→ In the Big Phar­ma world, com­pa­nies like J&J and Mer­ck have ex­pe­ri­enced a pro­nounced sea change in lead­er­ship over a two-year pe­ri­od, and you can be­gin to say the same at No­var­tis, which dis­missed head of de­vel­op­ment John Tsai and head of on­col­o­gy Su­sanne Schaf­fert as part of CEO Vas Narasimhan’s wide-rang­ing re­struc­tur­ing plan. The next shoe to drop is Jay Brad­ner, the pres­i­dent of the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, who is leav­ing his post on Hal­loween and pass­ing the ba­ton to Fiona Mar­shall, Mer­ck’s SVP and glob­al head of dis­cov­ery sci­ences, pre­clin­i­cal de­vel­op­ment and trans­la­tion­al med­i­cine.

In a LinkedIn post that made the rounds on Thurs­day, Brad­ner said, “I can­not prop­er­ly ex­press my grat­i­tude to all of my 5,600 in­cred­i­ble NI­BR col­leagues. In the dark­est and most iso­lat­ing mo­ments of the pan­dem­ic, we leaned on each oth­er and flour­ished per­son­al­ly and sci­en­tif­i­cal­ly, with grace and of­ten good hu­mor. Thank you, NI­BR, for the gift of your warm con­fi­dence, gen­er­ous ad­vices and to­tal com­mit­ment to our re­search; it has been hum­bling and in­spir­ing to be your leader.”

As Mar­shall ven­tures off to NI­BR, Mer­ck has her suc­ces­sor all fig­ured out. George Ad­dona joined the phar­ma gi­ant — from NI­BR, co­in­ci­den­tal­ly — in 2008 and has in­cre­men­tal­ly tak­en on big­ger roles ever since: For al­most three years, Ad­dona has been Mer­ck’s VP of quan­ti­ta­tive bio­sciences. You can read more of our cov­er­age about each of these ap­point­ments here and here.

→ Now that the clin­i­cal hold has been lift­ed on its ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy — a field that has seen its share of sim­i­lar ac­tions from the FDA — Dyne Ther­a­peu­tics has tapped Francesco Bib­biani as SVP, head of de­vel­op­ment. Bib­biani had led glob­al clin­i­cal de­vel­op­ment at Ul­tragenyx, which just bought its An­gel­man syn­drome part­ner GeneTx in Ju­ly, since Feb­ru­ary 2021 and has held oth­er lead­er­ship po­si­tions in clin­i­cal de­vel­op­ment at PTC Ther­a­peu­tics and Ei­sai.

→ Mor­phoSys has a po­ten­tial block­buster on its hands with the myelofi­bro­sis drug pelabre­sib from its Con­stel­la­tion Phar­ma­ceu­ti­cals buy­out, but the Ger­man biotech will push for­ward with­out Malte Pe­ters, who will re­tire as chief R&D of­fi­cer at the end of the year. Schooled in Ger­many with a four-year run as Mer­ck KGaA’s head of glob­al clin­i­cal de­vel­op­ment on­col­o­gy, Tim De­muth will take over for Pe­ters at the Mon­ju­vi mak­er. Peer Re­view told you about where De­muth land­ed af­ter he left the Ger­man phar­ma, tak­ing the CMO job at Pieris Phar­ma­ceu­ti­cals in Au­gust 2021. This planned tran­si­tion comes af­ter Mor­phoSys struck a deal to ship off two an­ti­body pro­grams to ARCH’s Hu­man Im­munol­o­gy Bio­sciences in June.

→ Pfiz­er has poached Drew Panayiotou from Al­pha­bet’s Ver­i­ly, nam­ing him bio­phar­ma glob­al chief mar­ket­ing of­fi­cer while Ver­i­ly pro­motes Al­ix Hart to his pre­vi­ous post. Panayiotou, the chief mar­ket­ing of­fi­cer at Ver­i­ly since late 2020, had been pres­i­dent of Chick-Fil-A sub­sidiary Red Wag­on Ven­tures and was al­so the US chief mar­ket­ing of­fi­cer for Best Buy from 2009-13. Hart is a for­mer Best Buy ex­ec in her own right who be­came Ver­i­ly’s head of con­tent and dig­i­tal strat­e­gy last year af­ter serv­ing as Nvidia’s glob­al head of dig­i­tal mar­ket­ing from 2016-21. Beth Bu­lik has more on both ap­point­ments.

