→ Mod­er­na is hop­ing this CFO is the one that sticks.

The mR­NA ti­tan has poached James Mock from PerkinElmer, an ap­point­ment that Peer Re­view has been wait­ing on CEO Stéphane Ban­cel to make since the last hire took a strange turn in May. Jorge Gomez played fi­nance chief for a day when Mod­er­na was made aware of an in­ves­ti­ga­tion in­to his fi­nan­cial re­port­ing prac­tices by the com­pa­ny he just left, Dentsply Sirona. Gomez was out be­fore he was ever re­al­ly in, trig­ger­ing yet an­oth­er search for a CFO and de­lay­ing David Meline’s re­tire­ment.

The ap­point­ment fol­lows the UK ap­proval of Mod­er­na’s Omi­cron-spe­cif­ic Covid-19 vac­cine ear­li­er in the week. Mock, a GE vet who had spent four years as PerkinElmer’s CFO, will take over on Sept. 6.

→ In a move that caused Peer Re­view to do a bit of a dou­ble take, Ge­of­frey Porges has left SVB Se­cu­ri­ties to take the CFO job at Schrödinger. Porges had pro­vid­ed his takes on the in­dus­try at SVB since 2015 as se­nior man­ag­ing di­rec­tor, di­rec­tor of ther­a­peu­tics re­search and se­nior re­search an­a­lyst, and he was al­so a mar­ket­ing ex­ec at Mer­ck’s vac­cine di­vi­sion in the 1990s. Add Porges to the grow­ing list of big-name an­a­lysts who have moved on to oth­er com­pa­nies in the last year: Biren Amin said good­bye to Jef­feries in April 2021 to be­come CFO of Im­muneer­ing, while Bern­stein’s Ron­ny Gal chose the Big Phar­ma route by start­ing his new gig as No­var­tis’ chief strat­e­gy & growth of­fi­cer on Ju­ly 18. Kyle LaHu­cik spoke with Porges about his ap­point­ment on Thurs­day.

→ Found­ed by Aaron Ring — one of our 20(+1) un­der 40 hon­orees this year — and scor­ing a $40 mil­lion Se­ries B in Jan­u­ary, cy­tokine-cen­tered Sim­cha Ther­a­peu­tics has in­stalled Sanuj Ravin­dran as CEO. Ravin­dran con­clud­ed a four-year run as chief ex­ec­u­tive of Bridge­Bio sub­sidiary Pelle­Pharm, and he’s al­so been CBO of aTyr Phar­ma and SVP of cor­po­rate de­vel­op­ment at The Med­i­cines Com­pa­ny. Else­where at Sim­cha, ARCH ven­ture part­ner and ex-MyoKar­dia CBO Jake Bauer has been named chair­man of a board that in­cludes Ring, Ravin­dran, SR One’s Sime­on George, WuXi AppTec’s Sean Li and Ar­cus CEO Ter­ry Rosen.

→ Am­brx Bio­phar­ma had a lot go­ing for it last year, rid­ing to Nas­daq with a $126 mil­lion IPO af­ter a $200 mil­lion crossover round in No­vem­ber 2020. But the bear mar­ket has shat­tered its stock and the run­away suc­cess of As­traZeneca and Dai­ichi Sankyo’s HER2 drug En­her­tu has put a crimp in its pipeline plans, prompt­ing a shake­up at the top. Just last month, Kate Her­mans joined Am­brx’s board of di­rec­tors, but she’s now been named in­ter­im CEO as Feng Tian steps down. Her­mans, the ex-VP of mar­ket­ing at Ra­dius Health, spent 13 years with Pfiz­er in myr­i­ad roles be­fore piv­ot­ing to Bris­tol My­ers Squibb in 2012, even­tu­al­ly lead­ing spe­cial­ty port­fo­lio com­mer­cial­iza­tion strat­e­gy. One more Am­brx note: Ym­muno­bio CEO Ka­trin Ru­pal­la has suc­ceed­ed Tian as chair of the board.

→ Amy Ma­h­ery has fin­ished up an 18-year stay at EMD Serono and will join Roivant as chief com­mer­cial of­fi­cer, an an­nounce­ment that Matt Gline’s crew dis­closed in its quar­ter­ly re­port this week. Ma­h­ery held a whole slew of posts at EMD Serono and led the glob­al busi­ness fran­chise, neu­rol­o­gy and im­munol­o­gy be­fore ven­tur­ing off to Roivant. One of its many sub­sidiaries, Der­ma­vant, passed through the ap­proval gate at the FDA three months ago with the plaque pso­ri­a­sis top­i­cal med Vta­ma.

