Am­gen, Ipsen vet moves up the lad­der with Co­herus' an­ti-PD-1 await­ing PDU­FA; It takes a vil­lage to re­place Frank Clyburn at Mer­ck­'s Hu­man Health busi­ness

Paul Rei­der

Af­ter decades in the bio­phar­ma in­dus­try, Paul Rei­der is now in his first C-suite role as chief com­mer­cial of­fi­cer. While he has been at Co­herus Bio­Sciences since last year, he of­fi­cial­ly start­ed his new job on Jan. 1, and it was pub­licly an­nounced on Tues­day.

The ap­point­ment will place Rei­der right in the thick­et of the biggest is­sues in can­cer drug de­vel­op­ment. Long a play­er in the biosim­i­lar world, Co­herus spent $150 mil­lion last year to li­cense a PD-1 from Shang­hai’s Jun­shi Bio­sciences, join­ing up to three oth­er ma­jor US com­pa­nies that promised to un­der­cut the high-priced mar­ket for PD-1 in­hibitors by bring­ing in Chi­nese drugs and sell­ing them well be­low the price of Keytru­da or Op­di­vo.

Giv­en the com­plex net­work of gate­keep­ers and mid­dle­men that gov­ern which drugs reach pa­tients in the US, that would have been a tall task for any com­mer­cial chief. But it just got even taller af­ter the FDA re­buked Eli Lil­ly last week for try­ing get a PD-1 ap­proved based on Chi­nese da­ta alone, sug­gest­ing Co­herus and oth­ers might not even reach mar­ket.

In oth­er words, Rei­der will have his work cut out for him.

Rei­der cred­its his mom’s in­flu­ence as a nurse for get­ting him in­to biotech orig­i­nal­ly — and meet­ing two peo­ple from a Kansas City-based phar­ma com­pa­ny that got bought out by Hoechst AG back in the mid 1990s be­fore ul­ti­mate­ly wind­ing up as part of Sanofi.

It was here, af­ter he grad­u­at­ed from Bowl­ing Green State Uni­ver­si­ty with his MBA and as he was spend­ing a se­mes­ter at the uni­ver­si­ty teach­ing an ad­ver­tis­ing class when a pro­fes­sor was on sab­bat­i­cal, that his in­ter­est was piqued for­ev­er.

“The stars aligned for me at that time, be­cause with that job, I was in­tro­duced to the folks at Mar­i­on Mer­rill Dow, which was my first en­try point in­to phar­ma­ceu­ti­cals,” Rei­der told End­points News. “It was at a fac­ul­ty in­dus­try lun­cheon. And I sat with these two ex­ec­u­tives from Mar­i­on Mer­rill Dow at the time, and they were talk­ing to me about the phar­ma­ceu­ti­cal busi­ness. And it was at that mo­ment that it hit me, and it was just like, you know, now I get it. I put it to­geth­er.”

What he put to­geth­er was not on­ly his mom’s in­flu­ence, but as Rei­der put it, the op­por­tu­ni­ty to work in a busi­ness that pro­vides med­i­cines to im­prove pa­tient’s lives. And he de­cid­ed that’s what he want­ed to do.

He lat­er land­ed a job at Am­gen as a hos­pi­tal sales rep in the phar­ma’s on­col­o­gy unit. Rei­der worked for the next 17 years mov­ing up the cor­po­rate lad­der — end­ing up as the ex­ec­u­tive sales di­rec­tor for Am­gen’s bone health busi­ness unit.

Rei­der then moved over to Ipsen for a few years, work­ing as a VP in their on­col­o­gy busi­ness unit and then went to Cana­da to be Ipsen Cana­da’s gen­er­al man­ag­er un­til late 2018. Then af­ter he moved in­to VP of sales at Puma Biotech­nol­o­gy, he then land­ed at his cur­rent com­pa­ny — Co­herus.