→ With Cigall Kadoch div­ing in­to her new job as an in­ves­ti­ga­tor with the Howard Hugh­es Med­ical In­sti­tute on Sept. 6, she has re­signed as a board mem­ber at the biotech she co-found­ed, Foghorn Ther­a­peu­tics. She’ll still be on the SAB at Foghorn, which has sus­tained a reg­u­la­to­ry dou­ble wham­my with a par­tial clin­i­cal hold in May that grad­u­at­ed to a full clin­i­cal hold last week with its blood can­cer drug FHD-286.

→ Putting a bow on a cou­ple of CEO de­par­tures End­points News re­port­ed on last Fri­day, Ker­ry Blan­chard walked away from Ever­est Med­i­cines short­ly af­ter hit­ting the moun­tain­top in Chi­na with Gilead-part­nered Trodelvy, gain­ing an ap­proval in the coun­try for un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic triple-neg­a­tive breast can­cer. Ever­est pres­i­dent and CFO Ian Woo will be in­ter­im chief un­til the Shang­hai biotech finds a per­ma­nent suc­ces­sor.

Austin, TX-based Ae­glea Bio­Ther­a­peu­tics is trim­ming its staff by 25%, while chief ex­ec­u­tive An­tho­ny Quinn scales back to an ad­vi­so­ry role and gen­er­al coun­sel Jim Kas­ten­may­er takes charge as in­ter­im pres­i­dent and CEO. The FDA threw down the stop sticks with a re­fusal-to-file let­ter for Ae­glea’s arginase 1 de­fi­cien­cy drug pegzi­larginase in June.

And then there’s Nordic Nanovec­tor, try­ing to keep its head above wa­ter af­ter wav­ing the white flag with the PAR­A­DIGME study of its lead as­set Be­talutin in ear­ly Ju­ly. CEO Erik Skullerud is out, and Ma­lene Brond­berg will step in tem­porar­i­ly as she con­tin­ues her CFO du­ties — and as the Oslo biotech hud­dles up with Carnegie In­vest­ment Bank to “ex­plore strate­gic op­tions.”

→ You say you want a Rev­o­lu­tion: Weeks re­moved from an up­sized pub­lic of­fer­ing to­tal­ing $230 mil­lion, RAS-mu­tat­ed can­cer biotech Rev­o­lu­tion Med­i­cines out of the Bay Area has se­lect­ed Daniel Si­mon as CBO while pro­mot­ing Jack An­ders to CFO and Jeff Cis­li­ni to gen­er­al coun­sel. Dur­ing Si­mon’s sev­en years with Guardant Health, he was SVP, bio­phar­ma busi­ness de­vel­op­ment and has worked in cor­po­rate de­vel­op­ment at Onyx Phar­ma­ceu­ti­cals. For­mer­ly SVP, fi­nance and the prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer for CEO Mark Gold­smith, An­ders logged 12 years at De­pomed be­fore piv­ot­ing to Rev­o­lu­tion Med­i­cines in 2018. Cis­li­ni, the deputy gen­er­al coun­sel since 2020, is a one-time le­gal ex­ec at Atara Bio­ther­a­peu­tics.

→ Ocu­gen wasn’t in the FDA’s good graces when they faced a $10,000 fine for not un­veil­ing tri­al re­sults, but now that the clin­i­cal hold has been lift­ed on its Covid-19 vac­cine can­di­date Co­v­ax­in, the Malvern, PA biotech has ush­ered in Robert Hop­kins as CMO and pro­mot­ed Arun Upad­hyay to CSO. Hop­kins has been around the block with Mer­ck Re­search Lab­o­ra­to­ries and Emer­gent BioSo­lu­tions, among oth­er com­pa­nies, and in Au­gust 2021 he was el­e­vat­ed to med­ical chief at Adap­tive Phage Ther­a­peu­tics. Upad­hyay joined Shankar Musunuri’s squad in 2017 and had been run­ning R&D at Ocu­gen since De­cem­ber.

→ With its stock price $GRTX lan­guish­ing in the pen­ny stock range af­ter a Phase III prat­fall with its lead drug ava­sopasem last Oc­to­ber, Penn­syl­va­nia’s Galera Ther­a­peu­tics has ap­point­ed Eu­gene Kennedy as CMO. Jon Holm­lund, Galera’s med­ical chief since 2012, is re­tir­ing as the year comes to a close. Kennedy, the med­ical chief for the last year and a half at In­no­v­a­tive Cel­lu­lar Ther­a­peu­tics, tack­led the same role at Lu­mos Phar­ma.

