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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.

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.

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.

Street Talk: Small-Cap Biopharmaceutical Stocks

August 1, 2007

When you start out, keep your small-cap exposure to no more than 10% of your holdings, and gradually increase.

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.

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.

Final Word: Are Biotechnology Meetings and Symposia Doing the Job?

July 1, 2007

Sir Isaac Newton said, back in 1676, "If I have seen further, it is by standing on the shoulders of Giants." Newton's modest self-assessment of his scientific competence holds relevance in today's debate on the value of scientific meetings, and our quest for faster scientific discovery.

Process Development: Maximizing Process Data from Development to Manufacturing

July 1, 2007

Process development and manufacturing for biopharmaceuticals are often disjointed activities. Disconnects among groups are aggravated by a lack of common terminology and poor data management practices. A UK biotech consortium has initiated a collaborative development effort to address data management issues. The proposed outcome is a data model, based on the ISA-88 Standard for Batch Control, to capture process and facility data throughout the product lifecycle. A data framework that follows the ISA-88 model can simplify process scale up and enable early views of project costs and facility fit.

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.

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