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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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US sup­ports ex­ten­sion for Covid-19 IP waiv­er de­ci­sion

After much debate, the US government is now calling for a deadline extension to discuss a controversial potential IP waiver for Covid-19 diagnostics and therapeutics.

Over the last five months, the Office of the United States Trade Representative said it has consulted with members of Congress, public health advocates, organized labor groups, academics, think tanks, companies and trade associations on the WTO’s recent TRIPS agreement, which established a 5-year waiver of certain patent requirements on Covid-19 vaccines.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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