Viewpoints

Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.

Best practices a pharmaceutical company can follow to execute their strategy sucessfully.

The industry needs to open up to validation failures.

Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.

Engaging executive leadership in the quality process is the key to compliance success.

The expanding globalization of the industry poses a challenge for international enforcement.

Both innovator and generics companies are using analytics to support comparability arguments.

The Chinese government is making consistent efforts to strengthen IP protection.

Eighty drugs will lose patent protection between 2007 and 2011.

CMOs must take a proactive approach to ensure the availability of local talent

One company even connected hollow fiber cell culture chambers to living cows.

Outsourcing has been a cornerstone of our industry for decades.

The pharmaceutical industry is well aware that FDA is trying to take a risk-based approach to enforcing the current good manufacturing practices (cGMP) regulations. This approach is driven by an economic reality: FDA simply does not have the resources to inspect every facility every other year. The organization doesn't even have the resources to inspect facilities every three years. Likewise, it is not cost-effective for our companies to carry out a complete, documentation-oriented revalidation for every process change, regardless of its significance or risk.

How much do regulatory agencies know about nanotechnology or microfluidics? Yesterday, the answer was probably, "not much." Tomorrow, it may be "a lot." The reason is that new technologies push the agencies to expand their expertise.

A key to bolstering FDA and its mission is securing balanced and consistent funding.

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

For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture-during fermentation, harvest, and early purification-to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting.

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

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.

On January 17, 2006, the FDA released new regulations, effective June 1, 2006, which affect the production of most investigational drug and biologic products intended for phase 1 clinical trials. These regulations are much broader in scope than the Exploratory IND guidance released on the same day, and which apply only to low-risk, CDER-regulated clinical studies.

A powerful film will have a hundred times the impact of a touchy-feely commercial.

Statisticians partner with technical experts to design statistically valid studies to construct the appropriate analysis.

On June 13, 2005, in Merck KgaA v. Integra Lifesciences I, Ltd., the US Supreme Court ruled unanimously that the exemption to patent infringement outlined in Title 35, Section 271(e)(1) of the US Code extends to all uses of patented inventions reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act, including preclinical studies. In practice, this means that the exemption will allow companies to use other firms' patented compounds for experimentation on drugs that are not ultimately the subject of a submission to the Food and Drug Administration.

Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.

The ripple effects of 9/11 are still being felt, creating changes among individuals, businesses, and government organizations. The biotech community is no different; companies are taking a new look at the way they do business and shifting their focuses in response to new opportunities presented by federal preparedness programs. In 2004, President Bush signed "Project BioShield," a bill that made $5.6 billion in federal funds available over a 10-year period to develop countermeasures against chemical, biological, radiological, or nuclear attack. An additional $2.5 billion was added to the initiative in 2005. Numerous grants and contracts have already been awarded to companies developing innovative prophylactic measures, treatments, and diagnostic tools to be used in the event of a biological attack.