Genen­tech gains clin­i­cal de­vel­op­ment ex­ec by ap­point­ing Lil­li Petruzzel­li; Paul Sekhri caps event­ful week, nam­ing Sap­na Sri­vas­ta­va CFO of eGe­n­e­sis

Lil­li Petruzzel­li

→ A spokesper­son for Genen­tech tells End­points News that Lil­li Petruzzel­li has forged a new path this week as SVP, ear­ly clin­i­cal de­vel­op­ment at Genen­tech’s Re­search and Ear­ly De­vel­op­ment or­ga­ni­za­tion (gRED). Petruzzel­li just spent two years as In­cyte’s group VP, ear­ly clin­i­cal de­vel­op­ment, and pri­or to In­cyte, she was glob­al head, trans­la­tion­al clin­i­cal on­col­o­gy at the No­var­tis In­sti­tutes of Bio­med­ical Re­search.

“Lil­li Petruzzel­li has a re­mark­able track record of part­ner­ing close­ly with dis­cov­ery teams to ad­vance in­no­v­a­tive mol­e­cules from re­search in­to first-in-hu­man stud­ies and through proof-of-con­cept,” Genen­tech’s head of gRED Aviv Regev said in a state­ment.

Sap­na Sri­vas­ta­va

→ Just a cou­ple days af­ter their Se­ries C haul, Paul Sekhri-led eGe­n­e­sis has a new CFO in place with Sap­na Sri­vas­ta­va. She’s pre­vi­ous­ly been chief fi­nan­cial and strat­e­gy of­fi­cer at Abide Ther­a­peu­tics, which Lund­beck ac­quired in the spring of 2019 in a $250 mil­lion deal. The ex-Mor­gan Stan­ley and Gold­man Sachs biotech an­a­lyst was al­so chief fi­nan­cial and strat­e­gy of­fi­cer at In­tel­lia Ther­a­peu­tics. Since its de­but three years ago this month, eGe­n­e­sis — which has been ge­net­i­cal­ly al­ter­ing pigs for the pur­pose of or­gan trans­plan­ta­tion in hu­mans — has to­taled more than $263 mil­lion in fund­ing, with al­most half ($125 mil­lion) com­ing in this week’s megaround.

→ While you or some­one you know have re­ceived their mR­NA vac­cine, Mod­er­na is fill­ing out lead­er­ship po­si­tions re­lat­ed to oth­er tar­gets, with Jonathan Hog­gatt locked in as di­rec­tor of hema­tol­ogy. Hog­gatt is a prin­ci­pal fac­ul­ty mem­ber at the Har­vard Stem Cell In­sti­tute and runs the Hog­gatt Lab, which con­cen­trates on tis­sue re­gen­er­a­tion and stem cell bi­ol­o­gy. He’s al­so a sci­en­tif­ic co-founder of Ma­gen­ta Ther­a­peu­tics.

Christophe Bour­don

Or­p­hazyme had been bask­ing in the glow of the FDA ac­cept­ing its NDA a few months ear­li­er for ari­mo­clo­mol in Nie­mann-Pick dis­ease type C pa­tients, and now Christophe Bour­don is helm­ing the Dan­ish biotech af­ter Kim Strat­ton de­cid­ed to re­sign Dec. 20. Bour­don takes con­trol at the Copen­hagen com­pa­ny af­ter his sec­ond stint at Am­gen, where he was SVP and GM of the US on­col­o­gy busi­ness. The Sanofi vet was Alex­ion’s SVP of Eu­rope, Mid­dle East, Africa, and Cana­da (EMEAC) in a two-year stay that was sand­wiched in be­tween his time at Am­gen.

