Joan Shen ends the year by say­ing good­bye to I-Mab; CRISPR Ther­a­peu­tics puts coal in R&D chief's stock­ing

Deck the halls with more ap­point­ments in the last Peer Re­view for 2021. Thanks for read­ing every week!

Joan Shen

→ When the cal­en­dar flips to 2022, Joan Shen is out at I-Mab “to pur­sue oth­er in­ter­ests,” leav­ing founder and chair­man Jing­wu Zang to suc­ceed her as act­ing CEO in a bit of a sur­prise. Un­der Shen’s lead­er­ship, I-Mab formed a CD47 al­liance with Ab­b­Vie in Sep­tem­ber 2020 with lem­zopar­limab as the cen­ter­piece, and a year lat­er our Am­ber Tong de­tailed I-Mab’s as­pi­ra­tions for oth­er com­pa­ra­ble part­ner­ships, no­tably for de­vel­op­ment of the CD73 an­ti­body uliledlimab. Shen was one of our 20 Women in Bio­phar­ma R&D hon­orees this month.

Else­where at I-Mab, An­drew Zhu — for­mer­ly a mem­ber of the Chi­nese biotech’s sci­en­tif­ic ad­vi­so­ry board — has been named pres­i­dent and will lead glob­al R&D ef­forts. He al­so grabs a seat on I-Mab’s board of di­rec­tors.

Tony Ho

→ Ac­cord­ing to a Form 8-K, CRISPR Ther­a­peu­tics has dis­missed EVP and R&D chief Tony Ho af­ter four years on the job in a terse­ly-word­ed state­ment: “Dr. Ho’s ter­mi­na­tion is with­out cause and not the re­sult of any dis­agree­ment with the Com­pa­ny.” Ho made the jump to CRISPR in 2017 from As­traZeneca, where he led de­vel­op­ment on such drugs as Imfinzi and was head of on­col­o­gy in­no­va­tion and in­te­gra­tion. His ouster comes two months af­ter End­points News looked un­der the hood at CRISPR’s off-the-shelf CAR-T da­ta, in which CEO Samarth Kulka­rni ex­pressed en­thu­si­asm about safe­ty while ques­tion marks re­main over dura­bil­i­ty.

Har­ald Rein­hart

→ End­points al­so spot­light­ed Saman­tha Du in our Women in Bio­phar­ma R&D spe­cial, and Zai Lab has pro­mot­ed Har­ald Rein­hart from CMO to pres­i­dent and head of glob­al de­vel­op­ment, neu­ro­science, au­toim­mune and in­fec­tious dis­eases. Rein­hardt, an ad­vi­sor when Zai Lab was found­ed and med­ical chief for the au­toim­mune and in­fec­tious dis­eases port­fo­lio since 2017, was Sh­iono­gi’s head of clin­i­cal de­vel­op­ment and med­ical af­fairs and is al­so the ex-VP and ther­a­peu­tic area head, clin­i­cal de­vel­op­ment and med­ical af­fairs at No­var­tis. Zai Lab’s busy 2021 be­gan by grab­bing the Greater Chi­na rights to ar­genx’s drug ef­gar­tigi­mod — which was just ap­proved for gen­er­al­ized myas­the­nia gravis this week — and it’s on­ly con­tin­ued by dip­ping in­to the neu­ro space with Karuna Ther­a­peu­tics and pay­ing $25 mil­lion up­front for the rights to two EGFR TKI in­hibitors from Blue­print Med­i­cines.

Kim Strat­ton

An­drin Os­wald is tak­ing a med­ical leave of ab­sence from his post as Cen­to­gene CEO “for a pe­ri­od of at least four weeks,” the rare dis­ease biotech said in a state­ment. Pinch-hit­ting for Os­wald is Kim Strat­ton, one year af­ter she re­signed as CEO of Or­p­hazyme — which has tried to keep its seat belts fas­tened dur­ing a bumpy ride of fail­ures per­tain­ing to its “pipeline-in-a-prod­uct” ari­mo­clo­mol. Os­wald re­placed found­ing CEO Arndt Rolfs at Cen­to­gene on Dec. 1, 2020.

