Categorized | QbD News

Andrew Witty on Art vs. Science in Pharma R&D

    Andrew Witty on Art vs. Science in Pharma R&D

    GSK’s CEO recently wrote an interesting editorial in The Economist on the drug industry’s challenges,  which was the subject of lively discussion on the blog, In the Pipeline. He criticizes the “Big R&D” approach, which, as he notes, didn’t work.

    But there was no mention anywhere of Quality by Design in his essay, and his views seem to betray pharma’s mistrust of (or lack of interest in) techniques and approaches that have been proven in other industries, and, perhaps a lack of insight into how industrial engineering principles could help advance pharma R&D.

    This isn’t really new (for more, read  the now-ancient blog post “Why Does Pharma Still Hate Lean” or Peter Pande’s thoughts on why pharma may be missing the boat with Six Sigma).

    Misapplied Toyota, Six Sigma and other programs have earned the contempt of many a pharmaceutical research scientist.

    No one could dispute GSK’s achievements in R&D, and in areas including genomics (as one commentator  noted), under Mr. Witty’s leadership.

    But this op-ed suggests some lingering C-level disconnect from the “D” in R&D, and from the fact that drug development is so closely connected to drug manufacturing.

    Is it time for a QbD outreach and education program?

    Doesn’t pharma need all the science (not traditional biology or chemistry, but physics, materials science, automation and engineering–including industrial engineering) it can get? And far more rigorous ways of mining and using its own rapidly increasing volumes of data?

    Six Sigma and Toyota methods may not work in drug discovery (although even here, advocates say, when used in the proper spirit–more from Peter Pande and Bikash Chatterjee–they can provide a framework to improve results), but they are urgently needed, in drug development.

    Witty mentions a number of conflicting problems and needs:

    • Addressing the industry’s “misguided theory that it could industrialize R&D”
    • The need for “art, not science” in R&D
    • Empowering those involved in drug discovery but also streamlining development, “in part, by ending earlier the development of drugs which do not offer the prospect of being truly distinctive.”
    • Getting R&D “right”

    The following paragraph, while eloquently written, seemed the most conflicted:

    “…First, we need to recapture the ability to empower creative talent in the discovery phase of R&D by creating an environment in the labs that reflects the fact that discovering a drug is as much an art as it is a process. But this needs to be combined with a more rigorous method for allocating resources only to where the prospects for success are greatest. Second, we need to streamline the development phase, in part by ending earlier the development of drugs which do not offer the prospect of being truly distinctive…”

    One can only streamline drug development, and get R&D right, by applying science and engineering principles,  industrial engineering concepts and by investing in, and using, IT correctly.  If that’s “industrializing” R&D, then so be it.

    And, serendipity aside,  isn’t it simply too “fuzzy,” luxurious and “nineteenth century” to refer to “art” when drug companies are laying off entire discovery and research departments and star researchers?

    Mr. Witty mentions the importance of partnerships to advancing pharmaceutical innovation. But there’s an awful lot of waste and  “reinventing the wheel” that goes on in that sphere too.

    Roche’s CFO recently commented on that company’s R&D information overload, and fears that much of the growing streams of data it receives from partners and would-be partners is nothing more than time-consuming spam.

    Mr. Witty, like most  pharma CEO’s is not a scientist or engineer by training. But that doesn’t matter. Good CEO’s are, by definition, big picture people.

    “Industrializing” drug development, in the right way, by applying modern principles and technologies, seems to be the only way to solve the dilemmas that Mr. Witty writes about and reduce the high cost of drug quality.

    It made me wonder how many of you work in an environment where you could invite CEOs to your labs to explain, not how you’re doing QbD, but what you’re trying to do, why it’s important, and, above all, why it’s going to save your companies  huge amounts of money, and the embarrassment of consent decrees and product recalls, down the line? (Not to mention an environment where he or she would accept that invitation…)

    AMS

    Related posts:

    1. Ali Afnan: Yes, Virginia, There is a Santa Claus (But Little Science, or Change, in Pharma…Yet)
      In the end, this industry is what we make it. Let’s base our actions on science and our goals, on...
    2. QbD for Pharma Packaging Components: A Solution Provider Gets More Science-Based
      Putting itself in the shoes of its customers, West Pharmaceutical Services aims to leverage Quality by Design to improve its...
    3. Hot Off the Press: ISPE’s Guide for Science- and Risk-Based Facilities, Systems, and Equipment
      The guide "provides direction to industry on the implementation of a science- and risk-based approach for demonstrating that pharmaceutical and...
    4. FDA Releases Strategic Plan for Advancement of Regulatory Science
      The plan covers various Science Priority Areas, including improving product manufacturing and quality through the furthering of continuous processes, analytical...
    5. Video: Ali Afnan of FDA on QbD and the Need for New Science and a Change in Mindset
      At a life sciences panel discussion during the 2009 Emerson Users Exchange, Ali Afnan, Senior Staff Fellow with the Office...

    One Response to “Andrew Witty on Art vs. Science in Pharma R&D”

    1. epcotint says:

      By George did I hear someone singing my song or I am in a haze. Mr. Andrew Witty in not being witty but is being realistic.

      Yes imagining is good and dreams can create cures but their execution to have a sustainable and economic process that produces quality product without umptillion intermediate samples is a science.

      We are taught how to be good engineers and scientists in our universities but have not been successful in incorporating as taught especially in the Pharmaceuticals. We have created our own barriers.

      We have to be technology proactive and have to have sustainable processes. If we do not, we will be leaving a poor legacy for our grandchildren. Do we want to do that?

      We all know we don’t but have nothing to show for in the last ten years. We are still stuck at “A” of the QbA. In order to get to “D” of the QbD, we have two hurdles B (our bullheadedness that it cant be done) & C(our lack of creativity to harness physical characteristics of the chemicals involved). The day we are able to do that the playing field will be a pleasure and joy. Let us all rise up to it as 2011 rolls around. Our destiny (our jobs) are in our own hands.

    Trackbacks/Pingbacks


    Leave a Reply

    You must be logged in to post a comment.