Paul Per­reault

→ As CSL trends up­ward, Paul Per­reault will soon step down, putting one of his lieu­tenants in the top spot.

Paul McKen­zie, the COO at the Aus­tralian phar­ma since 2019, will be­come CSL’s chief ex­ec­u­tive on March 6, while Per­reault lends a hand in an ad­vi­so­ry ca­pac­i­ty for six more months af­ter the tran­si­tion takes ef­fect. McKen­zie owns Big Phar­ma ex­pe­ri­ence from Mer­ck, Bris­tol My­ers Squibb and J&J’s Janssen, and was Bio­gen’s EVP of phar­ma­ceu­ti­cal op­er­a­tions & tech­nol­o­gy be­fore CSL came call­ing.

The he­mo­phil­ia B drug Hem­genix, which CSL de­vel­oped with uniQure, was ap­proved in late No­vem­ber. But its $3.5 mil­lion price tag dwarfs that of No­var­tis’ spinal mus­cu­lar at­ro­phy gene ther­a­py Zol­gens­ma, known as phar­ma’s most ex­pen­sive drug at $2 mil­lion. Per­reault, who was named CEO in 2013, al­so steered CSL to an $11.7 bil­lion ac­qui­si­tion of Vi­for Phar­ma and teed up an mR­NA al­liance with Arc­turus for $200 mil­lion up­front.

“In work­ing close­ly with Dr. McKen­zie for more than three years, I am con­fi­dent he will con­tin­ue to in­no­vate and build on CSL’s track record of growth for years to come,” Per­reault said in a state­ment.

De­bra Yu

→ De­bra Yu and Bing Li built Lian­Bio as its first staffers in 2019, but Yu is walk­ing away as pres­i­dent and chief strat­e­gy of­fi­cer on Jan. 1 “to pur­sue oth­er busi­ness and pro­fes­sion­al in­ter­ests and op­por­tu­ni­ties,” ac­cord­ing to the press re­lease.

With a large sup­port­ing cast, RA Cap­i­tal and Ven­rock led Lian­Bio’s $310 mil­lion fi­nanc­ing round in Oc­to­ber 2020 — and a month lat­er, Pfiz­er fol­lowed up with $70 mil­lion more. The Per­cep­tive US-Chi­na start­up land­ed on Nas­daq with a $325 mil­lion IPO in No­vem­ber 2021, and through Bris­tol My­ers’ ac­qui­si­tion of MyoKar­dia, the Big Phar­ma and Lian­Bio picked up an FDA nod with Camzyos, the ob­struc­tive hy­per­trophic car­diomy­opa­thy (HCM) drug known in­ves­ti­ga­tion­al­ly as mava­camten.

Yu jumped from CBO to chief strat­e­gy of­fi­cer in Sep­tem­ber 2021, not long af­ter Eli Lil­ly’s Yizhe Wang re­placed Li as CEO.

Bill An­der­son

→ Things were al­ready go­ing to look marked­ly dif­fer­ent from a lead­er­ship per­spec­tive at Roche when CEO Sev­erin Schwan an­nounced that he would de­part on March 14, 2023. But Roche Phar­ma­ceu­ti­cals CEO Bill An­der­son will leave first as the turnover con­tin­ues. This week’s press re­lease in­di­cates An­der­son will ex­it to “pur­sue op­por­tu­ni­ties out­side of Roche” on Dec. 31, while Roche’s CEO-in-wait­ing Thomas Schi­neck­er will lead Roche Phar­ma on an in­ter­im ba­sis.

Else­where at Roche, Silke Hörn­stein — the glob­al head of strat­e­gy and trans­for­ma­tion for Roche’s di­ag­nos­tics group — takes on a new role as head of cor­po­rate strat­e­gy in April 2023, while Nestlé CEO Mark Schnei­der and Yale pro­fes­sor Akiko Iwasa­ki are slat­ed to be the newest board mem­bers.

Roche re­ceived a num­ber of FDA nods in An­der­son’s tenure, with Zol­gens­ma and Spin­raza com­peti­tor Evrys­di as the stand­out, but an at­tempt at res­ur­rect­ing the Alzheimer’s drug gan­tenerum­ab re­cent­ly whiffed in two Phase II­Is.