Rob Michael

→ Peek­ing at an­oth­er Form 8-K, Ab­b­Vie CFO Rob Michael has tacked on vice chair­man, fi­nance and com­mer­cial op­er­a­tions to his ti­tle af­ter three years as EVP. Michael got his start at Ab­bott in 1993, and af­ter the Ab­bott-Ab­b­Vie split, he be­came the phar­ma gi­ant’s VP, fi­nan­cial plan­ning and analy­sis. Pri­or to his pro­mo­tion to CFO, he served as VP, cor­po­rate con­troller. Back in late Sep­tem­ber, Ab­b­Vie stepped on Bio­haven’s turf with an FDA ap­proval for ato­gepant, an oral CGRP re­cep­tor an­tag­o­nist now mar­ket­ed as Qulip­ta.

Mark Fitz­patrick

→ Zurich-based liv­er dis­ease biotech Ver­san­tis has named Mark Fitz­patrick as CEO, end­ing co-founder Vin­cent Forster’s run in the top spot be­gin­ning Jan. 1. Fitz­patrick is the ex-pres­i­dent and CEO at Chi­as­ma, the mak­er of the acromegaly drug My­capssa which was sold to Am­ryt in May for $330 mil­lion, and he’s in his first year on the board of di­rec­tors at Al­lena Phar­ma­ceu­ti­cals. Forster will tran­si­tion to the role of CSO at Ver­san­tis, which raised its last bun­dle of cash in Sep­tem­ber 2019.

An­drew Hall

An­drew Hall has torn off the in­ter­im la­bel and has been named per­ma­nent CEO of No­va Sco­tia-based IMV. The Mer­ck and Cel­gene vet had re­placed CEO Fred­er­ic Ors on an in­ter­im ba­sis in Au­gust af­ter tak­ing the CBO job in No­vem­ber 2020. Be­fore join­ing IMV — which is de­vel­op­ing its lead can­di­date maveropepimut-S in mul­ti­ple can­cer in­di­ca­tions — Hall was Cel­gene’s ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment and glob­al al­liances.

Derek Hicks

Derek Hicks has left Spark to be­come CBO at In­tel­lia, the biotech co-found­ed by Jen­nifer Doud­na that caused a tec­ton­ic shift this sum­mer by show­ing that CRISPR could be used to ed­it DNA di­rect­ly in­to pa­tients. In Oc­to­ber 2020, Hicks had joined Spark as head of busi­ness de­vel­op­ment af­ter spend­ing more than 16 years at Pfiz­er, clos­ing out his time as the drug gi­ant’s VP of cor­po­rate de­vel­op­ment, world­wide busi­ness de­vel­op­ment. In­tel­lia al­so inked a CRISPR part­ner­ship with Spar­ingVi­sion in Oc­to­ber, fo­cus­ing on three eye dis­ease tar­gets.

Neera Ravin­dran

Shankar Ra­maswamy’s gene ther­a­py out­fit Kriya Ther­a­peu­tics has se­lect­ed Neera Ravin­dran as CFO. Ravin­dran spent the last two years with Glax­o­SmithK­line’s Covid-19 an­ti­body part­ner Vir as VP, head of in­vestor re­la­tions & strate­gic com­mu­ni­ca­tions, and she’s al­so been head of in­vestor re­la­tions for North Amer­i­ca with Roche/Genen­tech. Kriya brought its to­tal raise to $180 mil­lion with a $100 mil­lion Se­ries B this sum­mer that was head­lined by board mem­ber Jim Mom­tazee at Pa­tient Square Cap­i­tal.