So, what’s next for him there? Well, in terms of his pro­mo­tion — he was al­ready do­ing most of what he nor­mal­ly does in his old job de­scrip­tion as EVP of com­mer­cial op­er­a­tions and mar­ket op­er­a­tions.

“Ba­si­cal­ly, I had every­thing ex­cept sales and gov­ern­ment af­fairs,” Rei­der said.

In terms of Co­herus, it’s about to be launch time — with Co­herus plan­ning to launch two prod­ucts in 2022 and two more prod­ucts next year.

This year’s prod­ucts in­clude two BLAs sub­mit­ted to the FDA: the first is for the an­ti-PD-1 an­ti­body tori­pal­imab, with the PDU­FA date some­time in April.

There’s al­so the oth­er BLA for Cimer­li, aka CHS-201, a Lu­cen­tis biosim­i­lar that Co­herus has de­vel­oped with a tar­get ac­tion date in Au­gust.

Paul Schloess­er

Arpa Garay

Mer­ck’s Hu­man Health pres­i­dent Frank Clyburn bid farewell on Feb. 1 to take a CEO job at In­ter­na­tion­al Fla­vors & Fra­grances (IFF), and Rob Davis is re­fash­ion­ing the Hu­man Health lead­er­ship, ef­fec­tive Feb. 28. Jan­nie Oost­huizen will be head of Hu­man Health US af­ter a short stint as pres­i­dent of glob­al mar­ket­ing for on­col­o­gy; Mer­ck brought him on board in 2014 af­ter two decades at Eli Lil­ly. Arpa Garay, Mer­ck’s pres­i­dent of glob­al mar­ket­ing and dig­i­tal for on­col­o­gy who start­ed at the com­pa­ny in 2006, will now be re­spon­si­ble for Hu­man Health glob­al mar­ket­ing. And a Mer­ck lif­er who joined the phar­ma gi­ant in 1988, Deep­ak Khan­na — the pres­i­dent of Hu­man Health EU­CAN (Eu­rope and Cana­da) — will pinch-hit as pres­i­dent of Hu­man Health In­ter­na­tion­al while “Mer­ck is re­cruit­ing ex­ter­nal­ly to fill the Hu­man Health In­ter­na­tion­al role,” ac­cord­ing to the re­lease.

Tony Kings­ley

→ Ex-Schol­ar Rock CEO Tony Kings­ley is back, this time as chief ex­ec­u­tive at Ver­sant-backed pro­tein sta­bi­liza­tion start­up Sta­blix. Un­der the watch­ful in­ter­im eye of Ver­sant part­ner Car­lo Riz­zu­to, Sta­blix notched a $63 mil­lion Se­ries A round in June 2021, not long be­fore Kings­ley de­cid­ed to part ways with Schol­ar Rock the fol­low­ing Au­gust. Al­though he kept most­ly mum on his de­par­ture, the vet­er­an of Bio­gen and The Med­i­cines Com­pa­ny did tell End­points that “the board and I didn’t see eye-to-eye on a few things.”

→ Af­ter los­ing VP, pre­clin­i­cal and trans­la­tion­al de­vel­op­ment Prashant Nam­biar to Strand Ther­a­peu­tics last week, Nick Leschly has gained a CMO at his blue­bird bio spin­out 2sev­en­ty bio, nam­ing Steven Bern­stein to the po­si­tion. Bern­stein’s four-year run at Turn­stone Bi­o­log­ics be­gan as SVP of clin­i­cal R&D and ends as chief trans­la­tion­al of­fi­cer. The for­mer head of in­te­grat­ed sci­ence, trans­la­tion­al med­i­cine at Bris­tol My­ers Squibb’s T-cell bi­ol­o­gy acu­men is the match Leschly is look­ing for as he tries to builds a pipeline be­yond Abec­ma. Else­where at 2sev­en­ty, Su­san Abu-Ab­si — the head of tech­ni­cal de­vel­op­ment and op­er­a­tions and a Bris­tol My­ers vet in her own right — has been pro­mot­ed to chief tech­nol­o­gy and man­u­fac­tur­ing of­fi­cer.

