Im­mune Reg­u­la­tion makes Pe­ter Green­leaf chair­man and as­sem­bles a quin­tet of new ex­ecs; Bob Cough­lin moves on from Mass­Bio to JLL

Pe­ter Green­leaf

→ In Sep­tem­ber, Im­mune Reg­u­la­tion raked in $53.4 mil­lion in a Se­ries B for two pro­grams in rheuma­toid arthri­tis and asth­ma. This week, the British biotech has named Au­rinia CEO Pe­ter Green­leaf chair­man of the board while an­nounc­ing five ap­pointees that have joined CEO Jonathan Rig­by’s crew. Green­leaf took the reins at Au­rinia — which just yes­ter­day struck up an agree­ment with Ot­su­ka to com­mer­cial­ize vo­closporin in Japan and Eu­rope — in April 2019. He was al­so the CEO of Cere­cor and Su­cam­po Phar­ma­ceu­ti­cals.

Im­mune Reg­u­la­tion’s new CBO, Woody Bryan, was pre­vi­ous­ly the SVP of busi­ness de­vel­op­ment at Uro­Gen and he was with Green­leaf in the same BD ca­pac­i­ty at Su­cam­po when Mallinck­rodt bought it out in late 2017 for $1.2 bil­lion. New­ly-mint­ed COO Per­ry Calias was Cere­cor’s CSO and head of R&D, and he was al­so with Su­cam­po/Mallinck­rodt serv­ing as VP of glob­al CMC and prod­uct de­vel­op­ment. And CMO Jeff My­ers hails from Por­to­la Phar­ma­ceu­ti­cals, where he was SVP of glob­al med­ical af­fairs and in­ter­im CMO.

Round­ing out the band of new ex­ecs, Nan­cy Vinh (VP, clin­i­cal op­er­a­tions) is an­oth­er Por­to­la alum who led their clin­i­cal op­er­a­tions, while pre­vi­ous stops for Mary­lyn Rig­by (VP of mar­ket­ing and in­vestor re­la­tions) in­clude Unit­ed Ther­a­peu­tics and SteadyMed Ther­a­peu­tics.

Robert Cough­lin

Robert Cough­lin has quick­ly found a new land­ing spot af­ter leav­ing Mass­Bio as their CEO: He’s now man­ag­ing di­rec­tor for JLL’s life sci­ence in­dus­try. It’s their sec­ond ma­jor hire in the life sci­ences prac­tice in three months as Travis Mc­Cready took on the role of JLL’s ex­ec­u­tive di­rec­tor and na­tion­al prac­tice leader in Sep­tem­ber.

Cough­lin spent 13 years at Mass­Bio in a pe­ri­od of sub­stan­tial growth. His in­ter­im suc­ces­sor is Kendalle Burlin O’Con­nell, who is Mass­Bio’s COO.

→ There’s a new sher­iff in town at Liq­uidia just weeks af­ter the FDA gave them a lump of coal in the form of a CRL for their lead pul­monary ar­te­r­i­al hy­per­ten­sion drug LIQ861. Dami­an de­Goa takes over as CEO fol­low­ing the re­tire­ment of Neal Fowler af­ter 2 years as CEO of RareGen, which Liq­uidia snapped up this year. Dur­ing his tenure, RareGen col­lab­o­rat­ed with San­doz in com­mer­cial­iza­tion ef­forts for tre­pros­tinil, a Re­mod­ulin gener­ic for pul­monary ar­te­r­i­al hy­per­ten­sion (PAH).

Louise Rodi­no-Kla­pac

Sarep­ta is do­ing some se­ri­ous lead­er­ship re­tool­ing while their saga con­tin­ues with the FDA over the biotech’s Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py. All the moves come from with­in: Ian Es­tepan slides in­to the CFO post af­ter serv­ing as SVP, chief of staff and cor­po­rate af­fairs; for­mer SVP of gene ther­a­py Louise Rodi­no-Kla­pac is the new CSO; Dal­lan Mur­phy rips off the in­ter­im tag and is now the per­ma­nent chief com­mer­cial of­fi­cer; and Ryan Brown, who joined Sarep­ta 2 years ago, re­places the re­tir­ing Ty How­ton as in­ter­im gen­er­al coun­sel. End­points’ Ja­son Mast has more on the ap­point­ments from ear­li­er this week.