Lynn Seely

→ Lynn Seely is back at the helm of an­oth­er biotech, re­plac­ing Liz Homans as pres­i­dent and CEO of Rick Klaus­ner’s T cell out­fit Lyell Im­munophar­ma. Seely, a board mem­ber at Lyell for the past year and a half, pi­lot­ed My­ovant Sci­ences to the ap­proval of its prostate can­cer drug Or­govyx dur­ing her tenure as CEO from 2016-21.

While My­ovant was get­ting an­oth­er OK for the uter­ine fi­broid med Myfem­bree in an aus­pi­cious start to the David Marek era, Lyell was about to make some noise of its own. In June 2021, at a time when com­pa­nies left and right were mak­ing a mad dash to Nas­daq, the South San Fran­cis­co biotech sep­a­rat­ed it­self from the pack by go­ing pub­lic with a $425 mil­lion IPO, the third-largest in the in­dus­try last year be­hind Sana and Re­cur­sion. But with a chill per­me­at­ing through the mar­kets, Lyell’s stock price $LYEL has fall­en near­ly 80% since.

Homans has agreed to take a con­sult­ing role with Lyell un­til June 2024.

→ Cu­rate Bio­sciences has found its next CEO in David Backer. Backer takes the reins from found­ing CEO Michael Gr­isham, who will tran­si­tion to the role of chair­man of Cu­rate’s board. Backer joins the crew from Ox­ford Bio­med­ica, where he served as CCO. Pri­or to that stint, Backer was SVP, com­mer­cial de­vel­op­ment at El­e­vate­Bio. Backer al­so boasts of an ear­li­er ca­reer at Mil­li­pore­Sig­ma as head of com­mer­cial de­vel­op­ment for gene edit­ing and nov­el modal­i­ties.

Ste­fan Os­chmann

→ Cit­ing “per­son­al rea­sons,” Ste­fan Os­chmann is out af­ter a year as chair­man of Bel­gian multi­na­tion­al UCB, mak­ing Ex­e­Vir Bio COO Fiona du Mon­ceau in­ter­im chair un­til a suc­ces­sor is named. Os­chmann rose to chair­man and CEO of Mer­ck KGaA in April 2016, re­plac­ing Karl-Lud­wig Kley, but pres­i­dent/CEO of health­care Belén Gar­i­jo took over in May 2021 up­on Os­chmann’s de­par­ture. UCB scored an FDA ap­proval in March for Fin­tepla — a drug it picked up from Zo­genix— in pa­tients ages 2 and up with Lennox-Gas­taut syn­drome. But the agency turned down UCB’s BLA for its plaque pso­ri­a­sis drug bimek­izum­ab two months lat­er.

→ An­ti­body-based drug de­vel­op­er Kling Bio­ther­a­peu­tics out of Am­s­ter­dam has tapped Michael Koslows­ki as CEO. Koslows­ki is a Boehringer In­gel­heim vet who co-found­ed Adap­tate Bio­ther­a­peu­tics and was CMO/R&D chief at Gam­maDelta Ther­a­peu­tics, a start­up that was sold to Take­da last year. Ex-mu­si­cian DA Wal­lach has not on­ly in­vest­ed in Kling, but in Elon Musk’s Neu­ralink with his VC firm Time BioVen­tures.

Steven Tuch

→ Now un­der the di­rec­tion of ex-eGe­n­e­sis chief Paul Sekhri, di­a­betes-fo­cused vTv Ther­a­peu­tics has in­stalled Steven Tuch as CFO. The ex-man­ag­ing di­rec­tor and head of health­care eq­ui­ty cap­i­tal mar­kets at BMO Cap­i­tal Mar­kets re­cent­ly led cor­po­rate de­vel­op­ment at Rally­bio, which just teamed up with Ab­Cellera on a rare dis­ease pact. With Sekhri run­ning the show, vTv hopes to re­bound af­ter a pipeline re­org, a sig­nif­i­cant staff re­duc­tion and the res­ig­na­tion of his pre­de­ces­sor Deepa Prasad, who last­ed four months.