Joseph Vit­tiglio

Finch Ther­a­peu­tics, the mi­cro­bio­me biotech that fol­lowed up its Se­ries C raise with a $128 mil­lion IPO in March, has pro­mot­ed Joseph Vit­tiglio to chief busi­ness and le­gal of­fi­cer. Vit­tiglio joined Finch a year ago as gen­er­al coun­sel and cor­po­rate sec­re­tary af­ter five years at AM­AG Phar­ma­ceu­ti­cals, where he was CBO and gen­er­al coun­sel. He’s al­so been a le­gal ex­ec with Flex­ion Ther­a­peu­tics and Aveo Phar­ma­ceu­ti­cals.

Christi­na Yi

Proven­tion Bio has spent the last cou­ple months of 2021 re­fash­ion­ing its lead­er­ship, and this week brings more of the same by nam­ing Christi­na Yi as COO and pro­mot­ing Bene­dict Os­o­rio to chief qual­i­ty of­fi­cer. Yi is an Am­gen alum who spent the last year in the COO post at Vac­cin­i­ty af­ter 11 years with Den­dreon, and Os­o­rio be­came SVP of qual­i­ty at Proven­tion Bio in Au­gust 2020 af­ter serv­ing as COO at Prog­en­ics Phar­ma­ceu­ti­cals. He’s al­so made stops as a qual­i­ty as­sur­ance ex­ec at Achillion and Acor­da Ther­a­peu­tics. Along with these ap­point­ments, Proven­tion Bio has al­so re­cent­ly hired a new CFO, re­search and ear­ly de­vel­op­ment chief and SVP of clin­i­cal de­vel­op­ment.

→ Suzhou, Chi­na-based Tran­scen­ta has pulled in for­mer CStone ex­ec Daniel Weng as CFO. Dur­ing his tenure at CStone, Weng served as VP and head of fi­nance. Pri­or to that, Weng had stints at Ever­est Med­i­cines (VP and head of fi­nance) and Am­gen (CFO of Chi­na).

Lau­rence de Schoulep­nikoff

Boehringer In­gel­heim can­cer part­ner OSE Im­munother­a­peu­tics out of Nantes, France has made a batch of hires, start­ing with Lau­rence de Schoulep­nikoff as CBO. An 11-year No­var­tis vet in busi­ness de­vel­op­ment, de Schoulep­nikoff spent the last three years as CBO and COO of AMAL Phar­ma­ceu­ti­cals and she was briefly the se­nior di­rec­tor of BD at Fer­ring Phar­ma­ceu­ti­cals.

Else­where, OSE Im­munother­a­peu­tics has wel­comed Lin­da Lebon as chief reg­u­la­to­ry of­fi­cer; Sil­via Comis as head of clin­i­cal de­vel­op­ment; and Françoise Bono as se­nior strate­gic de­vel­op­ment di­rec­tor. Lebon has been chief reg­u­la­to­ry of­fi­cer be­fore with Os­i­vax and was VP of reg­u­la­to­ry af­fairs at ar­genx. Comis hails from IQVIA, where she was se­nior med­ical di­rec­tor, on­col­o­gy, and she was el­e­vat­ed to Eu­ro­pean head of ear­ly prod­ucts med­ical af­fairs in on­col­o­gy dur­ing her sev­en years at No­var­tis. And Bono, a Sanofi vet and the for­mer head of on­col­o­gy at Evotec, al­so held the role of CSO at Onx­eo.

Ding Ding

→ Fo­cused on G-pro­tein cou­pled re­cep­tors (GPCRs) and equipped with a $100 mil­lion Se­ries B, ShouTi has ap­point­ed Ding Ding as CFO. She was re­cent­ly head of health­care in­vest­ment bank­ing and cap­i­tal mar­kets at Cred­it Su­isse af­ter stints at UBS and Bar­clays. Led by Re­cep­tos co-founder Ray­mond Stevens, ShouTi is tack­ling pul­monary ar­te­r­i­al hy­per­ten­sion first and has stud­ies lined up for type 2 di­a­betes/obe­si­ty and id­io­path­ic pul­monary fi­bro­sis.