→ Re­gen­er­a­tive med­i­cine com­pa­ny Ser­ax­is has reeled in Paul Strumph as CMO. Strumph brings ex­pe­ri­ence from his times at Meta­vant Sci­ences (CMO), Lex­i­con Phar­ma­ceu­ti­cals (VP, clin­i­cal de­vel­op­ment), Quin­tiles (North Amer­i­cal re­gion­al CMO), and Ju­ve­niles Di­a­betes Re­search Foun­da­tion (CMO). Strumph jump­start­ed his ca­reer at GSK, Mer­ck KGaA/EMD Serono and Bris­tol My­ers Squibb.

→ Que­bec-based Va­leo Phar­ma has re­cruit­ed Kyle Steiger as chief com­mer­cial of­fi­cer and Jean-François Fournier as busi­ness unit head — oph­thal­mol­o­gy. Both are No­var­tis Cana­da alums: Steiger was VP of oph­thal­mol­o­gy to cap off 19 years with the Big Phar­ma, and Fournier had spent the last three years as com­mer­cial di­rec­tor, mar­ket­ing & sales. Be­fore his time with No­var­tis Cana­da, Steiger was briefly the na­tion­al sales di­rec­tor for Ipsen’s on­col­o­gy port­fo­lio.

→ Af­ter ap­point­ing In­hibitor Ther­a­peu­tics chair­man Mark Wat­son to the board of di­rec­tors in ear­ly Au­gust, Vaxart has wel­comed Ray Sta­ple­ton as chief tech­nol­o­gy of­fi­cer. Sta­ple­ton comes to the South San Fran­cis­co vac­cine mak­er from Geno­cea Bio­sciences, where he held the same ti­tle and was EVP. He al­so rose through the ranks in 15 years at Mer­ck, be­com­ing ex­ec­u­tive di­rec­tor, glob­al vac­cines tech­nol­o­gy and en­gi­neer­ing un­til he left the phar­ma gi­ant in 2015.

→ Ad­vanc­ing its lead as­set — a drug for Char­cot-Marie-Tooth dis­ease type 1A named PXT3003 — in­to Phase III, French neu­ro biotech Pharnext has in­stalled GSK fi­nan­cial vet Rob Quinn as CFO, while Valérie Wor­rall has moved on “to pur­sue oth­er in­ter­ests” af­ter more than six months on the job. Quinn’s most re­cent gig as fi­nance chief was with Benev­o­len­tAI, and he’s al­so been CFO for Si­lence Ther­a­peu­tics.

→ Gink­go Bioworks has lined up Be­hzad Mah­davi as SVP of bio­phar­ma man­u­fac­tur­ing & life sci­ence tools af­ter raid­ing the bar­gain bin and buy­ing out Zymer­gen — which had en­dured a dis­as­trous ride on the strug­gle bus — for $300 mil­lion in Ju­ly. Mah­davi makes the leap to Gink­go from Catal­ent, where the 13-year Lon­za vet served as VP, glob­al open in­no­va­tion.

→ Not to be con­fused with the In­dy­Car su­per­star, Scott Dixon has reached the check­ered flag as chief com­mer­cial of­fi­cer of dig­i­tal clin­i­cal tri­al out­fit Ob­vio­Health. Dixon, who has worked at such com­pa­nies as Or­a­cle, Web­MD and Parex­el, spent the last year as chief rev­enue of­fi­cer of Fly­wheel.io.

→ Texas-based Biote has las­soed in Samar Kam­dar as CFO. Kam­dar hops aboard af­ter a stint as CFO of Slync.io and Tax­Act. Pri­or to that, Kam­dar had gigs at CROSS­MARK, Avail­i­ty, and Pep­si­Co.

→ World­wide Clin­i­cal Tri­als has brought aboard Bar­ry Le­d­er­man as CFO. This isn’t Le­d­er­man’s first time don­ning the CFO hat, hav­ing served in the role at Perime­ter So­lu­tions and Ha­lo Phar­ma­ceu­ti­cals. Ear­li­er in his ca­reer, Le­d­er­man had gigs at Ei­sai and Ny­comed and a 10-year run at Roche.

