Pharmaceutical Technology, Aug 1, 2012 - Pharmaceutical Technology

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Pharmaceutical Technology, Aug 1, 2012
Articles
CROs and CMOs Have Cause to Celebrate
By Jim Miller
Annual survey shows strong growth for service providers and promises to continue into 2013.
Quality by Design: A Contract Organization's Perspective
By Anil Kane
The author discusses how a CDMO helps in gaining process understanding and in developing robust, high-quality products and processes.
A Manufacturing Capacity-Sharing Model: Merck & Co. and MedImmune LLC
By Patricia Van Arnum
The manufacturing capacity-sharing model in biologics and Merck & Co. and MedImmune ushers in a new paradigm of "co-opetition".
Market Strengths and Weaknesses in Biosimilars
By Patricia Van Arnum
An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.
Strategies in Outsourcing: Insourcing Emerges as an Alternative Model
By Patricia Van Arnum
AMRI, a contract research and manufacturing organization, discusses its adaption of an insourcing model with Eli Lilly.
Strategies in Outsourcing Facilities Management
By Rakesh Kishan , Andrew Cieslak
The authors highlight costs, benefits, and implementation success factors across first, second, and third generations of facility management outsourcing contracts.
Size Associations in the CRO Outsourcing Relationship
By Janice Hutt
The author provides results and commentary on a survey analyzing outsourcing strategies, practices, challenges, and outcomes in the selection of a CRO.

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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
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Expedited reviews of drug submissions
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35%
Breakthrough designations
12%
Protecting the supply chain
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Expedited reviews of drug submissions
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More stakeholder involvement
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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