→ Af­ter say­ing good­bye to Al­ny­lam this sum­mer, Bar­ry Greene has tak­en on a new chal­lenge as CEO of Sage Ther­a­peu­tics. And what a chal­lenge it will be: Sage put 340 em­ploy­ees on the chop­ping block in April, which amount­ed to more than half of the biotech’s work­force, with the deep cuts com­ing short­ly af­ter a Phase III fail for their ex­per­i­men­tal de­pres­sion drug Sage-217. Greene, who logged 17 years at John Maraganore-led Al­ny­lam, re­places Jeff Jonas, who makes the tran­si­tion to his new role of chief in­no­va­tion of­fi­cer. Greene had been a mem­ber of Sage’s board of di­rec­tors since Oc­to­ber.

Michael Var­ney

Michael Var­ney is tack­ing on a new role at Jonathan Lim-led Eras­ca by join­ing the com­pa­ny’s board of di­rec­tors. Var­ney stepped in­to the com­pa­ny in Au­gust, open­ing up a new chap­ter in his ca­reer af­ter step­ping down from a high-pro­file job as head of re­search and ear­ly de­vel­op­ment at Roche’s pres­ti­gious gRED or­ga­ni­za­tion in South San Fran­cis­co. Var­ney cur­rent­ly serves as Eras­ca’s chair­man of R&D and is al­so a part of their sci­en­tif­ic ad­vi­so­ry board. In ad­di­tion, Var­ney is a life sci­ences se­nior ad­vi­sor at Fra­zier Health­care Part­ners.

Abid Ansari

Abid Ansari has de­cid­ed to step down as CFO of Durham, NC-based Pre­ci­sion Bio­Sciences to pur­sue an­oth­er op­por­tu­ni­ty. Ansari will stick around un­til the end of the year dur­ing the tran­si­tion while Alex Kel­ly, who was just in this space a cou­ple months back when he took the chief cor­po­rate af­fairs of­fi­cer job, as­sumes the in­ter­im CFO gig in Ansari’s stead. Ansari had been with Matt Kane’s crew at Pre­ci­sion Bio­Sciences for the last 5 years. The news comes just weeks af­ter Pre­ci­sion part­nered with Eli Lil­ly on a genome edit­ing deal ap­proach­ing $2.7 bil­lion.

Toss­ing their lead pro­gram for an­ti-ag­ing in the waste­bas­ket and fol­low­ing that up with job cuts and re­struc­tur­ing, Uni­ty Biotech­nol­o­gy pres­i­dent Ned David is step­ping down Dec 31, while ear­ly in­vestor Bob Nelsen and David Lacey have ex­it­ed Uni­ty’s board of di­rec­tors. Con­cur­rent with these moves, they’re wav­ing in a new board mem­ber with Gilmore O’Neill, a Bio­gen vet who is Sarep­ta’s CMO and EVP of R&D. Our Max Gel­man has more de­tails.

Jean-Marc Bellemin

→ The folks at Io­vance have se­lect­ed Jean-Marc Bellemin as CFO. Be­fore mak­ing the switch to Io­vance — in a hold­ing pat­tern with a de­lay in their BLA fil­ing for li­fileu­cel, the Cal­i­for­nia biotech’s tu­mor-in­fil­trat­ing lym­pho­cyte (TIL) ther­a­py — Bellemin was CFO of Grit­stone On­col­o­gy for near­ly 3 years. Bellemin al­so spent more than 15 years in a num­ber of ca­pac­i­ties at Acte­lion, round­ing out his time there as SVP and CFO, head of fi­nance and mar­ket ac­cess un­til J&J grabbed hold of the com­pa­ny in 2017.