→ Neu­rode­gen­er­a­tive dis­ease-fo­cused Neu­roSense Ther­a­peu­tics has brought on a slate of new hires to its ex­ec team and board of di­rec­tors. The Cam­bridge, MA-based com­pa­ny has brought in Fer­enc Tracik as CMO. Tracik comes with ex­pe­ri­ence from for­mer stints at Bio­gen, No­var­tis and Or­p­hazyme.

The four new board mem­bers con­sist of Yael Ger­man (Is­raeli mem­ber of Knes­set and for­mer min­is­ter of health); Caren Dear­dorf (CCO of Ma­gen­ta Ther­a­peu­tics); Chris­tine Pel­liz­zari (chief le­gal of­fi­cer of Sci­ence 37); and Cary Clai­borne (COO of Adi­al Phar­ma­ceu­ti­cals).

Thomas Heine­man has climbed high­er in the ranks at Cal­gary-based On­colyt­ics Biotech, mov­ing from glob­al head of clin­i­cal de­vel­op­ment and op­er­a­tions to CMO. Heine­man joined On­colyt­ics in Au­gust 2020, and pri­or to that he served as SVP and head of clin­i­cal de­vel­op­ment at De­n­o­vo Bio­phar­ma.

George Mont­gomery

→ San Diego whole-cell can­cer vac­cine biotech Neu­vo­gen has cor­ralled George Mont­gomery as CFO. Mont­gomery, the co-founder and ex-fi­nance chief at Co­herus Bio­Sciences, has re­cent­ly been man­ag­ing di­rec­tor of WestRiv­er Group and is cur­rent­ly on the board of di­rec­tors at Ash­vattha Ther­a­peu­tics. He’s al­so had seats on the boards of Lu­men Bio­science, Viome and Boston Phar­ma­ceu­ti­cals.

Maria Nichol

→ Bel­gian biotech Agomab is mak­ing a pair of hires af­ter a $74 mil­lion Se­ries B raise in March with Regi­nald Brys as head of re­search and Maria Nichol as head of IP. Brys and Nichol both hail from Gala­pa­gos — Brys was VP, head of dis­ease bi­ol­o­gy and Nichol was VP, head of in­tel­lec­tu­al prop­er­ty at the Gilead part­ner that’s been on a down­ward spi­ral across the pipeline af­ter the fil­go­tinib fail, has­ten­ing the ex­it of CEO On­no van de Stolpe. Agomab’s lead can­di­date, ORG-129, is an oral small mol­e­cule ALK-5 in­hibitor in Phase I for Crohn’s dis­ease.

→ It’s on­ly been two whole months since ex-AM­AG Phar­ma­ceu­ti­cals chief Scott My­ers was ap­point­ed chair­man some­where (we kid here at Peer Re­view) — this time around he’s chair­ing the board at French hear­ing loss out­fit Sen­so­ri­on. Dy­navax and Har­poon Ther­a­peu­tics tapped My­ers as chair­man on the same week in late Oc­to­ber.

Dale Pfost

Chemomab CEO Dale Pfost has al­so been named chair­man of the board as Gen­nao Bio CEO Stephen Squin­to steps aside com­plete­ly from the board. Pfost, the ex-CEO of Lo­do Ther­a­peu­tics, took on the chief ex­ec­u­tive role at the Is­raeli fi­brot­ic dis­ease biotech in Sep­tem­ber.

Michelle Mc­Mur­ry-Heath

BIO’s pres­i­dent and CEO Michelle Mc­Mur­ry-Heath is mak­ing her way over to the board of di­rec­tors at Bioven­tus. Mc­Mur­ry-Heath brings to the role her ex­pe­ri­ence from her role as VP, ex­ter­nal in­no­va­tion, glob­al leader for reg­u­la­to­ry sci­ence at J&J as well as her time spent at the FDA and the As­pen In­sti­tute.

