Bernstein’s Tim Anderson has been holding some in-depth discussions with the executive team at Eli Lilly, including Dan Skovronsky, the incoming head of R&D. And it’s clear that Skovronsky — who’s taking Jan Lundberg’s place June 1 — intends to get more aggressive in early-stage development as he works to completely shed a well-earned reputation for a go-slow clinical approach that has frequently put them at the end of a long line of rivals.
“If you look at some of the most exciting targets in our industry, targets that Lilly has worked on, things like CDK 4/6, IL-17, IL-23, PCSK9, CGRP, in each of these we could easily have been first,” Skovronsky, the former CEO of Avid Radiopharmaceuticals, told Anderson. “Our scientists were among the first working on these targets in the lab and making drugs against them. In many cases, we were slow getting up the courage to move into human trials for various reasons. We are looking to change that.”
That means launching more Phase I studies, looking for early signs of whether they’re on the right track. Then they can decide to move forward quickly, or kill it in the case of weak data.
“We want to be the first testing novel mechanisms, so that is one change,” Skovronsky noted. “You should see more Lilly Phase I trials and proof-of-concept trials on novel mechanisms. Another change that you can expect is that sometimes I think Lilly has a reputation for being a fast follower or develop me-too drugs in the past. We do not think that is sustainable for our industry. We need to be focused on drugs with large effect sizes. I think that is always our intent, but we continue to ratchet up the pressure here to really only move forward the drugs that we believe can deliver that kind of large differentiated effect for patients.”
Quick translation: Go big or go home. And no more lingering.
“That means in Phase II proof-of-concept studies you should expect us to test new mechanisms in a small number of patients looking for the large effect size. If we do not get it, we will move on to the next mechanism and not try and eke out an OK drug. We can talk about that with Alzheimer’s, diabetes and other areas; it is working obviously in oncology and immunology. So speed and large effect sizes. Then the third thing is continued evolution on external innovation. In the past, we have been pretty good at bringing in drugs late in development, lots of Phase III partnerships or Phase II after proof of concept. I think where we are seeking to improve is on earlier-stage deals. So we will continue to do those late deals, but we also want to bring in more novel targets, novel technologies, novel drugs in earlier higher risk stages of development. Some of the changes we have already announced, for example, moving business development into R&D should help facilitate that. But you should expect to see more of that in the future.”
Eli Lilly is one of the world’s top 15 R&D operators, with a string of new drug approvals in the last few years that followed a long and incredibly frustrating development drought. It’s had some big setbacks along the way, including the initial rejection of baricitinib, now back on track at the FDA. Its painstaking progress in the clinic has delivered some impressive data, but Skovronsky knows that competition among the top players is heating up.
Now he’s signed off on a new mission statement to fix what still ails Lilly.
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