Randy Schatz­man jumps to the helm of an­oth­er start-up; No­vo Nordisk vet lands top post at Macrophage Phar­ma

In biotech, long-term sur­vival in the ex­ec­u­tive ranks can de­pend a lot on the qual­i­ty of your con­nec­tions in the ven­ture/in­vest­ing side of the busi­ness.

Randy Schatz­man Bolt Bio­ther­a­peu­tics

So when Randy Schatz­man ex­it­ed Alder af­ter tak­ing the com­pa­ny from con­cep­tion to the thresh­old of a like­ly ap­proval for a new mi­graine ther­a­py, it was his re­la­tion­ship with long­time back­ers that led him to his new job as CEO of Bolt Bio­ther­a­peu­tics, an­nounced this week.

Con­nec­tions at No­vo and an­oth­er in­vestor asked him to check out the Red­wood City, CA start­up, which has been work­ing on what they call “im­mune-stim­u­lat­ing an­ti­body con­ju­gates” to turn cold tu­mors hot — a pop­u­lar theme in the on­col­o­gy field.

He was im­pressed with the tech­nol­o­gy and the team of about 35, which he ex­pects to see dou­ble in size in the next 18 to 24 months. But the big move will be the shift to the clin­ic in Q1 2020, which is right around the cor­ner now. Fund­ing as al­ways will be a key con­sid­er­a­tion for the start­up, but Schatz­man al­ready knows just how com­mit­ted the syn­di­cate is — which helps con­sid­er­ably.

“I think I got some in­sights, build­ing a com­pa­ny from scratch to the com­mer­cial en­vi­ron­ment,” Schatz­man tells me. So he’ll stay fo­cused on the fun­da­men­tals: tech and clin­i­cal de­vel­op­ment plans, re­cruit­ment, fi­nanc­ing and mak­ing sure he has a rock-sol­id board back­ing him.

Schatz­man’s ad­vice for oth­er CEOs: Hav­ing a “board that is row­ing in the same di­rec­tion,” he says. 

He’s grab­bing an oar to help set the tem­po. — John Car­roll

Michael Slater Syn­log­ic

→ A few months af­ter Syn­log­ic — a pi­o­neer in reengi­neer­ing non-path­o­gen­ic bac­te­ria in­to med­i­cines — inked a col­lab­o­ra­tion with Gink­go Bioworks, it’s ap­point­ed Richard Riese as CMO and Michael Slater as head of reg­u­la­to­ry af­fairs. Riese most re­cent­ly served as the vice pres­i­dent, clin­i­cal de­vel­op­ment at Al­ny­lam and was pre­vi­ous­ly at Alex­ion. Slater was the head of reg­u­la­to­ry af­fairs and, lat­er, de­vel­op­ment op­er­a­tions at Mer­ri­mack Phar­ma­ceu­ti­cals, where he helped lead the com­pa­ny to the 2015 US ap­proval of Onivyde for the treat­ment of metasta­t­ic pan­cre­at­ic can­cer. Slater has held var­i­ous stints, in­clud­ing at Mil­len­ni­um Phar­ma­ceu­ti­cals, Ani­ka Ther­a­peu­tics and Bio­gen. In ad­di­tion, the com­pa­ny an­nounced that CFO Todd She­gog will be hit­ting the ex­it to pur­sue oth­er op­por­tu­ni­ties. 

Richard Riese Syn­log­ic

→ Paris-based Step Phar­ma — an au­toim­mune-fo­cused biotech on the cusp of ush­er­ing its first oral nu­cleotide syn­the­sis in­hibitor tar­get­ing CTPS1 to the clin­ic — has wooed for­mer Zealand Phar­ma CSO An­drew Park­er as CEO, suc­ceed­ing Ge­of­froy de Rib­ains. Park­er an­nounced his res­ig­na­tion from Zealand in ear­ly Au­gust af­ter a three-year stint with the com­pa­ny. Dur­ing his time at Zealand, Park­er helped as­sem­ble a pre­clin­i­cal pipeline of ion chan­nel block­ers, GLP-1 as­sets and a com­ple­ment C3 in­hibitor. Pri­or to that, he was gen­er­al part­ner and sci­en­tif­ic di­rec­tor of life sci­ences in­vest­ment com­pa­ny Eclo­sion2 & Cie SCPC. Park­er’s pre­vi­ous stints in­clude roles at As­traZeneca, John­son & John­son and Op­sona Ther­a­peu­tics

An­drew Park­er

“The com­pa­ny has made sig­nif­i­cant progress in op­ti­miz­ing se­lec­tive CTPS1 in­hibitors and ex­plor­ing the role of CTPS1 in au­toim­mune dis­eases. My role will be to de­sign and im­ple­ment a plan to trans­late the phe­nom­e­nal sci­en­tif­ic progress made to date in­to a clin­i­cal pipeline,” not­ed Park­er.

