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 that they can’t efficiently carry out the subsequent phases of drug development as a compound moves into clinical trials? But in a way, his comment was telling precisely because of its generalized nature. It represents a blanket view that is not uncommon in the industry (i.e., academia can’t make drugs) which is both right and wrong—and which stands as a barrier to bridging the infamous bench-to-bedside gap.
This gap is wide. The making of a drug usually starts with an interesting observation made by a bench scientist, and ends with an FDA-approved product. In between there are years of painstaking and costly work. Once a promising drug target has been identified it must be validated, any candidate compounds must be optimized and refined through specialized chemistry work, and those compounds must then be put through many animal studies to look at pharmacokinetics and toxicity. Then, paperwork must be filled to get permission from the FDA to study the compound in humans, and of course clinical trials must be designed and carried out at great expense.
This process must integrate two cultures—academia and industry–which often don’t know how to talk to each other. Academics, perched in their ivory tower, look down on the industry folks as uncreative and bureaucratic. People in industry resent the arrogance of academia and shake their heads at academia’s unfocused approach. More than once I have heard the comment that, when it comes to drug development, academics “just don’t know what they don’t know.”
From my own days in the lab, I know there’s some truth to the latter charge. Basic scientists are simply not trained to design their experiments in a way that will make it easier to move towards a clinical path. I worked with a set of proteins that had medical applications for bone regeneration. I knew everything about the proteins—all the downstream pathways possibly linked to them—and I knew the kinds of effects these molecules had on bone growth in mice and chickens. But never in my four years as a bench scientist did I think to design my experiments to help address a medical need. I wouldn’t have known how to, actually. And honestly, I didn’t really care. My pursuit was that of knowledge, not medicines.
Yet now, more than ever, those who pursue knowledge and those who pursue medicines must learn to coexist and cooperate with each other. The traditional model for drug development—in which academia’s role was largely restricted to … Next Page »