BioBusiness

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.

Wyeth today relies on biotech product revenue to drive approximately 25% of its revenues.

When former Federal Reserve chairman Alan Greenspan's term in office expired on January 31, 2006, many people said, "There goes a legend." Maybe the better expression was, "Here comes the spin."

In 2005, 10 biopharma- ceuticals gained marketing approval in the US or Europe, although only five of them were genuinely new molecular entities.

Congress is not considering legislation that would expand FDA authority to regulate biologics.

Many CMO relationships are established while a product is early in clinical or preclinical development.

Buffett prefers to buy small, publicly traded companies with ample room for growth.

Food and Drug Administration is encouraging public–private collaborations to more fully explore the physical and chemical characteristics of nanoparticles.

The lack of biomanufacturer acquisitions seems surprising.

The courts regard biotechnology as highly unpredictable

Without generic competition, the US is at risk of losing its position of leadership in biopharmaceuticals.

Disposables can be used for media preparation, clarification, filling in downstream processes . . .

The top 10 Chinese companies in the biopharm sector account for only 20% of the market... leaving plenty of room for growth for Western companies.

Motorola recognized that vartion is the death knell of any process, so the company established a methodology called Six Sigma

Certain areas of the vaccine market appear to be in vogue again, revitalized by blockbusters such as Prevnar, the pneumococcal pneumonia vaccine that reaped $1.5 billion in sales last year, and the human papilloma virus vaccines, which are projected to reach $4 billion per year.