Gar­ry Neil

→ At the mi­cro­cap for­mer­ly known as Cere­cor — im­munol­o­gy and rare dis­ease biotech Ava­lo Ther­a­peu­tics — it’s a next-man-up men­tal­i­ty as CEO Mike Co­la and CFO Schond Green­way step aside, while Gar­ry Neil and Chris Sul­li­van slide in­to those re­spec­tive po­si­tions. Neil has held po­si­tions at such large phar­mas as As­traZeneca, Mer­ck KGaA and J&J, and the Are­na Phar­ma­ceu­ti­cals chair­man since 2017 had been the CSO of Ava­lo for near­ly two years. Af­ter near­ly a year as the biotech’s in­ter­im fi­nance chief and his re­cent stint as chief ac­count­ing of­fi­cer, Sul­li­van now has the CFO job to him­self.

John Mas­co­la

→ In an­oth­er blow to the pool of avail­able gov­ern­ment vac­cine ex­perts on hand, John Mas­co­la, the di­rec­tor of NI­AID’s Vac­cine Re­search Cen­ter and lead on vac­cines for Op­er­a­tion Warp Speed, is re­tir­ing at the end of March. News of his de­par­ture comes on the heels of NIH di­rec­tor Fran­cis Collins’ ex­it. Mas­co­la, who’s spent over 20 years work­ing at NIH, was at the cen­ter of ef­forts to de­vel­op not on­ly Mod­er­na’s Covid-19 vac­cine, but al­so the mon­o­clon­al an­ti­bod­ies used against Covid-19. Mas­co­la joined the Vac­cine Re­search Cen­ter in 2000 and was named di­rec­tor in 2013. Richard Koup, cur­rent deputy di­rec­tor for the NI­AID vac­cine cen­ter, will serve as Mas­co­la’s in­ter­im suc­ces­sor while the agency search­es for a per­ma­nent re­place­ment.

Robert Califf

→ In what has been a re­al nail-biter lead­ing up to a sec­ond shot at FDA com­mis­sion­er, famed car­di­ol­o­gist and Duke Uni­ver­si­ty clin­i­cal tri­al ex­pert Robert Califf has fi­nal­ly se­cured the votes he need­ed for his Sen­ate con­fir­ma­tion. It was a close vote as the fi­nal tal­ly came in at 50-46 — with five De­moc­rats and 41 Re­pub­li­cans vot­ing against him and five sen­a­tors ab­stain­ing. Califf had re­ceived a fi­nal vote of 89-4 when he was con­firmed in 2016 as the 22nd com­mis­sion­er un­der the Oba­ma ad­min­is­tra­tion.

Califf will be tak­ing over for in­ter­im FDA com­mis­sion­er Janet Wood­cock, who an­nounced that she will be stay­ing on with the agency in the ca­pac­i­ty of prin­ci­pal deputy to Califf.

Saman­tha Truex, the for­mer CEO of short-lived Quench Bio, looks to have said good­bye to her post at At­las Ven­ture and se­cured the CEO spot at Or­biMed-led Up­stream Bio, ac­cord­ing to a Nov. 30 fil­ing in Mass­a­chu­setts. The for­mer Bio­gen ex­ec and ex-CBO at Pad­lock Ther­a­peu­tics is keep­ing it hush and un­der wraps, for now, say­ing the com­pa­ny is still in stealth.

