Jose Car­los 'JC' Gutiér­rez-Ramos hits the ex­it at Syn­log­ic; Rich Hey­man pass­es Oric reins to ex-Igny­ta CFO

Jose Car­los Gutier­rez-Ramos

→ An abrupt res­ig­na­tion by pres­i­dent and CEO Jose Car­los Gutiér­rez-Ramos has left Syn­log­ic $SYBX in the hands of CMO Aoife Bren­nan. JC Gutiér­rez-Ramos ex­its the Cam­bridge biotech al­most ex­act­ly a year af­ter he or­ches­trat­ed its re­verse merg­er on­to Nas­daq, leav­ing be­hind an op­er­a­tion with two on­go­ing Phase I stud­ies and one dis­cov­ery pact with Ab­b­Vie, all built up­on Syn­log­ic’s spe­cial­ty in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics. No rea­sons were giv­en for his de­par­ture, which comes three years af­ter he joined from Pfiz­er, where he held a high-pro­file R&D job. Pe­ter Bar­rett is step­ping in­to the ex­ec­u­tive chair­man’s role to en­sure Bren­nan can bal­ance her in­ter­im ex­ec­u­tive du­ties with all the re­search, pre­clin­i­cal ac­tiv­i­ties and clin­i­cal tri­als un­der­way. Gutiér­rez-Ramos” will serve in an ad­vi­so­ry ca­pac­i­ty as need­ed.”

→ Hav­ing led Oric Phar­ma’s tran­si­tion from re­search to de­vel­op­ment stage, se­r­i­al en­tre­pre­neur Rich Hey­man fig­ured it’s time to pass the reins to a per­ma­nent CEO. En­ter Ja­cob Chacko, the for­mer Igny­ta CFO who helped grow the com­pa­ny from a val­u­a­tion of $50 mil­lion to $1.7 bil­lion — the price at which Roche bought it out. So while this will be his first time in the chief ex­ec­u­tive role, he brings to Oric both fundrais­ing ex­pe­ri­ence and knowl­edge about an ear­ly-stage on­col­o­gy com­pa­ny. (Be­fore Igny­ta, he worked as an in­vestor for pri­vate eq­ui­ty firm TPG Cap­i­tal.) For now, his pri­or­i­ty lies in pro­gress­ing the pipeline of drugs ad­dress­ing treat­ment re­sis­tance, es­pe­cial­ly lead can­di­date ORIC-101. Hey­man, who over­saw a $50 mil­lion Se­ries C fi­nanc­ing dur­ing his one-year-plus in­ter­im term, will stay on as board chair­man.

→ A start­up try­ing to de­vel­op a stem cell cure for type 1 di­a­betes has re­cruit­ed for­mer Ma­gen­ta ex­ec­u­tive Bas­tiano San­na — a guy best known for lead­ing the de­vel­op­ment of No­var­tis’ cell-based med­i­cines — to serve as the com­pa­ny’s new CEO. Cam­bridge-based Sem­ma Ther­a­peu­tics is bring­ing San­na in to re­place its in­ter­im CEO Eliz­a­beth Ston­er. San­na comes di­rect­ly from Ma­gen­ta — an­oth­er start­up de­vel­op­ing stem cell tech — where he was chief op­er­at­ing of­fi­cer. Be­fore that, San­na was an ex­ec­u­tive at No­var­tis’ cell and gene ther­a­py di­vi­sion, over­see­ing the de­vel­op­ment of CAR-T drugs.

→ Fol­low­ing its first pub­lic ap­pear­ance with $14 mil­lion in Se­ries A cash, Austin-based TFF Phar­ma­ceu­ti­cals an­nounced that it has tapped Glenn Mattes as CEO. A J&J vet and two-time biotech CEO, Mattes has been brought in for the long haul, trust­ed to take the biotech to com­mer­cial suc­cess. In­stead of an­tivi­ral ther­a­pies or can­cer treat­ments, how­ev­er, he will now fo­cus on TFF’s dry pow­der in­haler ver­sions of pul­monary drugs gen­er­at­ed with its name­sake, the Thin Film Freez­ing tech­nol­o­gy. He takes over from Robert Mills, who is now chair­man of the board.

David Moataze­di

→ Al­ler­gan aes­thet­ics chief David Moataze­di is leav­ing to take the helm of Evo­lus, a much small­er biotech de­vel­op­ing a ri­val to Botox. Evo­lus’ new drug DWP-450 (Prabot­u­linum­tox­inA) is un­der re­view. Moataze­di not­ed: “The team at Evo­lus has done a fan­tas­tic job in bring­ing for­ward what I be­lieve will be the most ex­cit­ing new prod­uct in aes­thet­ics. I look for­ward to work­ing with this tal­ent­ed group of pro­fes­sion­als and com­plet­ing the build out of a best in class lead­er­ship team.”