→ Clin­i­cal tri­al ser­vice provider THREAD is weav­ing in Kim Bo­er­icke to its lead­er­ship team as chief de­liv­ery of­fi­cer. Bo­er­icke joins with ex­pe­ri­ence from her times at Icon (pres­i­dent, Icon com­mer­cial­iza­tion and out­comes), Quin­tiles (VP and man­ag­ing di­rec­tor) and i3 Re­search (glob­al VP).

→ Get­ting this year off to an aus­pi­cious start with a $100 mil­lion Se­ries B round, UK cell and gene ther­a­py man­u­fac­tur­er Ori Biotech has made a bevy of moves, start­ing with Kale Feeter and Lind­sey Clarke as di­rec­tors of busi­ness de­vel­op­ment.

Feeter comes to Ori from Cy­ti­va, where he was en­ter­prise busi­ness de­vel­op­ment leader, cell & gene ther­a­py, while Clarke was Bio-Techne’s se­nior man­ag­er, glob­al prod­uct mar­ket­ing, cell & gene ther­a­py. Ori has al­so en­list­ed Sar­to­rius alum Quentin Vic­ard as di­rec­tor of prod­uct man­age­ment, Bri­an Macauley as cloud plat­form lead, and ex-Au­to­lus se­nior sci­en­tist Claire Hor­lock as prin­ci­pal sci­en­tist. Fi­nal­ly, Is­abelle Riv­ière and Ja­son Bock are now mem­bers of the sci­en­tif­ic ad­vi­so­ry board.

→ ProKid­ney is bring­ing in a pro it­self in the likes of Glenn Schul­man as SVP of in­vestor re­la­tions. Schul­man pre­vi­ous­ly served as VP of in­vestor re­la­tions at X4 Phar­ma­ceu­ti­cals and was SVP, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions at Au­rinia Phar­ma­ceu­ti­cals. Schul­man has al­so held roles at Achillion Phar­ma­ceu­ti­cals and Cura­Gen.

→ Avid Bioser­vices has re­cruit­ed Pramthesh Pa­tel as VP, process de­vel­op­ment. Pa­tel, a 23-year vet from GSK, most re­cent­ly served as se­nior di­rec­tor. Pri­or to that, Pa­tel had a decade-long stint at Bris­tol My­ers.

→ Gate­way to a new chair­per­son: 16-year Pfiz­er vet Na­tal­ie Mount has been named to the po­si­tion at St. Louis cell ther­a­py out­fit Wu­gen, re­plac­ing John McK­earn, who will stay on the board. The ex-CSO of Gam­maDelta Ther­a­peu­tics, Mount was al­so CEO of Gam­maDelta spin­out Adap­tate Bio­ther­a­peu­tics — two com­pa­nies that have been sold to Take­da in the last year.

→ Taiyin Yang has joined the board of di­rec­tors at Brii Bio­sciences af­ter re­tir­ing from a ca­reer at Gilead that be­gan in 1993. For­mer Sana ex­ec Stacey Ma suc­ceed­ed Yang as Gilead’s EVP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing on Ju­ly 18.

→ Irish biotech Prothena has re­served space for He­len Kim — the for­mer EVP of busi­ness de­vel­op­ment at Kite — on the board of di­rec­tors. Since 2019, the ex-NGM Bio­phar­ma­ceu­ti­cals CBO has been a se­nior di­rec­tor at Arie Bellde­grun’s Vi­da Ven­tures. No­vo Nordisk forked over $100 mil­lion up­front for Prothena’s AT­TR amy­loi­do­sis drugs last sum­mer.

→ Ex-Fer­ring US chief Paul Navarre has clinched a spot on the board of di­rec­tors at Dan­ish biotech Leo Phar­ma dur­ing a pe­ri­od of job cuts — up to 150 on the R&D team alone — and re­struc­tur­ing. Af­ter his 15 years at Proc­ter & Gam­ble, Navarre held a string of lead­er­ship roles for a decade at Al­ler­gan and has been a strate­gic ad­vi­so­ry board mem­ber at Flag­ship Pi­o­neer­ing.

→ Speak­ing of Flag­ship, the epi­ge­net­ics-fo­cused Omega Ther­a­peu­tics has elect­ed Rain­er Boehm to the board of di­rec­tors. Boehm fin­ished up a long ca­reer at No­var­tis as chief com­mer­cial & med­ical af­fairs of­fi­cer in 2017 and is a board mem­ber at Cel­lec­tis and Hu­mani­gen.