David En­loe has been named pres­i­dent and CEO of Malvern, PA-based CD­MO Re­cro, suc­ceed­ing Ger­ri Hen­wood. En­loe pre­vi­ous­ly helmed Aji­nomo­to Bio-Phar­ma Ser­vices, a CD­MO out of San Diego. Be­fore Aji Bio-Phar­ma, he led the vi­ral ther­a­peu­tics busi­ness unit at Lon­za.

Andy Kidd

Aptinyx may have a new lease on life with their pos­i­tive Phase II re­sults in post-trau­mat­ic stress dis­or­der from Oc­to­ber af­ter their di­a­bet­ic pe­riph­er­al neu­ropa­thy im­plo­sion near­ly two years ago. Now Andy Kidd has added pres­i­dent to his cur­rent COO ti­tle. Kidd start­ed out as Aptinyx’s chief com­mer­cial of­fi­cer in 2017 be­fore mov­ing to the COO post in March 2019. Pri­or to Aptinyx, he was with Bax­ter for a decade, even­tu­al­ly work­ing his way up to SVP of strat­e­gy and busi­ness de­vel­op­ment.

Ver­tex alum Sath Shuk­la has jumped on board at Spero Ther­a­peu­tics as CFO. Shuk­la makes the switch from em­bat­tled Zio­pharm On­col­o­gy — which fi­nal­ly end­ed its ac­tivist at­tack from mi­nor­i­ty in­vestor Wa­ter­Mill — where he served in the same ca­pac­i­ty. Shuk­la had a sev­en-year run at Ver­tex as their VP and glob­al head of cor­po­rate fi­nance be­fore his brief stay at Zio­pharm. Spero is de­vel­op­ing their lead can­di­date tebipen­em HBr, an oral car­bapen­em an­tibi­ot­ic, for those with com­pli­cat­ed uri­nary tract in­fec­tions and acute pyelonephri­tis.

Diego Ca­david

Diego Ca­david has signed on as CMO of Boston-based X4 Phar­ma­ceu­ti­cals af­ter the biotech nabbed fel­low Bio­gen alum Art Taveras as CSO last month. Ca­david heads over to X4 as the com­pa­ny press­es on­ward in their Phase III tri­al of ma­vorix­afor to treat those with WHIM syn­drome. Ca­david was pre­vi­ous­ly SVP and head of clin­i­cal de­vel­op­ment at Ful­crum Ther­a­peu­tics, which in Au­gust re­port­ed a Phase II dud in fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy (FSHD) with its lead drug losmapi­mod. Try­ing to put an op­ti­mistic spin on it at the time, Ca­david said, “The ini­tial ob­ser­va­tion of greater re­duc­tion by losmapi­mod over place­bo in DUX4-dri­ven gene ex­pres­sion in the biop­sied mus­cles with the high­est base­line ex­pres­sion may rep­re­sent the po­ten­tial losmapi­mod has to treat the root cause of the dis­ease.”

Sanofi alum Howard Surks is join­ing Car­du­ri­on Phar­ma­ceu­ti­cals as the car­dio­vas­cu­lar dis­ease biotech’s CSO and head of trans­la­tion­al med­i­cine. This year Car­du­ri­on’s C-suite has seen some turnover with Pe­ter Lawrence tak­ing the helm as CEO and Chris Mora­bito tak­ing on the role of CMO. Surks was Sanofi’s head of trans­la­tion­al med­i­cine and clin­i­cal phar­ma­col­o­gy US, and be­fore his tenure at Sanofi, he was in­volved in trans­la­tion­al med­i­cine and car­dio­vas­cu­lar clin­i­cal de­vel­op­ment at fel­low phar­ma gi­ant Mer­ck.

John Maxwell

→ Feel­ing the ef­fects from the FDA’s re­buff of Liber­vant — an oral film for seizure con­trol — NJ-based Aque­s­tive Ther­a­peu­tics has re­vealed John Maxwell is step­ping down from his CFO post, ef­fec­tive at the end of the year. In his place will be in­ter­im CFO Ernie Toth, who had been CFO of EHE Health. Aque­s­tive in­tends to re­file an NDA de­spite re­ceiv­ing the CRL.