→ Cara Cassi­no has re­signed af­ter near­ly sev­en years as CMO of Con­tra­Fect, which is chop­ping 37% of its staff fol­low­ing a Phase III prat­fall with exe­ba­case in Ju­ly. Is­tari On­col­o­gy CMO Gar­rett Nichols will be pitch­ing in re­lief un­til Con­tra­Fect choos­es a per­ma­nent suc­ces­sor. Nichols, the ex-VP, glob­al HIV clin­i­cal de­vel­op­ment at GSK, has al­so served as med­ical chief of Chimerix.

→ Pil­ing on the cash with a $270 mil­lion Se­ries C three months ago, Shankar Ra­maswamy’s gene ther­a­py play Kriya Ther­a­peu­tics has wel­comed Pe­dro Huer­tas as CMO of its rare dis­ease di­vi­sion. The role of med­ical chief isn’t a new one for Huer­tas as he ar­rives at a biotech where there are CMOs for dif­fer­ent ther­a­peu­tic ar­eas: There­sa Heah was named CMO and pres­i­dent of Kriya’s oph­thal­mol­o­gy di­vi­sion in Oc­to­ber 2021, and Ma’an Muhsin ar­rived in Feb­ru­ary as CMO and pres­i­dent of the on­col­o­gy di­vi­sion. Huer­tas was pre­vi­ous­ly the CMO with In­ozyme Phar­ma, Sen­tien Biotech­nolo­gies and Eloxx Phar­ma­ceu­ti­cals, and ear­li­er he was a glob­al med­ical lead with Shire and Pfiz­er.

→ Bay Area-based Nu­vig Ther­a­peu­tics, a start­up sprout­ing from the lab of Jeff Ravetch at The Rock­e­feller Uni­ver­si­ty, has propped the door open for Joanne Quan as CMO fol­low­ing its $47 mil­lion Se­ries A in May. Quan, a for­mer clin­i­cal de­vel­op­ment ex­ec at Are­na Phar­ma­ceu­ti­cals, is the ex-CMO of Eiger Bio­Phar­ma­ceu­ti­cals who was pre­vi­ous­ly the med­ical chief at Modis Ther­a­peu­tics from 2018-21.

→ Af­ter tak­ing the in­ter­im tag off co-founder and now-CEO Do­minique Ver­helle, the Bob Langer-linked Nex­tR­NA Ther­a­peu­tics out of Dana-Far­ber has tapped Ja­son Katz as head of drug dis­cov­ery. Katz put in 13 years at Mer­ck be­fore be­com­ing di­rec­tor of chem­istry (and lat­er se­nior di­rec­tor of chem­istry) at IFM Ther­a­peu­tics. Ver­helle, the in­ter­im chief when Nex­tR­NA took the wraps off a $56 mil­lion round of fund­ing in ear­ly March, pre­vi­ous­ly held lead­er­ship posts at Cel­gene, Pfiz­er and Take­da, where she was head of aca­d­e­m­ic in­no­va­tion at the Japan­ese phar­ma’s Cen­ter for Ex­ter­nal In­no­va­tion.

→ As NetSci­en­tif­ic com­pletes its stake buy of Vor­tex Bio­sciences, the com­mer­cial­iza­tion and in­vest­ment com­pa­ny has now named Paul Jones as CEO. Jones joins Vor­tex from Il­lu­mi­na, where he served as glob­al head of pop­u­la­tion ge­nomics. Jones is al­so the founder and CEO of My­Gene and ear­li­er in his ca­reer held roles at As­traZeneca, Sanofi and No­var­tis.

→ Look­ing to tar­get can­cers caused by HPV, San Diego-based Tor­a­gen is bring­ing in some new faces to its team. The com­pa­ny an­nounced the ap­point­ments of Cheryl Col­lett as CFO, Richard Lump­kin as di­rec­tor, re­search & de­vel­op­ment, and Paul En­gler (founder of Cac­tus Feed­ers) to its board of di­rec­tors. Col­lett sad­dles up to the com­pa­ny af­ter a stint as CFO of Ani­vive Life­sciences and pre­vi­ous ex­pe­ri­ence with Puma Biotech­nol­o­gy, Sier­ra Sci­en­tif­ic In­stru­ments, Cougar Biotech­nol­o­gy, Hythi­am and 20th Cen­tu­ry Fox.

