Cher­ry Thomas joins Cari­bou as SVP of clin­i­cal de­vel­op­ment; Ar­tax locks in Joseph Lobac­ki as CEO

Cher­ry Thomas

→ CRISPR genome edit­ing play­er Cari­bou Bio­sciences has ap­point­ed Cher­ry Thomas as SVP of clin­i­cal de­vel­op­ment, a new­ly-cre­at­ed po­si­tion. Thomas jumps to Berke­ley-based Cari­bou from Ar­ray Bio­phar­ma, where she was VP of clin­i­cal de­vel­op­ment of their on­col­o­gy di­vi­sion. She’s al­so been the ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment at BeiGene.

Joseph Lobac­ki

→ Not on­ly has au­toim­mune dis­ease-fo­cused Ar­tax Bio­phar­ma brought Joseph Lobac­ki to the helm as CEO, but the Cam­bridge, Mass­a­chu­setts-based com­pa­ny has al­so made some new ad­di­tions to its man­age­ment team. Lobac­ki takes over the reins from Damia Tor­mo, who re­mains on the com­pa­ny’s board of di­rec­tors. Lobac­ki joins the team af­ter a stint at Ve­rastem as EVP and CCO and as COO of Finch Ther­a­peu­tics. In ad­di­tion, Lobac­ki has held posts at Medi­va­tion, Mi­cromet and Gen­zyme.

Join­ing Lobac­ki are Chris Van­Deusen as CSO, Richard Polis­son as CMO and Bris­tol My­ers vet Karen LaRochelle as CBO. Both Van­Deusen and Polis­son hop aboard from Sanofi Gen­zyme, while LaRochelle hails from PsiOxus Ther­a­peu­tics.

Michelle Mc­Mur­ry-Heath

BIO has se­lect­ed its next CEO to suc­ceed James Green­wood as one of biotech’s top lob­by­ists. Michelle Mc­Mur­ry-Heath has joined the fray, af­ter spend­ing more than 5 years large­ly cen­tered on reg­u­la­to­ry work for J&J, spe­cial­iz­ing in de­vices. Mc­Mur­ry-Heath jumped in­to the in­dus­try from the FDA, where she was as­so­ciate di­rec­tor for sci­ence, cen­ter for de­vices and ra­di­o­log­i­cal health. Mc­Mur­ry-Heath’s ré­sumé in­cludes a stint on Capi­tol Hill, work­ing for for­mer Sen­a­tor Joe Lieber­man.

Green­wood came to BIO straight from Con­gress, where he had been a play­er in the House for 6 terms. That made him in­stru­men­tal in gain­ing pas­sage of key leg­is­la­tion — per­haps most no­tably the ex­tend­ed patent pro­tec­tion en­joyed by bi­o­log­ics. Green­wood knew many of the key law­mak­ers on a first-name ba­sis, af­ter cre­at­ing bi­par­ti­san re­la­tion­ships that clear­ly played to the ad­van­tage of biotech.

Michael Var­ney is step­ping away from his top post in Genen­tech R&D, and the sto­ried biotech is pluck­ing a star cell ex­pert from the Broad as his re­place­ment. In a state­ment, Roche CEO Sev­erin Schwan high­light­ed their in­ter­est in tap­ping Aviv Regev’s knowl­edge of “da­ta-based drug dis­cov­ery and de­vel­op­ment,” one of the mantras de­vel­op­ing in Big Phar­ma re­search. Regev — a mem­ber of the Na­tion­al Acad­e­my of Sci­ences — will be step­ping away from her job as fac­ul­ty chair and ex­ec­u­tive team mem­ber at the Broad In­sti­tute of Har­vard and MIT, her role as a pro­fes­sor at MIT as well as an in­ves­ti­ga­tor with the vir­tu­al Howard Hugh­es Med­ical In­sti­tute.

Regev will now be tak­ing a lead­ing role in a $10 bil­lion re­search or­ga­ni­za­tion as head of Genen­tech Re­search and Ear­ly De­vel­op­ment, bet­ter known as gRED to Basel-based pRED, and join­ing the ex­ec­u­tive com­mit­tee at Roche.

Joseph Tru­itt

BioSpecifics, a Delaware-based bio­phar­ma fo­cused on col­la­ge­nase-based ther­a­pies with its first-in-class prod­uct Xi­aflex, has re­moved the in­ter­im tag from Joseph Tru­itt and he will be the per­ma­nent CEO. He was named in­ter­im CEO by the board of di­rec­tors on April 6. Tru­itt has moved to BioSpecifics from Achillion, where he joined the com­pa­ny in 2009 and filled the roles of CCO and COO be­fore be­ing pro­mot­ed to CEO in May 2018.

Mi­cro­bi­ot­i­ca — which struck a $534 mil­lion mi­cro­bio­me pact with Roche in 2018 — has an­nounced the pass­ing of the com­pa­ny’s chair­man, Thomas Lynch. Lynch served as chair­man for the com­pa­ny since Sep­tem­ber 2019. Sam Williams, in­vestor di­rec­tor for IP Group, will serve as act­ing chair­man.