Kati­na Dor­ton

→ Pro­pelled by No­vo Ven­tures and Sanofi Ven­tures in a $55 mil­lion Se­ries B round in June, NL­RP3 in­flam­ma­some-fo­cused NodThera is flesh­ing out its C-suite with Don­ald Johns as CMO and Kati­na Dor­ton as CFO. Johns, a Bio­gen and No­var­tis vet, has moved on to Nodthera af­ter be­ing CMO and EVP of med­ical and sci­en­tif­ic af­fairs at Syn­tim­mune, bought out by Alex­ion in a $1.2 bil­lion deal. Dor­ton was just here this month when she se­cured a board ap­point­ment at Pan­dion Ther­a­peu­tics, and she was pre­vi­ous­ly the CFO at Re­pare Ther­a­peu­tics, Avro­bio and Im­mat­ics.

→ Sin­ga­pore-based cell ther­a­py biotech Tes­sa Ther­a­peu­tics is putting the fin­ish­ing touch­es on 2020 with an­oth­er change on the team, and this time it’s David McIn­tyre com­ing in as CFO. Tes­sa had cho­sen a new CEO (Jef­frey Buchal­ter) and new chair­man (Göran An­do) ear­li­er this year. McIn­tyre’s pre­vi­ous CFO stop was at Avi­ta Med­ical, and he’s al­so been a part­ner at Ap­ple Tree Part­ners.

Djord­je Fil­ipovic

→ Swiss au­toin­flam­ma­to­ry dis­ease biotech AB2 Bio has en­list­ed Djord­je Fil­ipovic as their chief com­mer­cial of­fi­cer. Fil­ipovic held nu­mer­ous lead­er­ship ti­tles at No­var­tis, start­ing at San­doz pre-merg­er in 1992 and serv­ing near­ly three decades, end­ing his run as the phar­ma gi­ant’s glob­al head of learn­ing, phar­ma. AB2 Bio is in a piv­otal Phase III tri­al with Tadekinig al­fa, and WuXi Bi­o­log­ics is col­lab­o­rat­ing with the biotech on man­u­fac­tur­ing the drug, a re­com­bi­nant IL-18 bind­ing pro­tein.

→ Rockville, MD-based CASI Phar­ma­ceu­ti­cals — which in-li­censed an an­ti-CD19 T cell ther­a­py from Chi­na’s Ju­ven­tas back in 2019 — has snagged Wei­hao Xu as CFO. Xu hails from Per­ma­nence Cap­i­tal, where he served as chief in­vest­ment of­fi­cer. Pri­or to that, he was CFO of Shang­hai-based dig­i­tal health­care com­pa­ny 111. In ad­di­tion, Xu for­mer­ly held roles at Matthews In­ter­na­tion­al Cap­i­tal Man­age­ment, Permal As­set Man­age­ment and Lans­downe Part­ners.

Ter­ri Gaskell

→ UK-based Rin­ri Ther­a­peu­tics, fo­cused on hear­ing restora­tion via cell-based ther­a­pies and spun out of the Uni­ver­si­ty of Sheffield, has se­lect­ed Ter­ri Gaskell as chief tech­nol­o­gy of­fi­cer. Gaskell takes the CTO job af­ter a 7-year run at the Cell and Gene Ther­a­py Cat­a­pult, where she was most re­cent­ly their head of pro­gram de­liv­ery.

→ Re­brand­ing from its pre­vi­ous name An­a­lyt­ics 4 Life, Toron­to-based CorVista Health has locked in Scott Burg­er as chief com­mer­cial of­fi­cer and VP. Burg­er has Big Phar­ma ex­pe­ri­ence as a di­rec­tor in J&J’s car­dio­vas­cu­lar group pri­or to his new po­si­tion at CorVista Health, which us­es a car­diac di­ag­nos­tic plat­form called the CorVista Sys­tem for heart dis­ease di­ag­noses.