Mean­while, Lump­kin served as for­mer se­nior di­rec­tor at re­cent­ly Pfiz­er-ac­quired Glob­al Blood Ther­a­peu­tics. Lump­kin’s oth­er stints in­clude roles at Por­to­la Phar­ma­ceu­ti­cals, Mil­len­ni­um Phar­ma­ceu­ti­cals, Cor Ther­a­peu­tics, Ri­bo­gene, Amylin and Cor­vas In­ter­na­tion­al.

→ Health tech out­fit Zephyr AI has pegged Allen Hodge as chief com­mer­cial of­fi­cer. The erst­while VP of US on­col­o­gy sales at Ar­ray Bio­phar­ma and an ex-re­gion­al sales di­rec­tor with Cel­gene, Hodge spent the last three years as BioCryst’s SVP and gen­er­al man­ag­er, US com­mer­cial.

→ Get­ting a fresh cash in­jec­tion this spring through a $275 mil­lion up­front pay­ment from Tai­ho Phar­ma­ceu­ti­cal as part of an al­liance that was forged in 2019, Cul­li­nan On­col­o­gy has named Jacque­lyn Sumer as chief le­gal of­fi­cer. Sumer, a Big Phar­ma le­gal vet with No­var­tis and Bris­tol My­ers, had been chief le­gal and com­pli­ance of­fi­cer at Geno­cea Bio­sciences be­fore the com­pa­ny de­cid­ed to shut­ter op­er­a­tions.

→ Portage Biotech CEO Ian Wal­ters has tacked on the role of chair­man, while the Con­necti­cut-based I/O play­er that just took full own­er­ship of iOx Ther­a­peu­tics has en­list­ed Justin Fairchild as VP of de­vel­op­ment. Fairchild is a 14-year vet of Bris­tol My­ers who’s been VP of clin­i­cal de­vel­op­ment at the Park­er In­sti­tute for Can­cer Im­munother­a­py. Wal­ters, who al­so has Bris­tol My­ers ties, has helmed Portage since 2019.

→ The pro­tein degra­da­tion spe­cial­ists at Arv­inas have picked up their sec­ond ex­ec of the month with Lisa Sin­clair as SVP, cor­po­rate op­er­a­tions, and the biotech al­so put out word late Thurs­day that it would carve out space for ex-Pfiz­er busi­ness chief John Young on the board of di­rec­tors as Liam Rat­cliffe moves on. Sin­clair spent 18 years with Pfiz­er be­fore mov­ing on to As­traZeneca in 2011 as VP of R&D port­fo­lio and per­for­mance. At her last two stops, she was head of pro­gram and al­liance man­age­ment with Pfiz­er spin­out Spring­Works Ther­a­peu­tics and head of cor­po­rate & com­mer­cial strat­e­gy since 2019 for Rally­bio. Arv­inas be­gan the month of Au­gust by nab­bing Nek­tar vet John North­cott as chief com­mer­cial of­fi­cer.

→ South Ram­part Phar­ma is adding Josh Blach­er to its team as CFO. Blach­er, who helped man­age Te­va In­no­v­a­tive Ven­tures, has pre­vi­ous­ly been the CFO of Galmed Phar­ma­ceu­ti­cals and Ther­a­pix Bio­sciences, and he al­so has CBO ex­pe­ri­ence from his time at In­med Phar­ma­ceu­ti­cals.

→ At Resver­logix, CSO Nor­man Wong is pass­ing the ba­ton to Eweli­na Ku­likows­ki as he heads off to re­tire­ment. Ku­likows­ki joined Resver­logix in 2005, hav­ing start­ed out as di­rec­tor of re­search de­vel­op­ment and cul­mi­nat­ing in her role as SVP, re­search & de­vel­op­ment.

→ Re­lief Ther­a­peu­tics has ush­ered in David Mc­Cul­lough as se­nior di­rec­tor and head of US mar­ket ac­cess. Mc­Cul­lough hails from Mirum Phar­ma­ceu­ti­cals, where he was na­tion­al ac­count di­rec­tor (pay­er ac­count lead). Mc­Cul­lough al­so has ex­pe­ri­ence un­der his belt from gigs at No­var­tis Gene Ther­a­pies, Spark Ther­a­peu­tics, Shire, Med­Im­mune and Ab­bott Labs.

