Ru­bius snaps up No­var­tis vet Pablo Cagnoni as CEO; MiMedx dumps two ex­ecs fol­low­ing in­ter­nal in­ves­ti­ga­tion

David Ep­stein has re­cruit­ed an­oth­er fel­low No­var­tis vet to Ru­bius Ther­a­peu­tics, the cell ther­a­py start­up that he’s chair­ing — this time straight to the top job. New CEO Pablo Cagnoni joins Flag­ship Pi­o­neer­ing part­ner Tor­ben Straight Nis­sen, who’s been lead­ing the com­pa­ny as pres­i­dent. The Cam­bridge, MA-based com­pa­ny be­lieves it can en­gi­neer red blood cells to trans­port pro­teins, in­stead of oxy­gen, need­ed to fight dis­eases. The ap­pli­ca­tions span from can­cer — which Cagnoni is in­ti­mate­ly fa­mil­iar with, first as an on­col­o­gist and then as an ex­ec at No­var­tis on­col­o­gy and Onyx Phar­ma — to au­toim­mune and rare dis­eases. With a pre­clin­i­cal biotech that’s eye­ing a whole new class of ther­a­pies, Cagnoni has his work cut out for him, but thanks to a re­cent­ly com­plet­ed mega-round, he al­so has $220 mil­lion in the bank to help.

Robert Azel­by

→ Now that the dust has set­tled on Juno’s sale, chief com­mer­cial of­fi­cer Robert Azel­by is mov­ing on to chart a mar­ket­ing path for Alder Bio­Phar­ma­ceu­ti­cals $AL­DR. He re­places in­ter­im pres­i­dent and CEO Paul Cleve­land, who was in turn fill­ing in for Randy Schatz­man af­ter the co-founder left the com­pa­ny in March. Azel­by, an Am­gen vet with ex­ten­sive back­ground in the on­col­o­gy busi­ness, will now lead lit­tle Alder’s fight in the in­tense CGRP mi­graine ri­val­ry with No­var­tis/Am­gen and Eli Lil­ly, among oth­ers.

→ Cana­da’s Ad­vanced Pro­teome Ther­a­peu­tics has ap­point­ed two-time CEO Bill Dick­ie to over­see de­vel­op­ment of its tar­get­ed can­cer ther­a­pies as the biotech con­tin­ues to build out its an­ti­body-drug con­ju­gate plat­form. A founder of di­ag­nos­tic com­pa­ny Atreus Phar­ma­ceu­ti­cals and for­mer leader of car­dio-fo­cused Liponex, Dick­ie’s ap­point­ment fills a va­can­cy left by Ran­dal Chase, who re­signed in April af­ter on­ly one year at the helm. The fu­ture strat­e­gy of Ad­vanced Pro­teome Ther­a­peu­tics will lean on joint ven­tures, col­lab­o­ra­tions and li­cens­ing agree­ments, Dick­ie said in a state­ment.

→ En­gulfed in a cu­ri­ous se­ries of reg­u­la­to­ry and fi­nan­cial woes, MiMedx $MDXG is let­ting its CFO Michael Senken go af­ter wrap­ping up an in­ter­nal in­ves­ti­ga­tion in­to its sales and dis­tri­b­u­tion prac­tices. Al­so shown the door: John Cranston, the cor­po­rate con­troller and trea­sur­er. An in­ter­im CFO, Ed­ward Borkows­ki, has been brought in to re­state fi­nan­cial state­ments from the past six years, as the com­pa­ny claims that in­for­ma­tion can no longer be re­lied up­on. That’s a con­clu­sion of the still on­go­ing in­ves­ti­ga­tion by its own au­dit com­mit­tee, which be­gan this Feb­ru­ary and de­layed the re­lease of 2017’s fi­nan­cial re­sults (the com­pa­ny still doesn’t have a time­line for fil­ing its 10-K). The in­ter­nal re­view was quick­ly fol­lowed by a re­port­ed pre­lim­i­nary probe by the US Jus­tice De­part­ment in the same mat­ter as well as whether the tis­sue graft mak­er over­charged the gov­ern­ment for its prod­ucts. Ma­ri­et­ta, Geor­gia-based MiMedx, which has a trou­bled his­to­ry with short sell­ers, saw its stock fall by close to 13%.