Chris Kurtz

→ With its an­ti­fun­gal can­di­date reza­fun­gin in Phase III, San Diego biotech Cidara Ther­a­peu­tics has poached Chris Kurtz from Gilead to be their EVP of tech­ni­cal op­er­a­tions. Kurtz led com­mer­cial API man­u­fac­tur­ing at the phar­ma gi­ant with such drugs as Vek­lury (known more com­mon­ly as remde­sivir in the age of Covid-19) and Bik­tarvy. Be­fore Gilead, Kurtz was VP for drug de­vice in­dus­tri­al­iza­tion at Ab­b­Vie and an ex­ec at Alexza Phar­ma­ceu­ti­cals and No­vo Nordisk.

→ Bei­jing gene edit­ing play­er Edi­Gene, which net­ted $67 mil­lion in an Oc­to­ber Se­ries B, has made two new ap­point­ments with Bo Zhang (head of US sub­sidiary) and Ke­hua Fan (head of busi­ness de­vel­op­ment). Zhang, a vet­er­an of Mer­ri­mack Phar­ma­ceu­ti­cals and Cobalt Bio­med­i­cine, was VP at Klus Phar­ma pri­or to his Edi­Gene ar­rival. And Fan, who has Big Phar­ma stints at GSK, Sanofi and Pfiz­er un­der her belt, leaves her po­si­tion at Jun­shi Bio­sciences as head of strat­e­gy and part­ner­ship.

Erik Rut­jens

→ UK-based Enara Bio, re­brand­ed in June from its orig­i­nal name Er­vaxx and try­ing to break through in off-the-shelf CAR-T and can­cer vac­cines with their TCR dis­cov­ery and “Dark Anti­gen” plat­forms, has in­stalled Erik Rut­jens as VP, cell ther­a­py op­er­a­tions. Rut­jens comes to Enara Bio af­ter hold­ing a se­ries of ti­tles at No­var­tis, cul­mi­nat­ing in his time as head of en­abling tech­nolo­gies & process en­gi­neer­ing. Enara Bio has al­so ap­point­ed two new mem­bers of their sci­en­tif­ic ad­vi­so­ry board with Vor Bio­phar­ma CTO Sadik Kas­sim and Michael Quigley, Gilead’s SVP, re­search bi­ol­o­gy.

→ Wa­ter­town, MA pro­tein degra­da­tion play­er Kymera Ther­a­peu­tics, one of a mul­ti­tude of biotechs to go pub­lic in 2020 by scor­ing an up­sized $173.7 mil­lion IPO, has wel­comed two new ex­ecs with William Leong as VP of CMC and Paul Cox as VP of in­vestor re­la­tions and com­mu­ni­ca­tions. Leong, a Cel­gene and Scher­ing-Plough vet, makes the move to Kymera from his gig at Com­plexa as VP, tech­ni­cal op­er­a­tions. Cox has pre­vi­ous­ly been in in­vestor re­la­tions at Sage Ther­a­peu­tics, Neon Ther­a­peu­tics and Voy­ager Ther­a­peu­tics.

Badred­din Edris

Spring­Works Ther­a­peu­tics — which swapped an ex-Pfiz­er drug out with Jazz Phar­ma­ceu­ti­cals for $35 mil­lion back in Oc­to­ber — has an­nounced two pro­mo­tions. Cur­rent CBO Badred­din Edris has moved up to the po­si­tion of COO, while L Mary Smith, cur­rent SVP of clin­i­cal re­search and de­vel­op­ment, has been pro­mot­ed to chief de­vel­op­ment of­fi­cer. Edris joined the com­pa­ny back in 2018 and pre­vi­ous­ly held roles at two Or­biMed port­fo­lio com­pa­nies: CBO at Sil­ver­back Ther­a­peu­tics and COO at Edge­wise Ther­a­peu­tics. Smith has been with the com­pa­ny since its in­cep­tion in 2017 and for­mer­ly served as EVP of gene ther­a­py at Pfiz­er sub­sidiary Bam­boo Ther­a­peu­tics and as VP of prod­uct de­vel­op­ment at Unit­ed Ther­a­peu­tics.