→ Just af­ter adding Sabine Sydow and Falk Nuern­berg­er to its lead­er­ship team last week, Ger­man CD­MO Rentschler Bio­phar­ma is now wel­com­ing aboard Mark Caswell as VP, site head of its Mass­a­chu­setts fa­cil­i­ties. Caswell joins the com­pa­ny from Lon­za, hav­ing served as head of op­er­a­tions at its site in New Hamp­shire. Pri­or to that Caswell had stints at Sanofi Gen­zyme, cul­mi­nat­ing in his role as di­rec­tor, glob­al en­gi­neer­ing and tech­nol­o­gy.

→ Eli­av Barr has picked up a seat on the board of di­rec­tors at Bay­er’s thy­roid can­cer part­ner Ve­r­a­cyte. Barr took over for Roy Baynes — now CMO for Roger Perl­mut­ter at Eikon Ther­a­peu­tics — at Mer­ck Re­search Lab­o­ra­to­ries and has worked for the Big Phar­ma since 1995.

→ Jeff Blue­stone has bol­stered the board at Sono­ma Bio­ther­a­peu­tics — chaired by Rick Klaus­ner — with the ad­di­tions of Kati­na Dor­ton and John Davis. Dor­ton has been a CFO with NodThera, Re­pare Ther­a­peu­tics and Avro­bio, while Davis is a Pfiz­er alum who led R&D and was CMO of Ma­gen­ta Ther­a­peu­tics.

→ While we’re think­ing of Davis’ old com­pa­ny, Michael Vas­con­celles is head­ed to Ma­gen­ta’s board of di­rec­tors. Be­fore his CMO gigs at Unum Ther­a­peu­tics and Roche’s Flat­iron Health, Vas­con­celles led the on­col­o­gy ther­a­py area unit at Take­da.

→ Now un­der the di­rec­tion of Bri­an Goff with Jack­ie Fouse rid­ing off in­to the sun­set last week, Agios has made room for Rahul Bal­lal and Mer­ck alum Cyn­thia Smith on the board of di­rec­tors. Bal­lal has helmed Imara for the last four years, and Smith is the ex-chief com­mer­cial of­fi­cer of ZS Phar­ma who has board seats with Pro­tara Ther­a­peu­tics, Spero Ther­a­peu­tics and Ake­bia Ther­a­peu­tics.

→ Rachel Humphrey has clinched a spot on the board of di­rec­tors at Pyx­is On­col­o­gy as it prunes the pipeline and shines the spot­light on PYX-201 and PYX-106. The ex-CMO at Black Di­a­mond is now pres­i­dent and CEO of I/O biotech Nor­mu­ni­ty.

→ Mer­ck hu­man re­sources vet Karen Ling has joined the board of di­rec­tors at Mallinck­rodt. Ling was chief hu­man re­sources of­fi­cer at Al­ler­gan from 2014-19, then took the same po­si­tion at AIG for two years. She al­so sits on the board of di­rec­tors at iRhythm Tech­nolo­gies and Ther­a­peu­tic­sMD.

→ Dinged by a par­tial clin­i­cal hold on its blood can­cer drug FHD-286 af­ter a pa­tient death, Flag­ship biotech Foghorn Ther­a­peu­tics has giv­en a seat to Lynne Par­shall on the board of di­rec­tors. Par­shall has had a 30-year as­so­ci­a­tion with Io­n­is, where she’s now a se­nior strate­gic ad­vi­sor and board mem­ber, and she’s on the boards of Cy­to­ki­net­ics, Reper­toire Im­mune Med­i­cines, and Ring Ther­a­peu­tics.

→ We pro­filed Schond Green­way not too long ago when he took the CFO job at MindMed — this time around, the psy­che­delics biotech has elect­ed Tia­ki Ther­a­peu­tics chief Suzanne Bruhn and Opi­ant Phar­ma­ceu­ti­cals CEO Roger Crys­tal to the board of di­rec­tors. Bruhn just be­came a board mem­ber at Vig­il Neu­ro­science, and Crys­tal is on the board of di­rec­tors at BIO.

→ Fund man­ag­er Justin Yorke (the San Gabriel Fund, JMW Fund and Rich­land Fund) has been named chair­man of the board at Hanover, MD-based Proces­sa Phar­ma­ceu­ti­cals. Khoso Baluch, the for­mer CorMedix CEO who was on the Eli Lil­ly team from 1984-2008, has joined XO­MA CEO Jim Neal on Proces­sa’s board.

