Article Archives » 2007


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November/December 2007

Assessing Potent Compound Safety Capabilities at CMOs


Applying the systematic approach


Allan W. Ader, Ph.D., DABT, John P. Farris, CIH and Robert G. Sussman, Ph.D., DABT



The High Cost of Selecting a Low-Cost 3PL Provider


Putting cost over quality can damage the supply chain


Dwayne Marcum and Bryan Hudson



Bioanalytical Outsourcing


What factors affect outsourcing decisions?


Anthony J. DeStefano and Stephen Lowes



Stability Optimization


Navigating the maze of container/closure systems


Kelly Lin and Andrea Wagner



Online Exclusive: CMC Puts Down U.S. Roots


Acquisition of ICOS Biologics Operation Gives CMC a U.S. Footprint


Joanna Cosgrove



October 2007

Building a Quality Formulation


The challenge of time vs. risk


Cindy H. Dubin



Executive Interview: Robert Maguire of Wyeth R&D


Building a pipeline means building a new clinical model


Gil Roth



Asian Outsourcing: Getting It Right


Choosing an outsourcing business structure that ensures successful outcomes


Daniel Bartholomew and Matthew Shocklee



Lean Practices in a Life Sciences Organization


Lean Six Sigma may help pharma manufacturers improve performance, increase operational efficiency and ensure quality


John Danese and Dennis Constantinou



September 2007

Outsourcing Analytical Testing


Price is less important than quality


Cindy H. Dubin



Parenteral Packaging Concerns


Biotherapeutics have unique demands


Frances L. DeGrazio



Biomarkers: Safety, Speed by Design


Learn to select markers -- and providers -- appropriately


Gordon Kapke, Ph.D.



Contracting Research: Criteria to Live By


How do we develop best practices for CRO partnerships?


Jeffrey Steinberg and Karoline Dubiel



Online Exclusive: Bigger is Better


Aptuit acquires Evotec to broaden its suite of drug development services


Joanna Cosgrove



Online Exclusive: Courting Controversy?


AZ exec makes waves with outsourcing comments, company clarifies


Joanna Cosgrove



July/August 2007

2007 Top 20 Pharmaceutical Companies Report


Gil Roth



2007 Top 10 Biopharmaceutical Companies Report


Gil Roth



Online Exclusive: India Report


S. Harachand



Online Exclusive: Heeding the Call of India


Joanna Cosgrove



Online Exclusive: Merck Acquires NovaCardia


The deal adds more clout to the pharmaceutical heavyweight's cardiovascular pipeline


Joanna Cosgrove



Online Exclusive: AFI Partners Acquires, Renames OSG Norwich Pharmaceuticals


The deal brings new investment opportunities


Joanna Cosgrove



June 2007

2007 Salary Survey



Technology Transfer by Design


The next stage in operational advantage


By Pedram Alaedini, Ronald D. Snee and Brian W. Hagen



Pharma RFID  Rolls Out


California is the new frontier in electronic pedigrees


Stephen Barlas



Site Lines: Lease To Grow


Unlocking the capital in real estate to finance growth and remain competitive


Benjamin P. Harris



Executive Interview: Riccardo Trecroce


Patheon learns lessons during restructuring


Gil Roth



May 2007

2007 Annual Outsourcing Survey


Gil Roth



CRO Industry Update


Addressing expansion, adapting to trends


Kristin Brooks



CTM  Supply Chain Management


How to bridge planning and execution


Gil Roth



Specialized Roles for Clinical Trial Site Design


How to optimize trial site management


Kelli Henry



Quality Assurance and Good Lab Practice


Examining the FDA’s and OECD’s GLPs


Paul Swidersky



Online Exclusive: Jubilant News for Hollister-Stier


Joanna Cosgrove



April 2007

Biopharmaceutical Contractor Selection


A new report details client criteria


William Downey



Six Essential Qualities of a Bio-Outsourcing Partner


What to look for in a Bio-CMO


Darren Hieber



Leveraging Strengths in Competitive API Markets


A provider's perspective on Asian partnership


Doris S. Symonds and Jeffery W. Frazier



Site Lines: Taking the LEED in cGMPs


Is a sustainable cGMP manufacturing facility achievable?


Terry Jacobs



March 2007

Negotiating a Manufacturing Agreement


What do you need to know?


Dan O'Korn



Optimizing Drug Development Strategies


Exploring methods to improve the process


Dr. Kenneth Sokoll



Pharma IT Outsourcing


ERP consolidates IT infrastructure


Kristin Brooks



Pharma IT Hiring Trends


Pharma hiring managers find tech talent in high demand


Jim Lanzalotto



Quality by Design in Solid Dosage Processes


How will QbD impact manufacturing?


Tom Spurgeon



January / February 2007

Consolidation in Outsourcing


Our annual report chronicling the M&A activity in the outsourcing sector in 2006


Michael Martorelli



API Manufacturing & Management Practices


What skills and responsibilities do managers need for API manufacturing?


Cliff R. King, Ph.D.



Developments in Needle-Free Drug Delivery


New technologies and formulations enhance opportunities


Paul Di Filippo



Semisolid Manufacturing Marketplace


What drives the niche market?


Gil Roth



Online Exclusive: Pfizer Transitions Forward


Pfizer major restructuring plan will shutter facilities and eliminate 10% of its workforce


Joanna Cosgrove