At­las-backed Dyne taps Joshua Brumm as CEO; Sekar Kathire­san woos car­di­ol­o­gist to gene edit­ing start­up

Ro­mesh Sub­ra­man­ian’s new biotech start­up, Dyne Ther­a­peu­tics, which is us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease has brought on Joshua Brumm as pres­i­dent and CEO. Sub­ra­man­ian will now take on the CSO role af­ter launch­ing the biotech as en­tre­pre­neur-in-res­i­dence at At­las Ven­ture. Brumm makes the leap af­ter a stint as COO and CFO of Kalei­do Bio­sciences, where he led the com­pa­ny’s IPO and helped bring its lead pro­gram in­to Phase II de­vel­op­ment. Pri­or to Kalei­do, Brumm was the COO and CFO at Ver­sar­tis. His oth­er pre­vi­ous roles span Phar­ma­cyclics, ZEL­TIQ Aes­thet­ics, Pro­te­olix, Cit­i­group Glob­al Mar­kets and Mor­gan Stan­ley

Sekar Kathire­san has wooed a vet­er­an car­di­ol­o­gist and sea­soned biotech en­tre­pre­neur to his mis­sion to pro­tect the world from heart dis­ease via gene edit­ing. An­drew Bellinger is the new CSO at Verve Ther­a­peu­tics, tak­ing up the same role he oc­cu­pied at Lyn­dra, a biotech he co-found­ed based on drug de­liv­ery tech in­vent­ed by Bob Langer. He will now di­rect the re­search and trans­la­tion­al skills ac­crued there (and Co­coon Biotech be­fore that) to safe­ly ed­it genes to low­er the risk of coro­nary artery dis­ease.

“In my car­di­ol­o­gy prac­tice, I’ve seen first­hand the lim­i­ta­tions of our present-day ap­proach to car­dio­vas­cu­lar dis­ease,” Bellinger, who sees pa­tients at Brigham and Women’s Hos­pi­tal, said in a state­ment. “With Verve, we have a pro­found op­por­tu­ni­ty to change the dy­nam­ic of health­care de­liv­ery for peo­ple liv­ing with or at risk for coro­nary artery dis­ease — con­fer­ring life­long re­sis­tance with a gene-edit­ing treat­ment giv­en once in life.”

Jnana Ther­a­peu­tics has brought on Al­ny­lam vet Car­o­line Stark Beer as CBO in search of new part­ners for its SLC trans­porter tech, which has spawned treat­ments for in­flam­ma­to­ry and neu­ro­log­i­cal dis­eases. Dur­ing her time at Al­ny­lam, Stark Beer served in a va­ri­ety of po­si­tions, in­clud­ing vice pres­i­dent and head of busi­ness de­vel­op­ment — where she helped fa­cil­i­tate part­ner­ships and li­cens­ing deals with Sanofi Gen­zyme and Re­gen­eron. Pri­or to her time at Al­ny­lam, Stark Beer held roles at Am­i­cus Ther­a­peu­tics and Bain & Com­pa­ny.

→ Fol­low­ing re­cent big changes at Vor Bio­phar­ma — the ap­point­ment of Robert Ang as CEO, the com­pa­ny’s re­cent move in­to an in­te­grat­ed head­quar­ters in Cam­bridge, MA and a $42 mil­lion Se­ries A round — the biotech has en­list­ed two more cell ther­a­py ex­perts to the team. Sadik Kas­sim and Tirtha Chakraborty have been named chief tech­nol­o­gy of­fi­cer and VP of re­search, re­spec­tive­ly. Kas­sim joins the com­pa­ny af­ter a stint as ex­ec­u­tive di­rec­tor at Kite Phar­ma and pre­vi­ous roles at Mus­tang Bio, No­var­tis (where he con­tributed to the BLA and MAA fil­ings for Kym­ri­ah), the Na­tion­al Can­cer In­sti­tute and Janssen. Chakraborty joins the com­pa­ny from Sana Biotech­nol­o­gy, where he served as VP of cell ther­a­py re­search. Pri­or to his time at Sana, Chakraborty was the head of hema­tol­ogy at CRISPR Ther­a­peu­tics and served a stint at Mod­er­na Ther­a­peu­tics

Sang­amo has se­lect­ed Bet­ti­na Cock­roft as the com­pa­ny’s SVP and CMO. Cock­roft draws from ex­pe­ri­ence from her time at Cy­tokinec­tics, where she was re­spon­si­ble for the clin­i­cal de­vel­op­ment of fast skele­tal mus­cle tro­ponin ac­ti­va­tors in dis­eases such as amy­otroph­ic lat­er­al scle­ro­sis and spinal mus­cu­lar at­ro­phy. In her new role, Cock­roft will shift fo­cus to gene-edit­ing pro­grams, in­clud­ing one for he­mo­phil­ia A part­nered with Pfiz­er. In ad­di­tion, Cock­roft has served as CMO of Au­ris Med­ical and pre­vi­ous­ly worked at Mer­ck Serono, No­var­tis Con­sumer Health and Menar­i­ni Ricerche

As­cle­tis Phar­ma — a com­pa­ny that paved the way in de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — has an­nounced that its CFO Lin­di Tan is de­part­ing. Tan’s de­par­ture comes weeks af­ter the Hangzhou-based biotech lost Zhengqing Li, a for­mer top Mer­ck ex­ec who jumped to the com­pa­ny as its CMO and pres­i­dent of R&D just months pri­or to help ex­tend its glob­al reach.

