Newsletter | April 26, 2012

04.26.12 -- Aptalis, Cephalon Win Federal Appeal For AMRIX Patents

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Welcome To Outsourced Pharma

Welcome to another edition of the Outsourced Pharma newsletter, published by our sister site, Pharmaceutical Online.

Outsourced Pharma will help pharmaceutical companies through the complex vetting process by presenting commentary from industry leaders, trends and analysis, white papers, and in-depth information on key outsourcing providers and their core capabilities.

We welcome your feedback and contributions to this newsletter since it is being produced to serve you. Also, watch for more ways to engage with Outsourced Pharma and the content you need to make solid outsourcing decisions in 2012.

Executive Q&A

5 Challenges CROs And Big Pharma Must Address
A Q&A With David Lathbury, Ph.D., VP of Chemical Development, AMRI
With pharmaceutical manufacturers' continued dependence on CROs — along with the growth of the global life sciences industry — challenges are bound to arise. For more on the current status of the big pharma-CRO relationship, we turned to David Lathbury of global contract research and manufacturing organization AMRI.

Outsourcing Articles

Accelerated Drug Development: The Promise Is In The Process
By Jan-Olav Henck, Ph.D., Chief Scientific Officer, Aptuit LLC
In 1993, the FDA issued the call to the pharmaceutical industry to streamline the drug development process from discovery to First In Man. Despite many efforts, the industry standard for the timeline for a drug to advance from discovery to First In Man still remains between 18 to 30 months. To address this challenge, Aptuit focused on reducing the length of time needed to advance the active pharmaceutical ingredient (API) to IND submission.


Connecting The FDA And Industry
By Rob Wright, Life Science Leader magazine
Even with more than 8,800 employees and an annual budget of around $3.2B, the FDA's task of protecting public health seems daunting, considering the complexity of products being developed by industry. Factor in other issues such as counterfeiting, terrorism, drug reimportation, and the globalization of drug discovery, development, and manufacturing, and you soon realize that working at the FDA is indeed quite a challenge.


Outsourcing Insights: Focusing On Innovation
By Kate Hammeke, research manager, Nice Insight
In 2011, innovation was a major topic among the various players in the drug development industry. Feedback from clients and sponsor-side industry personnel prompted a change in the outsourcing drivers included in the Nice Insight Pharmaceutical and Biotechnology Outsourcing survey, such that innovation — or the ability to improve in-house capabilities with customized solutions — replaced accessibility for the 2012 research cycle.

Outsourcing News

Aptalis, Cephalon Win Federal Appeal For AMRIX® Patents
Dalton Signs Manufacturing Agreement For Potent Antiviral Agent
Therapure Opens Custom Biologics Manufacturing Wing
Quintiles Names New CEO
Cetero Reaches Final Resolution With The FDA
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Outsourcing Spotlight

ABC Laboratories Pharmaceutical Brochure
Established in 1968, ABC has been helping companies develop regulated products for over 40 years. Our 325 scientists and support staff bring a wealth of pharmaceutical, CRO, and R&D experience to your programs.

Chiral Technologies In Dr. Reddy's CPS
Custom Pharma Services (CPS) as a strategic business unit of Dr. Reddy's draws on Dr. Reddy's expertise and capabilities in pharmaceutical development and manufacturing to provide innovators with customized services and solutions for starting materials, intermediates, active ingredients, and finished dosage forms.

Brochure: Non-GLP In Vivo Discovery Contract Services
BASi utilizes the Culex Automated In Vivo Sampling System to carry out a variety of non-GLP research functions including pharmacokinetics, microdialysis, and much more.
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