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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.