William Link, the chair­man at Glaukos the last 20 years, is re­tir­ing ef­fec­tive Dec. 31 and Thomas Burns will re­place the Ver­sant co-founder at the Cal­i­for­nia oph­thalmic dis­ease play­er. Burns has helmed Glaukos and held a board seat since March 2002. Glaukos al­so an­nounced that Mark Fo­ley, a board mem­ber since 2014, has been named lead in­de­pen­dent di­rec­tor.

Joy Yan

Art Krieg’s Check­mate Phar­ma­ceu­ti­cals, look­ing for a per­ma­nent CEO af­ter Bar­ry Labinger’s ex­it, has elect­ed Joy Yan to the board of di­rec­tors. A vet­er­an of Bay­er, Janssen and Bris­tol My­ers Squibb, Yan is the cur­rent CMO at Am­brx Bio­phar­ma.

Cabome­tyx mak­er Ex­elix­is has added tech ex­ec Jacque­line Wright to its board of di­rec­tors. Wright, the cor­po­rate VP and chief dig­i­tal of­fi­cer, US busi­ness at Mi­crosoft, joined the tech gi­ant 10 years ago as VP, IT strate­gic en­ter­prise ser­vices.

Anne Marie de Jonge Schuer­mans

Anne Marie de Jonge Schuer­mans will take over Ré­mi Droller’s seat on the board of di­rec­tors at Phar­varis, chaired by Rhythm Phar­ma­ceu­ti­cals CEO David Meek­er. Cur­rent­ly head of tech­ni­cal op­er­a­tions at So­bi, de Jonge Schuer­mans spent three years as a man­u­fac­tur­ing and sup­ply chain ex­ec at Bio­gen.

Su­san Clement-Davies and Sir Robert Lech­ler have been added to the board of di­rec­tors at Lon­don-based Eli Lil­ly RNA part­ner Mi­NA Ther­a­peu­tics. Clement-Davies was man­ag­ing di­rec­tor of eq­ui­ty cap­i­tal mar­kets at Cit­i­group, while Lech­ler is provost and SVP (health) at King’s Col­lege Lon­don and a board mem­ber at Quell Ther­a­peu­tics. He’s al­so been head of the Di­vi­sion of Med­i­cine at Im­pe­r­i­al Col­lege Lon­don.

Ed­ward Williams

→ San Diego-based BioAt­la has reeled in Ed­ward Williams to its board of di­rec­tors. Williams brings a wealth of ex­pe­ri­ence to the role with for­mer stints at No­vo Nordisk, No­var­tis and Up­john. Ad­di­tion­al­ly, Williams serves as an ad­vi­sor to the CEO of As­cendis Phar­ma and has served as the com­pa­ny’s in­ter­im US CCO from Au­gust 2020 to May 2021.

Vu­ja De Sci­ences has brought on Carl Bar­rett to its board of di­rec­tors. Bar­ret cur­rent­ly serves as VP of trans­la­tion­al sci­ence in the on­col­o­gy in­no­v­a­tive med­i­cines di­vi­sion at As­traZeneca. Pri­or to that, Bar­rett held roles at No­var­tis On­col­o­gy Trans­la­tion­al Med­i­cine, the NCI’s Cen­ter for Can­cer Re­search and the Na­tion­al In­sti­tute of En­vi­ron­men­tal Health Sci­ences.

→ Dig­i­tal cell bi­ol­o­gy com­pa­ny Berke­ley Lights has pulled out a seat for Jes­si­ca Hop­field on its board of di­rec­tors. Hop­field cur­rent­ly serves as pres­i­dent of J Hop­field Con­sult­ing and for­mer­ly served as a part­ner of McK­in­sey & Com­pa­ny.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

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.