Mark Sten­house

Pen­cil­ing in a $125 mil­lion IPO last month af­ter scor­ing $130 mil­lion in fund­ing back in No­vem­ber, Mark McKen­na-led Prometheus Bio­sciences is hand­ing the role of COO to Mark Sten­house. He’s an Ab­b­Vie vet of al­most 30 years (1990-2018) who was the phar­ma gi­ant’s VP of US im­munol­o­gy and, be­fore that, VP and GM of the gas­troen­terol­o­gy fran­chise. In all, he spent 10 years with Ab­b­Vie in IBD, which is San Diego-based Prometheus’ fo­cus. Af­ter Ab­b­Vie, Sten­house was GM, screen­ing busi­ness at Ex­act Sci­ences, lead­ing com­mer­cial du­ties with the col­orec­tal can­cer de­tec­tion test Co­lo­guard.

Joel Schnei­der

Sol­id Bio’s clin­i­cal hold for its Duchenne mus­cu­lar dy­s­tro­phy drug lift­ed last Oc­to­ber, fend­ing off re­peat­ed slings and ar­rows from the FDA. Now Sol­id has pro­mot­ed Joel Schnei­der to COO and Erin Pow­ers Bren­nan is on board as chief le­gal of­fi­cer. Schnei­der — who was chief tech­ni­cal of­fi­cer and head of ex­plorato­ry R&D be­fore set­tling in his new gig on Tues­day — has spent sev­en years at Sol­id over­all, while Bren­nan leaves Cov­etrus, where she was SVP, gen­er­al coun­sel & sec­re­tary. Else­where at Sol­id, for­mer Glax­o­smithK­line and Pfiz­er reg­u­la­to­ry ex­ec Clare Kahn and ex-Take­da COO of R&D Geor­gia Ker­esty have been waved in to the Cam­bridge biotech’s board of di­rec­tors.

Si­mon Coop­er has suc­ceed­ed John Ryan as CMO of Kad­mon as Ryan piv­ots to the new role of ex­ec­u­tive med­ical di­rec­tor, clin­i­cal and reg­u­la­to­ry de­vel­op­ment. Coop­er has cer­tain­ly made the Big Phar­ma rounds as a clin­i­cal sci­ence leader at Roche, a glob­al pro­gram di­rec­tor at No­var­tis, the glob­al project head for im­munol­o­gy and in­flam­ma­tion at Sanofi, and as­set strat­e­gy di­rec­tor for Skyrizi with Ab­b­Vie. Af­ter his work with those heavy hit­ters, Coop­er took his first CMO gig with Anokion in 2019 be­fore of­fi­cial­ly start­ing at Kad­mon on Mon­day.

Sean Zhang

→ Bei­jing-based can­cer biotech In­no­Care, which racked up $289 mil­lion in its Hong Kong IPO in March 2020, has brought on Sean Zhang as CMO, leav­ing his CEO post at Hen­grui Ther­a­peu­tics. Be­fore get­ting pro­mot­ed to the top spot, Zhang was Hen­grui’s CMO and a board mem­ber. He too has hop­scotched around Big Phar­ma most of his ca­reer, first as a re­search sci­en­tist in Mer­ck and then as a clin­i­cal leader at J&J. He al­so spent four years in dis­cov­ery med­i­cine and clin­i­cal phar­ma­col­o­gy at Bris­tol My­ers Squibb and an­oth­er three years in clin­i­cal de­vel­op­ment at Glax­o­SmithK­line.

Aa­van­tiBioBo Cum­bo’s post-Sarep­ta gene ther­a­py en­deav­or — has en­trust­ed the CFO and trea­sur­er du­ties to Dou­glas Swirsky sev­er­al months af­ter tak­ing the tarp off with a meaty $107 mil­lion launch round. Swirsky, who had been in a con­sult­ing role at Aa­van­tiBio since Feb­ru­ary, helmed Rex­ahn Phar­ma­ceu­ti­cals for two years and has al­so been pres­i­dent and CEO of Gen­Vec. He al­so chairs the board of di­rec­tors at Cel­lec­tar Bio­sciences and Neu­roBo Phar­ma­ceu­ti­cals.

