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From the Editor: Score One for Preparedness

May 1, 2007

Fortunately for all of us, not everyone's head is in the sand.

Successful Steps for Outsourcing the Manufacture of Clinical Trials Materials

April 2, 2007

Consider the number of patients, the dose each will receive (and how this dose is calculated), the number of doses per patient, and what overage is needed to allow for vial breakage.

Outsourcing: What is the Path Forward?

April 2, 2007

The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.

Outsourcing Virtually Everything: Making the Semi-Virtual Model Work

April 2, 2007

Partnering with a surging number of CROs, CMOs, CSOs, and other niche providers, biopharm companies in 2007 will have an estimated spend of more than $7 billion on international clinical trial outsourcing alone.

The Importance of Project Management

April 2, 2007

Are the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time? Is the original budget of your study typically exceeded?

Analytical Testing to Support Biopharmaceutical Products

April 2, 2007

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

Match.Contractmanufacturing: Finding The Perfect Match

April 2, 2007

The contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.

Book Review: Advances in Biopharmaceutical Technology in China

April 1, 2007

This 1,230-page tome is a must-have encyclopedia for any person or organization planning to interact with the biopharmaceutical market in China. It contains 23 well-written chapters and five appendices written by individuals who are experts in the areas they address. Some of these experts are not well known in the US; thus the book also provides an excellent introduction to people whose knowledge and opinions are important when considering biopharmaceuticals in China. Many chapters were translated from Chinese and this is the first time that their information has been provided to the West.

From the Editor: Focus on What Matters

April 1, 2007

Financial pressure to show short-term results also affects the pharmaceutical industry, from Big Pharma to small biotech.

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