→ Sev­en years in­to a tu­mul­tuous tenure at Te­va — in which he was charged with down­siz­ing and clos­ing out man­u­fac­tur­ing op­er­a­tions while the com­pa­ny faced a probe in­to gener­ic drug price hikes in the US — Car­lo de No­taris­te­fani, EVP of glob­al op­er­a­tions, is step­ping down to re­tire.  Er­ic Drapé has been cho­sen as his suc­ces­sor and will be based out of the com­pa­ny’s glob­al head­quar­ters in Is­rael. Drapé joined the com­pa­ny in 2014 and has since served var­i­ous roles, in­clud­ing as EVP and chief qual­i­ty of­fi­cer and SVP, tech­ni­cal op­er­a­tions ster­iles, res­pi­ra­to­ry and bi­o­log­ics. No­taris­te­gani’s ex­it comes in the wake of two oth­er top ex­ec ex­its — CFO Michael Mc­Clel­lan and EVP glob­al brand and com­mu­ni­ca­tions Iris Beck-Cod­ner.

→ Af­ter it was an­nounced last week, in a sur­prise twist, that Akcea pres­i­dent Sarah Boyce along with her two top ex­ec col­leagues, CEO Paula Soteropou­los and COO Jef­frey Gold­berg were leav­ing the Io­n­is spin­off, Boyce has found a new home at Avid­i­ty Bio­sciences. The com­pa­ny is work­ing on an­ti­body-oligonu­cleotide con­ju­gates (AOCs), and as their new CEO Boyce will draw from ex­pe­ri­ence from her pre­vi­ous stints at Io­n­is, For­est Lab­o­ra­to­ries, Alex­ion Phar­ma­ceu­ti­cals, No­var­tis On­col­o­gy, and Roche.

→ Back in Ju­ly, AM-Phar­ma raised $113 mil­lion from a Eu­ro­pean syn­di­cate to help fund its planned Phase III tri­al in pa­tients with sep­sis-as­so­ci­at­ed acute kid­ney in­jury. Now the com­pa­ny is ex­pand­ing its lead­er­ship team with the ap­point­ments of Ju­liane Bern­holz as COO and Kristie Bass as VP clin­i­cal op­er­a­tions. Bern­holz will draw up­on ex­pe­ri­ence from her roles at Janssen, Sanofi, No­var­tis and Acte­lion. Bass tran­si­tions to her new po­si­tion af­ter serv­ing as se­nior di­rec­tor of project de­liv­ery at CRO PRA Health Sci­ences and di­rec­tor, project man­ag­er at PPD. Both Bern­holz and Bass will move from the US to the Nether­lands.

Neu­ro­crine Bio­sciences — which, back in Jan­u­ary, struck up a $1.8 bil­lion gene ther­a­py pact with Voy­ager Ther­a­peu­tics to snag the rights of four of their gene ther­a­py pro­grams — has wel­comed David Boy­er aboard as chief cor­po­rate af­fairs of­fi­cer. Boy­er makes the jump af­ter a stint at BGR Group as prin­ci­pal and head of the health & life sci­ences prac­tice. Pri­or to his role at BGR, Boy­er served as spe­cial as­sis­tant to the pres­i­dent for leg­isla­tive af­fairs un­der Pres­i­dent George W Bush, as­sis­tant com­mis­sion­er for leg­is­la­tion at the FDA and spe­cial as­sis­tant to the sec­re­tary at the US De­part­ment of Health and Hu­man Ser­vices. He’s al­so held po­si­tions at BIO and PhRMA.

→ Months af­ter strik­ing a re­verse merg­er deal with strug­gling His­to­gen­ics, Malvern, PA-based Ocu­gen has ap­point­ed San­jay Sub­ra­man­ian to the role of CFO. Sub­ra­man­ian joins the rare eye dis­ease-fo­cused biotech from the same po­si­tion at Ar­alez Phar­ma­ceu­ti­cals, where he helped the com­pa­ny close $350 mil­lion in fi­nanc­ing. Pri­or to his stint at Ar­alez, Sub­ra­man­ian held po­si­tions at Bausch Health Com­pa­nies and Gen­er­al Mo­tors.