In November of 1937, editors from JAMA magazine penned a scathing letter about the United States’ inability to protect patients from toxins that masquerade as therapeutics, saying the drug development process was in dire need of laws with “common scientific decency.” In the preceding months, the nation had been riveted by the sudden deaths of nearly 100 people after taking elixir sulfanilamide. According to a congressional report, the elixir had been given to patients despite having only been “tested for its flavor but not its effect on human life.” Up until this point, drug manufacturers were not required to test therapeutics before sending them to market.

Seven years ago, Jay Bradner left high-profile posts at Harvard Med and Dana-Farber and jumped to the leadership role at Novartis’ global research arm, the storied Novartis Institutes for BioMedical Research, where one of his first jobs was reorganizing the group and cutting staff. And today we learned that he’s wrapping up his stint at the pharma giant in the midst of a major shakeup that forced development chief John Tsai out.

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An administrative judge ruled Illumina’s $8 billion acquisition of cancer-testing company Grail didn’t violate antitrust law, Illumina said on Thursday.

A Federal Trade Commission lawsuit threatened to unwind Illumina’s acquisition of Grail, a blood testing company that screens for cancers at an early stage.

“As we’ve stated from the outset, this transaction is procompetitive, will advance innovation, lower healthcare costs and save lives,” Illumina general counsel Charles Dadswell said in a statement.

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The FDA’s briefing docs are in ahead of its unusual second adcomm for Amylyx Pharmaceuticals’ experimental ALS drug next week — and the agency’s opinion is largely negative.

While acknowledging that ALS treatments are “desperately needed” and providing an extensive history of their previous flexibility for the disease, FDA reviewers wrote that Amylyx’s submission of new analyses is “not independent data and is simply a new method for analyzing the same survival data presented in the original NDA submission.” The new data packages involve patients who switched over from treatment to placebo after the Phase II trial wrapped up, suggesting better survival results than the study originally indicated.

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The FDA on Friday expanded its approval of Vertex’s blockbuster cystic fibrosis pill Orkambi to include children between 12 and 24 months.

Orkambi first won approval in 2015 for ages 2 years and older with two copies of the F508del mutation, but Vertex went for the earlier age indication, as CMO Carmen Bozic said in a statement: “Treating children with cystic fibrosis as early in life as possible is critically important, because early treatment has the potential to slow the progression of this devastating disease.”

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United Therapeutics claimed victory earlier this week in a patent battle against Liquidia Technologies, which won tentative FDA approval for its treprostinil inhalation powder, Yutrepia, to treat pulmonary arterial hypertension (PAH) and would compete directly with United’s soon-to-be blockbuster Tyvaso DPI.

The Delaware-based district court found that Liquidia failed to prove by “clear and convincing evidence” that certain claims on one of the patents are invalid. But both companies claimed victory over other parts of the decision, and when Yutrepia will launch is still up in the air.

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Some shuffling is taking place at the top ranks of Pfizer.

Longtime exec Andy Schmeltz announced on LinkedIn that he’s moving onto his next tour of duty to helm the newly established Pfizer Commercial Strategy & Innovation (CSI) group, which will be in charge of portfolio strategy and investment decisions. Taking his place leading the oncology unit will be Suneet Varma — a fellow Pfizer vet with almost 22 years at the pharma giant — who’s been appointed as global oncology & US president.

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While Biocon continues to be one of the major players in the generics and biosimilars markets, several of the company’s manufacturing sites have ended up on the FDA’s radar.

In a letter submitted to the stock exchange of India, Biocon stated that the FDA inspected three manufacturing facilities in the city of Bengaluru, India, and Johor, Malaysia. According to the letter, the inspections started with the Bengaluru site on Aug. 11 and concluded in Malaysia on Aug. 31.

While the ad industry is navigating a jittery economy — and the looming threat of marketing budget cuts — the pharma sector seems to be humming along. One proof point this week is Real Chemistry, the second-largest healthcare agency in North America, with a healthy first-half report and double-digit growth.

The digital communications and marketing company reported on Wednesday’s first half revenues of more than $270 million, a 21% increase compared to the first half of 2021. While the 2022 jump won’t surpass the pandemic affected 2020 to 2021 increase of 35%, Real Chemistry CEO Shankar Narayanan said it’s projecting full-year growth of 20%. Real Chemistry notched $439 million in 2021 sales, putting the projected 2022 full year at more than $525 million.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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