'Don't eat me' up­start taps Take­da vet on path to the clin­ic; Greg Mayes leaves An­tios for Cana­di­an psy­che­delics play­er

Ne­nad Gr­musa

Ne­nad Gr­musa was “re­al­ly hap­py” at Take­da, where he’d been for more than a decade in var­i­ous R&D strat­e­gy and fi­nance po­si­tions. How­ev­er, the more he learned about DEM Bio­Phar­ma, the more in­trigued he be­came by can­cer’s un­ex­plored “don’t eat me” sig­nals.

Jonathan Weiss­man and team launched the apt­ly-named biotech back in June to de­ploy macrophages and oth­er myeloid ef­fec­tor cells against tu­mors by us­ing so-called “don’t eat me” and “eat me” sig­nals, which al­low can­cer cells to evade the im­mune sys­tem.

The Long­wood-backed start­up of­fi­cial­ly tapped Gr­musa as CEO on Tues­day, along­side On­corus vet Christophe Qué­va, who’s join­ing as CSO. Qué­va’s re­sume boasts stints at iTeos, as well as As­traZeneca, Am­gen and Gilead. The team al­so took the op­por­tu­ni­ty to in­tro­duce Loise Fran­cis­co-An­der­son, who re­cent­ly joined as VP and head of bi­ol­o­gy.

Christophe Qué­va

“I was amazed how much da­ta the group has gen­er­at­ed in such a short pe­ri­od of time and I’m re­al­ly re­al­ly im­pressed by the qual­i­ty of the sci­en­tif­ic team,” Gr­musa said.

He’s tak­ing over from found­ing CEO David Don­abe­di­an, who will con­tin­ue to ad­vise the com­pa­ny. For­mer Tril­li­um Ther­a­peu­tics CEO Jan Skvar­ka is al­so on board as ex­ec­u­tive chair­man. Up­on launch­ing with a $70 mil­lion Se­ries A, Don­abe­di­an pre­dict­ed that the com­pa­ny might be in the clin­ic in the next two to three years.

Gr­musa con­firmed that time­line on Thurs­day, adding that the com­pa­ny is hop­ing to get IND-en­abling stud­ies un­der its belt by 2024. The start­up’s plat­form, dubbed Co-cul­ture with Hu­man Myeloid Phago­cytes or CHoMP, seeks tar­gets us­ing CRISPR screen­ing.

The team is cur­rent­ly 15-large, though Gr­musa added that the com­pa­ny’s look­ing to grow.

“It’s been a very short pe­ri­od of time, but we’ve re­cruit­ed the top sci­en­tif­ic tal­ent, and I’m amazed,” he said.

Gr­musa’s back­ground is in fi­nance and eco­nom­ics, where he grad­u­at­ed from the Bran­deis In­ter­na­tion­al Busi­ness School with his mas­ter’s. He lat­er held an­a­lyst po­si­tions at Boston Bio­med­ical Con­sul­tants and Mil­len­ni­um Phar­ma­ceu­ti­cals, be­fore jump­ing to Take­da in 2012. Most re­cent­ly, he was SVP of R&D strat­e­gy and ex­ter­nal in­no­va­tion, and CFO of R&D. — Nicole De­Feud­is

Greg Mayes

Greg Mayes has bolt­ed from An­tios Ther­a­peu­tics, tak­ing over from Joseph del Moral as pres­i­dent and CEO of Toron­to psy­che­delics biotech Re­union Neu­ro­science. On Mayes’ watch, An­tios pulled to­geth­er a $96 mil­lion raise in April 2021 and an­oth­er $75 mil­lion in No­vem­ber to form its Se­ries B, but the biotech ran in­to trou­ble a few months ago when the FDA threw down the stop sticks with a clin­i­cal hold on its HBV drug. As­sem­bly Bio­sciences would pull the plug on its col­lab­o­ra­tion with An­tios as a re­sult.

As del Moral be­comes chair­man, Mayes now leads a com­pa­ny once known as Field Trip Health with its lead pro­gram RE-104 in ear­ly-stage tri­als for treat­ment re­sis­tant de­pres­sion and a Phase II planned in Au­gust 2023 for post­par­tum de­pres­sion. “My goal as pres­i­dent and CEO of Re­union is to lead a com­pa­ny that will bold­ly dis­rupt the men­tal health sec­tor with dif­fer­en­ti­at­ed sero­ton­er­gic psy­che­del­ic ther­a­pies,” Mayes said in a state­ment.