Wildon Far­well

→ With its oligonu­cleotide ther­a­py pipeline for rare mus­cle dis­eases in de­vel­op­ment, 2020 IPO boom par­tic­i­pant Dyne Ther­a­peu­tics has cor­ralled Wildon Far­well as CMO soon af­ter Ash Dugar was ap­point­ed glob­al head of med­ical af­fairs. Far­well spent a decade at Bio­gen, lead­ing the de­vel­op­ment of oligonu­cleotide Spin­raza and hold­ing nu­mer­ous posts that cul­mi­nat­ed in his role as VP, glob­al head of neu­ro­mus­cu­lar dis­eases, med­ical af­fairs.

Jes­si­ca Stitt

→ Fresh off sparkling da­ta for AMD gene ther­a­py GT005, Lon­don-based Gy­ro­scope Ther­a­peu­tics has wel­comed Jes­si­ca Stitt as CFO. Stitt, who’s al­so held fi­nance po­si­tions at Alk­er­mes and Ther­a­vance, was pre­vi­ous­ly VP of fi­nance and op­er­a­tions at MyoKar­dia, which Bris­tol My­ers Squibb swooped in to buy for more than $13 bil­lion back in Oc­to­ber.

→ New York-based An­ti­body Ra­di­a­tion-Con­ju­gate (ARC) phar­ma Ac­tini­um ap­point­ed two clin­i­cal de­vel­op­ment ex­ecs (Avinash De­sai and Mary Mei Chen) in a two-week span late last fall, and now Mark Ku­bik has ac­cept­ed the role of Ac­tini­um’s CBO. A for­mer busi­ness de­vel­op­ment di­rec­tor at such biotechs as Macro­Gen­ics and Seat­tle Ge­net­ics (now Seagen), Ku­bik makes the tran­si­tion to Ac­tini­um af­ter a brief stay as CBO at On­coIm­mune, which Mer­ck bought for $425 mil­lion in a deal that was bro­kered by then-Op­er­a­tion Warp Speed chief Mon­cef Slaoui.

Mary Kay Fen­ton

→ Long­time Achillion CFO Mary Kay Fen­ton will take on the same re­spon­si­bil­i­ty at Ta­laris Ther­a­peu­tics, which land­ed a $115 mil­lion Se­ries B in its quest to help make or­gan trans­plan­ta­tion safer for pa­tients. Fen­ton was VP of strate­gic op­er­a­tions at Ver­tex’s cell and ge­net­ic ther­a­pies unit, and had been Sem­ma’s CFO and COO be­fore Ver­tex bought the com­pa­ny for $950 mil­lion in 2019.

→ Six months af­ter Sven Rohmann grabbed hold of the reins as CEO, Swedish can­cer biotech Im­mu­nicum AB has tapped Jeroen Rovers to be CMO. Rovers hails from DCprime, an­oth­er den­drit­ic cell ther­a­py out­fit which merged with Im­mu­nicum to­ward the end of last year, where he had been CMO since 2018. The ex-CMO at Kiadis and Ceron­co Bio­sciences re­places Pe­ter Sue­naert, who sticks with Im­mu­nicum as a clin­i­cal ad­vi­sor. Rovers’ ap­point­ment fol­lows that of Lot­ta Ferm as in­ter­im CFO and comes af­ter Im­mu­nicum’s or­phan drug des­ig­na­tion for il­ix­aden­cel to treat he­pa­to­cel­lu­lar car­ci­no­ma.

Al­i­son Schecter

Flag­ship-backed Ax­cel­la, which has lead drug can­di­dates for NASH and he­pat­ic en­cephalopa­thy in its pipeline, has made Al­i­son Schecter pres­i­dent of R&D af­ter com­plet­ing a year as CMO of Se­lec­ta Bio­sciences. Just be­fore that, Schecter was Sanofi Gen­zyme’s glob­al project head, rare dis­eases and the glob­al pro­gram head for he­mo­phil­ia at Bax­al­ta. She al­so brings ex­pe­ri­ence from the North­east J&J In­no­va­tion Cen­ter and the No­var­tis In­sti­tutes of Bio­med­ical Re­search.