→ Af­ter quite the ug­ly bat­tle, Zio­pharm‘s saga with Wa­ter­Mill has fi­nal­ly drawn to a close. Zio­pharm has made the ad­di­tions of Jaime Vieser and Hol­ger Weis to its board of di­rec­tors, with chair­man Scott Tar­riff hit­ting the ex­it. It’s not clear if Wa­ter­Mill will push for the last in­di­vid­ual to step down and be re­placed with Wa­ter­Mill founder Robert Post­ma. Weis was the for­mer pres­i­dent of De­meRx while Vieser is co-founder and chief in­vest­ment of­fi­cer of Cas­tle Hill As­set Man­age­ment.

Jen­nifer Hon­ey­cutt

Jen­nifer Hon­ey­cutt start­ed at Dana­her 21 years ago af­ter the Hach ac­qui­si­tion. Now she’ll take on a new role as EVP, ef­fec­tive Jan 1. Hon­ey­cutt had been VP and group ex­ec­u­tive over­see­ing three en­ti­ties: Pall (which Dana­her pur­chased in 2015, earn­ing her the ti­tle of pres­i­dent of Pall), IDT and Dana­her’s Life Sci­ences plat­form in Chi­na.

Karyopharm Ther­a­peu­tics — which won an FDA OK last year for its mul­ti­ple myelo­ma drug de­spite fevered ob­jec­tions — has pulled in Michael Mano as SVP, gen­er­al coun­sel. Mano joins the com­pa­ny af­ter a stint as coun­sel, busi­ness de­vel­op­ment at Bio­gen.

Lin­da Holm­ström

→ Stock­holm phar­ma On­copep­tides, now helmed by ex-Toca­gen CEO Mar­ty Du­vall, has wel­comed Lin­da Holm­ström as di­rec­tor of in­vestor re­la­tions. Holm­ström, who worked in com­mu­ni­ca­tions at Re­ci­pharm, joins hema­to­log­i­cal dis­ease-fo­cused On­copep­tides af­ter four years as se­nior cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions man­ag­er for So­bi.

→ UK-based Touch­light — fo­cused on the de­vel­op­ment of DNA-based ge­net­ic med­i­cines — has tapped Satish Muchakay­ala as di­rec­tor of reg­u­la­to­ry af­fairs. Muchakay­ala brings to the ta­ble ex­pe­ri­ence from his time at UCB, J&J and GSK. In ad­di­tion, the com­pa­ny has brought on John Dwyer, for­mer part­ner at PwC UK, to its board of di­rec­tors as non-ex­ec­u­tive di­rec­tor.

Camille Bedrosian

→ Boston-based Rhythm Phar­ma­ceu­ti­cals, led by David Meek­er and weeks re­moved from get­ting the FDA seal of ap­proval on set­melan­otide for rare ge­net­ic dis­or­ders of obe­si­ty, has hit two new notes on the board of di­rec­tors with Camille Bedrosian and Lynn Tetrault. Bedrosian has been CMO at Ul­tragenyx since 2018, and Tetrault was in cor­po­rate af­fairs at As­traZeneca from 1993-2014.

→ Dutch macro­mol­e­cule biotech Sapreme has tapped Björn Cochlovius to be chair­man of the board. Cochlovius, who al­so chairs the board at Iso­geni­ca, has worked in busi­ness de­vel­op­ment for Ab­b­Vie and Roche.

Kel­ly Ro­mano

Rais­ing $204 mil­lion in an up­sized IPO this fall and tar­get­ing Alzheimer’s and Parkin­son’s, Leen Kawas-helmed Athi­ra Phar­ma out of Seat­tle has added Kel­ly Ro­mano to their board of di­rec­tors. Ro­mano is the founder and CEO of BlueRip­ple Cap­i­tal and spent more than three decades at Unit­ed Tech­nolo­gies Corp.

→ Neu­ro­bi­ol­o­gy play­er XW­Phar­ma has reeled in Michael Mor­ris­sey to its board of di­rec­tors. Mor­ris­sey is the cur­rent di­rec­tor, pres­i­dent and CEO of Ex­elix­is.