Vi­et Nguyen

Re­silience, a stand­out in Bob Nelsen’s trea­sure trove of big ideas that seeks to be the “Ama­zon Web Ser­vices of drug man­u­fac­tur­ing,” has tapped Alex Szi­don as CBO and Vi­et Nguyen as chief man­u­fac­tur­ing of­fi­cer. Szi­don was most re­cent­ly the VP and head of busi­ness de­vel­op­ment for gRED at Genen­tech and has held posts at Mer­ck Re­search Lab­o­ra­to­ries and NI­BR. Nguyen worked at Genen­tech him­self and moves on from Mer­ck KGaA, where he was SVP of glob­al biotech man­u­fac­tur­ing. In Sep­tem­ber 2021, Re­silience inked a deal to man­u­fac­ture mR­NA for Mod­er­na in Cana­da.

→ Look­ing to dis­pense with its con­sumer health­care busi­ness by po­ten­tial­ly sell­ing it to French brethren May­oly Spindler, Ipsen has se­lect­ed Cather­ine Abi-Habib as EVP strat­e­gy, trans­for­ma­tion, and dig­i­tal. Abi-Habib, a part­ner in the life sci­ences prac­tice at McK­in­sey since 2010, will re­place Do­minique Bery —who will be Ipsen’s head of Nordics & Baltics — be­gin­ning March 1.

Mar­cia Moore

Mar­cia Moore has been named COO over at Car­du­ri­on Phar­ma­ceu­ti­cals, the car­dio­vas­cu­lar dis­ease biotech that re­ceived a fi­nan­cial boost from Adam Kop­pel and Bain to the tune of $300 mil­lion last Oc­to­ber. Moore, who be­gan her ca­reer at Bris­tol My­ers, most re­cent­ly served as SVP, strate­gic op­er­a­tions at Arv­inas, and she’s al­so been the di­rec­tor, strate­gic drug de­vel­op­ment and project plan­ning for Alex­ion.

David Bharucha

David Bharucha has re­placed Fran­cis Plat as CMO of car­dio­vas­cu­lar dis­ease biotech Mile­stone Phar­ma­ceu­ti­cals, while Plat slides in­to the role of CSO. Bharucha had been Al­ler­gan’s VP, R&D, clin­i­cal de­vel­op­ment be­fore set­ting off for Mile­stone, where lead pro­gram etri­pamil is in Phase III stud­ies for pa­tients with parox­ys­mal supraven­tric­u­lar tachy­car­dia and in a Phase II proof-of-con­cept tri­al for atri­al fib­ril­la­tion and rapid ven­tric­u­lar rate.

→ Irish drug de­vel­op­er Avadel Phar­ma­ceu­ti­cals, which is still await­ing FDA re­view of its nar­colep­sy drug FT218, has ap­point­ed Dou­glas Williamson as CMO. Williamson is a 17-year Eli Lil­ly vet who tran­si­tions to Avadel from Lund­beck, where he was SVP, head of US R&D and deputy glob­al CMO. At Parex­el from 2012-16, Williamson took on the role of VP, glob­al ther­a­peu­tic ar­eas.

Sean Clay­ton

→ While Tim Wal­bert’s folks at Hori­zon have been gear­ing up for a new rare dis­ease cam­paign with an as­sist from the Doug the Pug Foun­da­tion and Sing Me A Sto­ry Foun­da­tion, they’ve al­so waved in Sean Clay­ton as EVP and gen­er­al coun­sel, ef­fec­tive Feb. 28. For the last 16 years, Clay­ton has been a part­ner at Cal­i­for­nia-based law firm Coo­ley LLP.

Shash­ki Kulka­rni

NeoGe­nomics, the Flori­da on­col­o­gy CRO helmed by ex-Iron­wood Phar­ma­ceu­ti­cals CEO Mark Mal­lon, has tapped Shash­ki Kulka­rni as CSO. Kulka­rni, who has taught at Wash­ing­ton Uni­ver­si­ty in St. Louis and the Bay­lor Col­lege of Med­i­cine, had been CSO and SVP of in­no­va­tion and emerg­ing busi­ness at Bay­lor Ge­net­ics.

