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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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