→ Vig­il Neu­ro­science an­nounced Thurs­day that its CMO Spyri­don Pa­pa­petropou­los was hit­ting the ex­it to pur­sue a CEO op­por­tu­ni­ty. Now, we know where he went. Pa­pa­petropou­los is show­ing up at Aussie-based Bio­nom­ics to steer the com­pa­ny as its new CEO and pres­i­dent, re­plac­ing Er­rol De Souza. Pri­or to his role at Vig­il, Pa­pa­petropou­los was chief de­vel­op­ment of­fi­cer and SVP, head of de­vel­op­ment at Aca­dia Phar­ma­ceu­ti­cals and CEO at Swan­Bio. Pa­pa­petropou­los’ ré­sumé al­so boasts of stints at Cavion, Bio­gen, Al­ler­gan, Pfiz­er and Te­va.

Spyri­don Pa­pa­petropou­los

→ Pa­pa­petropou­los‘ de­par­ture from Vig­il wasn’t the on­ly change at the com­pa­ny. The Cam­bridge, MA-based biotech had al­so brought on David Gray as CSO. Gray joins from In­scopix, where he served in the same role. Pri­or to that, Gray was VP of chem­istry at Tony Coles-led Cerev­el Ther­a­peu­tics and had a 16-year long gig at Pfiz­er, cul­mi­nat­ing in his role as se­nior di­rec­tor, neu­ro­science bi­ol­o­gy.

→ Leonar­do Faoro has signed on as CMO of RAS ther­a­py de­vel­op­er Quan­ta Ther­a­peu­tics. Faoro comes to the South San Fran­cis­co biotech from Ex­elix­is, where he was SVP and ear­ly clin­i­cal de­vel­op­ment lead, and he worked on Avastin at Genen­tech from 2009-14. Sofinno­va, Ab­b­Vie, Sur­vey­or Cap­i­tal and Lon­gi­tude Cap­i­tal were among those that con­tributed to Quan­ta’s $60 mil­lion Se­ries C in Oc­to­ber 2021.

Ka­tia Schlienger

→ Vi­en­na-based im­munother­a­py com­pa­ny Hookipa Phar­ma will be ring­ing in the new year with a pro­mo­tion and board ap­point­ment. Hookipa is pro­mot­ing its EVP, clin­i­cal re­search and de­vel­op­ment Ka­tia Schlienger to the role of CMO. Schlienger joined Hookipa in Jan­u­ary 2021 af­ter a 14-year long stint at Mer­ck, where she held a va­ri­ety of roles across ear­ly and late-stage clin­i­cal de­vel­op­ment in on­col­o­gy and vac­cines.

Join­ing the board will be Mor­phoSys’ chief re­search and de­vel­op­ment of­fi­cer Malte Pe­ters, who al­so sits on the board of Tan­go Ther­a­peu­tics.

→ Co­manche Bio­phar­ma has re­cruit­ed Al­li­son Au­gust as CMO. Au­gust hails from Mod­er­na, where she was VP of clin­i­cal de­vel­op­ment, in­fec­tious dis­eases. Al­so dur­ing her time with Mod­er­na, Au­gust helped lead clin­i­cal de­vel­op­ment of sev­er­al vac­cines in­clud­ing RSV, hM­PV-PIV, Zi­ka and chikun­gun­ya. Ear­li­er in her ca­reer, Au­gust was with No­vavax and No­var­tis Vac­cines and Di­ag­nos­tics.

Wendy Dwyer

→ Wendy Dwyer ap­peared in this space last Sep­tem­ber when she took the CBO job at San­iona; this week she’s turned up as busi­ness chief of AI Pro­teins, a de no­vo pro­tein mak­er from Boston. Pri­or to her time at San­iona, Dwyer was CBO at Sur­face On­col­o­gy and VP, cor­po­rate busi­ness de­vel­op­ment with Ipsen.

→ Lon­don VC Abing­worth has wel­comed Joy Ghosh to the team as man­ag­ing di­rec­tor. Ghosh, who held busi­ness de­vel­op­ment po­si­tions at No­var­tis and Bio­gen, had re­cent­ly been a port­fo­lio man­ag­er with Even­tide As­set Man­age­ment.

