David Chang steps up to CEO spot at WuX­i's cell and gene ther­a­py CD­MO; David Meline is the new CFO at Mod­er­na

David Meline

David Meline didn’t stay re­tired for long. As re­port­ed yes­ter­day, the for­mer Am­gen ex­ec will re­place Lorence Kim as CFO of Mod­er­na as the Big Phar­ma has sprint­ed to the front of the Covid-19 vac­cine pack, get­ting se­lect­ed as one of the fi­nal­ists for Op­er­a­tion Warp Speed. Meline, who gets start­ed on Mon­day, an­nounced his re­tire­ment as Am­gen’s CFO in Oc­to­ber 2019, re­main­ing in the role un­til the end of the year. But he’s back in the sad­dle at a cru­cial time as Mod­er­na pre­pares for Phase III stud­ies of their SARS-CoV-2 vac­cine. Meline pre­vi­ous­ly held lead­er­ship po­si­tions at 3M and Gen­er­al Mo­tors.

WuXi AppTec has called up­on David Chang to be CEO of the WuXi Ad­vanced Ther­a­pies busi­ness unit, the com­pa­ny’s cell and gene ther­a­py CD­MO. Chang has held po­si­tions at sev­er­al ma­jor play­ers: At Cel­gene, he was cor­po­rate VP and head of cell ther­a­py glob­al man­u­fac­tur­ing; at Roche, he was the glob­al head of en­gi­neer­ing and strat­e­gy; and at Genen­tech, he was se­nior di­rec­tor of glob­al man­u­fac­tur­ing, sci­ence & tech­nol­o­gy, as well as the di­rec­tor of process de­vel­op­ment.

→ In 2017 Steven Da­mon joined the board of di­rec­tors at Mi­cron Bio­med­ical. Now, he’s sit­ting in the CEO chair at the At­lanta-based com­pa­ny, which de­vel­ops nee­dle patch tech­nol­o­gy for self-dos­ing of vac­cines and ther­a­peu­tics. Be­fore Da­mon as­sumed his new role, he was VP, busi­ness and com­mer­cial de­vel­op­ment at Fe­masys and al­so has di­rec­tor­ships at Tem­ple Ther­a­peu­tics and Nu­triband, which he found­ed as 4P Ther­a­peu­tics and sold two years ago. Pri­or to 4P Ther­a­peu­tics, Da­mon was the SVP of busi­ness and cor­po­rate de­vel­op­ment at Al­tea Ther­a­peu­tics.

Brent Ra­gans

Fer­ring Phar­ma­ceu­ti­cals CCO Brent Ra­gans has been pro­mot­ed to pres­i­dent. Ra­gans start­ed out at Par­sip­pa­ny, NJ-based Fer­ring as their VP of com­mer­cial op­er­a­tions in 2012. He al­so spent a dozen years at Sanofi in sev­er­al ca­pac­i­ties, even­tu­al­ly be­com­ing the phar­ma gi­ant’s SVP, con­sumer health­care strat­e­gy and cor­po­rate de­vel­op­ment for North Amer­i­ca.

→ Oslo biotech Ex­act Ther­a­peu­tics, a GE Health­care spin­out, has cho­sen Rafiq Hasan as CEO. In pre­vi­ous years, Hasan steered Eylea from its launch as SVP and glob­al head of oph­thal­mol­o­gy at Bay­er, and he was al­so glob­al head of oph­thal­mol­o­gy at No­var­tis.

Wei Li

Cy­tovia, an NK start­up that’s part­nered with the New York Stem Cell Foun­da­tion, has tapped Wei Li as CSO. Most re­cent­ly, Li served as chief de­vel­op­ment of­fi­cer at South Ko­re­an biotech OliX Phar­ma­ceu­ti­cals.  In ad­di­tion, she was EVP, prod­uct de­vel­op­ment at Boston Bio­med­ical and held a post at Ar­Qule.

Ali­gos Ther­a­peu­tics — fo­cused on the de­vel­op­ment of ther­a­pies in­clud­ing chron­ic he­pati­tis B, Covid-19 and NASH — has wooed Les­ley Ann Cal­houn as CFO. Cal­houn jumps aboard from Glob­al Blood Ther­a­peu­tics, where she served as SVP of fi­nance & ad­min­is­tra­tion and chief ac­count­ing of­fi­cer. Pri­or to that, she held posts at Hy­pe­r­i­on Ther­a­peu­tics and Ther­a­vance.

Af­ter snap­ping up X-Chem, GHO Cap­i­tal has in­stilled Matt Clark as the CEO of X-Chem. Pri­or to his new role, Clark was co-founder and SVP of chem­istry for X-Chem. He suc­ceeds Rick Wag­n­er. Pri­or to join­ing the com­pa­ny, Clark served as di­rec­tor of dis­cov­ery chem­istry at GSK.

Ra­jesh Mis­try

→ Us­ing CAR-T and im­munomod­u­la­tion ther­a­pies to treat sol­id tu­mors, Den­ver-based TriSalus Life Sci­ences has brought in Ra­jesh Mis­try as CFO. Mis­try was the se­nior di­rec­tor, head of cor­po­rate de­vel­op­ment & strat­e­gy (M&A) at Op­tion Care Health. Pri­or to that, Mis­try held the role of di­rec­tor of strate­gic fi­nance & in­vestor re­la­tions at Melin­ta Ther­a­peu­tics.