→ French biotech Trans­gene has ap­point­ed Steven Bloom as VP, CBO. Be­fore join­ing Trans­gene, Bloom was SVP at Boston Phar­ma­ceu­ti­cals and CBO at Vavotar Life Sci­ences (which was once Nan­ti­BodyFc). Bloom al­so spent 18 years at Eli Lil­ly in sales/mar­ket­ing and cor­po­rate af­fairs.

Bri­an Wi­ley

→ Lots to straight­en out at im­muno-on­col­o­gy play­er Portage Biotech out of West­port, CT: Bri­an Wi­ley has signed on as CBO and Joseph Ciaverel­la grabs the new­ly cre­at­ed role of chief ac­count­ing of­fi­cer. Wi­ley, an on­col­o­gy mar­ket­ing gu­ru at Aven­tis, Mil­len­ni­um and Cel­gene, be­came a strate­gic ad­vi­sor at Portage last sum­mer and he’s al­so been chief com­mer­cial of­fi­cer and head of busi­ness de­vel­op­ment at NewLink Ge­net­ics. Ciaverel­la had served as a fi­nan­cial con­sul­tant at Portage since 2020, and once up­on a time he was al­so the CFO at New York Med­ical and telecom­mu­ni­ca­tions com­pa­ny AboveNet.

We don’t stop there: Portage founder Jim Mel­lon, Bris­tol My­ers vet Lin­da Kosick and Tor­reya Cap­i­tal co-founder Mark Si­mon have all joined the board of di­rec­tors.

→ Try­ing to push two can­di­dates to­ward the clin­ic — one for pem­phi­gus vul­garis, the oth­er for celi­ac dis­ease — Ger­man biotech Topas Ther­a­peu­tics has en­list­ed Cristi­na de Min as CMO. de Min spent 14 years as an ex­ec­u­tive at Roche, where she served as life cy­cle leader for Actem­ra as well as med­ical di­rec­tor of Roche’s af­fil­i­ate in Italy. Af­ter her time at Roche, she served for nine years as CMO at Novim­mune un­til it was pur­chased by So­bi.

Lau­rence Ri­ot Lam­otte

→ French can­cer biotech Di­ac­cu­rate, a rel­a­tive un­known that in-li­censed a PAM in­hibitor from Mer­ck KGaA in Sep­tem­ber and has re­named it DI­ACC3010, has wel­comed Lau­rence Ri­ot Lam­otte as CFO. Lam­otte had spent near­ly a decade as the fi­nance chief for In­te­gra­Gen and start­ed out with the au­dit de­part­ment at De­loitte in the 1980s.

→ Ox­ford, UK-based “dark genome” biotech Nu­cle­ome Ther­a­peu­tics has in­stalled Nigel Clark as CBO. Clark spent more than eight years at Kymab, part of Paul Hud­son’s buy­out bo­nan­za at Sanofi where he claimed the eczema drug KY1005 in a bolt-on deal val­ued at $1.1 bil­lion up­front. Clark, who was Kymab’s SVP of busi­ness de­vel­op­ment, has been a busi­ness chief be­fore at Syn­tax­in (bought by Ipsen in 2013).

Valérie Wor­rall

Valérie, call on me: Try­ing to cross the goal line with Char­cot-Marie-Tooth dis­ease type 1A can­di­date PXT3003, Paris-based Pharnext has brought in Valérie Wor­rall as CFO af­ter sev­er­al crit­i­cal ap­point­ments last year, in­clud­ing CMO Burkhard Blank. A 17-year fi­nan­cial alum for No­var­tis, Wor­rall was pre­vi­ous­ly the fi­nance chief for EOS Imag­ing.

