Tired of fin­ish­ing in last place, Eli Lil­ly’s new R&D chief wants to shake things up

Dan Skovron­sky. LIL­LY PAD

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.”

Tim An­der­son

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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(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Arie Belldegrun, Endpoints @ JPM20 Breakfast Panel. Photography by Jeff Rumans.

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