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.
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…)
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