Pharmaceutical Technology, Feb 1, 2014 - Pharmaceutical Technology

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Pharmaceutical Technology, Feb 1, 2014
Featured Content
Outsourcing Trends in Biopharmaceutical Manufacturing
By Eric Langer
A changing biopharmaceutical industry is going beyond typically outsourced activities and is using CMOs for more challenging processes. Review the top 10 outsourcing trends.
A New Dawn for Western CMOs
By Andreas Weiler
Increased competition from CMOs in Asia means that Western CMOs need to understand fundamental changes in the market.
Partnership Models Structure R&D Change
By Benjamin K. Gill , Jim Prutow
Pharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.
Managing Clinical Development Risk: Pharma and CRO Report
By Denise Calaprice-Whitty , Janis Hall
The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
By Clinton Weber , Ashok Kumar , Lisa Joslin , Roland Ashton , James Schmid , Michael Larson
Traditional project decision-making is compared with a QbD approach.
Global Markets Demand Local Knowledge
Contract manufacturing organizations that are established in key markets can provide a competitive edge.
Clinical-Trial Material Supply by Way of Shanghai
Geographic location, customs and drug-development regulations knowledge, and transportation infrastructure were factors in Catalent Pharma Solutions' selection of Shanghai for its clinical-trials supply facility.
Ensuring Sound Bioanalytical Methods Transfer
For a drug-development process that relies on outsourced services, special considerations are needed to ensure the proper transfer of technology and information from one phase to the next.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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