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.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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