Retrophin has tapped Pe­ter Heer­ma as CCO. Heer­ma will be in charge of the com­pa­ny’s com­mer­cial­iza­tion strat­e­gy for ap­proved prod­ucts and pre-com­mer­cial plan­ning of pipeline pro­grams, which in­cludes sparsen­tan — cur­rent­ly be­ing eval­u­at­ed in Phase III tri­als for fo­cal seg­men­tal glomeru­loscle­ro­sis and IgA nephropa­thy. But that group won’t in­clude fos­met­pan­tote­nate, the drug that its no­to­ri­ous founder Mar­tin Shkre­li co-in­vent­ed, af­ter it flopped in a piv­otal tri­al. Most re­cent­ly, Heer­ma was the glob­al prod­uct man­ag­er for on­col­o­gy and car­dio­vas­cu­lar prod­ucts at Am­gen and has al­so served roles at Ab­b­Vie and Ab­bott

→ UK-based VC and life sci­ences com­pa­ny, Ar­ix Bio­science — which re­cent­ly co-led a $63 mil­lion round for drug de­vel­op­er Imarahas an­nounced that their CFO, James Rawl­ing­son is hit­ting the ex­it. Rawl­ing­son is the cur­rent non-ex­ec­u­tive di­rec­tor and chair­man of the au­dit and risk com­mit­tee at Citibank UK. In ad­di­tion, the com­pa­ny’s group fi­nan­cial con­troller, Mar­cus Karia, has been pro­mot­ed to group fi­nance di­rec­tor.  

→ Neoanti­gen play­er PACT Phar­ma has wooed Tim Moore from Kite to run tech­ni­cal ops as the com­pa­ny’s pres­i­dent and chief tech­ni­cal of­fi­cer. The prospect of tack­ling sol­id tu­mors by hit­ting neoanti­gens that form a unique sig­na­ture on each — drew him to the new op­por­tu­ni­ty, Moore told End­points News

In­com­ing Ver­tex CEO Resh­ma Ke­wal­ra­mani has se­lect­ed her re­place­ment as CMO, choos­ing to pro­mote a mem­ber of the R&D team to the post. Car­men Boz­ic, who joined the com­pa­ny last May from Bio­gen, has been named EVP, Glob­al Med­i­cines De­vel­op­ment and Med­ical Af­fairs to­day and gets to add the new ti­tle of CMO next April as Ver­tex cau­tious­ly trans­fers the reins to a new CEO who much to prove in or­der to win over some skep­ti­cal an­a­lysts. Boz­ic’s first job at Ver­tex was lead­ing clin­i­cal de­vel­op­ment of the com­pa­ny’s cys­tic fi­bro­sis and al­pha-1 an­tit­rypsin de­fi­cien­cy pro­grams, as well as clin­i­cal op­er­a­tions across the pipeline. In ad­di­tion, Nia Tat­sis, Ver­tex’s SVP, glob­al reg­u­la­to­ry af­fairs, is tak­ing over as head of reg­u­la­to­ry, ef­fec­tive im­me­di­ate­ly. 

→ Just a lit­tle more than 3 years af­ter Michael Ehlers took the job as glob­al head of R&D for the now deeply trou­bled Bio­gen, he’s jump­ing ship. CEO Michel Vounatsos has ap­point­ed CMO Al San­drock, a chief ar­chi­tect of the drug­mak­er’s deeply flawed pipeline strat­e­gy, as his re­place­ment. Ehlers will go on to a new ca­reer op­por­tu­ni­ty as a ven­ture part­ner and CSO at Ap­ple Tree, which comes with a CEO job at a gene ther­a­py start­up named Lime­light Bio. In ad­di­tion, Vounatsos named Alphonse Galdes ex­ec­u­tive vice pres­i­dent, phar­ma­ceu­ti­cal op­er­a­tions and tech­nol­o­gy.

→ For­mer FDA Com­mis­sion­er Robert Califf and his inim­itable mus­tache will be on proud dis­play as he makes his way to Al­pha­bet to take a full-time role as head of med­ical strat­e­gy and pol­i­cy across the Google Health and Ver­i­ly units, come mid-No­vem­ber. 

→ Ther­a­peu­tic pro­tein man­u­fac­tur­er AGC Bi­o­log­ics has ap­point­ed Jef­frey Mow­ery as site head/gen­er­al man­ag­er of the com­pa­ny’s Copen­hagen, Den­mark fa­cil­i­ty. He will work with his col­leagues in Seat­tle to com­bine the com­pa­ny’s glob­al ca­pa­bil­i­ties. Mow­ery’s pre­vi­ous stints in­clude Juno Ther­a­peu­tics, Lon­za and Genen­tech.

