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.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.