→ Fresh off a new fi­nanc­ing round, Gele­sis has re­cruit­ed for­mer Wal­greens CMO Har­ry Lei­der to lead its med­ical strat­e­gy. That in­volves in­ter­act­ing with med­ical as­so­ci­a­tions, pa­tients ad­vo­ca­cy groups and oth­er or­ga­ni­za­tions in ser­vice of its pipeline of gas­troin­testi­nal drugs — in­clud­ing a weight loss drug dubbed Gele­sis100. Lei­der has been an ad­vis­er to PureTech Health, which has a 20% own­er­ship stake in the com­pa­ny. His ap­point­ment co­in­cides with a move for found­ing CMO Has­san Hesh­mati, free­ing Hesh­mati up to fo­cus on a dif­fer­ent set of clin­i­cal ac­tiv­i­ties as EVP, en­docrinol­o­gy and me­tab­o­lism. Help­ing guide some of their work will be Paul Fonteyne, chair­man and for­mer CEO of Boehringer In­gel­heim USA, who’s just joined the board of di­rec­tors.

Louise Rodi­no-Kla­pac

Sarep­ta $SRPT is on an ex­ec­u­tive hir­ing spree. First, the Cam­bridge, MA-based com­pa­ny of Ex­ondys-51 fame has snagged a top ex­ec­u­tive from one of its part­ners, Louise Rodi­no-Kla­pac, to lead its new­ly cre­at­ed gene ther­a­py unit. Rodi­no-Kla­pac is com­ing from Na­tion­wide Chil­dren’s Hos­pi­tal, where she was head­ing up the lab­o­ra­to­ry for gene ther­a­py re­search for mus­cu­lar dy­s­tro­phies, and will con­tin­ue to dou­ble as the CSO of My­onexus, an­oth­er part­ner of Sarep­ta’s. A few days lat­er, Sarep­ta an­nounced ex-Bio­gen ex­ec­u­tive Gilmore O’Neill will be­come the CMO, a po­si­tion held briefly by Re­gen­eron vet Cather­ine Stehman-Breen. O’Neill’s range of drug dev ex­pe­ri­ence spans Tec­fidera, Zin­bry­ta, Ple­gridy, and Spin­raza, the com­pa­ny said. And that’s all in line with Sarep­ta’s over­all strat­e­gy: CEO Doug In­gram told End­points that the com­pa­ny has grown its staff by 100 peo­ple since the start of 2018, from 240 t0 340, with plans to reach near­ly 480 by the end of the year.

An­tho­ny Di­Ton­no is up­ping his in­volve­ment with Tenax Ther­a­peu­tics $TNEX, tak­ing up an ap­point­ment to the CEO seat. Un­til re­cent­ly, the board di­rec­tor head­ed up a med­ical de­vice com­pa­ny, but can now de­vote him­self to ex­e­cut­ing a busi­ness strat­e­gy he helped form. The pri­or­i­ty will be ad­vanc­ing lev­osi­men­dan, a crit­i­cal care drug for a sub­set of pul­monary hy­per­ten­sion pa­tients that’s avail­able in over 60 coun­tries but not the US, through a Phase II tri­al.

→ Ex-Mallinck­rodt ex­ec Ronald Lloyd is the new pres­i­dent and CEO of Aziyo Bi­o­log­ics, tak­ing over com­mer­cial strat­e­gy and busi­ness de­vel­op­ment for the com­pa­ny, which is mar­ket­ing a slate of re­gen­er­a­tive med­i­cine from grafts to car­dio im­plants.

→ Just one month af­ter Por­to­la won a long-await­ed FDA ap­proval of its bleed­ing an­ti­dote for blood thin­ners, the com­pa­ny’s chief ex­ec­u­tive is re­lin­quish­ing the reins to re­tire. CEO William Lis, who’s been lead­ing the com­pa­ny since 2008, will stay on un­til Au­gust 1, then ex­it both the com­pa­ny and the board. Por­to­la $PT­LA has ap­point­ed the com­pa­ny’s EVP of R&D John Cur­nutte and CFO Mar­di Di­er as in­ter­im co-pres­i­dentson top of their cur­rent po­si­tions.

