Chris Roberts jumps back in­to biotech with CSO gig at Black Di­a­mond; Trou­bled Five Prime ap­points in­ter­im CEO

Chris Roberts Black Di­a­mond

→ Af­ter spend­ing two years as en­tre­pre­neur-in-res­i­dence at SR One — the ven­ture arm of his for­mer em­ploy­er, Glax­o­SmithK­line Chris Roberts is back at the front­lines of biotech.

As CSO of Black Di­a­mond Ther­a­peu­tics, Roberts joins CEO David Ep­stein in dri­ving their tar­get­ed ki­nase in­hibitors to­ward the clin­ic. He will lead re­search and ear­ly de­vel­op­ment on the biotech’s MAP plat­form, which ze­roes in on al­losteric mu­ta­tions of onco­genes. Its lead can­di­date, BDTX-189, tar­gets EGFR and HER2 re­gard­less of tu­mor type.

Can­cer, and par­tic­u­lar­ly ge­net­ic dri­vers of the dis­ease, was some­thing Roberts had some ex­pe­ri­ence with as VP of chem­istry and ear­ly de­vel­op­ment at Sy­ros, where he fo­cused on drug­ging tran­scrip­tion and was cred­it­ed for guid­ing two as­sets in­to clin­i­cal de­vel­op­ment. Be­fore that, he had spear­head­ed in­fec­tious dis­ease projects at GSK and Genelabs

Cam­bridge, MA-based Black Di­a­mond has al­so re­cruit­ed Matt Lu­cas from Yu­man­i­ty Ther­a­peu­tics to lead chem­istry and Tai-An Lin from Mer­ck KGaA to lead bi­ol­o­gy. Its first Phase I/II tri­al is slat­ed for the first half of next year.

Things haven’t been the same for can­cer-fo­cused Five Prime Ther­a­peu­tics, ever since their part­nered drug cabi­ral­izum­ab in com­bi­na­tion with Op­di­vo showed signs of weak ef­fi­ca­cy and a trou­bling safe­ty pro­file in an ear­ly-stage pan­cre­at­ic can­cer study in late 2017. As a re­sult of that fail­ure, the com­pa­ny axed 41 jobs in Jan­u­ary — rough­ly 20% of the com­pa­ny’s work­force — to fo­cus on late-stage pipelines. The South San Fran­cis­co-based com­pa­ny has tapped William “Bill” Ringo as act­ing in­ter­im CEO, suc­ceed­ing Aron Knicker­bock­er “who has re­signed from the com­pa­ny to pur­sue new chal­lenges and op­por­tu­ni­ties.” Cur­rent­ly, Ringo is the chair­man of com­pa­ny’s board of di­rec­tors  — and de­spite his tem­po­rary new role, will re­main in that po­si­tion. Ringo’s past ex­pe­ri­ence in­cludes pres­i­dent and CEO of Ab­genix and gigs at Pfizer and Eli Lil­ly.

Nadir Mah­mood Nkar­ta

→ Af­ter NASH con­tender CymaBay Ther­a­peu­tics re­leased neg­a­tive da­ta back in June show­ing that its lead drug se­ladel­par per­formed worse than a place­bo at a three-month read­out from its on­go­ing 52-week mid-stage study, the com­pa­ny’s stock plum­met­ed about 44.5%. Now, its CMO Pol Boudes is hit­ting the ex­it “to ex­plore oth­er op­por­tu­ni­ties.” Be­fore join­ing CymaBay, Boudes served in the same po­si­tion at Am­i­cus Ther­a­peu­tics and held oth­er stints at Berlex Lab­o­ra­to­ries (lat­er merged with Bay­er Health­Care Phar­ma­ceu­ti­cals), Wyeth-Ay­erst Re­search, Hoff­mann-La Roche and Pas­teur-Merieux Serums & Vac­cines. The com­pa­ny has ini­ti­at­ed a search for a suc­ces­sor. 

→ Fol­low­ing plans to map out clin­i­cal man­u­fac­tur­ing of CAR-NK af­ter a $114 mil­lion Se­ries B round led by Sam­sara ear­li­er this month, Nkar­ta Ther­a­peu­tics has pro­mot­ed Nadir Mah­mood from SVP, cor­po­rate de­vel­op­ment to the new­ly-cre­at­ed po­si­tion of CBO. Mah­mood pre­vi­ous­ly head­ed cor­po­rate de­vel­op­ment at Sec­ond Genome and brings ex­pe­ri­ence from roles at Kythera Bio­phar­ma­ceu­ti­cals (ac­quired by Al­ler­gan) — where he over­saw the pre­clin­i­cal re­search for their lead mol­e­cule, Ky­bel­la — and Gold­man Sachs

An­drew Sto­ber En­cod­ed

→ Back in June, Or­chard Ther­a­peu­tics an­nounced the pric­ing of its IPO — 9 mil­lion Amer­i­can de­posi­tary shares (ADSs) for to­tal gross pro­ceeds of about $128 mil­lion. Now, the UK gene ther­a­py de­vel­op­er has an­nounced that its CCO, Ja­son Meyen­burg is leav­ing the com­pa­ny “to take on a chief ex­ec­u­tive role in the in­dus­try.” Un­til the com­pa­ny can find a per­ma­nent re­place­ment, Mark Rothera, the com­pa­ny’s pres­i­dent and CEO, will as­sume glob­al com­mer­cial lead­er­ship re­spon­si­bil­i­ties. 