No­vo Nordisk vet Søren Bre­gen­holt is tak­ing up his first CEO post at Macrophage Phar­ma in Eng­land to steer the start­up through ear­ly ef­forts of ap­ply­ing its Es­terase Mo­tif Tech­nol­o­gy. CRT Pi­o­neer Fund, Agla­ia On­col­o­gy Fund II, No­vo Hold­ings and M Ven­tures had pooled to­geth­er £9 mil­lion back in 2017 for the ESM plat­form, which gen­er­ates small mol­e­cule drugs that in­duce tran­scrip­tion­al re­pro­gram­ming of mono­cytes and macrophages. The lead pro­gram tar­gets p38 MAPK. While Bre­gen­holt brings fresh ex­pe­ri­ence in im­muno-on­col­o­gy from a brief CBO stint at IO Biotech, he is al­so talked with un­lock­ing ESM’s po­ten­tial in oth­er dis­eases.

Søren Bre­gen­holt Macrophage

→ Ready to stake a bold claim in the nascent field of RNA mod­i­fi­ca­tion, Ac­cent Ther­a­peu­tics has wooed sea­soned deal­mak­er Shak­ti Narayan to be­come its CEO. Narayan, who most re­cent­ly served as CBO of Tan­go Ther­a­peu­tics, was cred­it­ed for lead­ing the biotech’s “trans­for­ma­tion­al” col­lab­o­ra­tion with Gilead, which was worth up to $1.7 bil­lion. Hav­ing spe­cial­ized in on­col­o­gy busi­ness de­vel­op­ment from Genen­tech to J&J, he will now team up with Ac­cent pres­i­dent and CSO Robert Copeland in pluck­ing the most promis­ing in­hibito­ry small mol­e­cule drugs (block­ing RNA-mod­i­fy­ing en­zymes) in their dis­cov­ery pipeline.

→ Months af­ter Night­star’s $800 mil­lion sale to Bio­gen, Ak­ou­os has scooped Gre­go­ry Robin­son as CSO, lever­ag­ing his ex­per­tise in both gene ther­a­py and rare dis­ease trans­la­tion­al re­search. While Robin­son had fo­cused on reti­nal dis­or­ders at Night­star (and CNS dis­eases be­fore that at Ag­ilis Bio­ther­a­peu­tic), he will now turn his at­ten­tion to sen­sorineur­al hear­ing loss. Al­so join­ing the C-suite is Michael McKen­na, a co-founder of Ak­ou­os, who’s ex­pand­ing his role to full-time CMO. A neu­ro­to­log­ic sur­geon at Mass­a­chu­setts Eye and Ear, McKen­na con­tributed years of re­search on in­ner ear drug de­liv­ery that was key to Ak­ou­os’ cre­ation.

Si­mon Rus­sell Ome­icos

→ Ger­man car­dio­vas­cu­lar and oph­thal­mol­o­gy biotech Ome­icos has named Si­mon Rus­sell chief busi­ness of­fi­cer as it ap­proach­es clin­i­cal proof-of-con­cept and dose con­fir­ma­tion for its atri­al fib­ril­la­tion pro­gram, OMT-28. Rus­sell spent the ear­li­er years of his ca­reer climb­ing the ranks at As­traZeneca and No­var­tis, end­ing as glob­al com­mer­cial leader for the Swiss phar­ma gi­ant’s ill-fat­ed canakinum­ab. He has since made the trek to biotech and is now an en­tre­pre­neur in res­i­dence at the Basel Area ac­cel­er­a­tor Base­Launch, co-found­ing his own com­pa­ny just weeks be­fore join­ing Ome­icos in Berlin. “Ome­icos has a very promis­ing ther­a­peu­tic plat­form tar­get­ing one of na­ture’s most im­por­tant cell-pro­tec­tive path­ways,” Rus­sell said of its syn­thet­ic epoxy eicosanoid analogs.

