Di­rec­tor of di­ver­si­ty and in­clu­sion ar­rives at Mass­Bio; Jerome Jab­bour takes the helm at Mati­nas; Ex-Eli Lil­ly CFO be­comes pres­i­dent of PBM busi­ness

Edie Stringfel­low

→ In a first, the Mass­a­chu­setts Biotech­nol­o­gy Coun­cil has brought on Edie Stringfel­low as its di­rec­tor of di­ver­si­ty and in­clu­sion, bol­ster­ing its ini­tia­tive to im­prove in­clu­sion and di­ver­si­ty in the life sci­ences in­dus­try. Her main man­date is to “serve as a re­source and li­aise” with the com­mu­ni­ty, help­ing mem­bers change mind­sets through ed­u­ca­tion, out­reach and ad­vo­ca­cy. Com­ing from the Cam­bridge biotech hub, the move was wide­ly ap­plaud­ed. “Mass­Bio is al­ways at the fore­front of change, and Edie is not afraid to have tough con­ver­sa­tions and to ed­u­cate our mem­bers and the in­dus­try at large that di­ver­si­ty and in­clu­sion is not just the right thing to do, but is a good busi­ness de­ci­sion,” said Mass­Bio CEO Robert Cough­lin in a state­ment.

→ Hav­ing steered Mati­nas Bio­Phar­ma $MTNB through a meet­ing with the FDA to sal­vage its an­ti-fun­gal, Roelof Ron­gen has de­cid­ed it’s time his co-founder Jerome Jab­bour take over as CEO. Like Ron­gen, Jab­bour has a back­ground in phar­ma busi­ness de­vel­op­ment. He or­ches­trat­ed the mi­cro-cap’s ac­qui­si­tion of Aquar­ius Biotech­nolo­gies, bring­ing in the cochleate lipid-crys­tal de­liv­ery tech plat­form that MAT2203 — the drug Mati­nas is hus­tling to a Phase II — is de­vel­oped on. Hav­ing served as pres­i­dent since 2016, Jab­bour said he has “a very clear vi­sion” for the both the lead drug and oth­er po­ten­tial new ther­a­pies to come out of part­ner­ships. Ron­gen is al­so step­ping down from the board.

Søren Tul­strup

→ Af­ter sev­er­al months of search­ing, Swe­den’s Hansa Med­ical has found its per­fect leader in Søren Tul­strup, who takes over from board chair­man Ulf Wi­in­berg. Wi­in­berg, a for­mer chief of Lund­beck, has been in­ter­im CEO since the sud­den death of Göran Arvid­son in No­vem­ber. Tul­strup is no stranger to the top job, hav­ing served as CEO of Vi­for Phar­ma and San­taris Phar­ma be­fore fo­cus­ing on ad­vi­so­ry roles. The board al­so liked that he’s trot­ted the globe man­ag­ing rare dis­ease and kid­ney dis­ease prod­ucts for the likes of No­var­tis, Mer­ck and Shire. Hansa is cur­rent­ly test­ing its own im­munoglob­u­lin-in­hibit­ing en­zyme for kid­ney trans­plant re­jec­tion — with Phase II da­ta pub­lished this week — among a slate of oth­er in­di­ca­tions.

Leila Al­land is join­ing Af­fimed’s $AFMD quest for nat­ur­al killer and T cell en­gager pro­grams as its CMO af­ter a stint at Tarve­da Ther­a­peu­tics. Hei­del­berg, Ger­many-based Af­fimed has a pipeline of bis­pe­cif­ic an­ti­bod­ies hit­ting dif­fer­ent can­cer tar­gets, but Al­land’s first fo­cus will like­ly be AFM13, a CD30 drug in Phase I and II tri­als — as a monother­a­py and in com­bos — for Hodgkin lym­phoma. Al­land has been in­volved in ear­ly-stage de­vel­op­ment for pret­ty much her en­tire bio­phar­ma ca­reer, hav­ing served in clin­i­cal roles at As­traZeneca, Bris­tol-My­ers Squibb and No­var­tis.

→ In a nod to Michael Skyn­ner’s busi­ness de­vel­op­ment con­tri­bu­tions, Bi­cy­cle Ther­a­peu­tics has pro­mot­ed the VP of op­er­a­tions and dis­cov­ery to COO. The biotech, head­quar­tered in Cam­bridge, UK with of­fices in Boston, MA, re­cent­ly ini­ti­at­ed the first ever clin­i­cal study of one of its unique drug con­ju­gates since it was found­ed in 2009. That tri­al, con­duct­ed in col­lab­o­ra­tion with Can­cer UK, is among the strate­gic al­liances that Skyn­ner guid­ed. Be­fore join­ing Bi­cy­cle in 2016, Skyn­ner — who co-found­ed a biotech ear­li­er in his ca­reer — led re­search and dis­cov­ery ef­forts at Pfiz­er and Glax­o­SmithK­line.

