Productivity and the Economics of Regulatory Compliance in Pharmaceutical Production

11/27/01


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Table of Contents

Productivity and the Economics of Regulatory Compliance in Pharmaceutical Production

Declaring a Few Biases ....

Our Thesis

Improving the Economics of Compliance

Our Business Environment - Tough & Getting Tougher

Shareholder Returns - Falling

R&D Productivity - Falling

Window of Exclusivity - Decreasing

Pharma Manufacturing - Unmet Performance Expectations

Conclusions

Our Findings - Problems Start in Development

EXAMPLE: Parenteral Emulsion

EXAMPLE: SVP Emulsion

What is the Potential for Improvement?

EXAMPLE: Value Added -vs- Non Value Added Process Time

EXAMPLE: See It to Fix It - Value-Added Time Only 3 Days!

Measurement Shows Potential for Improvement

EXAMPLE: Traditional MRP II Measurement - For Accountants.

EXAMPLE: Measuring for Productivity - Reveals Potential

EXAMPLE: Sigma - Getting it Right First Time.

Measure Spread & Variability

Calculating The Purely Business Benefits

A Thought Experiment - 5 Sigma Pharmaceutical Production

Benefits - Increased Effectiveness of Compliance Infrastructure

How this is a Win-Win

Author: Doug Dean