From the Editor

Capable of great works, pharma too often yields to the lesser angels of its nature

So often a leader on the world stage, the US is a laggard when it comes to regulating follow-on biologics.

Biotech, and bioprocessing more specifically, is a great place to be. But it's time for a new adventure.

China's regulators acknowledge the quality gap, and have a plan for steady improvement.

Good leaders look beyond industry woes to focus on patients

The third holy grail of biosimilars: interchangeability.

Regulatory relief requires that regulators trust companies to know what they are doing, and to do it-consistently.

A single standard should apply to all comparability exercises for biologics, be they for biosimilars or manufacturing changes.

New R&D models must be tried, but it will take time to see if they work. In the meantime, a new kind of threat is on the horizon: biobetters.

We all know that experience is the best teacher. With H1N1, we have a great opportunity to learn important lessons.

Given today's challenges, traditional strategies were bound to change. Now, there is one more big threat (or opportunity?) on the horizon.

Sharing information is a critical part of security-whether we're protecting travelers from bombs or patients from adulterated medicines.

One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.

QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.

Do we really have to choose between saving money and saving time?

What football and bioprocessing both have in common is that in both cases, success is a minimum requirement.

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

If risk assessments only identify "the usual suspects," the process will not add much value.

Perhaps the best way to regulate drugs is to regulate them not conservatively or liberally, but effectively.

The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.

Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.

Avoiding healthcare reform is not the best option for the pharmaceutical industry.

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.

At some point, will heavy investments in large, stainless-steel based facilities become a burden to US companies?

How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.

Looking ahead at the biopharmaceutical industry into 2009.

The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase.

Despite creating plastic waste, the disposables option is better for the environment.

The country is reeling from US Treasury Secretary Henry Paulson's proposed $700 billion Wall Street bailout. In appealing for support, Paulson stressed this was a crisis. This sense of urgency is reminiscent of the way millions of Americans without health insurance cope with medical problems-in the emergency room, because they have no access to routine and preventive care.

The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.