David Chang and Arie Bellde­grun have wooed a heavy­weight ex­ec to the C-suite of Al­lo­gene Ther­a­peu­tics, the next chap­ter of their biotech ca­reer af­ter sell­ing Kite to Gilead. Al­i­son Moore, for­mer­ly of Am­gen and Genen­tech, will now take charge of the nit­ty grit­ty de­tails nec­es­sary to turn their al­lo­gene­ic CAR-T dreams in­to re­al­i­ty. Her of­fi­cial ti­tle is chief tech­ni­cal of­fi­cer, and her re­spon­si­bil­i­ty cov­ers every­thing from prod­uct sci­ences, sup­ply chain, man­u­fac­tur­ing, qual­i­ty to tech­ni­cal op­er­a­tions. She is join­ing in very ear­ly days of Al­lo­gene, which launched in April with $300 mil­lion from well-heeled in­vestors and a port­fo­lio of can­cer cell ther­a­pies from Pfiz­er.

→ Phar­ma vet Yap­ing Shou is mak­ing the jump to biotech at Tril­li­um Ther­a­peu­tics $TRIL, sign­ing on as CMO just as the com­pa­ny preps its CD47 drug for first-in-hu­man tri­als. Be­tween Glax­o­SmithK­line, No­var­tis and most re­cent­ly Take­da, Shou has amassed 18 years of clin­i­cal ex­pe­ri­ence, much of which was in on­col­o­gy.

→ A boom­ing Zai Lab $ZLAB has poached As­traZeneca’s top on­col­o­gy drug mar­keter in Chi­na to help with the planned launch of its first can­cer drugs in the mas­sive Asian mar­ket. William Liang played a key role in bur­nish­ing As­traZeneca’s Q1 num­bers with the suc­cess­ful growth in Tagris­so sales, which the phar­ma gi­ant bad­ly needs to prove to an­a­lysts that the next chap­ter at the com­pa­ny will in­clude grow­ing rev­enue num­bers. Dur­ing his stretch at As­traZeneca as vice pres­i­dent of the on­col­o­gy busi­ness unit, Liang’s sales group grew from 500 to around 2,000.

→ Af­ter play­ing a key role in No­var­tis’ ac­qui­si­tion of AveX­is, Phillip Do­nen­berg has joined Lake For­est, IL-based De­pomed as CFO — the same role he had at the gene ther­a­py start­up and a few oth­er com­pa­nies. Au­gust Moret­ti, who’s had the job for six years, is re­turn­ing to Cal­i­for­nia (where De­pomed has just re­lo­cat­ed from) for his next gig. De­pomed ex­ecs like the com­bi­na­tion of fi­nance, M&A and op­er­a­tions ex­pe­ri­ence that Do­nen­berg brings to the ta­ble as they nav­i­gate a way out of opi­oids and in­to new dis­ease ar­eas.

Roivant-part­nered Ar­bu­tus $ABUS has found a per­ma­nent CFO in David Hast­ings, a long­time CFO of In­cyte. Ko­ert Van­de­nEn­den, who’s been do­ing the job ad in­ter­im, will con­tin­ue to shoul­der some ac­count­ing re­spon­si­bil­i­ties dur­ing the tran­si­tion and be­yond.

→ For­mer Gilead ex­ec Ut­pal Kop­pikar is bring­ing his glob­al fi­nan­cial man­age­ment skills to Atara Bio­ther­a­peu­tics $ATRA as the South San Fran­cis­co com­pa­ny po­si­tions it­self for a Phase III read­out of one of its al­lo­gene­ic T cell im­munother­a­pies. As CFO, he will al­so be in­volved in pre-com­mer­cial ac­tiv­i­ties.  

→ Still con­tend­ing with a clin­i­cal hold, a strug­gling Ad­vax­is $ADXS has en­list­ed Mol­ly Hen­der­son as its CFO, pulling her out of the con­sult­ing busi­ness and back on the front lines of biotech. Her hir­ing comes just a day be­fore the im­munother­a­py com­pa­ny an­nounced it’s ax­ing a clin­i­cal pro­gram — a par­al­lel ef­fort to slash burn rate and guard cash.