→ While some things, such as man­u­fac­tur­ing plans and over­all busi­ness mod­el, re­main opaque in Syn­thego’s new $200 mil­lion Se­ries E round, one clear thing is the new hir­ing of Avi Raval as CFO. Raval joins the broth­er duo-found­ed com­pa­ny, which is al­so be­ing ad­vised by No­bel Prize win­ner Jen­nifer Doud­na, from Perel­la Wein­berg Part­ners, where he served as COO. Pri­or to that, Raval had a 7-year stint with JP Mor­gan.

Al­bert Park­er

Zyner­ba Phar­ma­ceu­ti­cals has tagged on Al­bert Park­er as chief le­gal of­fi­cer and cor­po­rate sec­re­tary — tak­ing over the man­tle from Suzanne Han­lon, who is re­tir­ing. Park­er most re­cent­ly served as COO and cor­po­rate sec­re­tary of On­co­cyte and be­fore that served in roles at GC Le­gal Ad­vi­sors, Sunovion Phar­ma­ceu­ti­cals, Wyeth Phar­ma­ceu­ti­cals and Schnad­er Har­ri­son Se­gal & Lewis.

Quan­tum-Si, which came out of stealth last June in a re­verse merg­er deal, has tapped its founder Jonathan Roth­berg as in­ter­im CEO, tak­ing over from out­go­ing CEO John Stark, as the com­pa­ny search­es for a per­ma­nent suc­ces­sor. Roth­berg’s ex­pe­ri­ence spans roles at 454 Life Sci­ences, Rain­Dance Tech­nolo­gies, But­ter­fly Net­work and Hy­per­fine Re­search.

Hei­di Hit­tner

Ag­ilon health has pro­mot­ed Hei­di Hit­tner to the po­si­tion of chief ex­pe­ri­ence of­fi­cer and Claire Mul­hearn to chief com­mu­ni­ca­tions and pub­lic af­fairs of­fi­cer. Lisa Dom­bro left the role of chief ex­pe­ri­ence and in­no­va­tion of­fi­cer to be­come chief of strate­gic growth at Up­stream Re­ha­bil­i­ta­tion. Hit­tner joined ag­ilon in Jan­u­ary 2019 as SVP, provider strate­gies and growth. Pri­or to that, she was with Fre­se­nius Med­ical Care North Amer­i­ca and Con­cen­tra. Mean­while, Mul­hearn came aboard the Austin, TX-based com­pa­ny in Au­gust 2021 af­ter stints as se­nior ex­ter­nal af­fairs roles at Mer­ck.

Lisa Ann Melia

Klean­this Xan­thopou­los’ crew at iP­SC NK cell play­er Shore­line Bio­sciences has ex­pand­ed by three: Pfiz­er vet Lisa Ann Melia (VP, clin­i­cal op­er­a­tions) has held the same role at Reg­u­lus Ther­a­peu­tics, MEI Phar­ma and In­dap­tus Ther­a­peu­tics; Pinky Doshi (VP, reg­u­la­to­ry af­fairs) had pre­vi­ous­ly de­vot­ed more than eight years to Bris­tol My­ers and was the glob­al reg­u­la­to­ry lead for Abec­ma; and Paschalis Sideras (VP, dis­cov­ery im­muno­bi­ol­o­gy) is an As­traZeneca R&D vet who hails from the Bio­med­ical Re­search Foun­da­tion (BR­FAA) of the Acad­e­my of Athens, where he was di­rec­tor of the Cen­tre for Clin­i­cal, Ex­per­i­men­tal Surgery and Trans­la­tion­al Re­search.

→ Lon­don-based my mhealth — a de­vel­op­er of dig­i­tal health pro­grams — has reeled in Joel Sanger­man as CCO. Pri­or to his new stint, Sanger­man held a va­ri­ety of roles in­clud­ing CCO of Click Ther­a­peu­tics, VP of mar­ket de­vel­op­ment for Wal­greens and di­rec­tor of re­im­burse­ment for J&J.

