Innovation used to be a term dedicated to a company’s visions for growth. Keeping one eye on the roots of your business and the other on long-term prospects was a smart strategy. Against a backdrop of a nose-diving economy, however, it seems as if “innovation” now has less to do with growth and more to do with survival. Read more »

Yesterday I completed my first vidcast at the AAPS Annual Meeting in Atlanta, Georgia. I had the pleasure of discussing quality by design (QbD) as it applies to analytical methods with one of the top experts in this area: Dr. Moheb Nasr, director of FDA’s Office of New Drug Quality Assessment. Read more »

First of all: Vote. Few other tasks you do today are more important.

Second: Voice your opinion again, this time to the next US President. Without a doubt, regardless of the outcome, there is much at stake, including the responsibility for appointing the next White House science advisor. Last week, both Sen. John McCain and Sen. Barack Obama received letters signed by the American Association for the Advancement of Science and 177 other scientific organizations, including major universities, health centers, and businesses, urging the next President to appoint a science advisor before Inauguration Day. Read more »

Over the years, I’ve heard several pharma industry members point out the catch-22 of seeking the advice of experts at agencies such as FDA and USP. These agencies hire some of the most well-respected experts in their field, however, when they are speaking as FDA or USP officials, they must be careful to stick to the agency script and may be somewhat restricted into providing only what has been “approved” to say. I’ve attended conferences in which the moderator will start off saying, “speaking as a (USP, FDA, etc.) officer, I can only say…” and so on. This may be necessary in front of a large audience, of course, but can also be a hurdle for real information sharing. Read more »

Erik Gordon, head of biomedical industry programs at Stevens Institute of Technology (Hoboken, NJ) compared Pfizer’s current crush of lawsuits to “having a thousand fleas attack a dog at the same time.” Last week, Pfizer finally decided it was time to lighten the load and the company agreed to settle a huge majority of its lawsuits over its now-withdrawn pain reliever “Bextra” and its still-marketed drug “Celebrex.” Read more »

My elementary-school kids have no idea what a typewriter is, and they like to hear how I didn’t even see a computer mouse until I was in college. The story is especially amusing to my first grader, who has to explain to me how the Smart Board in her classroom works. There’s no doubt we are preparing the next generation for jobs that haven’t been invented yet. So thinking about how the next generation of drug therapies may have their start, not in research laboratories but rather within computer databases is exciting. Read more »

It has long been predicted that breakthroughs in genomics will foster an entirely new generation of pharmaceutical and biopharmaceutical therapies. Now, five and a half years after the Human Genome Project published the full sequence human genome, the first population-wide study to gather human genetic data is set to begin. Read more »

It’s amazing how much time we spend “talking shop” among colleagues, regardless of where our shop is located or what we happen to do for a living. With so many changes going on right now in industry regulation, world economy, and private-sector shifting, there is certainly a lot more to talk about. Read more »

Biotechnology pundits have pointed out the similar views current major presidential candidates share on stem cell research even including embryonic stem cell research. So far, it appears the issue has not played quite the major role in politics as it did in 2004. Perhaps this has to do with the increased familiarity with the purpose and promises of stem cell work within medical research and development. Read more »

Nanoparticles have fascinated scientists and technology followers for several years now, and the popularity of these particles is growing, especially in pharmaceutics. Nanoparticles have matured beyond being considered as simply smaller versions of traditional-sized particles, advancing to become sophisticated and intricately designed systems. Read more »