James Mack­ay has wooed a for­mer col­league from Ardea Bio­sciences to help ex­pand the clin­i­cal port­fo­lio of his new start­up, Aris­tea. Ni­har Bhak­ta jumps to the CMO po­si­tion from Gos­samer Bio, where he was a project team leader. At San Diego-based Aris­tea he will keep a laser fo­cus on in­flam­ma­to­ry dis­eases, start­ing with a lead drug from As­traZeneca cur­rent­ly in Phase II. His pri­or ex­pe­ri­ence spans Roche and Bris­tol-My­ers Squibb.

→ An­ti­calin pro­tein-based drugs fo­cused Pieris Phar­ma­ceu­ti­cals had some change-ups to its lead­er­ship team with the ad­di­tion of Hit­to Kauf­mann as SVP and CSO and the an­nounce­ment of the de­par­ture of Al­lan Reine, SVP and CFO. In this new role, Kauf­mann will be re­spon­si­ble for the com­pa­ny’s drug dis­cov­ery, pro­tein en­gi­neer­ing and bio­man­u­fac­tur­ing ac­tiv­i­ties, while over­see­ing al­liance man­age­ment and serv­ing as site head for its Ger­man R&D fa­cil­i­ty. Kauf­mann held a stint at Sanofi be­fore hop­ping over to the Boston, Mass­a­chu­setts-based com­pa­ny. His pri­or ex­pe­ri­ence spans roles at Boehringer In­gel­heim and at the Wal­ter and Eliza Hall In­sti­tute in Mel­bourne. Pieris in­tends to ini­ti­ate a search for a new CFO as Reine will be pur­su­ing an­oth­er busi­ness op­por­tu­ni­ty. Up­on Reine’s res­ig­na­tion, Tom Bu­res, the com­pa­ny’s vice pres­i­dent of fi­nance, will serve as trea­sur­er and prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer.

Ab­Cellera has ex­pand­ed its ex­ec­u­tive team with the ad­di­tions of An­drew Booth as CFO and Tryn Sti­mart as gen­er­al coun­sel. Booth makes the jump from the com­pa­ny’s board of di­rec­tors and brings ex­pe­ri­ence to the role from his pre­vi­ous stint at STEM­CELL Tech­nolo­gies as vice pres­i­dent of in­stru­men­ta­tion, CFO and CMO. Sti­mart draws from ex­pe­ri­ence from his roles at Gib­bons PC, Finnegan, Coo­ley and Womble Bond Dick­in­son, where he has rep­re­sent­ed clients from Gilead, Take­da, Ge­vo, Sunovion and Ap­tal­is

Gil McVean Ge­nomics

→ Da­ta sci­ence com­pa­ny Ge­nomics — which was found­ed in 2014 by four pro­fes­sors out of the Uni­ver­si­ty of Ox­ford — has brought on one of its founders, pro­fes­sor of sta­tis­ti­cal ge­net­ics Gil McVean, as chief in­for­ma­tion of­fi­cer of the com­pa­ny. McVean is a found­ing di­rec­tor of the Big Da­ta In­sti­tute (BDI) and brings ex­pe­ri­ence from his time as head of bioin­for­mat­ics and sta­tis­ti­cal ge­net­ics at Ox­ford’s Well­come Cen­tre for Hu­man Ge­net­ics to the ta­ble. 

→ Af­ter bank­ing €12M to de­vel­op a drug for mul­ti­ple sys­tem at­ro­phy (MSA) — tar­get­ing tox­ic pro­tein ag­gre­ga­tion — in June, Ger­man biotech MODAG has ap­point­ed Jo­hannes Levin as CMO. Levin brings ex­pe­ri­ence in MSA along with a back­ground in pro­tein ag­gre­ga­tion. He re­cent­ly led a clin­i­cal MSA study with pro­fes­sor Armin Giese, CSO of MODAG — the find­ings were pub­lished in The Lancet Neu­rol­o­gy. In his new role, Levin will be re­spon­si­ble for ad­vanc­ing the com­pa­ny’s lead can­di­date, an­le138b, in­to the clin­ic.

