Ed­i­tas CMO to ex­it as CRISPR tech gears up; Roche di­ag­nos­tics di­vi­sion CEO Roland Diggel­mann is out

Roland Diggel­mann is step­ping down as CEO of Roche’s di­ag­nos­tics di­vi­sion to “pur­sue his ca­reer out­side of the com­pa­ny.” The Swiss drug­mak­er $RHH­BY, which part­ed ways with R&D chief John Reed in re­cent months, has ap­point­ed Michael Heuer — the re­gion head of Eu­rope, Mid­dle East, Africa, and Latin Amer­i­ca — to fill the role ad in­ter­im. This year marks the 10th year of Diggel­man’s ca­reer at Roche Di­ag­nos­tics, where he pre­vi­ous­ly led the Asia Pa­cif­ic re­gion.

Bris­tol-My­ers Squibb $BMY found a re­place­ment for Mur­do Gor­don, the ex-com­mer­cial chief who re­cent­ly jumped ship to take the same reins at Am­gen. And CEO Gio­van­ni Caforio didn’t have to go far to find him. Christo­pher Boern­er, a sea­soned vet who’s been in charge of in­ter­na­tion­al sales at Bris­tol-My­ers, is get­ting the big pro­mo­tion to com­mer­cial chief and ex­ec­u­tive vice pres­i­dent. Boern­er — who’s worked at Seat­tle Ge­net­ics, Den­dreon and Genen­tech in the past — will like­ly be giv­en the chance of push­ing Bris­tol’s new PD-1 ap­proach on tu­mor mu­ta­tion bur­den in­to the mar­ket, where it will like­ly face a con­sid­er­able amount of con­fu­sion and kick­back over the tests that would be re­quired to iden­ti­fy pa­tients. But to his ad­van­tage, he knows the port­fo­lio bet­ter than most.

→ In the lat­est move in a reshuf­fle of se­nior ex­ecs among the biggest play­ers in bio­phar­ma, Gilead has tapped long­time Am­gen vet Lau­ra Hamill to head its com­mer­cial team. Hamill fills a po­si­tion va­cat­ed by the re­tire­ment of James Mey­ers, whose ca­reer tra­jec­to­ry was quite sim­i­lar to hers: He joined Gilead in 1996 as a re­gion­al sales di­rec­tor, climb­ing all the way up to EVP, com­mer­cial op­er­a­tions. Hamill had been with Am­gen since 2002, most re­cent­ly serv­ing as SVP, US busi­ness op­er­a­tions. Her new role gives her broad au­thor­ity over Gilead’s mar­ket­ing strat­egy and prod­uct launch­es around the world. Hamill joins Gilead at a time the big biotech is un­der­go­ing a ma­jor soul search­ing amidst a C-suite ex­o­dus.

Ed­i­tas Med­i­cine is search­ing for a new ex­ec to steer the first clin­i­cal tests of its CRISPR gene edit­ing tech as CMO Ger­ald Cox plans to de­part the com­pa­ny at the end of the year. Cox, a 16-year Sanofi Gen­zyme vet who joined Ed­i­tas in 2016, did not give a rea­son for his res­ig­na­tion ex­cept that it “felt like a nat­ur­al tran­si­tion point.” Cox will con­tin­ue to lead the ef­forts in sub­mit­ting Ed­i­tas’ first IND, which is ex­pect­ed in 2018.

→ Last we heard from Arc­turus Ther­a­peu­tics, CEO Joseph Payne was cel­e­brat­ing his vic­to­ry against the board of di­rec­tors that oust­ed him. Now, he’s ready to build up his own team in the af­ter­math of the bat­tle royale, putting An­drew Sas­sine — one of the new board mem­bers he brought on to re­place his old foes — in the CFO seat tem­porar­i­ly while he search­es for a per­ma­nent hire. For­mer­ly of Fi­deli­ty In­vest­ments, Sas­sine has spent the past few ears on the boards of sev­er­al life sci­ence com­pa­nies.