→ Gene ther­a­py-fo­cused En­cod­ed Ther­a­peu­tics has ex­pand­ed its lead­er­ship team with the ap­point­ments of An­drew Sto­ber as chief man­u­fac­tur­ing of­fi­cer and David Mc­N­inch as CBO. Sto­ber joins the com­pa­ny af­ter lead­ing gene ther­a­py man­u­fac­tur­ing at No­var­tis and af­ter roles at AveX­is, Bio­gen, Mer­ck and Am­gen. Pre­vi­ous­ly, Mc­N­inch served as chief com­mer­cial of­fi­cer at Prothena and dur­ing his stint at In­ter­Mune he helped or­ga­nize the launch of the first treat­ment for IPF and the com­pa­ny’s lat­er ac­qui­si­tion by Roche. Mc­N­inch al­so spent time at Ipsen, Genen­tech, No­var­tis and As­traZeneca pri­or to his new gig.

David Mc­N­inch En­cod­ed

→ In April, Ever­est Med­i­cines inked a deal with Im­munomedics — mak­ing it one of the top 5 in-li­cens­ing com­pa­nies in Chi­na in the past 11 years. Ever­est is now bol­ster­ing its team with sev­er­al new ap­point­ments. Ja­son Brown, who has been serv­ing as the com­pa­ny’s SVP of busi­ness de­vel­op­ment, has been ap­point­ed to the po­si­tion of CBO. In ad­di­tion to his ap­point­ment, Ever­est has named pre­vi­ous Sanofi ex­ec, Frank Grams, as SVP of al­liance man­age­ment; for­mer Sanofi Chi­na head, Sophia Zhu, as SVP of port­fo­lio de­vel­op­ment and strate­gic plan­ning; Ex-Ab­bott gen­er­al man­ag­er, Alex Wang, as head of in­ter­na­tion­al busi­ness and for­mer head of fi­nance of Am­gen Chi­na, Daniel Weng, as vice pres­i­dent of fi­nance.

Flag­ship-backed Foghorn Ther­a­peu­tics has ex­pand­ed its lead­er­ship with the ap­point­ments of Samuel Agres­ta as CMO and Al­lan Reine as CFO. Agres­ta for­mer­ly served in the same po­si­tion at In­fin­i­ty Phar­ma­ceu­ti­cals — and has worked as vice pres­i­dent and head of clin­i­cal de­vel­op­ment at Agios Phar­ma­ceu­ti­cals, where he over­saw the de­vel­op­ment and reg­is­tra­tion of ivosi­denib (Tib­so­vo) and enasi­denib (Id­hi­fa). Reine hops on board af­ter serv­ing in the same po­si­tion at Pieris Phar­ma­ceu­ti­cals. Stints at Lom­bard Odi­er As­set Man­age­ment, SAC Cap­i­tal Ad­vi­sors and Alexan­dra In­vest­ment Man­age­ment dot Reine’s re­sume.

Salarius Phar­ma­ceu­ti­cals has ap­point­ed Scott Jor­dan on board as CBO and Mark Rosen­blum as ex­ec­u­tive vice pres­i­dent fi­nance and in­ter­im CFO. With these new ad­di­tions, the com­pa­ny can fur­ther op­er­a­tions in its lead clin­i­cal pro­grams in Ew­ing sar­co­ma and ad­vanced sol­id tu­mors to aim at pro­duc­ing po­ten­tial da­ta in 2020. Jor­dan tran­si­tioned to the role af­ter serv­ing as Salarius’ CFO. Pre­vi­ous­ly, he served as CFO at Be­ta Cat Phar­ma­ceu­ti­cals and chief in­vest­ment of­fi­cer at Stingray Ther­a­peu­tics. He’s al­so the co-founder and ad­vi­sor at Health­ios Xchange. Rosen­blum was pre­vi­ous­ly brought on to the com­pa­ny as a fi­nan­cial con­sul­tant to as­sist with the merge with Flex Phar­ma. Pri­or to that role, Rosen­blum served as chair­man and CEO at Ac­tive­Care.

