BioPharm International, August 2009 (PDF)
Pfizer Tackles Lean and Six Sigma
Use of Change-Point Analysis for Process Monitoring and Control
A better method for trend analysis than CUSUM and control charts.
Analytical Tools for Process and Product Characterization
Select the best approach to determine critical quality attributes.
Laying the Foundation
Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.
Garbage In, Garbage Out: The Case for More Accurate Process Modeling in Manufacturing Economics
A case study in capturing indirect costs and benefits.
Embedding a Culture of Continuous Improvement & Lean Manufacturing Across Pfizer Global Manufacturing
Enabling site-wide process efficiency.
Recent Patent Rulings Can Impede the Progress of Personalized Medicine
The Bilski and Classen decisions can render numerous in vitro diagnostic claims unpatentable.
Waiting for Godot: Will Venture Funding Return?
Contract research, development, and manufacturing organizations betting on a comeback in venture capital financing will have a long wait.
Health Reform Challenges Biotech Industry
Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.
Avoiding the Regulatory Catch 22
Companies often wait for a critical mass before adopting new technologies. But if no one takes the risk, critical mass will never be reached.