→ Just af­ter they hired Steve Harbin as COO and chief of staff, Cam­bridge, MA vi­ral im­munother­a­py out­fit On­corus has made Scott Canute a mem­ber of the board of di­rec­tors. Canute, the for­mer man­u­fac­tur­ing ex­ec at Eli Lil­ly and Gen­zyme, is al­so on the board at Flex­ion Ther­a­peu­tics.

Al­bert Cha

As­cendis Phar­ma A/S SVP and chief le­gal of­fi­cer Michael Wolf Jensen won’t put him­self up for re-elec­tion to the board of di­rec­tors, while Al­bert Cha has re­placed him at the Copen­hagen-based com­pa­ny as chair­man. Cha, a Vi­vo Cap­i­tal vet and board mem­ber for the last six years, is al­so on the board KalVista Phar­ma­ceu­ti­cals. Jensen had been chair­man since 2008.

Sandip Ka­pa­dia has been ap­point­ed to the board of di­rec­tors at Lu­ca Santarel­li start­up Vec­tivBio. Ka­pa­dia, the CFO at In­ter­cept, held sev­er­al po­si­tions at No­var­tis, in­clud­ing CFO of San­doz in North Amer­i­ca.

An­drea Hes­lin Smi­ley

→ Set­tling in with a new CEO af­ter the Robert Chioi­ni dra­ma, Rock­well Med­ical has brought in Eli Lil­ly vet An­drea Hes­lin Smi­ley as a board mem­ber. Smi­ley has been pres­i­dent and CEO at VMS Bio­Mar­ket­ing for nine years.

Spec­trum Phar­ma­ceu­ti­cals — which saw its shares crater last De­cem­ber — has re­cruit­ed No­ra Bren­nan to its board of di­rec­tors. Bren­nan cur­rent­ly serves as CFO of TELA Bio and has pre­vi­ous­ly served as CFO at Xeris Phar­ma­ceu­ti­cals.

Jef­frey Vacir­ca

→ Be­yond­Spring, a can­cer-fo­cused biotech with deep roots in Chi­na, has named Jef­frey Vacir­ca a mem­ber of its board of di­rec­tors. Vacir­ca comes from New York Can­cer & Blood Spe­cial­ists, where he serves as CEO and chair­man. In ad­di­tion, he sits on the boards of OneOn­col­o­gy, the Amer­i­can Red Cross of Greater New York, New York Can­cer Foun­da­tion, Odonate Ther­a­peu­tics and Spec­trum Phar­ma­ceu­ti­cals.

SAB Bio­ther­a­peu­tics has ap­point­ed Mani Mo­hin­dru and Mer­ck vet Mervyn Turn­er to its board of di­rec­tors. Mo­hin­dru was the for­mer CFO of CereX­is and was CFO and chief strat­e­gy of­fi­cer at Cara Ther­a­peu­tics. Mean­while, Turn­er cur­rent­ly op­er­ates his own con­sult­ing firm, MJ Turn­er Con­sult­ing.

Michel Thérin

→ Medtech Tis­si­um has pulled in Michel Thérin to its board of di­rec­tors. Cur­rent­ly, Thérin is pres­i­dent of ad­vanced ther­a­pies at Siemens Health­i­neers. Pri­or to that, he spent more than a decade at Medtron­ic.

→ Man­u­fac­tur­ing tech com­pa­ny Ori Biotech has reeled in Mor­rie Ruf­fin, Jian Irish and Dean­na Pe­tersen to its ad­vi­so­ry board. In ad­di­tion, the com­pa­ny has made sev­er­al new ap­point­ments with the hir­ing of David Smith as VP of tech­ni­cal op­er­a­tions; Shaun Mans­field as sci­en­tist; and Amisha Pa­tel as qual­i­ty man­ag­er.

→ Is­rael-based MeMed has wel­comed Chris Hi­b­berd to its board of di­rec­tors. Cur­rent­ly, Hi­b­berd serves as CEO and ex­ec­u­tive chair­man of Nu­cle­ix.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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