PhRMA has named Jen­nifer Bryant as EVP of pol­i­cy and re­search, suc­ceed­ing Lori Reil­ly who was re­cent­ly ap­point­ed COO. Bryant has been with PhRMA for 13 years and most re­cent­ly served as SVP of pol­i­cy and re­search. Pri­or to her time at PhRMA, Bryant served as vice pres­i­dent at health­care con­sult­ing firm, The Lewin Group and worked at the Blue Cross Blue Shield As­so­ci­a­tion.

Opti­nose has hired Michael Richard­son as VP, busi­ness de­vel­op­ment to beef up its port­fo­lio of po­ten­tial treat­ments for ear, nose and throat. As the com­pa­ny be­gins to mar­ket its Xhance nasal spray for nasal polyps, Richard­son will eval­u­ate new op­por­tu­ni­ties to sup­port long-term growth, the com­pa­ny said. He joins from a com­mer­cial role at Prince­ton Bio­phar­ma.

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Paul Hudson, Sanofi

Paul Hud­son promis­es a bright new fu­ture at Sanofi, kick­ing loose me-too drugs and fo­cus­ing on land­mark ad­vances. But can he de­liv­er?

Paul Hudson was on a mission Tuesday morning as he stood up to address Sanofi’s new R&D and business strategy.

Still fresh into the job, the new CEO set out to convince his audience — including the legions of nervous staffers inevitably devoting much of their day to listening in — that the pharma giant is shedding the layers of bureaucracy that had held them back from making progress in the past, dropping the duds in the pipeline and reprioritizing a more narrow set of experimental drugs that were promised as first-in-class or best-in-class.  The company, he added, is now positioned to “go after other opportunities” that could offer a transformational approach to treating its core diseases.

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Left top to right: Mark Timney, Alex Denner, Vas Narasimhan. (The Medicines Company, Getty, AP/Endpoints News)

In a play-by-play of the $9.7B Med­Co buy­out, No­var­tis ad­mits it over­paid while of­fer­ing a huge wind­fall to ex­ecs

A month into his tenure at The Medicines Company, new CEO Mark Timney reached out to then-Novartis pharma chief Paul Hudson: Any interest in a partnership?

No, Hudson told him. Not now, at least.

Ten months later, Hudson had left to run Sanofi and Novartis CEO Vas Narasimhan was paying $9.7 billion for the one-drug biotech – the largest in the string of acquisitions Narasimhan has signed since his 2017 appointment.

The deal was the product of an activist investor and his controversial partner working through nearly a year of cat-and-mouse negotiations to secure a deal with Big Pharma’s most expansionist executive. It represented a huge bet in a cardiovascular field that already saw two major busts in recent years and brought massive returns for two of the industry’s most eye-raising names.

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Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

This is the second biotech buyout pact today, marking a brisk tempo of M&A deals in the lead-up to the big JP Morgan gathering in mid-January. It’s no surprise the acquisitions are both for cancer drugs, where Sanofi will try to make its mark while Merck beefs up a stellar oncology franchise. And bolt-ons are all the rage at the major pharma players, which you could also see in Novartis’ recent $9.7 billion MedCo buyout.

ArQule — which comes out on top after their original lead drug foundered in Phase III — highlighted early data on ‘531 at EHA from a group of 6 chronic lymphocytic leukemia patients who got the 65 mg dose. Four of them experienced a partial response — a big advance for a company that failed with earlier attempts.

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Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Amgen has signed up to be AbbVie’s neighbor in South San Francisco as it moves into a nine-story R&D facility in the booming biotech hub.

The arrangement gives Amgen 240,000 square feet of space on the Gateway of Pacific Campus, just a few minutes drive from its current digs at Oyster Point. The new hub will open in 2022 and house the big biotech’s Bay Area employees working on cardiometabolic, inflammation and oncology research.

Ab­b­Vie, Scripps ex­pand part­ner­ship, for­ti­fy fo­cus on can­cer drugs

Scripps and AbbVie go way back. Research conducted in the lab of Scripps scientist Richard Lerner led to the discovery of Humira. The antibody, approved by the FDA in 2002 and sold by AbbVie, went on to become the world’s bestselling treatment. In 2018, the drugmaker and the non-profit organization signed a pact focused on developing cancer treatments — and now, the scope of that partnership has broadened to encompass a range of diseases, including immunological and neurological conditions.

South Ko­rea jails 3 Sam­sung ex­ecs for de­stroy­ing ev­i­dence in Bi­o­Log­ics probe

Three Samsung executives in Korea are going to jail.

The convictions came in what prosecutors had billed as “biggest crime of evidence destruction in the history of South Korea”: a case of alleged corporate intrigue that was thrown open when investigators found what was hidden beneath the floor of a Samsung BioLogics plant. Eight employees in total were found guilty of evidence tampering and the three executives were each sentenced to up to two years in prison.