Julie Brown

→ The changes are pro­nounced at GSK as the phar­ma gi­ant con­scious­ly brands it­self as the “New GSK,” spin­ning off its con­sumer health­care busi­ness while plac­ing a pre­mi­um on spe­cial­ty med­i­cine and vac­cine R&D. You can al­so sense it with the lead­er­ship team: R&D chief Hal Bar­ron is gone, land­ing a CEO gig at the am­bi­tious an­ti-ag­ing play Al­tos Labs, and now CFO Iain Mack­ay has de­cid­ed to re­tire in May 2023. Mack­ay will be re­placed by Julie Brown, the chief op­er­at­ing and fi­nan­cial of­fi­cer at Burber­ry who spent a quar­ter-cen­tu­ry with As­traZeneca in a num­ber of ex­ec­u­tive roles, in­clud­ing in­ter­im CFO and VP of group fi­nance. Ef­fec­tive im­me­di­ate­ly, Brown has left the board of di­rec­tors at Roche, and Patrick Frost will re­place her tem­porar­i­ly as chair of the Swiss phar­ma’s au­dit com­mit­tee. Am­ber Tong has more on Brown’s ap­point­ment.

Juan An­dres

→ Us­ing its Covid-19 jab as a spring­board for more po­ten­tial vac­cine launch­es — cy­tomegalovirus and the flu among them — Stéphane Ban­cel will give Juan An­dres a new role on Jan. 1 at Mod­er­na, nam­ing him pres­i­dent, strate­gic part­ner­ships and en­ter­prise ex­pan­sion. Jerh Collins, a 30-year No­var­tis vet who has been the Big Phar­ma’s chief cul­ture of­fi­cer since Sep­tem­ber 2020, will re­place An­dres as chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer, and will join the mR­NA biotech three months ear­ly on Oct. 3. An­dres has ties to No­var­tis him­self, serv­ing as glob­al head of tech­ni­cal op­er­a­tions there un­til he took off for Mod­er­na as SVP of late-stage tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing in Au­gust 2017.

Fred Ka­mal

Fred Ka­mal has been pro­mot­ed to pres­i­dent and COO of 4D Mol­e­c­u­lar Ther­a­peu­tics, the Emeryville, CA gene ther­a­py biotech with pro­grams that go af­ter wet AMD, Fab­ry dis­ease and cys­tic fi­bro­sis. Ka­mal, the op­er­a­tions chief since Feb­ru­ary 2020, came to 4DMT in the fall of 2018 as chief tech­ni­cal of­fi­cer af­ter stints at In­ter­Mune, Juno Ther­a­peu­tics and Avex­is. UCSF pro­fes­sor Noriyu­ki Kasa­hara, prin­ci­pal in­ves­ti­ga­tor at the school’s Brain Tu­mor Cen­ter, has claimed a spot on 4DMT’s board of di­rec­tors.

Mic­ah Ben­son

→ Take­da part­ner KSQ Ther­a­peu­tics has pro­mot­ed head of im­munol­o­gy Mic­ah Ben­son to CSO and has re­cruit­ed Tom Leitch as chief tech­nol­o­gy of­fi­cer. Ben­son was head of tol­er­ance ther­a­peu­tics for Pfiz­er’s im­munol­o­gy and in­flam­ma­tion re­search unit, then signed on as KSQ’s head of im­muno-on­col­o­gy in 2016. An 11-year Mer­ck vet who held lead­er­ship roles at Alex­ion, Leitch is the lat­est to peel away from blue­bird bio in the wake of its two gene ther­a­py ap­provals, mov­ing on to KSQ af­ter two years as blue­bird’s head of man­u­fac­tur­ing and five years over­all. Ad­di­tion­al­ly, Dunad Ther­a­peu­tics chief Pearl Huang is leav­ing the board of di­rec­tors, while Ben­son’s pre­de­ces­sor Frank Stegmeier steps in to keep it a six-mem­ber board.

Dave An­der­son

Dave An­der­son has been named CSO of Philadel­phia’s Code Bio­ther­a­peu­tics, the gene ther­a­py out­fit led by for­mer GSK ex­ec Bri­an McVeigh that made Take­da stand up and take no­tice with a $2 bil­lion AAV deal in Feb­ru­ary. An­der­son once led pre­clin­i­cal re­search for neu­ro­log­i­cal dis­eases at Spark and had just been pro­mot­ed to SVP of re­search at Swan­Bio in June. Code has com­pe­ti­tion with the non-vi­ral ap­proach, as biotechs like Xalud Ther­a­peu­tics and Ver­sant-backed Vec­tor Bio­Phar­ma jock­ey for po­si­tion.