Schond Green­way is jump­ing on board as CFO of Cere­cor, suc­ceed­ing Chris Sul­li­van, who had been in the in­ter­im CFO slot for a year and will now be­come the Mary­land phar­ma’s chief ac­count­ing of­fi­cer. Green­way had pre­vi­ous­ly been Mesoblast’s VP, in­vestor re­la­tions and was al­so an ex­ec­u­tive di­rec­tor in in­vestor re­la­tions at Halozyme.

→ Strik­ing up a $10 mil­lion up­front pact with Sarep­ta last sum­mer to de­vel­op im­li­fi­dase as a pre-treat­ment for DMD and LGMD pa­tients, Hansa Bio­phar­ma out of Swe­den has giv­en the nod to Mag­nus Ko­rs­gren to be head of R&D. An As­traZeneca and No­var­tis vet, Ko­rs­gren has de­vot­ed the last six years to Fer­ring Phar­ma­ceu­ti­cals, more re­cent­ly as VP, head of trans­la­tion­al med­i­cine.

Ger­ald Cox

→ Ex-Ed­i­tas Med­i­cine CMO Ger­ald Cox has been named act­ing CMO at Gainesville, FL biotech Cy­clo Ther­a­peu­tics, which is work­ing on cy­clodex­trin-based drugs that tar­get Nie­mann-Pick dis­ease type C and Alzheimer’s. Cox, a long­time staff physi­cian at Boston Chil­dren’s Hos­pi­tal, had spent more than 15 years at Gen­zyme, leav­ing as VP of rare dis­ease clin­i­cal de­vel­op­ment be­fore his two years at Ed­i­tas.

Gary Sender has re­tired as CFO of Dublin-based Nabri­va Ther­a­peu­tics, and start­ing March 12, Daniel Dolan will take his place. The 12-year Shire vet had been Ra­dius Health’s VP of fi­nan­cial plan­ning & analy­sis since 2017. Nabri­va got side­tracked with a CRL in June 2020 for its an­tibi­ot­ic Con­tepo, with man­u­fac­tur­ing is­sues at Nabri­va’s Eu­ro­pean CMO site as the main cul­prit. Nabri­va pinned the lack of re­sponse to the FDA’s con­cerns on trav­el re­stric­tions.

Leonard Pao­lil­lo

→ Seat­tle-based Im­pel Neu­roPhar­ma, with its pri­ma­ry fo­cus on CNS dis­eases, has a pair of new faces with Leonard Pao­lil­lo as chief com­mer­cial of­fi­cer and Ger­ald Penn as VP, mar­ket ac­cess & trade. Pao­lil­lo makes the leap from Ky­owa Kirin’s North Amer­i­can af­fil­i­ate, where he was EVP and CCO, while Penn just held the same ti­tle at Es­pe­ri­on that he does at Im­pel Neu­roPhar­ma. The new lead­er­ship comes af­ter Im­pel Neu­roPhar­ma brought Amarin alum Rigo Canal in­to the fold as VP, com­mer­cial op­er­a­tions and an­a­lyt­ics.

→ British biotech 4D phar­ma got in on the SPAC ac­tion, merg­ing with blank check com­pa­ny Longevi­ty back in Oc­to­ber, and in an­tic­i­pa­tion of break­ing through on Nas­daq, the mi­cro­bio­me play­er has re­cruit­ed John Beck as CFO. Beck’s most re­cent CFO ex­pe­ri­ence was a two-year run at Rit­ter Phar­ma­ceu­ti­cals from 2018-20. Else­where at 4D phar­ma, ex-Lig­and and Se­quenom CFO Paul Maier has climbed on to the board as a non-ex­ec­u­tive di­rec­tor.