→ As the PDU­FA date for Ve­rastem On­col­o­gy’s PI3K drug ap­proach­es, it has re­cruit­ed Robert Gagnon to han­dle its fi­nances as CFO. A for­mer chief ac­count­ing of­fi­cer at Bio­gen, Gagnon has since worked in two CFO roles at an in­dus­tri­al ser­vices com­pa­ny and a life sci­ence re­search tools provider. It will on­ly be weeks be­fore we know whether du­velis­ib, an Ab­b­Vie castoff with a no­madic past, will fi­nal­ly get an OK at the FDA de­spite mixed re­sults.

→ Toron­to-based top­i­cal cream de­vel­op­er De­liv­ra has pro­mot­ed Pas­cal At­tard to CFO af­ter two years as VP of fi­nance.

Longeveron, a Mi­a­mi-based com­pa­ny de­vel­op­ing stem cell ther­a­pies for age-re­lat­ed dis­eases, has named Arin Maer­cks chief com­mer­cial of­fi­cer. With their lead prod­uct for ag­ing frailty in Phase II, ex­ecs be­lieve Maer­cks’ ex­pe­ri­ence guid­ing growth in a slate of in­dus­tries — from med­ical de­vice to point of care tech­nol­o­gy — will come in­to play. Oth­er pro­grams in the pipeline in­clude an Alzheimer’s treat­ment.

→ The hir­ing spree at Al­lo­gene Ther­a­peu­tics is con­tin­u­ing with the ap­point­ment of David Tillet as SVP, head of qual­i­ty. Tillet shares the same Am­gen roots with Al­lo­gene’s new chief tech­ni­cal of­fi­cer, Al­li­son Moore, though he’s been work­ing as a con­sul­tant in the past few years — Al­lo­gene be­ing one of his clients. “I look for­ward to build­ing and over­see­ing the qual­i­ty func­tion and be­ing a part of this ex­cit­ing time at Al­lo­gene,” he said in a state­ment, as the up­start looks to claim the fron­trun­ner po­si­tion in CAR-T with a pipeline of cell ther­a­pies from Pfiz­er.

→ Look­ing to up its IT game, Ei­sai has tapped Stephen Davies to over­see its glob­al tech­nol­o­gy in­fra­struc­ture and app de­vel­op­ment as well as the IT func­tion for its Amer­i­c­as re­gion. Jump­ing from a re­search di­rec­tor role at ad­vi­so­ry firm Gart­ner’s life sci­ence di­vi­sion, Davies’ of­fi­cial ti­tle will be VP, Ei­sai strat­e­gy in­for­ma­tion sys­tems.

Chi-Chang Wung is the new di­rec­tor of an­a­lyt­i­cal de­vel­op­ment at UPM Phar­ma­ceu­ti­cals. Pri­or to the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion, he’s worked at Alk­er­mes and Siga Tech­nolo­gies.

→ Af­ter a stint at gener­ics mak­er Lupin Phar­ma, Mer­ck vet Jef­fery Palmer has land­ed at Tris Phar­ma. As VP of qual­i­ty and com­pli­ance, he will build up a qual­i­ty team as the com­pa­ny looks to piv­ot to com­mer­cial­iza­tion with a pair of cold meds.

→ Cana­da’s Tetra Bio-Phar­ma has hired Steeve Neron to strate­gize mar­ket­ing for its cannabi­noid-based drug can­di­dates. The new VP jumps from Bausch Health Cana­da — bet­ter known by its for­mer iden­ti­ty as Valeant.

→ Not­ed CAR-T in­ves­ti­ga­tor Michel Sade­lain is lend­ing his cell ther­a­py ex­per­tise to the plat­form builders at Berke­ley Lights, where he’s the lat­est mem­ber of its strate­gic sci­en­tif­ic ad­vi­so­ry board.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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