Article Archives » 2001


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November/December 2001

Biosafety Testing


Discussing biocompatibility methodology and outsourcing


D. Keith Goins, Ph.D.



Vendor's Viewpoint: Biologics Outsourcing


Is there a workable high-growth business model?


Daniel D. Adams



Drug Discovery: Outsourcing Chemistry


How has genomics and proteomics altered the chemistry outsourcing arena?


Gil Y. Roth



October 2001

Managing CRO Selection


How will the rise of specialist intermediary organizations affect the process?


David Cavalla, MA, Ph.D.



The Future of Biogenerics


When will we see legal generics of top biopharmaceuticals?


Dr. Enrico T. Polastro



The Not-So-New Rule


Understanding 21CFR11: How to make sense of the rules on electronic data


Carol Brandt



September 2001

A Time To Build Capacity


As biopharmaceuticals gain FDA approval, where will supply come from?


Sandra Fox, Lynne Sopchak, Ph.D., and Richard Khoury, Ph.D.



Assessing Bioanalytical Services


What to consider when outsourcing this pivotal aspect of drug development


Timothy D.J. Halls, Ph.D.



Regulating the Outsource Provider


How to choose an effective regulatory partner


Evan B. Siegel, Ph.D., and Eri



June 2001

Salary Survey Special Feature


Read the results of Contract Pharma's annual salary survey, as well as reports from other organizations


Gil Roth



Biopharmaceutical Outsourcing


Will a supply crunch hurt this growing market?


Gil Y. Roth



Making the Move to Web- Based Clinical Trials


Technology can trim clinical trial timeframes


Paul Bleicher, M.D., Ph.D



Validation Requirements


Continuing a series on 21CFR11 compliance


Kevin Lloyd



April/May 2001

Contracting with Central Laboratories


It's as much about defining expectations as it is about science, testing and data


Andrew R. Ginsberg



So You Want To Be A Preferred Supplier . . .?


A pharmaceutical industry purchasing manager's perspective


Martin H. Joyce



Clinical Trial Packaging


Effective project planning makes all the difference


Joseph Saccomanno



March 2001

Early Phase Outsourcing


A sponsor discusses the benefits of moving outsourcing earlier in the value chain


Anthony De Stefano



Outsourcing for the Future


Making the transition from a traditional model to a technology-based drug discovery service partner


John L. Flavin, Constance S. Cassidy, Ph.D., Sara Moran, Ph.D., and Ben Schiltz



Conducting an Effective cGMP and Quality Systems Audit


A sponsor's guide to the audit process


Shamik Pandit and Marcia Gartzke



January/February 2001

System Validation Requirements


21CFR11 enables use of electronic records and signatures, but it requires a comprehensive validation program


Kevin Lloyd



Man in Plant: Benefit or Liability?


Should sponsors designate an employee to stay on site at a CMO?


Thomas E. Handel



Contract Packaging, The eMarketplace Way


A new web site helps solve the packaging puzzle


Sarah W. Madley