Nicholas Hols­man

→ Ire­land’s Shorla Phar­ma, which pulled in $8.3 mil­lion in a mod­est Se­ries A in June 2020, has en­list­ed Nicholas Hols­man as chief com­mer­cial of­fi­cer. Be­fore tran­si­tion­ing to the on­col­o­gy play­er, Hols­man had led com­mer­cial op­er­a­tions since the sum­mer of 2019 at On­copep­tides, now helmed by for­mer Toca­gen CEO Mar­ty Du­vall.

→ With pro­grams in se­vere in­flam­ma­to­ry dis­eases (ABX464) and he­pa­to­cel­lu­lar car­ci­no­ma (ABX196), Paris-based Abi­vax has se­lect­ed So­phie Biguenet as CMO, re­plac­ing the re­tir­ing Jean-Marc Steens. Biguenet’s Big Phar­ma ex­pe­ri­ence traces back to Bio­gen and Bris­tol My­ers Squibb and she’s been Ab­b­Vie’s med­ical di­rec­tor and pe­di­atric lead for HCV, RSV and HIV glob­al pe­di­atric clin­i­cal de­vel­op­ment. Biguenet joins Abi­vax af­ter hold­ing her first CMO post at Swiss biotech Ver­san­tis.

→ Ich­nos Sci­ences has re­cruit­ed Michael D Price as CFO. Price for­mer­ly served as VP and CFO of Akcea Ther­a­peu­tics and held po­si­tions at Novleion Ther­a­peu­tics, Noven Phar­ma­ceu­ti­cals and Bent­ley Phar­ma­ceu­ti­cals.

Byung Ha Lee

T-cell-fo­cused NeoIm­muneTech has pro­mot­ed Byung Ha Lee to the po­si­tion of CSO. Lee joined the com­pa­ny in 2016 as prin­ci­pal sci­en­tist be­fore be­ing named di­rec­tor of R&D in 2019. Pri­or to his roles at NeoIm­muneTech, Lee was at Sam­sung Bio­med­ical Re­search In­sti­tute and at Genex­ine.

→ A fa­mil­iar face and a new staffer have shored up the C-suite at Bay Area biotech Cor­cept Ther­a­peu­tics, with Atabak Mokari as CFO and his pre­de­ces­sor Charles Robb step­ping in as CBO. Mokari was pre­vi­ous­ly the CFO for Bel­licum, while Robb slides in­to the CBO po­si­tion af­ter nine years as Cor­cept’s CFO. Cor­cept’s drug Ko­r­lym was ap­proved in 2012 for en­doge­nous Cush­ing’s syn­drome.

Richard Pye

Sen­syne Health has named Richard Pye as CFO and ex­ec­u­tive di­rec­tor. Pye pre­vi­ous­ly served as chief in­vest­ment of­fi­cer for the com­pa­ny and hopped aboard from Sum­mit Ther­a­peu­tics. In ad­di­tion, the com­pa­ny’s in­ter­im CFO Michael Nor­ris and Ge­off Race are join­ing the board of di­rec­tors as non-ex­ec­u­tive di­rec­tors. Nor­ris is cur­rent­ly di­rec­tor and CFO of Beck­ley Psytech, while Race is the co-founder, EVP, CFO and CBO of Min­er­va Neu­ro­sciences.

ERS Ge­nomics has ap­point­ed Jon Kra­tochvil as VP for busi­ness de­vel­op­ment & li­cens­ing for North Amer­i­ca. Kra­tochvil hops aboard from Mil­l­li­pore­Sig­ma, where he was di­rec­tor of busi­ness de­vel­op­ment and li­cens­ing. His oth­er roles in­clude stints at Wash­ing­ton Uni­ver­si­ty and Ab­bott Lab­o­ra­to­ries.

eTh­eR­NA has reeled in David Rick­etts as con­sul­tant di­rec­tor of busi­ness de­vel­op­ment for man­u­fac­tur­ing ser­vices. Rick­etts comes aboard with ex­pe­ri­ence as CEO of Phar­ma­Di­ag­nos­tics and Link Tech­nolo­gies.