→ Six months in­to Daniel O’Con­nor’s tenure at On­cosec $ONCS, Punit Dhillon is phas­ing out even more from the biotech he co-found­ed and once helmed. In a con­sol­i­da­tion, O’Con­nor will now serve as both CEO and pres­i­dent — a role that for­mer­ly be­longed to Dhillon. Dhillon will, how­ev­er, re­main on the board.

→ In­di­cat­ing its dri­ve to gain mar­ket share in the gene en­gi­neer­ing ser­vices space, Hori­zon Dis­cov­ery has pro­mot­ed its head of com­mer­cial op­er­a­tions Ter­ry Pizzie to CEO, fill­ing a va­can­cy left by the de­par­ture of Dar­rin Dis­ley three months ago. Richard Vel­la­cott, who’s been shoul­der­ing most of the re­spon­si­bil­i­ties, will go back to just be­ing CFO. Be­fore join­ing Cam­bridge, UK-based Hori­zon last year and start­ing to build out its team, Pizzie had led com­mer­cial op­er­a­tions for Genetix and Bi­a­core.

Michael Stocum is step­ping down from Ini­va­ta, the liq­uid biop­sy com­pa­ny he’s led for four years, to make way for a new CEO “with a dif­fer­ent set of skills” as the Uni­ver­si­ty of Cam­bridge spin­out en­ters its “next stage of growth.” Stocum, for­mer­ly of GSK, found­ed and con­tin­ues to run a strat­e­gy con­sult­ing busi­ness called Per­son­al­ized Med­i­cine Part­ners.

→ A se­nior glob­al R&D leader at Genen­tech is leav­ing the biotech gi­ant for a new post at South San Fran­cis­co’s Atara Bio­ther­a­peu­tics. Di­et­mar Berg­er will join Atara $ATRA as glob­al head of R&D, tak­ing the com­pa­ny’s al­lo­gene­ic T cell treat­ments through the clin­ic. Berg­er is best known for his re­cent role at Genen­tech/Roche, where he’d been work­ing as se­nior vice pres­i­dent and glob­al head of prod­uct de­vel­op­ment with­in the com­pa­ny’s hema­tol­ogy and on­col­o­gy unit since 2014. There, he led med­ical strat­e­gy for Genen­tech’s port­fo­lio of can­cer med­i­cines, in­clud­ing glob­al fil­ings of ap­proved drugs like Gazy­va, Cotel­lic, Ale­cen­sa, Tecen­triq and Hem­li­bra. At Atara, he will man­age a slate of R&D pro­grams, in­clud­ing a CAR-T part­ner­ship with Juno co-founder Michel Sade­lain an­nounced just a day af­ter his ap­point­ment.

→ In the af­ter­math of a de­ci­sive PhII fail­ure for one in­di­ca­tion of its sole drug, Men­lo Ther­a­peu­tics $MN­LO has reshuf­fled its C-suite to divvy up ear­ly- and late-stage clin­i­cal re­spon­si­bil­i­ties. Paul Kwon, a Genen­tech vet who’s been CMO for the last two years, will now take on the role of CSO, iden­ti­fy­ing po­ten­tial new in­di­ca­tions for ser­lop­i­tant and run­ning ear­ly-stage tri­als. Mary Spell­man, pre­vi­ous­ly SVP of clin­i­cal de­vel­op­ment, has been tapped to man­age the plan­ning and ex­e­cu­tion of late-stage clin­i­cal pro­grams as CMO. The new ap­point­ments for Kwon and Spell­man, both of whom are der­ma­tol­o­gists, un­der­scores Men­lo’s con­vic­tion for its drug in the pruri­go nodu­laris itch and pso­ri­a­sis itch in­di­ca­tions, though it does have Phase II da­ta for its re­frac­to­ry cough pro­gram com­ing up lat­er this year.

Au­dentes Ther­a­peu­tics COO Na­tal­ie Holles is adding “pres­i­dent” to her ti­tle. Her new man­date cov­ers day-to-day op­er­a­tions of the com­pa­ny $BOLD, in­clud­ing R&D, man­u­fac­tur­ing, pro­gram man­age­ment and cor­po­rate de­vel­op­ment. For Au­dentes, this marks an evo­lu­tion in their lead­er­ship struc­ture, part of a quest to bring gene ther­a­py for rare dis­eases to the mar­ket.

→ As Third Rock-backed Tan­go Ther­a­peu­tics be­gins to trans­late its CRISPR-based dis­cov­ery plat­form in­to next-gen im­muno-on­col­o­gy ther­a­peu­tics, it has pro­mot­ed a found­ing staffer to the C-suite and brought in an­oth­er ex­ec from No­var­tis. New CSO Alan Huang and SVP of phar­ma­ceu­ti­cal sci­ences Charles Davis share roots in No­var­tis In­sti­tutes for Bio­Med­ical Re­search; Huang lat­er went on to be­come a con­sul­tant at Third Rock. To­geth­er with Davis, a GSK vet of 20 years, he will work to build a pipeline for the young biotech.