Kevin Bunker

→ New Zen­tal­is CEO Kim Black­well is con­tin­u­ing to tin­ker with the lead­er­ship around her, pro­mot­ing co-founder Kevin Bunker to CSO af­ter swing­ing the door open for med­ical chief Car­rie Brown­stein last week and el­e­vat­ing an­oth­er co-founder, Cam Gal­lagher, to pres­i­dent in her first cou­ple weeks on the job. A for­mer se­nior sci­en­tist in Pfiz­er’s drug dis­cov­ery re­search group, Bunker — hereto­fore the COO at Zen­tal­is — co-found­ed and was CSO of Ka­lyra Phar­ma­ceu­ti­cals.

→ What about Brown­stein’s suc­ces­sor at her for­mer em­ploy­er? Cel­lec­tis is look­ing in­ward for that, as Mark Frat­ti­ni moves in­to the CMO slot. Frat­ti­ni piv­ot­ed to Cel­lec­tis in Au­gust 2020 as SVP of clin­i­cal sci­ences af­ter his turn as ex­ec­u­tive med­ical di­rec­tor, pro­gram lead, glob­al clin­i­cal R&D in the hema­tol­ogy ther­a­peu­tic area for Cel­gene and Bris­tol My­ers Squibb. “Mark al­ready had an im­pres­sive track record be­fore join­ing Cel­lec­tis,” CEO An­dré Chouli­ka said in a state­ment. “He has con­tin­ued to lead our clin­i­cal teams suc­cess­ful­ly over the last two years and I am thrilled to con­tin­ue work­ing with him in this ex­pand­ed role.”

David Poon

→ Van­cou­ver-based Gan­dee­va Ther­a­peu­tics, a cryo­genic elec­tron mi­croscopy (cryo-EM) biotech that notched a $40 mil­lion Se­ries A in Jan­u­ary from the likes of Leaps by Bay­er and Am­gen, has se­lect­ed Matthew Lu­cas as CSO and David Poon as CBO. Lu­cas, the ex-se­nior di­rec­tor of chem­istry at Yu­man­i­ty, closed out his three years at Black Di­a­mond as SVP of drug dis­cov­ery, while Poon is a 15-year Zymeworks vet who was re­cent­ly the heav­i­ly re­struc­tured com­pa­ny’s VP, busi­ness de­vel­op­ment and al­liance man­age­ment.

Mayank Gand­hi

→ Af­ter eF­FEC­TOR Ther­a­peu­tics plucked new CMO Dou­glas Warn­er from Am­gen in Au­gust, Mayank Gand­hi has re­placed Alana Mc­Nul­ty as CBO of the Cal­i­for­nia can­cer biotech. In 2020, Gand­hi jumped on the now-rick­ety SPAC band­wag­on as VP of cor­po­rate de­vel­op­ment & strat­e­gy at Jiya Ac­qui­si­tion Corp, the blank check com­pa­ny set up by Sri­ni Akkara­ju. Ear­li­er, he con­clud­ed a sev­en-year run at Genen­tech as busi­ness de­vel­op­ment & li­cens­ing di­rec­tor.

Rah­saan Thomp­son

Rick Klaus­ner’s T cell ther­a­py shop Lyell Im­munophar­ma has ap­point­ed Rah­saan Thomp­son as chief le­gal of­fi­cer. Thomp­son is an Acte­lion le­gal vet who moves on to Lyell fol­low­ing his two years as Grit­stone bio’s gen­er­al coun­sel, and it’s the sec­ond big C-suite pick­up for Lyell this year: Gary Lee jumped on board as CSO in late Jan­u­ary. Klaus­ner sold 11,100 shares of Lyell’s stock last Fri­day, with an uptick in the stock price $LYEL most of this week.

Matthew Calde­mey­er

→ Led by for­mer Seagen ex­ec Nan­cy Whit­ing and Blue­print Med­i­cines alums, San Diego’s Re­cludix Phar­ma has en­trust­ed Matthew Calde­mey­er with CBO du­ties. Calde­mey­er just spent four years in busi­ness de­vel­op­ment at Ever­est Med­i­cinesnow un­der new man­age­ment — and the Eli Lil­ly vet has al­so built his BD ré­sumé with Am­gen, Ar­ray Bio­Phar­ma and Am­brx. Re­cludix pulled off the tarp in No­vem­ber 2021 with a $60 mil­lion Se­ries A as the crew takes aim at STAT3 and STAT6.