→ Prince­ton, New Jer­sey-based Oys­ter Point Phar­ma has wel­comed Dan Lochn­er as CFO and John Snis­arenko as CCO. Lochn­er joins af­ter a gig as man­ag­ing di­rec­tor at Gold­man Sachs. Snis­arenko hops over to the com­pa­ny fol­low­ing time as group vice pres­i­dent and head of Shire’s (now Take­da) oph­thalmic busi­ness, lead­ing sales for Xi­idra, Lu­cen­tis, Rit­ux­an and Actem­ra.

in­sitro — led by AI star Daphne Koller — has added Matthew Ras­mussen as vice pres­i­dent of da­ta en­gi­neer­ing and Du­ane Valz as gen­er­al coun­sel. Ras­mussen joins the com­pa­ny from Myr­i­ad Ge­net­ics as vice pres­i­dent of soft­ware en­gi­neer­ing and a pre­vi­ous stint at Coun­syl. Valz joins from Zymer­gen — where he served as the com­pa­ny’s first in-house lawyer and gen­er­al coun­sel, help­ing to struc­ture their Se­ries B and C fi­nanc­ings. Valz held pre­vi­ous po­si­tions at Google, Ya­hoo! and Howard Rice Ne­merovs­ki Canady Falk & Rabkin (now com­bined with Arnold & Porter). 

→ Back in Ju­ly, Cel­gene col­lab­o­rat­ed with Nim­bus Ther­a­peu­tics to bag an op­tion for their ‘high­ly prized’ I/O tar­get, an HPK1 in­hibitor pro­gram. Now, Chris­tine Loh has joined Nim­bus as their SVP, head of bi­ol­o­gy af­ter spend­ing time as the vice pres­i­dent of trans­la­tion­al med­i­cine at Kymera Ther­a­peu­tics. Pre­vi­ous­ly, she served as the ex­ec­u­tive di­rec­tor of re­search — fo­cus­ing on he­mo­phil­ia and sick­le cell dis­ease — at Bio­gen spin­out Biover­a­tiv. She has held po­si­tions at Sir­tris, Pfiz­er and ICOS Cor­po­ra­tion

X4 Phar­ma­ceu­ti­cals — which col­lab­o­rat­ed with the Leukemia & Lym­phoma So­ci­ety in May to ac­cel­er­ate the de­vel­op­ment of their lead prod­uct can­di­date ma­vorix­afor for the treat­ment of Walden­ström’s macroglob­u­line­mia — has named one of its orig­i­nal founders, Re­na­to Skerlj, as SVP, re­search and de­vel­op­ment. He draws from his ex­pe­ri­ence as the in­ven­tor of both pler­ix­afor, a stem cell mo­bi­liz­er ap­proved by the FDA in 2008, and er­tapen­em, an an­ti-bac­te­r­i­al ap­proved by the FDA in 2001. Skerlj’s re­sume in­cludes gigs at Lyso­so­mal Ther­a­peu­tics, Gen­zyme and AnorMED

Vi­nee­ta Be­langer Busi­ness Wire

→ Two years af­ter Zosano Phar­ma re­port­ed pos­i­tive Phase III da­ta for its mi­cronee­dle patch sys­tem for de­liv­er­ing an old mi­graine drug — set­ting up a cam­paign to file an NDA — the com­pa­ny has brought on Dushyant Pathak as SVP of busi­ness de­vel­op­ment. Most re­cent­ly, Pathak served as the as­so­ciate vice chan­cel­lor of re­search, in­no­va­tion and tech­nol­o­gy com­mer­cial­iza­tion, as well as the ex­ec­u­tive di­rec­tor of Ven­ture Cat­a­lyst  at Uni­ver­si­ty of Cal­i­for­nia Davis. Pathak brings ex­pe­ri­ence from his times at iP­ier­ian, as CEO and pres­i­dent of Cellex­i­con, founder of Ven­tureEdge and roles at Axys Phar­ma­ceu­ti­cals and Ch­i­ron

→ While their lead drug can­di­date LYR-210 is in Phase II for the treat­ment of chron­ic rhi­nos­i­nusi­tis, ear, nose and throat dis­eases, Lyra Ther­a­peu­tics has added Vi­nee­ta Be­langer as the com­pa­ny’s SVP of clin­i­cal af­fairs. Be­langer most re­cent­ly served as vice pres­i­dent of clin­i­cal af­fairs at Ave­dro and has held po­si­tions at Iron­wood Phar­ma­ceu­ti­cals, Neu­ro­Vi­sion and Al­con.

