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Outsourcing: Managing Your Contractor Relationship—A Smart Investment

August 1, 2007

Companies need to avoid operating in a manner that is inconsistent with the priorities established in the strategic sourcing decision.

Process Development: Think Like a Scientist—Behave Like a Business

August 1, 2007

Understanding the end-to-end management of chemistry, manufacturing, and controls (CMC) resources provides the opportunity to enhance long-term planning, leverage development options, manage resource trade offs, and track progress against plans. The goal is to improve the pharmaceutical development process to deliver the pipeline. This article provides an overview of the organizational structure of Process Research and Development (PR&D) and the CMC teams at Genentech; the alignment of resources based on CMC contracts, process development activity maps and project resource plans; and the business economic analysis for evaluating development options.

China Today: Biopharmaceutical Exports

August 1, 2007

In 2006, China exported a total of $890 million in biologics to other countries—a 30.61% increase, compared with the previous year.

Biotech Manufacturers Face Competition from "Similar" Follow-Ons

August 1, 2007

The main testing and regulatory provisions of the FOB legislation reflect multiple trade-offs between the demands of innovators and generics firms.

Drug Delivery: What The Future Holds

August 1, 2007

Drug delivery technologies have the potential to enable drug candidates with poor pharmaceutical or biopharmaceutical properties, both for macromolecule and traditional compounds. While there have been many success stories to date, the future offers even more promise. In this article, the author surveys the top ten areas in drug delivery looking forward.

From the Editor: After Zheng

August 1, 2007

The corruption of China's food and drug sectors is not limited to one man. Likewise, real reform will require the efforts of many.

Outsourcing Insights: Why European CMOs Are Coming to America

July 1, 2007

The BIO annual meeting in early May had an upbeat tone. Investment capital is flowing into the industry at high levels, resulting in strong demand for contract development services. The funding stream is particularly strong in the US, and that is attracting more European contract manufacturers (CMOs) eager to improve business development here.

Street Talk: Cautious Optimism: the Watchwords for Volatile Sector

July 1, 2007

We're seeing an uptick in biotech investing from the venture capital community, a good sign that biotech can rise even higher than the broader markets.

Upstream Processing: Regulatory Considerations Regarding Quality Aspects of Monoclonal Antibodies

July 1, 2007

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