Abrax­ane de­vel­op­er Igle­sias joins Sen­ti Bio­sciences; AB2Bio re­cruits CEO

Jose Igle­sias

→ Af­ter ac­cu­mu­lat­ing more than 30 years of bio­phar­ma ex­pe­ri­ence, Jose Igle­sias has been named CMO of Sen­ti Bio­sciences, a gene cir­cuit com­pa­ny based in the San Fran­cis­co area. Igle­sias is slat­ed to lead Sen­ti’s clin­i­cal de­vel­op­ment pro­grams with an em­pha­sis on treat­ing sol­id and liq­uid tu­mors. Igle­sias de­signed the can­cer drug Abrax­ane while he was at Abrax­is and Cel­gene, and his ex­ten­sive back­ground al­so in­cludes lead­er­ship po­si­tions at Eli Lil­ly, Apo­bi­ologix and Boston Bio­Med­ical.

Michael Sol­dan has been brought on as CEO of Swiss-based AB2Bio. Sol­dan jumps on board at the biotech af­ter a two-and-a-half-year stint as CEO of glob­al biosim­i­lars at Fre­se­nius Kabi. He al­so pre­vi­ous­ly led the biosim­i­lars busi­ness at Mer­ck and held posts at Boehringer In­gel­heim and Biotest, among oth­ers.

→ At the same time as their $105 mil­lion fi­nanc­ing round, ear gene ther­a­py play­er Ak­ou­os has wel­comed for­mer pres­i­dent of Ver­tex Vic­ki Sato and Heather Pre­ston, a man­ag­ing part­ner at Piv­otal bioven­ture Part­ners, to its board of di­rec­tors.

→ An­oth­er ex­ec is join­ing the ex­o­dus at Bio­gen. Head of ear­ly R&D Anir­van Ghosh is hit­ting the ex­it to take the helm of an­ti-ag­ing biotech Uni­ty Biotech­nol­o­gy — backed by ARCH Ven­ture and Be­zos Ex­pe­di­tions. Ghosh joined the com­pa­ny in 2017 and pre­vi­ous­ly held roles at Roche and E-Scape Bio. Ghosh is the third Bio­gen ex­ec­u­tive to de­part in the last 5 months, join­ing R&D chief Michael Ehlers and, as of last week, cor­po­rate de­vel­op­ment EVP Daniel Karp.

→ Head­ing in­to 2020, AM­AG Phar­ma­ceu­ti­cals has sketched big plans to sal­vage its wob­bly op­er­a­tions — bat­tling a rev­enue squeeze and a crit­i­cal FDA re­view of its preterm birth drug — un­der a new CEO. To­day, it an­nounced that the chief med­ical of­fi­cer won’t be stay­ing, ei­ther. Julie Krop, who joined AM­AG in 2015, will de­camp by the end of the month, leav­ing a void in the biotech’s de­vel­op­ment group just as it pledges to per­suade the FDA to keep Mak­e­na on the mar­ket and ad­vance a “po­ten­tial­ly ex­cit­ing pipeline.”

Julie Krop

At­las Ven­ture-backed Unum, which once har­bored am­bi­tions to ri­val the two CAR-T ther­a­pies Kym­ri­ah and Yescar­ta, is pay­ing the price for a laun­dry list of set­backs. On Mon­day, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny said it was cut­ting its work­force by 43 em­ploy­ees (rough­ly 60% of the to­tal head­count) to fo­cus its ef­forts on a pre­clin­i­cal pro­gram. It al­so dis­closed the de­par­ture of its chief sci­en­tif­ic of­fi­cer, Seth Et­ten­berg, as it ceas­es the de­vel­op­ment of tri­als har­ness­ing its maid­en tech­nol­o­gy: AC­TR.

→ In a chang­ing of the guard at bi­o­log­ics-fo­cused In­tegri­ty Bio, Michael Reil­ly has been pro­mot­ed to CEO. He re­places Byeong Chang, In­tegri­ty Bio’s founder, own­er and pre­vi­ous CEO who will stay on as CSO. Reil­ly’s tenure as In­tegri­ty Bio’s VP of busi­ness de­vel­op­ment spanned eight years, and he head­ed the Ex­celse Bio high-con­cen­tra­tion for­mu­la­tion tech­nol­o­gy di­vi­sion. His pre­vi­ous stops in­clude Bax­ter Bio­Science and Am­gen.

→ Stephen Ru­bi­no has joined Celyad as its CBO. Ru­bi­no brings more than 25 years of ex­pe­ri­ence to the Bel­gian bio­phar­ma, which fo­cus­es on de­vel­op­ing CAR-T cell-based ther­a­pies. Ru­bi­no had re­cent­ly been the chief busi­ness & strat­e­gy of­fi­cer at Omega Ther­a­peu­tics. Be­fore that, he was at No­var­tis for 17 years as its glob­al head of busi­ness de­vel­op­ment & li­cens­ing and new prod­uct mar­ket­ing, cell & gene ther­a­py unit.

Shali­ni Sharp

→ The CFO and EVP of rare and ul­tra­rare dis­ease-fo­cused Ul­tragenyx has de­cid­ed to step down. Shali­ni Sharp is hit­ting the ex­it to fo­cus more on her fam­i­ly and her board mem­ber­ships at sev­er­al oth­er biotechs — Neu­ro­crine Bio­sciences, Sutro Bio­phar­ma, Pre­ci­sion Bio­sciences and TB Al­liance.

→ AI-fo­cused twoXAR Phar­ma­ceu­ti­cals has tapped Mark Eller as SVP of R&D and An­jali Pandey as SVP of non­clin­i­cal R&D and chem­istry. Eller joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where he pre­vi­ous­ly served as SVP re­search & clin­i­cal de­vel­op­ment. Pandey pre­vi­ous­ly served as CSO at Bridge­Bio Phar­ma sub­sidiaries TheRas and Fer­ro Ther­a­peu­tics.

HEL Group — a de­vel­op­er and man­u­fac­tur­er of lab­o­ra­to­ry tools — has wooed Qing (Steven) Chen as Chi­na gen­er­al man­ag­er, aid­ing the com­pa­ny in its tran­si­tion to a whol­ly for­eign-owned en­ti­ty in Chi­na. Chen hops aboard from Nanopho­ton Cor­po­ra­tion and pre­vi­ous­ly held posts at PerkinElmer and Bruk­er Op­tics.

Steven Chen HEL Group

Rafael Phar­ma­ceu­ti­cals has wel­comed San­jay Se­h­gal as its chief reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance of­fi­cer, a post that was just cre­at­ed. Pri­or to his ap­point­ment at Rafael, Se­h­gal was at Celu­lar­i­ty as its SVP of reg­u­la­to­ry af­fairs and con­for­mance.

→ Af­ter as­sum­ing the role as CFO of Im­muno­vant in No­vem­ber, Pam Yanchik Con­nealy has been added to Penn­syl­va­nia-based Or­ches­tra Bio­Med’s board of di­rec­tors as au­dit com­mit­tee chair. Yanchik Con­nealy’s pre­vi­ous roles in­clude serv­ing at Genen­tech and the Bill & Melin­da Gates Foun­da­tion.

An­ders Götzsche has been ap­point­ed to the board of di­rec­tors at Ob­sid­i­an Ther­a­peu­tics, which spe­cial­izes in con­trol­lable cell and gene ther­a­pies. The cur­rent EVP and CFO of H Lund­beck, Götzsche will be chair­ing the Cam­bridge, Mass­a­chu­setts-based biotech’s au­dit com­mit­tee.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serves, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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