Pe­ter Catal­i­no has as­sumed a new gig at Ver­tex as SVP, head glob­al mar­ket­ing. He tran­si­tions to the com­pa­ny af­ter time as glob­al busi­ness fran­chise head car­dio-meta­bol­ic med­i­cines at No­var­tis. While at No­var­tis he worked un­der Paul Hud­son — crank­ing out block­buster heart drug En­tresto  and con­tribut­ing to the Akcea-Io­n­is li­cense deal. Pre­vi­ous­ly, Catal­i­no was an as­so­ciate prin­ci­pal at McK­in­sey & Com­pa­ny

→ Last week, Soli­genix brought Jonathan Guar­i­no on board as their SVP and CFO, suc­ceed­ing Karen Krume­ich who hit the ex­it to pur­sue new op­por­tu­ni­ties. This week the com­pa­ny made the ad­di­tion of Mer­ck vet Daniel Ring as vice pres­i­dent of busi­ness de­vel­op­ment and strate­gic plan­ning. Ring brings ex­pe­ri­ence from his time as vice pres­i­dent of busi­ness de­vel­op­ment at Ex­ela Phar­ma Sci­ences and as ex­ec­u­tive di­rec­tor of cor­po­rate li­cens­ing at Mer­ck

Allen Poir­son has hopped to twoXAR as the com­pa­ny’s SVP of bio­phar­ma­ceu­ti­cal busi­ness de­vel­op­ment. Be­fore join­ing the AI-dri­ven com­pa­ny, Poir­son served as a part­ner at Sil­i­con Val­ley-based VC firm Mighty Cap­i­tal. He for­mer­ly served as the CEO of Sony sub­sidiary Sony Biotech­nol­o­gy and held po­si­tions at NASA and Howard Hugh­es Med­ical In­sti­tute

→ Med­ical de­vice com­pa­ny, BioVen­trix, has tapped Pe­dro Mar­ques as vice pres­i­dent of sales for the Eu­ro­pean mar­ket. Mar­ques pre­vi­ous stints in­clude roles as vice pres­i­dent of glob­al ac­cess and clin­i­cal de­vel­op­ment at Medtron­ic and as VP of in­ter­na­tion­al sales for Heart­Ware

Bio­Th­eryX — fo­cused on mul­ti-ki­nase in­hi­bi­tion and tar­get­ed pro­tein degra­da­tion — has wel­comed Al­ler­gan vet Jef­frey Ed­wards to its board of di­rec­tors. Ed­wards spent 22 years at Al­ler­gan — hold­ing sev­er­al roles in­clud­ing EVP, fi­nance and busi­ness de­vel­op­ment and CFO. 

Ted Love, cur­rent pres­i­dent and CEO of Glob­al Blood Ther­a­peu­tics — which re­cent­ly re­ceiv­ing pri­or­i­ty re­view from the FDA for its sick­le cell dis­ease drug — has joined the board of di­rec­tors at Por­to­la Phar­ma­ceu­ti­cals. Love pre­vi­ous­ly worked at Onyx Phar­ma­ceu­ti­cals, Nu­velo, Ther­a­vance and Genen­tech.

→ Cam­bridge-based Verve Ther­a­peu­tics — who is purs­ing a gene-edit­ing ap­proach to coro­nary artery dis­ease — can now count An­drew Geall, as a mem­ber of the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry board. Geall is the vice pres­i­dent of for­mu­la­tions, an­a­lyt­ics and chem­istry at Avid­i­ty Bio­sciences

→  An­a­lysts hate to lose a biotech CFO they’ve come to trust and ad­mire — es­pe­cial­ly if they’re be­ing blind­sided by a sur­prise ex­it. And Alex­ion’s un­ex­pect­ed an­nounce­ment af­ter the mar­ket close on Tues­day that Paul Clan­cy is on his way out — to be re­placed by a strat­e­gy and busi­ness chief they know vir­tu­al­ly noth­ing about — qual­i­fied as a nasty shock for some high-pro­file com­pa­ny ob­servers. 

Arad­hana Sarin

The Q3 re­port will be a joint ef­fort of Clan­cy and his re­place­ment, Arad­hana Sarin, who will then pick up the CFO job as Clan­cy con­tin­ues to ad­vise the com­pa­ny in­to the mid­dle of next year. So what’s up with that? Clan­cy on­ly ar­rived 2 years ago, step­ping in from Bio­gen, where he al­so com­mand­ed lots of re­spect in a spot­light po­si­tion.

His hir­ing was seen as a coup for Alex­ion watch­ers, as CEO Lud­wig Hantson put to­geth­er his new team, re­or­ga­nized the com­pa­ny af­ter a bruis­ing in­ves­ti­ga­tion over ethics vi­o­la­tions, moved to Boston and laid out his ba­sic strat­e­gy on pro­tect­ing the big Soliris fran­chise. Sarin will take over with a lot to prove. And some an­a­lysts are set­ting the bar high. 

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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