→ RNA edit­ing up­start ADARx Phar­ma­ceu­ti­cals has tapped Christo­pher Pren­tiss as CFO. The for­mer fi­nance chief at Adamas Phar­ma­ceu­ti­cals comes to a biotech that made a splash a year ago with a $75 mil­lion Se­ries B in a space that al­so in­cludes Shape Ther­a­peu­tics and Pro­QR. Pren­tiss has pri­or fi­nance ex­pe­ri­ence in the in­dus­try with In­ter­Mune, Dy­navax and MannKind.

In­grid De­laet

→ Fresh off its £48.3 mil­lion ($56.57 mil­lion) ac­qui­si­tion of Di­ur­nal Group a month ago, Neu­ro­crine has pro­mot­ed In­grid De­laet to chief reg­u­la­to­ry of­fi­cer. De­laet had been VP of reg­u­la­to­ry af­fairs since Jan­u­ary 2021, and she was SVP, reg­u­la­to­ry af­fairs at In­ter­cept be­fore her move to Neu­ro­crine. In 19 years with Bris­tol My­ers, she worked in clin­i­cal R&D and was ther­a­peu­tic area lead for im­munol­o­gy with­in glob­al reg­u­la­to­ry af­fairs.

Karin Schmitt

→ Cam­bridge, UK-based Mursla has wel­comed Karin Schmitt to its lead­er­ship team as COO. Schmitt brings with her a wealth of ex­pe­ri­ence from pre­vi­ous stints at Ex­elix­is, Mil­len­ni­um Phar­ma­ceu­ti­cals, Ther­mo Fish­er Sci­en­tif­ic, Hori­zon Dis­cov­ery Group, Pre­dic­tIm­mune and Mo­gri­fy.

Lar­ry Green is seiz­ing the reins once again at Ali­vaM­ab Dis­cov­ery Ser­vices, tak­ing over from Justin Mi­ka. Green was the found­ing CEO of the San Diego-based com­pa­ny and has served as Ali­vaM­ab’s ex­ec­u­tive chair since May 2020. Ear­li­er in his ca­reer, Green served in roles at Am­gen and Ab­genix among oth­ers. Green al­so wears the CEO hat at Ablex­is and will con­tin­ue to serve in his role there.

→ Cal­i­for­nia VC Sec­tion 32 has plugged in Nick Smith as chief in­vestor re­la­tions of­fi­cer. Smith had led in­vestor re­la­tions at Fore­site Cap­i­tal since 2018, and in an­oth­er re­cent stop, he was di­rec­tor and re­gion­al head of client ad­vi­so­ry for Win­ton Group.

Bren­da Van Vreeswyk

→ Just as we were pub­lish­ing last week’s Peer Re­view, T cell en­gager play­er Janux Ther­a­peu­tics wel­comed Bren­da Van Vreeswyk as head of hu­man re­sources. Van Vreeswyk was di­rec­tor of HR dur­ing a six-year stay at Neu­ro­crine be­fore mov­ing on to the Mer­ck part­ner, which al­so added Win­ston Kung to its board of di­rec­tors last week.

Will Lewis

In­smed CEO and Aege­ri­on co-founder Will Lewis has been named chair­man of Adres­tia Ther­a­peu­tics, a GSK-backed “syn­thet­ic res­cue” biotech out of Cam­bridge, UK. Adres­tia al­so has a pair of new ex­ecs: Jen­nifer Mil­lian (VP of US op­er­a­tions) had a near­ly 16-year as­so­ci­a­tion with Sanofi Gen­zyme be­fore join­ing uniQure as di­rec­tor, pro­gram man­age­ment, and she was re­cent­ly VP of pro­gram and al­liance man­age­ment for Affinia Ther­a­peu­tics. And Phil Cox­on (VP of busi­ness de­vel­op­ment) as­cend­ed to se­nior di­rec­tor of trans­ac­tions in glob­al on­col­o­gy busi­ness de­vel­op­ment and li­cens­ing at As­traZeneca last year, af­ter join­ing the Big Phar­ma from Te­va in 2018.

Jen­nifer Nichol­son

→ In­flam­ma­tion-fo­cused RAPT Ther­a­peu­tics has brought in Jen­nifer Nichol­son as SVP of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance, and Ad­nan Rah­man as VP of com­mer­cial. Nichol­son makes her way to RAPT from Kro­nos Bio, where she was VP of reg­u­la­to­ry af­fairs, and she’s held reg­u­la­to­ry po­si­tions at Roche/Genen­tech, Jazz Phar­ma­ceu­ti­cals, Bavar­i­an Nordic and Ac­er­ta Phar­ma. Rah­man, mean­while, steps away from his gig as glob­al com­mer­cial lead of der­ma­tol­ogy at Pfiz­er sub Are­na Phar­ma­ceu­ti­cals. Ear­li­er, he wrapped up a 16-year ca­reer at Am­gen as US com­mer­cial di­rec­tor of the bone drug Xge­va.

