We've now entered a new chapter in the book of GlaxoSmithKline's 'Really Useful Abbreviations For The Way We Organize Our R&D'. In case you missed it: the CEDDs are dead. It's official. The Centers of Excellence for Drug Discovery, therapy-area focused groups spanning discovery through proof-of-concept, which flew onto the scene post-merger in 2001, are gone.
Back in the naughties, the CEDDs were considered quite radical, buzzing of smallness, accountability, and autonomy -- at least relative to the highly centralized, over-corporate, lots-of-corners-to-hide-in-style R&D of the time. They went on to inspire a host of similar initiatives elsewhere.
Now the CEDDs look sooo last decade (although we think the externally-facing CEEDD is still around). This decade the new acronym is fully-integrated Therapy Area Units (TAUs) -- five of them, covering Metabolic Pathways and Cardiovascular, Respiratory, Infectious Diseases, Immuno-inflammation, Neurosciences and Oncology R&D.
We knew which way the wind was blowing when we wrote this January IN VIVO feature. Even then it was clear GSK's R&D chairman Moncef Slaoui and SVP Medicines discovery & development Patrick Vallance wanted to move on from the notion of any sort of divide between pre- and post-proof-of-concept, the point at which the CEDDs passed suitable candidates onto the Medicines Development Centers (MDCs) for the really expensive work.
Slaoui and Vallance instead wanted full visibility from discovery through to registration and reimbursement -- not least so that payer requirements and commercial reality weren't an after thought simply pasted on in Phase III, but could actually influence which discovery programs to advance.
But don't assume the TAUs are a hark back to the pre-CEDD days of large sluggish R&D groups. That would be to forget the DPU chapter (you've still got your acronym cheat sheet right?) By 2008, these even smaller, even nimbler, even more accountable so-called drug performance units (DPUs) had begun to supercede their CEDD cousins. And given there were always a couple of standalone DPUs -- like Ophthiris in ophthalmology, for instance -- one reckons they were a harbinger of the evolving GSK.
Today, these DPUs -- which came complete with investment boards and three-year, milestone-linked funding cycles -- remain the R&D building blocks within GSK. It's just that now they have highly porous borders with downstream development. (And they're also spawning external versions, too, like the academic discovery performance unit set up at Cambridge University.)
So who are the new TAU chiefs? By and large, they're whoever won the battle between the CEDD-head and MDC-head in that particular therapy area: Zhi Hong (CEDD) in infectious diseases; Dave Allen (CEDD) in respiratory, Murray Stewart (MDC) in Metabolic Pathways & Cardiovascular, Perry Nissen in Oncology R&D (so-named because oncology is fully-integrated all the way through commercial, as at Novartis and Sanofi-Aventis). The Immuno-inflammation TAU chief has been appointed from academia but hasn't started yet, and Neurosciences apparently still has two heads.
Almost certainly, TAUs -- whose fully-integrated philosophy is also apparent within Sanofi Aventis' Therapeutic Strategy Units (TSUs?), while AstraZeneca's iMeds are more CEDD-like -- won't be the last chapter in this book. (How would consultants earn their keep?)
The next exciting bit to look forward to, though, is when the 3-year DPU funding cycle comes to an end later this year. That might kill off a few poorly-performing DPUs; indeed, "until and unless GSK actually shuts something down, no one will see the connection between data and funding, and really 'get' the model," opined one external advisor.
Slaoui isn't about to do any culling just to relay a message, though. "I may terminate a DPU even if [it] reaches [its] numbers, because the biggest limitation to numbers is that they don't [necessarily] reflect quality," he said. So by next year a few DPUs may slip away, or be tweaked...but we reckon the overall DPU concept has somewhat longer to run.
image by flickrer purplenina used under creative commons
Back in the naughties, the CEDDs were considered quite radical, buzzing of smallness, accountability, and autonomy -- at least relative to the highly centralized, over-corporate, lots-of-corners-to-hide-in-style R&D of the time. They went on to inspire a host of similar initiatives elsewhere.