→ NASH drug de­vel­op­er Med­i­ci­No­va $MNOV has tak­en on an­oth­er CFO af­ter Ryan Sel­horn re­signed from the po­si­tion. Like Sel­horn, Car­la Reyes is an out­sources ex­ec from the ac­count­ing ser­vices firm Sig­na­ture An­a­lyt­ics.

→ With Phase III stud­ies of its mon­o­clon­al an­ti­bod­ies — which it be­lieves can treat both hema­to­log­i­cal ma­lig­nan­cies and au­toim­mune dis­eases — un­der­way, TG Ther­a­peu­tics $TGTX has scooped Adam Wald­man from Cel­gene’s hema­tol­ogy-on­col­o­gy unit. As chief com­mer­cial of­fi­cer, he is ex­pect­ed to build a team from scratch in an­tic­i­pa­tion of sev­er­al launch­es in the com­ing years.

At­las Ven­ture has brought on An­drea Arm­strong as its chief tal­ent of­fi­cer, trust­ing her to re­cruit and nur­ture star ex­ecs for both at the VC firm and for the ear­ly-stage biotechs it’s in­cu­bat­ing. A sea­soned hu­man re­sources pro­fes­sion­al, Arm­strong has served in a va­ri­ety of ad­min­is­tra­tion and or­ga­ni­za­tion­al roles at C4 Ther­a­peu­tics, the New York Genome Cen­ter and In­fin­i­ty Phar­ma.

→ New York’s Uro­Gen Phar­ma $URGN is los­ing its CFO Gary Ti­tus, the com­pa­ny an­nounced Tues­day. Uro­Gen is putting its COO Stephen Mul­len­nix in an in­ter­im CFO role while the com­pa­ny hunts for his re­place­ment. Uro­Gen al­so an­nounced the ad­di­tion of Ja­son Pa­tel, the for­mer se­nior di­rec­tor of ac­count­ing and fi­nance at Kite, as the com­pa­ny’s new VP of fi­nance.

→ Af­ter get­ting blast­ed by the fail­ure of its lead drug for Alzheimer’s, Vivek Ra­maswamy’s Ax­o­vant $AX­ON is go­ing to try and blaze a new path for­ward by de­vel­op­ing a gene ther­a­py for Parkin­son’s. To hus­tle along the as­set, which Ax­o­vant is pay­ing Ox­ford Bio­Med­ica $30 mil­lion for, CEO Pa­van Cheru­vu has re­cruit­ed Fras­er Wright — who had a se­nior role at gene ther­a­py pi­o­neer Spark Ther­a­peu­tics — as chief tech­nol­o­gy of­fi­cer. A for­mer Penn in­ves­ti­ga­tor, Wright is al­so a vet­er­an of the gene ther­a­py pro­gram at The Chil­dren’s Hos­pi­tal of Philadel­phia, which pro­vid­ed Spark with its ini­tial pipeline in gene ther­a­py.

→ Fol­low­ing a ca­reer in gov­ern­ment, Marykay Marchi­giani is now CFO at ABL, a con­tract re­search and man­u­fac­tur­ing or­ga­ni­za­tion head­quar­tered in Rockville, MD.

Gilead $GILD is pro­mot­ing An­drew Dick­in­son to EVP, cor­po­rate de­vel­op­ment and strat­e­gy, in prepa­ra­tion for Mar­tin Sil­ver­stein’s de­par­ture. Dick­in­son, who’s head­ed up a cou­ple of ac­qui­si­tion ef­forts since join­ing the com­pa­ny in 2016, will now have an ex­pand­ed role.

Sage Ther­a­peu­tics CEO Jeff Jonas has tak­en a board seat at At­las-backed Gen­er­a­tion Bio.


The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better.

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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The man who led Gilead’s au­toim­mune piv­ot heads to Boston; No­var­tis gets a new chief for its AI In­no­va­tion Cen­ter

The hospital’s gone now but across the street from it, there used to be a clinic, a beat-up thing with peeling paint that, in a past life, a past city, had been a bank. John Sundy was a medical student training at the hospital, in downtown Philadelphia. He walked in and saw a crowd of patients in all manner of autoimmune conditions waiting to see a tan, distinguished-looking man in a white lab coat: well-known rheumatologist Ralph DeHoratius.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.