Jen­nifer Schranz

→ With Phase III da­ta and reg­u­la­to­ry fil­ing in sight for lefa­mulin, Nabri­va Ther­a­peu­tics $NBRV has tapped for­mer Shire ex­ec Jen­nifer Schranz to run the next stretch of its clin­i­cal de­vel­op­ment. As CMO, Schranz will con­tribute to the an­ti-in­fec­tive com­pa­ny’s busi­ness strate­gies in ad­di­tion to over­see­ing med­ical af­fairs. Top-line oral da­ta of lefa­mulin for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia is ex­pect­ed any time now; if this sec­ond PhI­II looks any­thing like the first, Schranz’s ex­pe­ri­ence in the reg­u­la­to­ry sub­mis­sion and ap­proval process will come in­to use. In her own words: “This is a time of sig­nif­i­cant op­por­tu­ni­ty and a po­ten­tial in­flec­tion point for Nabri­va and I look for­ward to part­ner­ing with its ex­pe­ri­enced man­age­ment team to ad­vance the first tru­ly new class of an­ti-in­fec­tives for in­tra­venous and oral use in hu­mans in near­ly 20 years.”

Avadel’s CCO $AVDL Gre­go­ry Di­vis has a new role. The Dublin-based spe­cial­ty phar­ma bumped Di­vis up to EVP and COO of the com­pa­ny, which mar­kets sev­er­al drugs tar­get­ed at hos­pi­tal set­tings. A for­mer CEO of women’s health com­pa­ny Lumara Health who over­saw its sale to AM­AG Phar­ma, Di­vis has been ac­tive in Avadel’s sup­ply chain, busi­ness de­vel­op­ment and com­mer­cial ac­tiv­i­ties. All of that will con­tin­ue as he helps launch Noc­ti­va, a noc­turia drug Avadel li­censed from Seren­i­ty Phar­ma af­ter Al­ler­gan dropped its com­mer­cial­iza­tion rights.

Si­en­na Bio­phar­ma­ceu­ti­cals $SNNA has re­cruit­ed Car­o­line Van Hove as its first chief com­mer­cial of­fi­cer. Her re­cent role in in­ter­na­tion­al strat­e­gy mar­ket­ing at Botox-mak­er Al­ler­gan like­ly pre­pared her for the port­fo­lio of med­ical der­ma­tol­ogy and aes­thet­ics prod­ucts that she’s now in charge of. Join­ing her in the C-suite will be John Smither, a one-time Si­en­na CFO that has been re-hired to re­place Richard Pe­ter­son. An Am­gen vet, Smither has been work­ing as a con­sul­tant since leav­ing the West­lake Vil­lage, CA biotech last year.

→ Just a few months af­ter re­tir­ing from Eli Lil­ly, De­r­i­ca Rice has signed on to run CVS Health’s phar­ma­cy ben­e­fit man­ag­er (PBM) busi­ness, Care­mark — the sec­ond not­ed phar­ma ex­ec to move in­to the PBM world in two weeks. (Ex-GSK chief An­drew Wit­ty made waves last week jump­ing to Unit­ed­Health‘s Op­tum di­vi­sion.) Rice’s 27-year tenure at the In­di­anapo­lis drug­mak­er cul­mi­nat­ed in a decade as CFO and fea­tured a few months as in­ter­im CEO. Now on the oth­er end of the ne­go­ti­at­ing ta­ble, he is tasked with strat­e­gy, new busi­ness de­vel­op­ment and client re­la­tion­ship man­age­ment on top of day-to-day over­sight. He suc­ceeds Jonathan Roberts, who was pro­mot­ed from Care­mark’s pres­i­dent to CVS Health’s COO.

Ori­ge­nis, a Ger­man biotech fo­cused on the cen­tral ner­vous sys­tem, has hired Pe­ter Seufer-Wasserthal to scout part­ner­ships for a range of ap­pli­ca­tions of its tech plat­form. While its own clin­i­cal pro­grams tack­le neu­rode­gen­er­a­tion, the com­pa­ny is con­fi­dent that its ca­pac­i­ty for dis­cov­er­ing and de­sign­ing brain-pen­e­trat­ing small mol­e­cule drugs can lead to promis­ing non-CNS and oph­thal­mo­log­i­cal as­sets. That will all fall un­der the purview of the new chief busi­ness of­fi­cer, who had plen­ty of prac­tice find­ing deals for a di­verse pipeline at In­trex­on. His ap­point­ment comes as Ori­ge­nis looks to build a Se­ries A syn­di­cate to back an IND.

