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.

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

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Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: Bris­tol My­ers sus­pends clin­i­cal tri­als, grounds field team; Vir ush­ers an­ti­body can­di­dates to hu­man test­ing

The global nature of the Covid-19 pandemic is manifesting more profoundly every day. With Spain’s death toll now surpassing China’s and India on full lockdown, the number of confirmed cases around the world has exceeded 436,000 while recoveries edged close to 112,000.

While the outbreak derails R&D at another pharma giant, several drugmakers have some encouraging updates on both experimental and repurposed molecules. Philanthropic campaigns in anticipation of the economic fallout continue. An Australian biotech is taking extreme measures to hunker down. There’s also an alternative epidemiology model emerging out of the UK, stirring up more discussion regarding the true extent of the infections in the country.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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