→ In Phase II tri­als with its MK2 in­hibitor zunseme­tinib for rheuma­toid arthri­tis, pso­ri­at­ic arthri­tis and hidradeni­tis sup­pu­ra­ti­va, Aclarus Ther­a­peu­tics has en­list­ed Robert Doo­dy as VP, in­vestor re­la­tions. He just held the same ti­tle at Proven­tion Bio and is the for­mer SVP of in­vestor re­la­tions & cor­po­rate com­mu­ni­ca­tions at Idera Phar­ma­ceu­ti­cals.

→ Swiss-based Pure­os Part­ners has tapped Veron­i­ca Gam­bil­lara Fon­ck as a new part­ner. Fon­ck has served in roles at Gly­co­V­axyn, was CEO and co-founder of Lim­maT­e­ch and CEO and founder of Gly­co­Era.

Stu­art Chaf­fee

Affini­vax’s for­mer CBO Stu­art Chaf­fee is mak­ing his way to the board of di­rec­tors at Olaris to be­come ex­ec­u­tive chair­man. Chaf­fee’s pri­or ex­pe­ri­ence in­cludes gigs at Prax­is Pre­ci­sion Med­i­cines (CBO and CFO), At­las Ven­ture (en­tre­pre­neur in res­i­dence), Kymera Ther­a­peu­tics (head of busi­ness op­er­a­tions), Am­gen and Bio­gen.

→ Ex-San­ten chief Adri­enne Graves is head­ed to the board of di­rec­tors at reti­nal dis­ease biotech Opus Ge­net­ics, join­ing its sci­en­tif­ic founder Jean Ben­nett, Opus CEO Ben Yerxa and Rus­sell Kel­ley from the Foun­da­tion Fight­ing Blind­ness. Graves chairs the FFB’s Reti­nal De­gen­er­a­tion Fund and is a board mem­ber at Iver­ic Bio.

Lori Mc­Neill

→ Prince­ton, NJ-based can­cer play­er Son­net Bio­Ther­a­peu­tics has elect­ed Lori Mc­Neill to the board of di­rec­tors. Dur­ing her ca­reer at Pfiz­er from 2001-14, Mc­Neill was chief of staff of glob­al op­er­a­tions in the in­te­grat­ed health busi­ness unit.

→ Grap­pling with its Phase III fail with lenaba­sum and turn­ing its at­ten­tion to pre­clin­i­cal sol­id tu­mor can­di­date CRB-601, Cor­bus Phar­ma­ceu­ti­cals has re­served a seat for Anne Alt­mey­er on the board of di­rec­tors. The ex-CBO of Sig­ilon Ther­a­peu­tics and Adicet Bio is the pres­i­dent and CEO of TigaTx.

→ US-Dan­ish biotech Al­lar­i­ty Ther­a­peu­tics has pulled out a seat on its board for Jer­ry McLaugh­lin. McLaugh­lin cur­rent­ly serves as CEO and board mem­ber of Life Bio­sciences. McLaugh­lin’s pre­vi­ous stints in­clude roles at Neos Ther­a­peu­tics (CEO and pres­i­dent), Nu­Pathe, En­do Phar­ma­ceu­ti­cals and Mer­ck. McLaugh­lin’s ap­point­ment comes on the heels of the com­pa­ny drop­ping its can­cer drug dovi­tinib from de­vel­op­ment af­ter the FDA re­quest­ed a new tri­al.

Fra­zier Life Sci­ences man­ag­ing di­rec­tor James Top­per is back on the board of di­rec­tors at Phath­om Phar­ma­ceu­ti­cals, the Take­da spin­out and vono­prazan de­vel­op­er co-cre­at­ed by Fra­zier. Top­per, the chair­man and CEO of Fra­zier Life­sciences Ac­qui­si­tion Cor­po­ra­tion, was a board mem­ber at Phath­om from 2018-21.

Spe­cial thanks to artist Kim Ryu for giv­ing Peer Re­view a new look start­ing this week!

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Ex­clu­sive: Cell ther­a­py biotech brings on Loxo vet amid glob­al ex­pan­sion plans; Re­tire­ment beck­ons for Vir's George Scan­gos

Bree Harlin, who used to be director of clinical operations at Loxo Oncology, now Loxo@Lilly, is now in the C-suite for the first time.

Harlin started at TC BioPharm on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.