Jin­qiu Tang has tak­en over as CFO of ear­ly can­cer screen­ing and de­tec­tion-fo­cused biotech An­Pac Bio-Med­ical Sci­ence, re­plac­ing Yu Zhang, who re­signed for per­son­al rea­sons ef­fec­tive May 31. Tang had been the cor­po­rate con­troller since Oc­to­ber for An­Pac, which hit the Nas­daq ear­li­er this year, rais­ing $16 mil­lion for its IPO. Be­fore join­ing An­Pac, he was a glob­al in­ter­nal au­di­tor at Natuzzi S.p.A.

David Gilham

→ Along with Peg­gy Sotiropoulou’s pro­mo­tion to head of R&D last week, Bel­gian biotech Celyad al­so moved David Gilham up to the po­si­tion of CSO. Gilham was named VP of re­search & de­vel­op­ment for the off-the-shelf CAR-T play­er in 2016 and pre­vi­ous­ly served on the com­pa­ny’s im­muno-on­col­o­gy sci­en­tif­ic ad­vi­so­ry board.

→ Sanofi Ven­tures — which re­cent­ly helped lead $55 mil­lion in fund­ing for NodThera — has some new faces in its man­age­ment team. Ja­son Hafler has moved to the po­si­tion of man­ag­ing di­rec­tor, while Cris De Lu­ca and Jim Tren­kle join as glob­al head of dig­i­tal in­vest­ments and head of in­vest­ments re­spec­tive­ly. Hafler has been with the com­pa­ny since 2014 and joined from RaNA Ther­a­peu­tics. De Lu­ca pre­vi­ous­ly was a found­ing team mem­ber of J&J In­no­va­tion and Glob­al Head of Dig­i­tal In­no­va­tion, while Tren­kle pre­vi­ous­ly did a stint at Gilead Sci­ences.

→ Acute kid­ney in­jury-fo­cused An­gion Bio­med­ica has re­cruit­ed Jen­nifer Rhodes as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. Rhodes joins from Adamas Phar­ma­ceu­ti­cals where she served in the same roles in ad­di­tion to chief com­pli­ance of­fi­cer and CBO. Pri­or to that, she held posts at Pfiz­er and Weil, Got­shal, & Manges. In ad­di­tion, the com­pa­ny wel­comed Jazz Phar­ma­ceu­ti­cals ex­ec Karen Wil­son, Gilbert Omenn, a for­mer di­rec­tor at Am­gen; and Allen Nis­senson, a pro­fes­sor of med­i­cine at UCLA, to its board of di­rec­tors.

Pao­lo Vici­ni

→ Sir­tex Med­ical — a man­u­fac­tur­er of tar­get­ed liv­er can­cer ther­a­pies — has ap­point­ed Mark Tur­co as glob­al CMO and EVP of re­search & de­vel­op­ment. Pri­or to his new role, Tur­co was chief in­no­va­tion and cor­po­rate out­reach of­fi­cer for the Uni­ver­si­ty of Penn­syl­va­nia’s Penn Cen­ter for In­no­va­tion (PCI). In ad­di­tion, he served in roles at Medtron­ic and Co­vi­di­en.

In a new­ly-cre­at­ed role, Bel­gian GPCR play­er Con­fo Ther­a­peu­tics has snagged Pao­lo Vici­ni as chief de­vel­op­ment of­fi­cer. Vici­ni has most re­cent­ly been VP, de­vel­op­ment sci­ences at Kymab, which just got a leg up in its on­go­ing court bat­tles with Re­gen­eron. Be­fore Kymab, he was Med­Im­mune’s se­nior di­rec­tor of trans­la­tion­al sci­ences, head­ing their clin­i­cal phar­ma­col­o­gy, phar­ma­co­met­rics and DMPK de­part­ment.

Ken­ton Stew­art

Vivek Ra­maswamy’s sick­le cell dis­ease and be­ta tha­lassemia-fo­cused Aru­vant has a new chief tech­nol­o­gy of­fi­cer in V. “Palani” Pala­niap­pan. He comes to Aru­vant from Sarep­ta, where he was SVP, head of glob­al tech­ni­cal op­er­a­tions and head of the bio­phar­ma’s An­dover and Burling­ton sites. Be­fore his time at Sarep­ta, he led teams at Take­da that cen­tered on CMC de­vel­op­ment and new modal­i­ty de­vel­op­ment.

→ An­oth­er Ra­maswamy com­pa­ny, Urovant Sci­ences, has new per­son­nel of its own. Walt John­ston has been se­lect­ed as SVP of com­mer­cial, while Ken­ton Stew­art is now the urol­o­gy-fo­cused bio­phar­ma’s SVP of mar­ket ac­cess. John­ston comes to Urovant af­ter 12 years at Astel­las, most re­cent­ly as SVP, urol­o­gy and hos­pi­tal busi­ness unit. The sea­soned vet was al­so at Pfiz­er for 18 years in a num­ber of roles. Like John­ston, Stew­art was al­so at Astel­las for 12 years, even­tu­al­ly be­com­ing SVP of health sys­tems. Be­fore join­ing Urovant, he held the same po­si­tion at Alk­er­mes.

