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Welcome to the March 2011 issue of Pharmaceutical Technology Sourcing and Management, your information resource about the pharmaceutical supply chain. In this issue, an analysis of the emerging US regulatory pathway for biosimilars and a roundup of Informex 2011. And the latest developments from the bio/pharmaceutical industry relating to corporate social responsibility and sustainability.

Biologics
The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do Where Go From Here
David Rosen and Larry Lian, Foley & Lardner.
The authors outline the key decision points FDA must consider in putting forth an US regulatory pathway for biosimilars. >> Read More

Contract Manufacturing
A Roundup of Informex
Patricia Van Arnum, senior editor at Pharmaceutical Technology and editor of Sourcing and Management.
Contract manufacturers and fine-chemical suppliers announce capacity expansions and service enhancements of Informex.
>> Read More

Outsourcing
Changes Underway for Biopharmaceutical Outsourcing
Eric Langer, president of BioPlan Associates
More crucial biomanufacturing operations are expected to be outsourced.
>> Read More

CSR and Sustainability Forum
Pharmaceutical Technology’s dedicated editorial coverage on the developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, other business sectors, and public and private organizations. This month, we feature articles on drug-development models for the developing world, a new pediatric HIV/AIDs clinic in Tanzania by Bristol-Myers Squibb, and a roundup of CSR and sustainability news.

Drug Development for Government, Nonprofit, and Developing-World Markets
Chan Harjivan and George Dougherty, PRTM
This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part I focuses on drug-development. Part II, which examines manufacturing, will be published in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and the supply chain, will be published in the May 2011 issue. >> Read More

Bristol-Myers Squibb Moves Forward with HIV/AIDS Project in Africa
Patricia Van Arnum, senior editor of Pharmaceutical Technology and editor of Sourcing and Management
Bristol-Myers Squibb, through a private–public partnership, opens a new pediatric HIV/AIDS clinic in Tanzania. >> Read More

CSR and Sustainability Forum
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations. >> Read More

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Sourcing and Management’s Community of Experts
The panel consists of leading professionals involved in the synthesis, manufacture, and sourcing of active pharmaceutical ingredients and intermediates, and experts in formulation and dosage-form manufacturing. The community of experts lends its expertise to the eNewsletter by providing reviews of technical articles as well as offering perspectives on topics of relevance to pharmaceutical manufacturers and their suppliers.
>> Read More

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For the full listing of calendar events, see the Calendar of Events page

March
Free Live Webcast from Pharmaceutical Technology: "The Future of Solid Dosage Manufacturing"
Available for viewing on-demand
Register here

Mar. 8
Free Live Webcast from Pharmaceutical Technology: "How to Optimize CMC Development and Manufacturing"
2:00 PM - 3:00 PM EST; 11:00 AM - 12:00 PM PST
Register here

Mar. 14–17
DCAT Week
New York

Mar. 22–23
SustaiNext Summit
Philadelphia

Mar. 29–31
Interphex
New York