Big Fish Help Out the Smaller Fish in the Life Sciences Pond

In spite of the abundance of PhDs, MDs, JDs, and MBAs in biotech and pharma, we all know that on-the-job learning is really how this industry is built. Nobody goes to university to learn how to be a great CEO or manager, and there aren’t any courses in grad school where budding researchers can learn … Continue reading “Big Fish Help Out the Smaller Fish in the Life Sciences Pond”

A One-Size-Fits-All License Agreement: The Holy Grail of Tech Transfer?

One common complaint I hear from biotech entrepreneurs is that negotiating a license agreement with a university can be a nightmare. There are universities—some of them within the very top echelons of academia—that are infamous for having technology transfer people who are described as very difficult to work with. It’s not that surprising that these … Continue reading “A One-Size-Fits-All License Agreement: The Holy Grail of Tech Transfer?”

The Embargo System in Science News Needs Some Peer Review

Ever wonder how it is that the day a big scientific paper is published, or a groundbreaking presentation is given at a meeting, all major media outlets seem to have the story right away? It doesn’t happen by chance. The massive coordination effort is known as the embargo system. It is one of the most … Continue reading “The Embargo System in Science News Needs Some Peer Review”

A Newly Candid FDA on the Future Of Medical Device Regulation

We all know the Food and Drug Administration is one of the most important entities for those who develop drugs and medical devices, but for the public, and even many of the people in industry, it remains a notoriously mysterious organization. So I was very excited about the opportunity to have an in-depth phone conversation … Continue reading “A Newly Candid FDA on the Future Of Medical Device Regulation”

Fixing the Broken Model: Look Inside Your Company

You know that ominous figure people always talk about, that one staggering number—$1.3 billion these days—that represents the cost to develop and market a drug? It is, to be sure, way too high and unsustainably so. The billions of dollars that have been invested to discover the next generation of blockbusters have, for the most … Continue reading “Fixing the Broken Model: Look Inside Your Company”

The Genomics Comeback

One of the things that fascinates me most about the slow-paced business of biotech is how utterly mismatched it is against the demands of Wall Street. Asking for quarterly earnings reports from companies that are in the red, and likely to remain so for years, while they test drug candidates in early-stage clinical trials (which … Continue reading “The Genomics Comeback”

Is it Time for the FDA to Chime in on Drug Company Tweets?

These days, when I least expect it, an e-mail pops into my inbox that I can’t ignore. It announces that someone is following me on Twitter. I’m still figuring out how it works (I have a measly 4 tweets to my name), which explains why, upon reading one of those e-mails, I usually succumb to … Continue reading “Is it Time for the FDA to Chime in on Drug Company Tweets?”

Can academia bridge the gap between bench and bedside?

A few weeks ago I heard a pharmaceutical executive say at an industry meeting that academia shouldn’t be trying to develop drugs. They don’t know how to do it, his message was. Now, he didn’t specify what he meant: Was it that academics do not know how to discover and optimize promising drug candidates, or … Continue reading “Can academia bridge the gap between bench and bedside?”

Tough Challenges for Clinical Trials

For those of you who, like me, wonder why the cost of getting a drug to market continues to grow each year, here’s what may be a piece of the puzzle: It’s getting harder to do clinical studies. A report released this morning by the Tufts Center for the Study of Drug Development describes how … Continue reading “Tough Challenges for Clinical Trials”