BioBusiness

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

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.

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

The Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model.

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.

Virtually every corner of the United States (not to mention the rest of the world) seeks to build a powerful biotech presence (see www.bio.org/local/). Since the dawn of biotechnology in the mid 1970s, private venture capital, major corporations, and state and federal governments have poured hundreds of billions of dollars into the industry. Results have been mixed, in terms of benefits to local economies and products that reached the marketplace.

Scale-up issues leading to long development times and deviations in the commercial facility is a critical challenge.

Cities, counties, states; every political entity in our country is driving to develop a biotechnology presence in its respective region.

All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.

Disposables are no longer a mistrusted new technology; they're seen as a potential solution to everyday problems.

Although IP due diligence is relevant to virtually any transaction between biotech companies, a detailed investigation into IP assets is particularly critical to M&A transactions.

The Chinese government's investments in the biopharmaceutical sector may help it become one of the leading industries in China by 2020.

NIH makes available a full range of licenses for commercial evaluation and for the sale of commercial products and services.

Utility patents are granted to anyone who invents any new and useful process, machine, article of manufacture, composition of matter, or any new improvement thereof.

In the September 2006 issue I wrote about the ticklish issue of CEO pay and how shareholder groups, especially the powerful pension and other institutional groups, are growing sick and tired of CEO overpayment and underperformance.

The changes in biologics manufacturing regulations contained in the 1997 FDA Modernization Act significantly bolstered the growth of CMOs.

China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing market segment and a huge population, simply getting pharmaceuticals to the patients and healthcare providers is becoming a daunting task. Biopharmaceuticals distributers face the same challenge, with the added complications associated with cold-chain management, shelf-life, and product stability.

China is home to more than 400 biogeneric manufacturers, which develop generic biopharmaceuticals for the domestic population.

On a recent plane ride from Phoenix to Philly, I was leafing through a copy of the San Francisco Business Journal. I was taken aback by a story on the emerging trend of biopharm exchange-traded funds (ETFs), and how much of an impact they're having on Wall Street and on investors.

The Act will establish third party rights to challenge the validity of a patent through postgrant opposition proceedings.

The biotechnology industry is thriving, and hopefully you are too. BioPharm International's first salary and employee satisfaction survey presents a wealth of data that will allow you to compare many aspects of your job with those of your peers. The survey reports on demographics, education, work experience, salary and benefits, and attitudes toward current employment.

Offshoring to China has captured the imagination of Western managers seeking to reduce operating costs. What is the best approach?

There are 72 maladies for which human patients have received some benefit from adult stem cell interventions.

Recently, 22 vice presidents of biopharmaceutical operations met in Boston to develop the first operational roadmap for their industry. This special executive-level consortium was organized to discuss two key questions.

In the big pharma world, drugstore aisle space is every bit as important as Times Square is to New York real estate developers. And few pharma giants fill that space as well as GlaxoSmithKline.