Now the CEDDs look sooo last decade (although we think the externally-facing CEEDD is still around). This decade the new acronym is fully-integrated Therapy Area Units (TAUs) -- five of them, covering Metabolic Pathways and Cardiovascular, Respiratory, Infectious Diseases, Immuno-inflammation, Neurosciences and Oncology R&D.
We knew which way the wind was blowing when we wrote this January IN VIVO feature. Even then it was clear GSK's R&D chairman Moncef Slaoui and SVP Medicines discovery & development Patrick Vallance wanted to move on from the notion of any sort of divide between pre- and post-proof-of-concept, the point at which the CEDDs passed suitable candidates onto the Medicines Development Centers (MDCs) for the really expensive work.
Slaoui and Vallance instead wanted full visibility from discovery through to registration and reimbursement -- not least so that payer requirements and commercial reality weren't an after thought simply pasted on in Phase III, but could actually influence which discovery programs to advance.
But don't assume the TAUs are a hark back to the pre-CEDD days of large sluggish R&D groups. That would be to forget the DPU chapter (you've still got your acronym cheat sheet right?) By 2008, these even smaller, even nimbler, even more accountable so-called drug performance units (DPUs) had begun to supercede their CEDD cousins. And given there were always a couple of standalone DPUs -- like Ophthiris in ophthalmology, for instance -- one reckons they were a harbinger of the evolving GSK.
Today, these DPUs -- which came complete with investment boards and three-year, milestone-linked funding cycles -- remain the R&D building blocks within GSK. It's just that now they have highly porous borders with downstream development. (And they're also spawning external versions, too, like the academic discovery performance unit set up at Cambridge University.)
So who are the new TAU chiefs? By and large, they're whoever won the battle between the CEDD-head and MDC-head in that particular therapy area: Zhi Hong (CEDD) in infectious diseases; Dave Allen (CEDD) in respiratory, Murray Stewart (MDC) in Metabolic Pathways & Cardiovascular, Perry Nissen in Oncology R&D (so-named because oncology is fully-integrated all the way through commercial, as at Novartis and Sanofi-Aventis). The Immuno-inflammation TAU chief has been appointed from academia but hasn't started yet, and Neurosciences apparently still has two heads.
Almost certainly, TAUs -- whose fully-integrated philosophy is also apparent within Sanofi Aventis' Therapeutic Strategy Units (TSUs?), while AstraZeneca's iMeds are more CEDD-like -- won't be the last chapter in this book. (How would consultants earn their keep?)
The next exciting bit to look forward to, though, is when the 3-year DPU funding cycle comes to an end later this year. That might kill off a few poorly-performing DPUs; indeed, "until and unless GSK actually shuts something down, no one will see the connection between data and funding, and really 'get' the model," opined one external advisor.
Slaoui isn't about to do any culling just to relay a message, though. "I may terminate a DPU even if [it] reaches [its] numbers, because the biggest limitation to numbers is that they don't [necessarily] reflect quality," he said. So by next year a few DPUs may slip away, or be tweaked...but we reckon the overall DPU concept has somewhat longer to run.
image by flickrer purplenina used under creative commons
CEDDs are dead because Slaoui and Vallance can't take credit for them. They need their own imprint - however misguided. DPU's? What a disaster. Just ask those working in them - if they dare admit it publicly. Maybe the reason for the move to TAU's now is to blunt the obvious criticism and second guessing that will arise when the 3-year DPU experiment comes to an end and the shockingly low productivity that resulted becomes clear. And don't forget that GSK R&D management has very creative ways of accounting for its success and others' failures when it comes to the tallysheet. And don't forget that at least several of the claimed current successes of drug discovery actually came out of CEDD research. It may not be obvious to those outside of GSK, but it is to the silent majority on the inside who have borne witness. You can only fool some of the people some of the time.
ReplyDeleteIt would be interesting to know what will become of the CEEDD under such reforms? They have had some success but a lot of turnover in their leadership.
ReplyDelete