→ With its liq­uid-biop­sy tech­nol­o­gy EpiCheck, de­signed for ear­ly de­tec­tion in can­cers, Nu­cle­ix is ex­pand­ing op­er­a­tions in­to the Unit­ed States and ush­er­ing in new lead­er­ship. In ad­di­tion to its of­fices in Is­rael, Nu­cle­ix will ex­pand to San Diego and has named Chris Hi­b­berd CEO and Todd My­ers CFO of the Cal­i­for­nia op­er­a­tion. Hi­b­berd and My­ers come to Nu­cle­ix from As­tute Med­ical, where Hi­b­berd was CEO and co-founder and My­ers was CFO. Ad­di­tion­al­ly, Nu­cle­ix has reeled in Eyal Miller as GM for Eu­rope, Mid­dle East and Africa (EMEA). Miller was pre­vi­ous­ly the VP & head of the health­care di­vi­sion at Strata­sys.

Jeff Bai­ley

Jeff Bai­ley is tak­ing on the role of in­ter­im CEO at BioDe­liv­ery Sci­ences (BD­SI), whose prod­ucts tack­le se­ri­ous and de­bil­i­tat­ing con­di­tions. Bai­ley had been a board mem­ber at BD­SI, based in the Re­search Tri­an­gle area in Raleigh, since March. He was the CEO of Il­lu­mi­nOss Med­ical, which was ac­quired last month by Health­point Cap­i­tal, and the pres­i­dent and CEO of Lan­theus Med­ical Imag­ing. He al­so had a stint at No­var­tis and had a 22-year tenure at J&J.

Vivek Ra­maswamy‘s gene ther­a­py com­pa­ny Spirovant Sci­ences — look­ing to out­bid ri­val Ver­tex in treat­ing cys­tic fi­bro­sishas brought on Roland Kol­beck as CSO. Most re­cent­ly, Kol­beck served as VP, head of res­pi­ra­to­ry, in­flam­ma­tion and au­toim­mune re­search at Med­Im­mune, As­traZeneca‘s glob­al bi­o­log­ics or­ga­ni­za­tion — where he led the de­vel­op­ment of FASEN­RA, a bi­o­log­i­cal for the treat­ment of se­vere eosinophilic asth­ma.

Don Mar­vin

→ Re­unit­ing with chair­man and CEO Dale Pfost at New York-based Lo­do Ther­a­peu­ticsDon Mar­vin has been en­list­ed as EVP and CFO. Mar­vin and Pfost were at Or­chid Bio­sciences to­geth­er in the ear­ly 2000s, where Mar­vin was COO, CFO and SVP of cor­po­rate de­vel­op­ment. The chair­man of Con­cen­tric af­ter five years as pres­i­dent and CEO, Mar­vin al­so helmed Identi­GEN and Di­a­tron Cor­po­ra­tion.

→ San Fran­cis­co Bay Area-based Bolt Ther­a­peu­tics —de­vel­op­ing im­mune-stim­u­lat­ing an­ti­body con­ju­gates (ISACs) to treat can­cer — has snagged William Quinn as CFO. Pri­or to his ap­point­ment, Quinn was CFO and SVP, fi­nance and cor­po­rate de­vel­op­ment of Sune­sis. Quinn pre­vi­ous­ly held an 8-year stint at Jazz Phar­ma­ceu­ti­cals and was al­so CEO and co-founder of Bul­let Tech­nol­o­gy.

→ Af­ter Kel­ly Mar­tin suc­ceed­ed him as pres­i­dent and CEO of Ra­dius Health, As­cendis Phar­ma has tapped Jes­per Høi­land as glob­al chief com­mer­cial of­fi­cer. Be­fore Ra­dius, Høi­land spent 29 years at No­vo Nordisk, cul­mi­nat­ing in a three-year run as pres­i­dent and SVP, USA.

Jeanne Ma­gram

Third Rock Ven­tures part­ner Christoph Lengauer is no longer in­ter­im CSO at the place he co-found­ed, Cel­sius Phar­ma­ceu­ti­cals. Jeanne Ma­gram has now tak­en over as CSO, as Lengauer stays in both his ad­vi­so­ry role and as a board mem­ber. A Pfiz­er and Boehringer In­gel­heim vet, Ma­gram was CSO at Quen­tis Ther­a­peu­tics and the found­ing CSO at North­ern Bi­o­log­ics. Mean­while, Xilio CEO René Rus­so has been named to Cel­sius’ board of di­rec­tors.

→ Be­cause of Covid-19 and “re­duced cor­po­rate ac­tiv­i­ty in busi­ness de­vel­op­ment and pro­mo­tion,” cannabi­noid-fo­cused Tetra Bio-Phar­ma has deemed pres­i­dent Syl­vain Chre­tien’s po­si­tion non-es­sen­tial and they have ac­cept­ed his res­ig­na­tion. CEO Guy Cham­ber­land, CFO Sabi­no Di Pao­la and COO Steeve Néron will han­dle Chre­tien’s re­spon­si­bil­i­ties.