East­Gate Biotech has en­list­ed Bill Aba­jian to over­see the li­cens­ing and mar­ket­ing of their liq­uid in­sulin mouth rinse so­lu­tion for type 2 di­a­betes as COO. Aba­jian, who’s pre­vi­ous­ly helped Generex com­mer­cial­ize an oral in­sulin spray in de­vel­op­ing coun­tries, will con­tin­ue to fo­cus on that part of the world. “We are on the cusp of ma­jor li­cens­ing ini­tia­tives and the com­pa­ny needs to be stream­lined and fo­cused to max­i­mize share­hold­er val­ue,” he said, adding about East­Gate’s pink sheet stock: “The mar­ket re­ac­tion to our fun­da­men­tal sto­ry has been ex­treme­ly dis­ap­point­ing as share­hold­ers choose to fo­cus on the struc­tur­al risks of di­lu­tion in­stead of the po­ten­tial of the tech­nol­o­gy. We are about to change the par­a­digm on how a small biotech brings drugs to mar­ket.”

Ter­ry-Ann Bur­rell has hopped over to Beam Ther­a­peu­tics — a com­pa­ny found­ed by CRISPR trail­blaz­ers David Liu, Feng Zhang and J Kei­th Joung — af­ter a stint as man­ag­ing di­rec­tor at JP Mor­gan. Dur­ing her time at JP Mor­gan, Bur­rell helped ex­e­cute over $10 bil­lion in eq­ui­ty and eq­ui­ty-linked fi­nanc­ings and more than $50 bil­lion in M&A trans­ac­tions. Pri­or to that, Bur­rell worked in eq­ui­ty re­search at Cit­i­group, cov­er­ing spe­cial­ty phar­ma­ceu­ti­cals and gener­ics. 

Juha Lau­ren Kally­ope

Jernej Godec has joined VC firm At­las Ven­ture. Pri­or to hop­ping on board to At­las, Godec was the se­nior as­so­ciate at Ap­ple Tree Part­ners, in­volved in build­ing El­star Ther­a­peu­tics, an ATP-found­ed com­pa­ny de­vel­op­ing next-gen­er­a­tion of mul­ti­func­tion­al im­munomod­u­la­to­ry an­ti­bod­ies for can­cer, where he al­so served as a board ob­serv­er.

Kally­ope — fo­cused on iden­ti­fy­ing and pur­su­ing ther­a­peu­tic op­por­tu­ni­ties in­volv­ing the gut-brain ax­is — has wel­comed Juha Lau­ren aboard as CBO. Lau­ren joins the com­pa­ny af­ter a stint as se­nior di­rec­tor, busi­ness de­vel­op­ment and R&D strat­e­gy at Re­gen­eron, fo­cus­ing on deals with Al­ny­lam, blue­bird bio and In­tel­lia Ther­a­peu­tics. Lau­ren be­gan as a neu­ro­sci­en­tist, pub­lish­ing stud­ies in jour­nals in­clud­ing Na­ture and Neu­ron be­fore launch­ing his busi­ness ca­reer as a man­age­ment con­sul­tant with Ac­cen­ture.  

Tracey Franklin has been cho­sen as the chief hu­man re­sources of­fi­cer at Mod­er­na — a com­pa­ny de­vel­op­ing mR­NA ther­a­peu­tics and vac­cines. Franklin hops over af­ter a 15-year stint at Mer­ck, serv­ing as vice pres­i­dent, HR chief tal­ent and strat­e­gy of­fi­cer.

Schol­ar Rock — fo­cused on dis­eases in which pro­tein growth fac­tors play a fun­da­men­tal role — has brought George Nomikos in­to their com­pa­ny as vice pres­i­dent, head of med­ical re­search, mus­cle fran­chise. In this new role, Nomikos will be the med­ical lead for the SRK-015 pro­gram in Spinal Mus­cu­lar At­ro­phy (SMA) as well as fu­ture clin­i­cal pro­grams in the mus­cle fran­chise. Pri­or to jump­ing on board, Nomikos served as the se­nior med­ical di­rec­tor, glob­al med­ical lead for the BI­IB054 clin­i­cal pro­gram for Parkin­son’s at Bio­gen. Nomikos’ pre­vi­ous clin­i­cal work con­tributed to the ap­proval of an­ti­de­pres­sant vor­tiox­e­tine and the ac­cep­tance of the drug la­bel up­dates in the US and EU. His oth­er stints in­clude roles at Sage Ther­a­peu­tics, Take­da, Astel­las Phar­ma, Am­gen and Eli Lil­ly