Walt John­ston

Nim­bus Ther­a­peu­tics, which ex­pand­ed its col­lab­o­ra­tion last sum­mer with Cel­gene to in­clude Nim­bus’ HPK1 in­hibitor pro­gram, has pro­mot­ed Alan Col­lis to SVP, pre­clin­i­cal de­vel­op­ment. Col­lis start­ed at Nim­bus in 2018, lead­ing their Tyk2 pro­gram and be­com­ing VP, pre­clin­i­cal de­vel­op­ment ear­ly last year. Be­fore jump­ing on board at Nim­bus 2 years ago, Col­lis was ex­ec­u­tive di­rec­tor of DMPK at For­ma Ther­a­peu­tics. He’s al­so held po­si­tions at Pfiz­er and No­var­tis, and was se­nior di­rec­tor of US chem­istry at Aven­tis.

→ While gun­ning to­wards a vagi­nal yeast in­fec­tion drug ap­proval, an­ti­fun­gal drug de­vel­op­er Scynex­is has en­list­ed Jim Maf­fez­zoli as VP of mar­ket­ing and sales. In his new role, Maf­fez­zoli will lead mar­ket­ing and com­mer­cial­iza­tion of the com­pa­ny’s clin­i­cal as­set, ibrex­a­fungerp. Maf­fez­zoli brings ex­pe­ri­ence from his times at Viveve Med­ical, Al­ler­gan and Pfiz­er.

Mert Sahin

Glob­al de­vel­op­er and man­u­fac­tur­er of lab­o­ra­to­ry tools H.E.L Group has wel­comed Mert Sahin as gen­er­al man­ag­er and SVP of North Amer­i­can op­er­a­tions. Sahin hails from GE Health­care, where he most re­cent­ly served as chief mar­ket­ing of­fi­cer for GE’s med­ical imag­ing busi­ness.

New York AAV biotech Pre­vail Ther­a­peu­tics has brought on Ki­ra Schwartz as gen­er­al coun­sel. Schwartz was pre­vi­ous­ly SVP, as­so­ciate gen­er­al coun­sel and as­sis­tant sec­re­tary at Al­ler­gan, lead­ing Ac­tavis’ ac­qui­si­tion of Al­ler­gan in 2015.

Life sci­ence ex­ec Dami­an Mar­ron is now the chair­man of Bris­tol, UK-based vac­cine start­up Imophoron as the com­pa­ny works on pre­clin­i­cal Covid-19 can­di­dates. The cur­rent chair­man of Tar­go­v­ax, Mar­ron is al­so a non-ex­ec­u­tive di­rec­tor at Bone Ther­a­peu­tics and Resolys Bio.

Ver­tex has made a new ad­di­tion to its board of di­rec­tors with the ap­point­ment of for­mer Am­gen ex­ec Di­ana McKen­zie as an in­de­pen­dent di­rec­tor. Dur­ing her time at Am­gen, McKen­zie served as SVP and chief in­for­ma­tion of­fi­cer.

Vick­ie Capps

Sil­ver­back Ther­a­peu­tics, where Lau­ra Shawver just signed on as CEO in April, has turned to Vick­ie Capps to be a mem­ber of their board of di­rec­tors and au­dit com­mit­tee chair. The for­mer CFO of DJO Glob­al from 2002-13, Capps was pre­vi­ous­ly a board mem­ber at Syn­thorx, where Shawver used to be CEO un­til Sanofi bought it for $2.5 bil­lion.

Biond Bi­o­log­ics has snagged for­mer Cel­gene CMO Jerome Zeld­is to its board of di­rec­tors. In ad­di­tion to his 20-year stint at Cel­gene, Zeld­is al­so served as CMO and pres­i­dent of clin­i­cal re­search, med­ical af­fairs, drug safe­ty, qual­i­ty and reg­u­la­to­ry at Sor­ren­to Ther­a­peu­tics.

Ann Rhoads

Ann Rhoads, most re­cent­ly the CFO at Forty Sev­en, has been ap­point­ed to the board of di­rec­tors at iTeos Ther­a­peu­tics, which grabbed $125 mil­lion in Se­ries B fi­nanc­ing in April. Rhoads was al­so the EVP and CFO at Zo­genix from 2010-17.

With their eyes set on a $100 mil­lion IPO, Vax­cyte — a vac­cine play­er that just changed its name — has ap­point­ed Hal­ley Gilbert to the com­pa­ny’s board of di­rec­tors. Gilbert’s ap­point­ment comes a lit­tle over a month af­ter she hopped on­to the board of di­rec­tors at Arc­turis Ther­a­peu­tics. Most re­cent­ly, Gilbert was SVP for cor­po­rate de­vel­op­ment and chief ad­min­is­tra­tive of­fi­cer at Iron­wood Phar­ma­ceu­ti­cals.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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).