Joseph Romanelli, Merck's incoming head of Human Health international division

In Frank Clyburn's ab­sence, Mer­ck taps sea­soned vet­er­an to run in­ter­na­tion­al Hu­man Health busi­ness

Frank Clyburn left some big shoes to fill. Mer­ck an­nounced back in Feb­ru­ary that it would take three peo­ple to re­place his role run­ning the com­pa­ny’s hu­man health busi­ness, and tapped the first two ex­ecs from with­in.

For the third, Mer­ck is bring­ing home a sea­soned vet­er­an who spent 25 years at the phar­ma gi­ant be­fore leav­ing for a short stint at the helm of a Chi­nese biotech.

Joseph Ro­manel­li has agreed to lead Mer­ck’s in­ter­na­tion­al Hu­man Health busi­ness, start­ing Aug. 1, the com­pa­ny an­nounced on Wednes­day. He’ll serve along­side Arpa Garay and Jan­nie Oost­huizen, two for­mer on­col­o­gy ex­ecs who now lead glob­al mar­ket­ing and US busi­ness for the Glob­al Health unit, re­spec­tive­ly.

All three will re­port di­rect­ly to CEO Robert Davis.

“Joe’s re­mark­able track record of dri­ving growth, un­wa­ver­ing com­mit­ment to keep pa­tients at the cen­ter, deep knowl­edge of the glob­al com­pet­i­tive land­scape and pas­sion for Mer­ck’s pur­pose to save and im­prove lives make him the ide­al leader for our grow­ing and ex­pan­sive in­ter­na­tion­al Hu­man Health busi­ness,” Davis said in a news re­lease.

It’s been less than a year since Ro­manel­li left Mer­ck to be­come CEO at Shang­hai-based JiX­ing Phar­ma­ceu­ti­cals.

While there, he steered an ex­pan­sion of the com­pa­ny’s part­ner­ship with Cy­to­ki­net­ics to de­vel­op the lat­ter’s close­ly watched heart fail­ure drug ome­cam­tiv mecar­bil in Chi­na. In Feb­ru­ary, the drug failed to demon­strate an im­proved per­for­mance in ex­er­cise ca­pac­i­ty among pa­tients suf­fer­ing heart fail­ure with re­duced ejec­tion frac­tion when com­pared to a sug­ar pill.

Ro­manel­li al­so re­cent­ly led JiX­ing to a li­cens­ing deal with LENZ Ther­a­peu­tics for its two pres­by­opia can­di­dates.

The Ford­ham Uni­ver­si­ty Gabel­li School of Man­age­ment grad­u­ate an­nounced he was step­ping down from JiX­ing in April, and the com­pa­ny’s found­ing CEO, Pe­ter Fong, has agreed to step back up to take his place.

Be­fore that, Ro­manel­li served at Mer­ck for 25 years, start­ing as a busi­ness man­ag­er and work­ing his way up to man­ag­ing di­rec­tor of MSD Tai­wan, and even­tu­al­ly, pres­i­dent of MSD Chi­na. He led Mer­ck’s busi­ness in Chi­na from 2016 to 2021, dur­ing which time Chi­na be­came Mer­ck’s sec­ond-largest mar­ket, ac­cord­ing to the com­pa­ny.

In his new role, Ro­manel­li will man­age Mer­ck’s $22 bil­lion in­ter­na­tion­al Hu­man Health busi­ness and a team of 14,000 staffers.

Clyburn, who was once said to be in the run­ning for the CEO role at Mer­ck, stepped down from his po­si­tion as pres­i­dent of the Hu­man Health unit ear­li­er this year to be­come CEO at DuPont-ma­jor­i­ty owned In­ter­na­tion­al Fla­vors & Fra­grances (IFF).

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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