Mar­tin Chavez

Mar­tin Chavez has been elect­ed chair­man of the board at Chris Gib­son-helmed Re­cur­sion, the Salt Lake City drug de­vel­op­er that raised a hefty $239 mil­lion Se­ries D last Sep­tem­ber and is part­ner­ing with Bay­er on fi­brot­ic dis­eases. Chavez, a mem­ber of Re­cur­sion’s board for al­most a year, was with Gold­man Sachs from 2005-20 in a num­ber of ca­pac­i­ties such as chief in­for­ma­tion of­fi­cer, CFO and glob­al co-head of the Se­cu­ri­ties Di­vi­sion.

→ Plant-based tech com­pa­ny Ca­lyxt has pulled Yves Ribeill as ex­ec­u­tive chair of the board of di­rec­tors as the com­pa­ny ini­ti­ates a search for a new CEO to suc­ceed ex­it­ing Jim Blome, who is pur­su­ing oth­er op­por­tu­ni­ties. Ribeill has served on the board of di­rec­tors for Ca­lyxt since Ju­ly 2018 and for a time served as the com­pa­ny’s in­ter­im CEO from Au­gust 2018 to Oc­to­ber 2018. Ribeill is the CEO of Ri­bo­gen­ics and a founder and for­mer CEO of Scynex­is. Pri­or to these roles, he served at Rhône-Poulenc and Aven­tis in France and the UK.

Don­nie Mc­Grath

→ Along with this week’s news of Ar­ti­zan Bio­sciences’ $11 mil­lion Se­ries A-2 round and a part­ner­ship with Bio­haven, New Haven, CT-based Ar­ti­zan Bio­sciences is al­so adding Don­nie Mc­Grath and Seth Rud­nick to the board of di­rec­tors. A Bris­tol My­ers Squibb alum, Mc­Grath is Bio­haven’s chief of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment, and ex-Canaan part­ner Rud­nick was chair­man and CEO of Cy­toTher­a­peu­tics.

Robert Gagnon has joined the board of di­rec­tors at Is­raeli on­col­o­gy out­fit Pur­ple Biotech. The Bio­gen alum has been Ve­rastem’s chief busi­ness and fi­nan­cial of­fi­cer since 2018.

June Bray

BioX­cel has re­served a seat for Al­ler­gan vet June Bray on its board of di­rec­tors. Bray, who’s served as Al­ler­gan’s SVP, glob­al reg­u­la­to­ry af­fairs and med­ical writ­ing, has al­so been a reg­u­la­to­ry ex­ec at Organon.

→ Red­wood City, Cal­i­for­nia-based Am­Max Bio has en­list­ed John Var­i­an for its board of di­rec­tors as an in­de­pen­dent board mem­ber. Var­i­an joins with ex­pe­ri­ence from his time as CEO and di­rec­tor of XO­MA. Pri­or to XO­MA, Var­i­an was COO of Aryx Phar­ma­ceu­ti­cals and CFO of An­er­gen, Genset and Neurex. Var­i­an al­so sits on the board of Stel­las Life Sci­ences.

→ Gas­troen­terol­o­gy com­pa­ny 9 Me­ters Bio­phar­ma has reeled in Michael Rice to its board of di­rec­tors. Rice is the co-founder and pres­i­dent of LifeSci Ad­vi­sors and the co-founder of LifeSci Cap­i­tal. Rice’s oth­er stints in­clude roles at Canac­cord Adams, ThinkE­quity, Bank of Amer­i­ca and JP­Mor­gan/Ham­brecht & Quist.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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Kenneth Galbraith, incoming Zymeworks CEO

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

New Zymeworks CEO Kenneth Galbraith is aiming to hit the ground running when his tenure officially begins next month, but he’ll be doing so with a much different looking team.

In a lengthy press release outlining the biotech’s 2022 goals, Galbraith said Zymeworks will be laying off at least 25% of its staff over the course of the year. Half of its C-suite will also be replaced immediately as Galbraith looks to remake the company in his image after Ali Tehrani, Zymeworks’ founder and CEO since 2003, stepped down two weeks ago.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.