Bri­a­Cell Ther­a­peu­tics has made the ad­di­tion of Giuseppe Del Pri­ore as CMO of the com­pa­ny. Del Pri­ore pre­vi­ous­ly served as CMO of TYME Tech­nolo­gies, had a stint at the Can­cer Treat­ment Cen­ters of Amer­i­ca and held fac­ul­ty po­si­tions at the In­di­ana Uni­ver­si­ty School of Med­i­cine, Weill Cor­nell Med­i­cine and New York Uni­ver­si­ty School of Med­i­cine.

Amy Locke

Amy Locke has been ap­point­ed VP, head of hu­man re­sources at Adicet Bio, which un­veiled da­ta for its off-the-shelf T cell ther­a­py AD-001 a cou­ple months ago. While with Al­lakos, Locke served as ex­ec­u­tive di­rec­tor, tal­ent ac­qui­si­tion and op­ti­miza­tion; she’s al­so spent 13 years at Bris­tol My­ers and an­oth­er 11 years at Genen­tech in an as­sort­ment of ca­pac­i­ties.

Jean Ben­nett’s new gene ther­a­py play Opus Ge­net­ics, which de­buted in Sep­tem­ber 2021 with help from the RD Fund, has re­cruit­ed Bri­an Leis­ing as VP, man­u­fac­tur­ing. Leis­ing ven­tures off to the Penn spin­out from work­ing with Zol­gens­ma at No­var­tis Gene Ther­a­pies as di­rec­tor of man­u­fac­tur­ing qual­i­ty. His Big Phar­ma ex­pe­ri­ence in­cludes a stint at Pfiz­er as di­rec­tor of clin­i­cal gene ther­a­py man­u­fac­tur­ing at the drug gi­ant’s Bam­boo fa­cil­i­ty in North Car­oli­na.

Ed­ward Berg

Vaxart has poached Ed­ward Berg from Bio­Marin, nam­ing him SVP and gen­er­al coun­sel. Berg comes to the San Fran­cis­co vac­cine out­fit af­ter three years as deputy gen­er­al coun­sel for JJ Bi­en­aimé and his team. Berg, the for­mer VP of le­gal at San­doz, brings plen­ty of Big Phar­ma ex­pe­ri­ence to the ta­ble from Mer­ck, Bris­tol My­ers (se­nior cor­po­rate coun­sel, R&D) and Sanofi (deputy gen­er­al coun­sel, phar­ma­ceu­ti­cal op­er­a­tions).

Pal­isade Bio — not to be con­fused with Nés­tle’s year-long Pal­isade tri­al for the world’s first-ever ap­proved peanut al­ler­gy med­i­cine —  has tapped Robert McRae as SVP, op­er­a­tions and strate­gic de­vel­op­ment. McRae joins with ex­pe­ri­ence from his time at Virac­ta Ther­a­peu­tics, where he served as VP, op­er­a­tions and strate­gic al­liance.

Lor­na Peers

Res­o­lu­tion Ther­a­peu­tics, fo­cused on treat­ing life-threat­en­ing in­flam­ma­to­ry or­gan dam­age, has signed on new ex­ecs to the team with the ap­point­ments of Vic­tor Dil­lard as VP cor­po­rate de­vel­op­ment and Lor­na Peers as VP fi­nance. Dil­lard hops aboard with ex­pe­ri­ence from his times at Flag­ship Pi­o­neer­ing, Desk­top Ge­net­ics and Owkin. Mean­while, Peers hails from Cen­so Biotech­nolo­gies, where she most re­cent­ly served as CFO.

→ Cannabi­noid play­er In­Med Phar­ma­ceu­ti­cals, which filed for a $12 mil­lion IPO pitch in 2020, has brought on Ger­ard Grif­fin III as VP of sales and mar­ket­ing at its sub­sidiary BayMed­ica. Grif­fin comes aboard from cannabi­noid pro­duc­er Creo In­gre­di­ents, where he served as VP of sales and busi­ness de­vel­op­ment.