→ On the brink of mov­ing its fi­bro­sis drugs in­to the clin­ic, Pli­ant Ther­a­peu­tics has brought in Éric Lefeb­vre from Al­ler­gan to lead de­vel­op­ment strat­e­gy and clin­i­cal op­er­a­tions for its prod­uct can­di­dates. As CMO, over time, Lefeb­vre is ex­pect­ed to chan­nel the many skills he’s ac­crued at To­bi­ra, Janssen and GSK — rang­ing from de­vel­op­ment and med­ical af­fairs to com­mer­cial­iza­tion. He will do all this un­der the lead­er­ship of new­ly in­stalled board chair­man Hoy­oung Huh, a for­mer McK­in­sey part­ner and vet­er­an board di­rec­tor who will guide the man­age­ment team on high-lev­el busi­ness strat­e­gy.

Flex­ion Ther­a­peu­tics $FLXN has found a suc­ces­sor for re­tir­ing CFO Fred­er­ick Driscoll in David Arkowitz. Be­tween Vis­ter­ra, AM­AG Phar­ma and Mer­ck, Arkowitz has served in COO, CBO and con­troller roles in ad­di­tion to be­ing the top fi­nan­cial per­son. Ex­ecs al­so liked his com­mer­cial ex­pe­ri­ence, giv­en that Flex­ion is still rel­a­tive­ly new in the mar­ket­ing game for its in­jectable drug for os­teoarthri­tis-re­lat­ed knee pain.

→ Look­ing to bring its cell-based im­plant to the US, Cana­da’s Ser­no­va has hired Sean Hod­gins to as­sist the CEO in ex­e­cut­ing the com­pa­ny’s busi­ness de­vel­op­ment and cap­i­tal mar­ket strate­gies. The new CFO man­aged a cou­ple of Nas­daq IPOs while work­ing in the US and has han­dled sev­er­al Cana­di­an list­ings and CFO jobs since then. He re­places Scott Langille.

→ Tap­ping what they see as a boom in stem cell-based re­gen­er­a­tive med­i­cine, Tel Aviv-based Cel­lect Biotech­nol­o­gy $APOP is open­ing a US cen­ter of op­er­a­tions and wooed a for­mer GE Health­care ex­ec to lead it. An­drew Sabati­er’s of­fi­cial ti­tle will be chief busi­ness of­fi­cer, in which he will lever­age his pre­vi­ous ex­pe­ri­ence mar­ket­ing raw ma­te­ri­als to a gen­er­a­tion of biotechs de­vel­op­ing new ther­a­pies.

→ Mov­ing from one women’s health bio­phar­ma to the next, John Fair has tak­en a CBO job at Daré Bio­science $DARE. The San Diego com­pa­ny is de­vel­op­ing a non-hor­mon­al con­tra­cep­tive and a drug for fe­male sex­u­al arousal dis­or­der us­ing the ac­tive in­gre­di­ent in Vi­a­gra; Fair will be seek­ing part­ner­ships for these and oth­er re­pro­duc­tive prod­uct can­di­dates in the works.

→ Fol­low­ing a four-month search, Sy­neos Health con­clud­ed that its in­ter­im CFO Ja­son Meg­gs is the best per­son for the job left be­hind by Greg Rush. For­mer­ly an EVP and CFO of com­mer­cial so­lu­tions, Meg­gs joined INC Re­search back be­fore it merged with In­Ven­tiv Health, cre­at­ing an in­te­grat­ed com­pa­ny $SYNH with both con­tract re­search and con­tract com­mer­cial­iza­tion ca­pa­bil­i­ties.

Adare Phar­ma­ceu­ti­cals’ Prince­ton, NJ head­quar­ters is bub­bling with ac­tiv­i­ty. En­do Phar­ma vet Robert Rush is join­ing as VP, fi­nance and CFO; Ajay Damani has left Lon­za to lead Adare’s phar­ma­ceu­ti­cal tech­nolo­gies busi­ness unit as a VP; and Giuseppe Di Vin­cen­zo has been pro­mot­ed to VP, strat­e­gy. To­geth­er, they will help bal­ance an op­er­a­tion that fea­tures both in-house R&D and clin­i­cal ser­vices. Joseph Del Buono, who used to have Rush’s job, has re­signed to pur­sue oth­er op­por­tu­ni­ties.

→ Leav­ing be­hind a clin­i­cal pro­gram lead po­si­tion at Bris­tol-My­ers Squibb’s vi­rol­o­gy unit, Stephanie Noviel­lo is now the VP of clin­i­cal de­vel­op­ment at an­tibi­otics mak­er Mo­tif Bio. Noviel­lo will stay — at least ini­tial­ly — laser-fo­cused on the EMA sub­mis­sion for Mo­tif Bio’s Phase III Gram-pos­i­tive bac­te­r­i­al in­fec­tion drug iclaprim.

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.