Kim Sablich

→ Dublin-based Jazz Phar­ma­ceu­ti­cals has re­cruit­ed Kim Sablich as their EVP and GM of North Amer­i­ca, ef­fec­tive June 1. Sablich has been My­ovant’s CCO since No­vem­ber 2018. Pri­or to My­ovant, Sablich was GSK’s VP, pri­ma­ry care mar­ket­ing in the US and al­so spent 15 years at Mer­ck.

→ With CEO William Chou in his first year, Aru­vant now has Joseph McIn­tosh step­ping in as CMO. McIn­tosh comes to Aru­vant, which tar­gets se­vere blood dis­or­ders, from PTC Ther­a­peu­tics, where he was SVP, head of clin­i­cal de­vel­op­ment and shep­herd­ed the ap­proval of the Duchenne mus­cu­lar dy­s­tro­phy drug Translar­na as VP of de­vel­op­ment. He’s al­so been with NPS Phar­ma­ceu­ti­cals, Ei­sai and Pfiz­er.

CorMedix, which fo­cus­es on in­fec­tious and in­flam­ma­to­ry dis­eases, has se­lect­ed Matt David as EVP and CFO. Be­fore join­ing the NJ-based bio­phar­ma, David was head of strat­e­gy at Ovid Ther­a­peu­tics. David has over 15 years of ex­pe­ri­ence in health­care in­vest­ment bank­ing, no­tably at Bank of Amer­i­ca, and al­so as an eq­ui­ty an­a­lyst.

Al­lan Shaw

→ Im­muno-on­col­o­gy play­er Portage has called up­on Al­lan Shaw to be CFO, re­plac­ing Kam Shah. Pri­or to join­ing Toron­to-based Portage, Shaw has been a CFO on four pre­vi­ous oc­ca­sions: at Syn­dax Phar­ma­ceu­ti­cals (where he was al­so trea­sur­er), Serono, NewLead Hold­ings and Vi­a­tel. He al­so found­ed Shaw Strate­gic Cap­i­tal in 2005.

De­bra Feld­man has joined the ranks at At­las-backed Dyne Ther­a­peu­tics as VP, head of reg­u­la­to­ry. Most re­cent­ly, Feld­man helped lead Sage Ther­a­peu­tics through its ap­proval of Zul­res­so as VP, reg­u­la­to­ry af­fairs.

Bill Haney-led up­start Drag­on­fly Ther­a­peu­tics has named Tapan Ma­niar as SVP and head of clin­i­cal de­vel­op­ment. Ma­niar leaps aboard from Reper­toire Im­mune Med­i­cines, where he was in the same role. Pri­or to that, Ma­niar was se­nior di­rec­tor of clin­i­cal de­vel­op­ment at Atara Bio­ther­a­peu­tics and glob­al de­vel­op­ment lead at Am­gen.

Machelle Manuel has joined Cam­bridge, MA-based Amy­lyx Phar­ma­ceu­ti­cals, which fo­cus­es on ALS, Alzheimer’s and oth­er neu­rode­gen­er­a­tive dis­eases, as VP, head of glob­al med­ical af­fairs. Manuel had just spent eight years at Iron­wood Phar­ma­ceu­ti­cals, where she was head of glob­al med­ical sci­en­tif­ic af­fairs and part of the ini­tial med­ical af­fairs lead­er­ship team.

→ Ex­o­some biotech Evox Ther­a­peu­tics has tapped Gilead vet Paul Carter as non-ex­ec­u­tive chair­man. Carter cur­rent­ly has di­rec­tor­ships at Hutchi­son Chi­na MediTech and Mallinkrodt Phar­ma­ceu­ti­cals, and un­til April, he was a di­rec­tor at Alder Bio­phar­ma. Dur­ing his time at Gilead, Carter was the EVP, chief com­mer­cial of­fi­cer and the SVP, head of com­mer­cial op­er­a­tions, in­ter­na­tion­al mar­kets. He was al­so at re­gion­al VP of Chi­na and Hong Kong at GSK.

→ No­var­tis-backed Al­tim­mune has en­list­ed for­mer Pfiz­er ex­ec Di­ane Jorkasky to its board of di­rec­tors. Dur­ing her time at Pfiz­er, Jorkasky served as VP of glob­al clin­i­cal re­search op­er­a­tions. In ad­di­tion, Jorkasky held ex­ec posts at En­do Phar­ma­ceu­ti­cals and Aileron Ther­a­peu­tics.

Bharat Tewarie has jumped on the board of di­rec­tors at Bay Area start­up Alveo Tech­nolo­gies, which an­nounced a col­lab­o­ra­tion with Janssen Phar­ma­ceu­ti­cals in April to bring its be.well plat­form to mar­ket. Tewarie found­ed Boston Bio­Phar­ma Con­sul­tants in Jan­u­ary and was the EVP, CMO and mem­ber of the Ex­ec­u­tive Com­mit­tee at UCB.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.