BioPharm International-11-01-2002

BioPharm International

Outsourcing Outlook: Will CROs find opportunity in a Reinvigorated European R&D Sector?

November 15, 2002

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by Jim Miller and Janet Lowenbach, PharmSource Information Services The EU must harness market forces that reward innovation and competitiveness to combat its current R&D drain.

Inside Washington: Major Changes Ahead for FDA

November 15, 2002

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by Jill Wechsler A new FDA commissioner will have to oversee agency consolidation and new initiatives to counter bioterrorism.

Bioinformatics Databases ? Questions of Copyright

November 15, 2002

Passing Inspections & Protecting Your Work

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by Elizabeth Howard and Gabriel Ramsey, Orrick, Herrington & Sutcliff With some planning, you can use intellectual property laws to adequately protect the wealth of data stored in your databases. Those valuable data may not be copyrightable, but the software used to store them is.

European Editor's Report ? An Industry Comes of Age

November 15, 2002

BioPharm Scale-Up: Going International

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by Kevin Robinson, BioPharm International As we approach the end of 2002, biotechnology companies continue to be the standard bearers for innovation in the pharmaceutical industry.

Guest Editorial: Back to the Beginning

November 15, 2002

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by Stefan Schuber, U.S. Pharmacopeia

Employing Near-Infrared Spectroscopic Methods of Analysis for Fermentation Monitoring and Control: Part 1, Method Development

November 15, 2002

Better Fermentation Control

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by S. Alison Arnold, Linda M. Harvey, and Brian McNeil from the Strathclyde Fermentation Center, Strathclyde, Scotland; and Jeffrey W. Hall, Foss NIRSystems Although rarely available, timely process information about fermentation biomass, substrates, intermediates, and nutrients is required to make control decisions. NIR spectroscopy offers the opportunity to improve fermentation processes by incorporating rapid, nondestructive, multiconstituent analyses of fermentation broth media directly into fermentation monitoring and control strategies.

You Have Failed . . . A Case Study in Warning Letter Remediation

November 15, 2002

Passing Inspections & Protecting Your Work

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by Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.

Survival Guide to FDA Inspections: Part 3, Responding to Observations

November 15, 2002

Passing Inspections & Protecting Your Work

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by Massoud Lavian and Paul W. Allen, Clarkston Consulting

Analytical Advances: The Protein ID Autobahn ? Automated Nanoelectrospray Mass Spectrometry

November 15, 2002

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by Gary Schultz, Advion BioSciences