New Merck CFO Caroline Litchfield (Merck)

Mer­ck­'s big C-suite shuf­fle con­tin­ues as Car­o­line Litch­field is tapped as new CFO

It’s out with the old in Mer­ck’s C-suite, as CEO Ken Fra­zier pre­pares to hand the reins to CFO Robert Davis. To fill that spot, the phar­ma gi­ant is bring­ing up its cur­rent trea­sur­er, who’s been at the com­pa­ny for more than three decades.

Car­o­line Litch­field will take the CFO spot start­ing April 1, Mer­ck said on Wednes­day. The Uni­ver­si­ty of Leices­ter grad­u­ate got her start in fi­nance at the com­pa­ny’s UK site back in 1990, and hopped to Ger­many, Switzer­land and the US to fill a va­ri­ety of roles span­ning “every as­pect of fi­nance,” ac­cord­ing to her LinkedIn page.

From 2014 to 2018, Litch­field led fi­nance for Hu­man Health, Mer­ck’s largest busi­ness, be­fore get­ting pro­mot­ed to trea­sur­er.

“Car­o­line’s ap­point­ment as our next CFO is the re­sult of a com­bi­na­tion of fac­tors – most im­por­tant­ly, Car­o­line’s fi­nan­cial ex­per­tise, re­mark­able track record, and lead­er­ship – as well as our com­mit­ment to de­vel­op­ing tal­ent and our suc­ces­sion plan­ning for lead­er­ship roles,” out­go­ing CEO Ken Fra­zier said in a state­ment.

The news comes just a week af­ter Mike Nal­ly an­nounced he’s step­ping away from the chief mar­ket­ing job at the phar­ma gi­ant to pur­sue an­oth­er op­por­tu­ni­ty. Fra­zier’s hit­ting the ex­it in June, and R&D MVP Roger Perl­mut­ter shared news of his re­tire­ment at the end of last year.

In Feb­ru­ary, Mer­ck ap­point­ed Davis, a four-year Mer­ck vet­er­an with a dec­o­rat­ed ré­sumé, to take Fra­zier’s role. He’s served time as EVP of glob­al ser­vices and CFO at Bax­ter and 14 years in the ranks at Eli Lil­ly.

The fresh C-suite will be tasked with lead­ing Mer­ck to the next big Keytru­da with­out Fra­zier and Perl­mut­ter, who’s hand­ed the reins to cur­rent dis­cov­ery lead Dean Li. Perl­mut­ter plans to stay on in a non-ex­ec­u­tive di­rec­tor role through mid-2021.

“I’m hon­ored to be­come Mer­ck’s CFO at such a piv­otal time, and to work close­ly with Ken, Rob and the ex­ec­u­tive com­mit­tee to con­tin­ue our com­pa­ny’s tru­ly unique lega­cy of sav­ing and im­prov­ing lives and cre­at­ing long-term val­ue for pa­tients, cus­tomers and share­hold­ers,” Litch­field said in a pre­pared state­ment.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

Back-to-back piv­otal fail­ures force Ther­a­vance to lay off 270 staffers, prune R&D fo­cus

If it all went well, Q3 was supposed to be harvest time for Theravance.

Both of its lead drugs — the pan-JAK inhibitor izencitinib and blood pressure drug ampreloxetine — were slated for crucial readouts. The biotech was, as SVB Leerink analyst Geoffrey Porges put it, “entering the most important period of validation events in its history.”

Instead, izencitinib flopped a key Phase IIb trial in ulcerative colitis, putting the J&J partnership around it in jeopardy. A month later, Theravance is reporting that the Phase III trial testing ampreloxetine in symptomatic neurogenic orthostatic hypotension is also a failure, imploding the company’s entire pipeline and forcing a rethink on R&D strategy.

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Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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