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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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