Kevin Duffy has hopped from Mer­ck and on­board to North­west Bio­ther­a­peu­tics — de­vel­op­ing DC­Vax im­mune ther­a­pies for sol­id tu­mor can­cers, such as Glioblas­toma mul­ti­forme (GBM) — as vice pres­i­dent, med­ical af­fairs and ex­ter­nal col­lab­o­ra­tions. At Mer­ck, Duffy served as re­search sci­en­tif­ic di­rec­tor for the past five years in the Keytru­da pro­gram. Pri­or to his work at Mer­ck, Duffy served in var­i­ous roles, in­clud­ing as re­gion­al sci­en­tif­ic man­ag­er for on­col­o­gy and car­dio­vas­cu­lar ther­a­peu­tics at As­traZeneca.

→ While its lead prod­uct can­di­date, losmapi­mod, is cur­rent­ly in a Phase IIb tri­al to in­ves­ti­gate its po­ten­tial use in fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy (FSHD), Ful­crum Ther­a­peu­tics has ush­ered in Pamela Strode as their se­nior vice pres­i­dent, reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance. Strode jumps to the com­pa­ny af­ter a stint in the same role at Epizyme, where she di­rect­ed mul­ti­ple US fast track and US/EU or­phan drug des­ig­na­tions. Strode for­mer­ly served at Bris­tol-My­ers Squibb, Boehringer In­gel­heim and Cerulean Phar­ma.

→ While col­lab­o­rat­ing with Jazz Phar­ma­ceu­ti­cals in de­vel­op­ing PF743, a re­com­bi­nant crisan­tas­pase, and PF745, a re­com­bi­nant crisan­tas­pase with half-life ex­ten­sion tech­nol­o­gy, Pfenex has an­nounced the ap­point­ment of Steve Kay to its sci­en­tif­ic ad­vi­so­ry board. Kay cur­rent­ly serves as the Di­rec­tor of the Uni­ver­si­ty of South­ern Cal­i­for­nia (USC) MESH Acad­e­my, the Di­rec­tor of the USC Michel­son Cen­ter for Con­ver­gent Bio­science, and is a Provost Pro­fes­sor of Neu­rol­o­gy, Bio­med­ical En­gi­neer­ing and Bi­o­log­i­cal Sci­ences at the Keck School of Med­i­cine of USC.

Eva-Lot­ta Al­lan Ale­ta

Ale­ta Bio­ther­a­peu­tics has made some new ad­di­tions to its board of di­rec­tors, with the ap­point­ments of Mark Leucht­en­berg­er as ex­ec­u­tive chair­man and Eva-Lot­ta Al­lan as non-ex­ec­u­tive di­rec­tor. Leucht­en­berg­er present­ly serves as the in­ter­im CEO at Brook­lyn Im­munoTher­a­peu­tics and Al­lan is the cur­rent non-ex­ec­u­tive di­rec­tor for Tar­go­v­ax and Crescen­do Bi­o­log­ics, as well as chair­man of C4X Dis­cov­ery.

Lyra Ther­a­peu­tics — a biotech fo­cused on de­vel­op­ing med­i­cines to tar­get ear, nose and throat (ENT) dis­eases — has wel­comed Gen­zyme vet, Ann Mer­ri­field, to its board of di­rec­tors. Pre­vi­ous­ly, Mer­ri­field served as the CEO of Patho­Genetix.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign

Most CMOs don’t start out as art students. But after getting her bachelor’s in art history from Princeton University, Jennifer Wheler decided to go after an MD from Cornell, kicking off a decades-long career in biopharma. Her next move? Leading the team at Codiak BioSciences to deliver therapeutics using a form of cellular postal service called exosomes.

“I was captivated by the science and the potential for exosomes to have transformational impact in cancer and other disease areas,” the incoming CMO told Endpoints News via email. “Codiak has a potent combination of great science and wonderfully experienced and kind people — it doesn’t get much better.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).