BioBusiness

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.

In the rush to save money, the consequences of potential problems often are ignored.

The number of biotechnology-based human therapeutic products in the late-stage pipeline, and the average cost to commercialize a biotech product, have steadily increased. This has required biotech companies to use economic analysis as a tool during process development and for making decisions about process design. Process development efforts now aim to create processes that are economical, as well as optimal and robust.

If a company wants to reduce costs, it should consider outsourcing some manufacturing and analytical testing to low-cost sites.

In the US, the patent term is 20 years from the filing date . . . commercial product may lose patent protection just as sales are ramping up.

A major shift is occurring in the way the biopharmaceutical industry sources goods and services. Price pressures at the retail end of the value chain and a difficult fundraising environment are forcing biopharmaceutical companies to take greater control of their costs. Purchased goods and services, including contract research and manufacturing services as well as raw materials and laboratory supplies, are a major expense in most companies, so control of those purchasing decisions is coming in for special scrutiny.

Formulations for pulmonary inhalation comprise spherical, porous particles that are 1–3 microns in diameter.

Fear leads to bad decisions on a Wall Street trading floor, or at a high-stakes Vegas poker table.

The challenge is to determine the optimal frequency for preventive maintenance and the optimal frequency and tolerances for calibration readings.

In case you haven't heard, Jeffrey Kindler, Pfizer's general counsel, is replacing long-time CEO Henry "Hank" McKinnell as the new head of the company. There is a long-range strategy in naming a lawyer to run a drug company and I'll get to that in a moment.

Better supplier management can begin in parallel to production-related improvements.

China is becoming a much more sophisticated economy, with a large and well-educated workforce.