→ Dou­bling down on ge­nomics, J. Craig Ven­ter has wooed a long­time ex­ec from fam­i­ly his­to­ry provider An­ces­try to be­come chief tech­nol­o­gy of­fi­cer of his an­ti-ag­ing start­up Hu­man Longevi­ty. Scott Sorensen spent 16 years at An­ces­try, help­ing trans­form the com­pa­ny from a fam­i­ly his­to­ry busi­ness in­to a ge­nomics busi­ness. Ven­ter likes the tech­nol­o­gy ar­chi­tec­ture he built there, and is trust­ing him to work the same mag­ic for HLI’s cus­tomer in­ter­faces and data­base.

Sor­ren­to Ther­a­peu­tics $SRNE has ap­point­ed in­vest­ment banker Jiong Shao as CFO, putting weight be­hind its ex­pressed in­tent to seek dual list­ing in Nas­daq and the Hong Kong ex­change this year. Hav­ing spent time in big-name banks in New York and Hong Kong, Jiong’s for­mer client list boasts of Chi­nese tech gi­ants like Al­iba­ba and Baidu. 2018 has been an event­ful year for Sor­ren­to, which just nabbed an FDA ap­proval for non-opi­oid pain patch ZTli­do, with es­ti­mat­ed peak sales of over $1 bil­lion. With a new ex­ec who be­lieves that its shares are “cur­rent­ly sub­stan­tial­ly un­der-val­ued,” it sounds like the San Diego com­pa­ny is just be­gin­ning.

Shire’s gen­er­al man­ag­er in Chi­na, Free­man Cong, is leav­ing the op­er­a­tion to spend more time with fam­i­ly in the US. For­mer­ly the gen­er­al man­ag­er of Bax­al­ta’s Chi­na di­vi­sion, Cong as­sumed the Shire post af­ter the rare dis­ease gi­ant ac­quired the he­mo­phil­ia com­pa­ny. Sipu Fang — Shire’s point per­son in Asia — will take over his du­ties ad in­ter­im.

→ Per­son­al­ized can­cer im­munother­a­py play­er Grit­stone On­col­o­gy has poached Sarep­ta’s VP of tech­ni­cal op­er­a­tions, Jayant Aphale, to run its man­u­fac­tur­ing plant in Pleasan­ton, CA. Process de­vel­op­ment and clin­i­cal ma­te­r­i­al man­u­fac­tur­ing is a key part of per­son­al­ized neoanti­gen R&D, and Aphale, a sea­soned pro­fes­sion­al who’s led a num­ber of ther­a­pies from vac­cines to oligonu­cleotides, seems just the per­son to tap. Grit­stone, which counts GV and Lil­ly Asia Ven­tures among its back­ers, is look­ing to en­ter the clin­ic mid-2018.

Mary Mattes’ lat­est move in CRO-land has tak­en her to Syn­ter­act, where she is now SVP of bio­met­rics and drug safe­ty. Con­tin­u­ing the work she did at PRA and Ac­celo­vance, she heads a team ad­vis­ing clients on da­ta man­age­ment, bio­sta­tis­tics and safe­ty across stages of clin­i­cal de­vel­op­ment. Ad­di­tion­al­ly, she is tasked with se­lect­ing tech­nol­o­gy en­hance­ments for the com­pa­ny it­self.

Jen­nifer Zachary is the new gen­er­al coun­sel at Mer­ck $MRK, suc­ceed­ing Michael Hol­ston, who’s set to be­come chief lawyer at Gen­er­al Electrics. A for­mer FDA staffer, Zachary has been ad­vis­ing health care man­u­fac­tur­ers as a law firm part­ner. At the phar­ma gi­ant, her re­spon­si­bil­i­ty will span glob­al le­gal, se­cu­ri­ty and avi­a­tion, and en­vi­ron­men­tal, health and safe­ty or­ga­ni­za­tions.

AM­PAC Fine Chem­i­cals, a Ran­cho Cor­do­va, CA-based man­u­fac­tur­er of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents and in­ter­me­di­ates, has ap­point­ed Lee Gau­thi­er to re­place re­tir­ing VP of op­er­a­tions Joseph Camp­bell.

→ For­mer Kite BD ex­ec He­len Kim and Kite’s cur­rent CMO David Chang are re­unit­ing at Dal­las-based can­cer biotech Pelo­ton Ther­a­peu­tics, where they are the two lat­est mem­bers of the board of di­rec­tors.

→ De­men­tia re­search Sharon Co­hen has joined ProMIS Neu­ro­sciences’ sci­en­tif­ic ad­vi­so­ry board, help­ing guide its lead ther­a­py for Alzheimer’s.

Trans­late Bio CEO Ronald Re­naud is lend­ing his lead­er­ship to Kyn Ther­a­peu­tics by be­com­ing its new board chair­man. The At­las-backed, Boston-based up­start works on the nascent field of im­munome­tab­o­lism. The biotech has al­so wel­comed Har­vard pro­fes­sor Fran­cis­co Quin­tana to its sci­en­tif­ic ad­vi­so­ry board.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.