Kirke Weaver

→ Kirke Weaver will soon re­move the in­ter­im la­bel at Organon: He’ll be the per­ma­nent gen­er­al coun­sel and cor­po­rate sec­re­tary for the Mer­ck women’s health­care spin­out when the ball drops in Times Square on Jan. 1. Weaver had filled sev­er­al le­gal po­si­tions at Mer­ck since 2003 be­fore piv­ot­ing to Organon as SVP, com­mer­cial, reg­u­la­to­ry, se­cu­ri­ties, em­ploy­ment & deputy cor­po­rate sec­re­tary in ear­ly 2021.

→ Cy­brexa Ther­a­peu­tics is bring­ing Michael Nee­dle in­to the fold as CMO, tak­ing over for Arthur DeCil­lis, who will be tran­si­tion­ing back in­to a con­sult­ing role. Nee­dle boasts for­mer stints as CMO at Aveo On­col­o­gy, Ar­ray Bio­Phar­ma and as VP, pe­di­atric strat­e­gy at Cel­gene.

→ Bay Area genome se­quenc­ing out­fit Per­son­alis is say­ing good­bye to its CEO, co-founder and board mem­ber John West as he heads in­to re­tire­ment. West found­ed the com­pa­ny in 2011 with four Stan­ford pro­fes­sors. In the mean­time, CFO Aaron Tachibana will serve as in­ter­im CEO and Christo­pher Hall, Per­son­alis’ SVP and head, di­ag­nos­tics busi­ness, has been pro­mot­ed to pres­i­dent.

→ Akron Bio is wav­ing in Christo­pher Mur­phy as CEO. Mur­phy brings ex­pe­ri­ence from his times at Ther­mo Fish­er (VP and gen­er­al man­ag­er of vi­ral vec­tor ser­vices), Bram­mer Bio (COO), Sanofi Gen­zyme, BioRe­liance and Led­er­le Lab­o­ra­to­ries.

Asha Ram­das

→ Texas-based car­diore­nal dis­ease play­er Renibus Ther­a­peu­tics has named Asha Ram­das as SVP, pro­gram man­age­ment, tech­ni­cal op­er­a­tions and man­u­fac­tur­ing. Ram­das had been glob­al prod­uct gen­er­al man­ag­er for teze­pelum­ab (mar­ket­ed as Tezspire) and then VP, com­mer­cial­iza­tion, pro­gram and port­fo­lio man­age­ment at Am­gen, the last phar­ma stand­ing to buy Hori­zon Ther­a­peu­tics in the in­dus­try’s biggest M&A news of the year.

→ Peer Re­view knows you’re shocked to hear this, but John Maraganore has land­ed an­oth­er ap­point­ment — long live the Maraganore Me­ter! This time around, the ex-Al­ny­lam chief has popped up as a strate­gic ad­vi­sor at Cal­i­co’s AI part­ner Ter­ray Ther­a­peu­tics. Maraganore al­so has ad­vi­so­ry roles at such com­pa­nies as Pro­QR, Evelo Bio­sciences and Chro­ma Med­i­cine, among many oth­ers.

Di­eter Weinand

→ Ex-Bay­er CEO Di­eter Weinand has added Seat­tle I/O play­er Umo­ja Bio­phar­ma to his list of chair­man­ships. The for­mer Pfiz­er and Bris­tol My­ers ex­ec chairs the boards of Replimune, Mnemo Ther­a­peu­tics, Ziel­Bio, Fore Bio­ther­a­peu­tics and RNA start­up Ap­tah Bio.

Dawn Svoronos

→ Dawn Svoronos has joined the board of di­rec­tors at Shao-Lee Lin’s Ace­lyrin, which loaded up on cash yet again with a $300 mil­lion Se­ries C in Sep­tem­ber. Svoronos had a 23-year ca­reer at Mer­ck un­til her re­tire­ment in 2011, and she’s cur­rent­ly on the boards of Xenon Phar­ma­ceu­ti­cals and Ad­verum Biotech­nolo­gies.

→ CSL’s afore­men­tioned mR­NA part­ner Arc­turus has added John Markels to the board of di­rec­tors. Markels, who re­tired from Mer­ck as pres­i­dent of glob­al vac­cines af­ter 35 years with the com­pa­ny, al­so has a board seat at Sang­amo.

