Now that GlaxoSmithKline ($GSK) has hit the three-year mark on its closely watched experiment with Drug Performance Units, R&D Chairman Moncef Slaoui (pictured) tells FierceBiotech the pharma giant has adopted a more flexible approach to reviewing their progress. Those DPUs--which will now include a special unit focused on traditional Chinese medicine--are given milestones and timelines tailored to the work they have on hand. And while the jury may still be out on the ultimate success of the DPUs, Slaoui says he has no doubt the gamble has paid off handsomely with a passionate and energetic group of development teams that have completely transformed the R&D culture at GSK.
GSK has tended to keep its DPU cards close to its vest for competitive reasons. In an interview with FierceBiotech, however, Slaoui noted two additions to the DPU organization. One new unit has been inspired by a young scientist with a "brilliant idea" regarding hemoglobin biology. Another is in the area of traditional Chinese medicine.
"We have a strong presence now in China," says Slaoui, who's eager to put traditional remedies to the test of modern drug development and clinical efficacy standards. Once GSK starts that, he adds, the pharma company has the opportunity to discover "new molecular entities with significant efficacy."
Slaoui also reveals there's been a steady turnover of DPUs over the past three years. Before the company announced this week it will shutter three of the units and add four more, GSK had already launched 8 units and closed 6.
Rolling out the whole DPU process had to be done at once, he says, but he counts the general three-year game plan as one of his biggest mistakes.
"A synchronized review of the whole pipeline at once is more disruptive as need be," says Slaoui. "Now we have defined milestones for new reviews," which can be 18 months out, or 56 months or whatever is right. Says Slaoui: "Spreading through time, that's a big learning."
And GSK will add new DPUs as needed. "If we see that something is exciting and new, we're not going to wait."
Slaoui says his other big mistake was hesitating on the decision to shut down GSK's work on neuroscience for psychiatric conditions. "We hesitated," he says, when GSK would have been better to have made the tough decision at that point, rather than wait another 18 months.
Demonstrating clinical efficacy of these drugs is incredibly tricky, he says. A drug development team can run a Phase IIb study and get one result, and then come up with a completely different result in another trial. "There's no way to understand why."
Patient-reported outcomes in the neuroscience field can vary dramatically and the biology is complex, making it a "hugely risky" field. Not that he's given up on it. Slaoui says he's been encouraging the NIH to support more academic work in the field, and he sees a lot of potential for experts to work together on "precompetitive" projects.
While failure can certainly become apparent inside three years, success in drug discovery and development takes significantly longer, says Slaoui. But there's no question in his mind that the "culture has absolutely been transformed."
When he arrived at GSK, investigators were largely disengaged, he explains. There "was not a passionate ownership of the project early in discovery." Instead of excitement and entrepreneurship, he found a "matter-of-factly turning of the machine."
Now, he says, DPU members from the top to the bottom are "absolutely passionate about their pipeline. They can identify their input, their partnership, hold themselves accountable and hold each other accountable. The energy is absolutely palpable. You feel it every minute."
Personal accountability also extends to new partnerships, says Slaoui. The units can make a decision about working on a new method of their own or partnering with another developer. They share in the budgeted cost of the partnership, as well as the fate of the technology. And that's enhanced the quality of the internal assessment of a partnership, he adds, especially when you consider that making the right choice can determine the "life or death" of a DPU.
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