Article Archives » 2009


Archives

2009

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October 2009

10th Anniversary: Having Your Say


Gil Y. Roth



10th Anniversary: CRO Perspectives


Gil Y. Roth



10th Anniversary: Where Are They Now?


Catching up with our first issue’s contributors


Gil Y. Roth



CMO Management Throughout the Lifecycle


Developing a process for working with providers


Nelson M. Lugo



Anticancer Drugs


No option but to outsource?


Enrico T. Polastro, Ph.D., and Sonia Tulcinsky



Formulation for Delivery


New concepts in colonic drug targeting


Dr. Stephen Brown



September 2009

cGMPS: Yesterday, Today and Tomorrow


Harmonizing extant FDA regulations and international cGMPs


Debbie Thomas



Building Agility into Pharma and Biopharma


Learning lessons from other industries


Chris Driscoll



Excipient Testing in a Global Environment


Anthony Grilli



Effective Project Management


Creating opportunities for lower costs and faster time-to-market


Peter Soelkner



Assuring Quality in the Global Supply Chain


Measuring risk in sourcing


Helena Champion



Sourcing Pharmacovigilance


An effective approach to realizing a sourcing solution


Chris Albani, Greg Meline, and Bryan Katz



Regional Report:New Jersey


Analyzing the past, anticipating the future


Susan Toth



July/August 2009

2009 Top 20 Pharmaceutical Companies Report



2009 Top 10 Biopharmaceutical Companies Report



June 2009

2009 Annual Salary Survey


Gil Roth



CRO Industry Update


Opportunities in uncertain times


Kristin Brooks



Formulation Development Options to the Clinic


Strategies for getting to Phase I quicker and saving API


Paul Skultety, Ph.D.



Silicone Excipients in Drug Development


A versatile ingredient works in excipient applications


Gerald K. Schalau II and Katherine L. Ulman



Improving Process Quality for Pharmaceutical Liquids


Aseptic blow/fill/seal vs. traditional aseptic processing


Chuck Reed



Clinical Trial Imaging


Innovation, trends and challenges


Kristin Brooks



Chemical Facility Anti-Terrorism Standards


Recent changes in security affect pharma facilities


Evan Wolff, Maida Oringher Lerner, and Matthew Melewski



Conquering the Challenges of EHR-EDC Integration


Can e-integration speed drug development?


Robert Barr



May 2009

2009 Annual Outsourcing Survey


Gil Roth



Capacity Utilization & Capacity Constraints


Trends and differences in the U.S. & Western Europe


Eric S. Langer



Facility Design for Bio-Manufacturing


CMOs can design for disposable components


Tony Garbarino and Dave Odegaard



Biopharma CMO Market Report


Optimism remains high among bio-contract manufacturers


William Downey



Mitigating Risk in the Biomaterial Cold Chain


Cold chain management is essential in biopharma development


Jeff Clark



Contract Manufacturing in a Cost-Conscious Environment


New models, new partnerships


Marcelo Morales



Also in This Issue


More features and columns in our print edition


Gil Roth



April 2009

Complex Aseptic Manufacturing Outsourcing


Tips and tactics for optimizing your CMO partnership


Carlos R. Fernandez and Douglas A. Jonas



QbD and Parenterals


Strategies for assessment of leachables in parenteral drugs


Diane M. Paskiet



Implementing 5S


Avoid the pitfalls and realize powerful benefits


Fred Greulich



Site Lines: Regional Capital Investment


Where’s the bio/pharma money and how is it being spent?


Tom Spurgeon



Also in this issue


More features and columns in our print edition


Gil Roth



March 2009

Openings for Outsourcing


Do we see a new paradigm in pharmaceutical manufacturing?


Dr. Enrico T. Polastro



Success in Partnerships


Success in Partnerships


Pedram Alaedini and Howard Kim



Generic Preformulation of Drug in Adhesive Patches


New delivery forms create new challenges


Mike Bly, Ph.D.



IT Focus: Streamlining Scientific Processes


Get out of the silos


Brian Karlak



Pharmaceutical Solid Dose Manufacturing


Stronger, Smarter, and not Quite so Big


Neil Canavan



January/February 2009

Outsourcing M&A Year In Review


Reviewing 2008’s mergers, acquisitions and buyouts


Michael A. Martorelli



Implications of REACH for the Pharma Industry


How will the new regulations affect your EU imports?


Carole Garcia



Core Vs. Non-Core Framework


How to combat cost structures in R&D


Neil MacAllister, Richard Evans, and Katherine Wallace



Executives & Improvement


10 things pharma executives need to know about improvement


Ronald D. Snee