→ Mod­er­na’s found­ing CSO An­tonin de Fougerolles is hop­ping in­to a seat on the board of di­rec­tors at Chimeron Bio. Since leav­ing his post at Mod­er­na, de Fougerolles has been CSO at Abl­ynx and is cur­rent­ly CEO of Evox Ther­a­peu­tics.

Grace Colón

→ Al San­drock’s gene ther­a­py biotech Voy­ager Ther­a­peu­tics has elect­ed Grace Colón to the board of di­rec­tors. The one-time Gilead ex­ec was re­placed by Are­na’s Robert Lisic­ki as pres­i­dent and CEO of In­Car­da Ther­a­peu­tics this fall.

→ GSK’s sci­ence com­mit­tee chair is get­ting a new face as Jesse Good­man ends his ro­ta­tion af­ter more than five years. Tak­ing his place will be Hal Di­etz, who is the for­mer pres­i­dent of the Amer­i­can So­ci­ety of Hu­man Ge­net­ics.

→ Simos Sime­oni­dis has re­signed from the board of di­rec­tors at mi­croR­NA shop Reg­u­lus Ther­a­peu­tics to fo­cus on his du­ties as co-CEO and co-chief in­vest­ment of­fi­cer at Al­ly Bridge Group. Bio­gen and Ex­elix­is chair­man Ste­lios Pa­padopou­los al­so chairs Reg­u­lus, a com­pa­ny he co-found­ed in 1994.

Paula Ham­mond

→ Re-eval­u­at­ing its pipeline and se­cur­ing a $123 mil­lion Se­ries C in Au­gust, Flag­ship’s Sen­da Bio­sciences has ap­point­ed MIT chem­i­cal en­gi­neer­ing de­part­ment head Paula Ham­mond to the board of di­rec­tors. Ham­mond is on Mod­er­na’s sci­en­tif­ic ad­vi­so­ry board and on the board of di­rec­tors at Alec­tor.

→ Randy Schatz­man-led Bolt Ther­a­peu­tics is ush­er­ing in Lau­ra Bern­er to its board of di­rec­tors. Bern­er cur­rent­ly serves as COO at TRexBio and pre­vi­ous­ly was with My­ovant as VP, head of busi­ness de­vel­op­ment & in­vestor re­la­tions.

Robert Gagnon

→ Last we heard of Ve­rastem On­col­o­gy, the com­pa­ny had clinched a break­through des­ig­na­tion nod from the FDA for its com­bo ther­a­py in ovar­i­an can­cer. Now, the bio­phar­ma is of­fer­ing up a seat on its board of di­rec­tors to its for­mer CFO and CBO Robert Gagnon. Since leav­ing his post, Gagnon has served as CFO and op­er­at­ing part­ner at Gur­net Point Cap­i­tal.

→ Vyv­gart mak­er ar­genx has named Ana Ce­s­pedes to the board of di­rec­tors. A for­mer mar­ket­ing ex­ec with Mer­ck KGaA, Ce­s­pedes is COO of the In­ter­na­tion­al AIDS Vac­cine Ini­tia­tive (IAVI).

→ Ad­ju­vant Cap­i­tal-backed syn­bio play­er Coda­genix has brought on Paul Grint to its board of di­rec­tors. Grint most re­cent­ly served as CEO of Am­pliphi Bio­sciences and has pri­or ex­pe­ri­ence at Reg­u­lus Ther­a­peu­tics, Cerexa, Ka­lyp­sys and at the For­est Re­search In­sti­tute.

Robert Ne­grin

→ Los An­ge­les-based Ap­pia Bio, whose sci­en­tif­ic co-founder Lili Yang was fea­tured in this year’s End­points’ Women in Bio­phar­ma R&D spe­cial re­port, has wel­comed Robert Ne­grin to its sci­en­tif­ic ad­vi­so­ry board. Ne­grin is a pro­fes­sor of med­i­cine and for­mer chief of the di­vi­sion of blood and mar­row trans­plan­ta­tion at Stan­ford Uni­ver­si­ty.

→ Phar­max­is has ap­point­ed Si­mon Green to its board of di­rec­tors. Green spent 17 years at CSL, where he was SVP, glob­al plas­ma R&D and gen­er­al man­ag­er of CSL’s man­u­fac­tur­ing sites in Ger­many and Aus­tralia.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.