Shawn Levy

→ San Diego-based DNA se­quenc­ing play­er El­e­ment Bio­sciences — which un­veiled a su­per­sized Se­ries C to­tal­ing $276 mil­lion last sum­mer — has brought on Shawn Levy as SVP of ap­pli­ca­tions and sci­en­tif­ic af­fairs. Be­fore join­ing the squad at El­e­ment, the ad­junct fac­ul­ty mem­ber at the Uni­ver­si­ty of Al­aba­ma-Birm­ing­ham was CSO at Dis­cov­ery Life Sci­ences.

Har­lan Wak­sal

Har­lan Wak­sal’s next steps af­ter Sanofi swept in to buy Kad­mon take him to Lyra Ther­a­peu­tics, where he’s been named ex­ec­u­tive chair­man. Sam Wak­sal found­ed Kad­mon in 2009 fol­low­ing his re­lease from prison, lat­er ced­ing his CEO re­spon­si­bil­i­ties to his broth­er. Har­lan then guid­ed the com­pa­ny to the FDA’s ap­proval of chron­ic graft-ver­sus-host dis­ease (cGVHD) drug Rezurock last sum­mer. As the pan­dem­ic took root in the spring of 2020, Lyra — co-found­ed by Bob Langeren­tered the fray on Nas­daq with a $56 mil­lion IPO.

→ Ex-Genen­tech CEO Ian Clark has col­lect­ed an­oth­er board ap­point­ment and it’s with South San Fran­cis­co’s Ash­er Bio­ther­a­peu­tics, the IL-2 biotech that launched with a $55 mil­lion round in March 2021. In ad­di­tion to Ash­er Bio, Clark — who led Genen­tech from 2010-16 — sits on the boards of Take­da, Agios, Guardant Health and Ole­ma On­col­o­gy.

Bahi­ja Jal­lal

→ Clark’s fel­low board mem­ber at Guardant Health, Im­muno­core CEO Bahi­ja Jal­lal, has been named to the board of di­rec­tors at Bing Yao’s lat­est en­deav­or, Ar­riVent Bio­phar­ma, which raised up to $150 mil­lion in its Se­ries A last June. Ar­riVent is tar­get­ing EGFR-mu­tat­ed non-small cell lung can­cer with its lead as­set, fur­mon­er­tinib.

→ For­mer Mod­er­na CFO Lorence Kim is mak­ing his way on­to the board of di­rec­tors of Cowen. Kim cur­rent­ly serves as a ven­ture part­ner at Third Rock Ven­tures and has held roles in the past at Gold­man Sachs.

Kris­ten Har­ring­ton-Smith

→ No­var­tis hema­tol­ogy vet Kris­ten Har­ring­ton-Smith has earned a seat on the board of di­rec­tors at eF­FEC­TOR Ther­a­peu­tics, which changed tac­tics with lead can­di­date tomivosert­ib a cou­ple weeks back. Har­ring­ton-Smith made a Peer Re­view ap­pear­ance in No­vem­ber when she was named chief com­mer­cial of­fi­cer at Im­muno­Gen.

→ San Diego-based Ver­sant spin­out Pipeline Ther­a­peu­tics, a neu­rore­gen­er­a­tion biotech that racked up $80 mil­lion in a Se­ries C a year ago, has added Eef Schim­melpen­nink to the board of di­rec­tors. Schim­melpen­nink is the CEO of Lenz Ther­a­peu­tics, a com­pa­ny once known as Pres­by­opia Ther­a­pies that al­so has Ver­sant con­nec­tions.

→ Mi­a­mi cell ther­a­py biotech Longeveron has ap­point­ed Todd Giro­lamo to the board of di­rec­tors. Giro­lamo is chief le­gal of­fi­cer, SVP of cor­po­rate de­vel­op­ment and cor­po­rate sec­re­tary for Cal­adrius Bio­sciences and has been a part of its team for 11 years.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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