Can academia bridge the gap between bench and bedside?

5/12/10

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 »

Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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  • Observer

    Well it is a provocative subject, but isn’t the question really whether the very applied art of drug discovery / development for profit is an appropriate activity for an academic institution using federal funding? Once the personal profit motive comes in the supposedly altruistic mores of academia presumably go out the window.
    Re the initial comment, the art and science of drug design is obviously very difficult to accomplish and is full of pitfalls, the knowledge of which comes with long experience, or there would be more new drugs. Why would one assume that the professionals in pharma, typically recruited from the best schools, are less adept than inexperienced academics?
    So there will be some successes, but it does not seem to make sense a priori as a way to spend tax dollars.

  • Ted

    A more pertinent question would be “why are academic institutions developing drugs, anyways?”

    It creates a host of ethical dilemmas from top to bottom, with what is likely a very limited social payoff. The only advantage I can see is the opportunity to leverage still more cheap labor from graduate and post-doctoral students.

    There are more problems with pharmaceutical drug development than you can shake a beaker at, but transferring the process into the academic system has dim prospects.

    -t

  • Anthony Rodriguez

    I agree with the previous comments that full drug development from discovery to clinic in academia is both ethically dangerous and commercially inefficient. These drug development groups based in academic institutions that are seeing success share a common theme: hiring industry seasoned scientists and leaders. Experience is the name of the game here and why certain groups will be successful in academia. You also have to consider the ability for an academic to learn and absorb new knowledge to be just as important. Remember all scientists with PhDs started as academics at one point before they transitioned to industry. If an academic wants to be involved in drug development and has access to industry knowledge, they will become the experts themselves. The academics CAN learn, pharma just needs to be willing to work with them and vice versa.

    I think these academic drug development groups are going to be successful to a certain degree because they combine industry experience with willing academics in a setting that allows for hands on patient (or customer) interaction and non-diluted R&D funding.

    Let’s face it, big pharma does not produce new drug leads like they use to do. Today’s model is to acquire ones in development in an effort minimize the cost. What does it matter if that acquisition target is from academia or an industry savvy start-up?

    Taxes should not be a concern either. My money goes to academic funding agencies like the NIH so they can execute a mission to improve health care in this country. What good will my taxes be to me if the novel life science innovation they fund is left on the academics bench?

    There is plenty of room for a pharma business model that utilizes academic resources to bring lead products to a position ready for the large capital investment required for clinical trials. Such a model would be cheaper and more efficient to the company and potentially lead to lower cost of pharmaceuticals and potentially better healthcare today.

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