Article Archives » 2008


Archives

2010

2009

2008

2007

2006

2005

2004

2003

2002

2001

2000

1999

November/December 2008

Outsourcing Stability Programs


Strategies for success


Stephen P. Mayock and Anita Koltay



Understanding Excipient Interfaces


Regulatory drivers for testing to better predict attributes


Andrew Parker, Ph.D.



API Risk Communication Case History


Building a potent compound matrix to communicate with CMOs


Jim Lieberman, CIH



Vaccine Viewpoint


Michael Kowolenko of Wyeth talks about the convergence of vaccines and biotech


Gil Roth



October 2008

Making Outsourcing Work


What are the best practices for you?


Patrick Kager



Success with Tech Transfer


Mastering the art of moving to a CMO


Mike Power



USP Changes


Are you ready?


John Daniels



Embracing Quality by Design


Applying QbD concepts can help CMOs create value


Russ Somma, Ph.D. and Andrew A. Signore, PE, PMP-DBIA, CPIP



The Myths of Operational Excellence


Where companies go wrong and how they can go right


Chris Driscoll



Considerations for Choosing a CMO


Build criteria for the best outsourcing experience


Sarah Crossman and Jeanne Lawson



September 2008

Selecting a Contract Manufacturer


Choosing a supplier that will satisfy your expectations


Mike Parry



Outsourcing Cytotoxics & Highly Potent Parenterals


The economics of choosing a CMO are changing


Burkhard Wichert, M.D., Mike Borlet and Raul Soikes



On the Fast Track


Project management and FDA interaction when an NDA is Fast Tracked


Gary A. Baker and Vince Ammoscato



Global Risk Management


The changing safety landscape in the EU and U.S.


Peter Summerfield and David Shoemaker



Sourcing APIs in Emerging Nations


Guidelines for new supply chains


Chris Merchant and Lynn Rideout



July/August 2008

2008 Top 20 Pharmaceutical Companies Report



Newsmaker Interview: Tony J. Maddaluna, Pfizer Global Manufacturing


Gil Roth



2008 Top 10 Biopharmaceutical Companies Report



Online Exclusive: Commentary on CRL accident


Steve Snyder



June 2008

2008 Annual Salary Survey


Gil Y. Roth



CRO Asia Pacific Expansion


Risk and reward


Kristin Brooks



Clinical Research Outsourcing


Moving from transactional to strategic partnership-based outsourcing


Kenneth Getz and Rachael Zuckerman



Clinical Trial Supply Chain Management


Making the leap from commercial to clinical


RS Kumar



Lean Outsourcing


A lean approach to compliance


John Avellanet



CRO Central Lab Expansion


Market demand broadens bundled services


Kristin Brooks



Adaptive Trial Design and IVRS


IVRS becomes a valuable tool


Edward Montoya



Online Exclusive: Strategic Partnering Supplement


Covance, Inc.



May 2008

2008 Annual Outsourcing Survey


Gil Roth



Biopharma CMO Market Report


Optimism is high among bio-contract manufacturers


William Downey



Paradigm Change in Bio-Manufacturing


Technology is transforming manufacturing options


Donald F. Gerson



Bio-Capacity in 2012


The outlook is bright for CMOs


Eric S. Langer



Thinking Inside the Box


CMOs work to contain high potency biologics and APIs


Cindy Dubin



Responding to a WARNING LETTER


Part 2 of 2 on what to do when the FDA sends you a letter


Shamik Pandit



Complying with Track and Trace


Biogen Idec blazes a path to California compliance


Stephen Barlas



April 2008

Achieving Agility in Contract Manufacturing


Criteria for thriving in the new era


Michael W. Cislo



Site Lines: Midwest U.S.


Contract Services Providers are finding homes in Indiana and other midwestern states


David L. Johnson



Supply Chain Dynamics


Cutting-edge systems strengthen the pharma production supply chain


Simon Kaye



Intellectual Property Protection


Joint Development Agreements can protect outsourced IP


John Avellanet



Anatomy of a WARNING LETTER: Part 1


Part 1 of 2 on what to do when the FDA sends you a letter


Shamik Pandit



Online Exclusive: Courting Controversy - Part II


AstraZeneca continues to send mixed messages about its long-term API sourcing strategy


Joanna Cosgrove



March 2008

The Role of CMC In Early Trials


Time, quality and budget form the decision matrix


Selma Djukic



CRO Market View


What lies ahead of the curve?


Brad Anderson



Contract Manufacturing Competition


Are strategic outsourcing plans in development?


Hussain Mooraj and Fenella Sirkisoon



Continuity and Connectivity: We Can Do That, Too


Are CDMOs the Next Big Thing?


Tom Spurgeon



Pharmaceutical Sterility Testing


Essential things to know


Steven Richter



January/February 2008

Consolidation in Outsourcing


Reviewing 2007's transactions and the trends they portend


Michael Martorelli



Opportunities Beyond Cost Savings


Maximizing the Strategic Value of Global R&D Outsourcing


Partha Ghosh and Kimberlee Luce



The Epicenter of Cold Chain Management


The Parenteral Drug Association plays a critical role


Kevin O\'Donnell



Vaccine Viewpoint: Emilio A. Emini


Wyeth's vaccine R&D head talks about vaccines past and future


Gil Y. Roth



Online Exclusive: Bringing it back to the States


Does WuXi's acquisition of AppTec signal contract manufacturing's return to the US?


Joanna Cosgrove