are the Quality and use of pharmaceuticalsFinancial 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 l.jpg
The result of today’s use of pharmaceuticalsmanufacturing 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 l.jpg
Main points from this: use of pharmaceuticals

  • 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 l.jpg
How can we make a difference? use of pharmaceuticals

  • 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 l.jpg
Opportunities use of pharmaceuticals

  • 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 l.jpg

R&D use of pharmaceuticals

The future vision pharmaceutical

business model

Marketing

Manufacturing


Slide17 l.jpg

Commercial use of pharmaceuticals

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 l.jpg
Today: A challenge use of pharmaceuticals

  • 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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