→ Non­prof­it biotech Odylia Ther­a­peu­tics has pulled out two seats on its board of di­rec­tors for Sharon Walk­er and Bri­an Fen­ton. Walk­er joins the At­lanta-based com­pa­ny with ex­pe­ri­ence as Sanofi’s se­nior coun­sel, vac­cines patents. Mean­while, Fen­ton was CBO of Trans­late Bio and for­mer­ly worked with­in the busi­ness de­vel­op­ment group at Shire.

→ Ym­muno­bio, the Swiss-based CEA­CAM1 biotech we ref­er­enced ear­li­er, is bol­ster­ing its board of di­rec­tors with the ap­point­ment of Juer­gen Heit­mann. Cur­rent­ly, Heit­mann serves as di­rec­tor of busi­ness de­vel­op­ment at Nordic Phar­ma. Heit­mann is the ex-CBO of Sen­so­ri­on and has held roles at McK­in­sey & Com­pa­ny, No­var­tis, Ny­comed and Take­da.

→ Need­ing to hit the re­set but­ton with the FDA af­ter pulling its BLA for be­va­cizum­ab in late May, Out­look Ther­a­peu­tics has added Ju­lia Haller to the board of di­rec­tors. Haller chairs the oph­thal­mol­o­gy de­part­ment at Sid­ney Kim­mel Med­ical Col­lege at Thomas Jef­fer­son Uni­ver­si­ty and is oph­thal­mol­o­gist-in-chief at Wills Eye Hos­pi­tal in Philadel­phia.

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

James Sabry’s BD team at Roche has a long track record in hunting the globe for new biotech deals. But they’ve never journeyed into China before to ink a worldwide development and commercialization pact with a China-based biotech on an experimental med.

As Max Gelman reported yesterday, Roche fronted a new alliance with China’s Jemincare with $60 million in cash and $590 million in milestones for worldwide commercial rights to an oral androgen receptor degrader. The deal itself is fairly typical of an early-stage alliance around a promising treatment. The Shanghai-based biotech is largely unknown outside China, but this is a classic high-risk, modest upfront pact that Roche routinely inks.

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Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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Roche’s Genentech is going high style next month for New York Fashion Week. The pharma is hosting its first-ever runway fashion show to raise disability visibility, featuring models from the spinal muscular atrophy (SMA) community.

“Double Take” will be held Sept. 8, the day before the official New York event begins, with models walking and rolling across the stage wearing stylish and functional adaptive clothing. Eleven people living with SMA and four advocates will show off the custom fashions created by Open Style Lab, a Brooklyn nonprofit and accessible clothing design collaborative.

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As Congress continues to mull whether and how to reform the FDA’s accelerated approval pathway, new research on the pathway continues to crop up, attempting to guide the way for new reforms.

Earlier this week, several prominent researchers from Harvard, UPenn and the Brookings Institution called for new financial incentives to encourage companies to finish the trials necessary to convert accelerated approvals to full approvals, or at least reform how companies are paid after winning an accelerated approval.

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It’s been just two days since Endo International filed for bankruptcy in an attempt to dig itself out of thousands of opioid lawsuits. Now one of its top sellers is in trouble.

A federal appeals court on Thursday affirmed a Delaware judge’s decision that Eagle Pharmaceuticals’ generic version of Endo’s vasopressin injection Vasostrict does not infringe on the company’s patents. Eagle’s version won approval back in December, and already, the generic and others like it have driven down Vasostrict sales.

Another Covid-19 vaccine will enter the fray as the EMA kicks off its conditional marketing authorization application for SK’s vaccine, dubbed Skycovion.

SK Chemicals GmbH submitted data to the EMA on how well the vaccine triggers the production of antibodies against the original strain of SARS-CoV-2, along with data on the safety and quality of the vaccine.

“The evaluation of Skycovion is one of the ongoing evaluations of data on Covid-19 vaccines. As the pandemic continues to evolve, it is important that the EU has a wide array of vaccines and treatments to enable the Member States to combat the pandemic effectively. EMA and its scientific committees are committed to ensuring a robust review of all data on COVID-19 vaccines and medicines,” the EMA said in a statement.

After a nearly 365-day delay, Axsome Therapeutics has secured its first drug approval with an FDA green light for Auvelity as a treatment for adults with major depressive disorder.

The biotech is keeping shy on the pricing for now and, on an investor call, CEO Herriot Tabuteau attributed the FDA’s yearlong delay mainly to the Covid-19 pandemic. The rapid-acting NMDA receptor antagonist is not a scheduled drug under the DEA, the CEO confirmed on the call.

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The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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

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