Ex-DARPA di­rec­tor pur­sues all-in-one can­cer pill as NED CEO; Karyopharm los­es com­mer­cial chief ahead of drug roll­out

“Why not try?”

That’s what Ge­of­frey Ling told me over the phone when asked about what led him to his jour­ney to the po­si­tion of CEO at NED Bio­sciences — a com­pa­ny with a lofty goal of cre­at­ing an all-in-one oral drug to treat all types of can­cer and mak­ing this drug avail­able to not on­ly de­vel­oped na­tions, but al­so the de­vel­op­ing world. 

Ling comes from an ex­ten­sive back­ground in med­i­cine and the gov­ern­ment. He is the co-leader of The Brain Health Pro­ject, a pro­fes­sor of neu­rol­o­gy and an at­tend­ing neu­r­o­crit­i­cal care physi­cian at John Hop­kins Uni­ver­si­ty and Hos­pi­tal, as well as the as­sis­tant di­rec­tor for Med­ical In­no­va­tion of the Sci­ence Di­vi­sion in pres­i­dent Oba­ma’s White House Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP). 

Ling, a re­tired colonel, served for 27 years in the US mil­i­tary where he toured Iraq and Afghanistan. Af­ter his time serv­ing his coun­try, Ling joined as a pro­gram man­ag­er at the De­fense Ad­vanced Re­search Pro­jects Agency (DARPA) of the US De­part­ment of De­fense — re­spon­si­ble for fund­ing the de­vel­op­ment of mil­i­tary tech­nol­o­gy — where he be­came a found­ing di­rec­tor of the DARPA Bi­o­log­i­cal Tech­nolo­gies Of­fice. Af­ter wit­ness­ing young Amer­i­cans bad­ly in­jured, and hav­ing lost their arms, Ling want­ed to find a way to give back to his fel­low sol­diers and cre­ate a pros­thet­ic arm con­trolled by thought. And in the face of skep­ti­cism, six months lat­er, Ling and his team were able to cre­ate FDA-ap­proved, thought-con­trolled pros­thet­ics.

It was dur­ing his time at DARPA that Ling came in­to con­tact with NED when they came to the or­ga­ni­za­tion to ask for fund­ing. 

“I thought their ap­proach was very straight­for­ward, re­al­ly made a lot of sense to me,” he said. “When they came to me with this drug cock­tail of theirs, I looked at it and I re­al­ly ad­mired the phar­ma­col­o­gy be­hind it. I un­der­stood the sci­ence. Can we find a straight­for­ward way of treat­ing mul­ti­ple can­cer types, in­ex­pen­sive­ly and with low tox­i­c­i­ty? And I looked at it and I said ‘this is re­al­ly cool.’ And I said we got­ta find a way to make it work.”

He was pas­sion­ate about NED’s mis­sion and once he left DARPA, he hopped on­to NED’s board of di­rec­tors. When the com­pa­ny de­cid­ed to take their drug in­to hu­man clin­i­cal tri­als and start rais­ing funds, Ling stepped up to the chal­lenge. He said that the chal­lenges he per­ceives that he’ll have in this role will be sim­i­lar to the one he had at DARPA: dis­mis­sive­ness from oth­er peo­ple.

At DARPA we would al­ways take on ideas that were con­sid­ered to be im­pos­si­ble to do, hereti­cal to the cur­rent way that peo­ple are do­ing things and it’s so out of the box that peo­ple who think tra­di­tion­al­ly, they want to be dis­mis­sive even though its a cool thing. Like an in­vis­i­ble air­plane, they want to dis­miss it and you say, why are you dis­miss­ing it? If it worked wouldn’t it be great? But that’s not the way peo­ple think. Peo­ple think ‘oh, it’s too hard. It’s too ex­pen­sive. It’ll nev­er work.’ They’re dis­mis­sive. And that’s the prob­lem the NED folks are hav­ing. Peo­ple are say­ing ‘oh, this is not a new bi­o­log­i­cal. It is not us­ing a sin­gle drug ap­proach. It is not a brand spank­ing new drug. In fact, it’s bor­ing.’ And be­cause of that peo­ple are dis­miss­ing them out of hand with­out giv­ing them a fair shake.

In ad­di­tion to Ling’s ap­point­ment, Pe­ter D’Erri­co — cur­rent­ly the CFO of NED — will add COO to his ti­tle. 

→ The ex­o­dus from As­traZeneca fol­low­ing its big R&D re­or­ga­ni­za­tion con­tin­ues. Boaz Hir­sh­berg, VP and head of car­dio­vas­cu­lar, meta­bol­ic and re­nal dis­ease at Med­Im­mune, has joined BOL Phar­ma as CMO. The Is­raeli com­pa­ny prides it­self for be­ing an ear­ly play­er in the med­ical cannabis in­dus­try and as­pires to be a lead­ing sup­pli­er of cannabi­noid-based APIs to phar­ma, uni­ver­si­ties and oth­er in­sti­tu­tions.

Anand Varadan

→ On the same day Karyopharm bagged a con­tro­ver­sial FDA OK for its mul­ti­ple myelo­ma drug se­linex­or (Xpovio), the com­pa­ny qui­et­ly dis­closed that its chief com­mer­cial of­fi­cer has re­signed. Anand Varadan’s tenure last on­ly one year, dur­ing which he was cred­it­ed for lay­ing the ground­work for a prod­uct launch. Per­ry Mona­co, the cur­rent VP of sales, will take up more re­spon­si­bil­i­ty with some help from CEO Michael Kauff­man. 

→ Cam­bridge, MA-based Tia­ki Ther­a­peu­tics has re­cruit­ed Suzanne Bruhn as its new CEO. She takes over from in­ter­im CEO Bar­bara Tate, the chief strat­e­gy of­fi­cer of the De­men­tia Dis­cov­ery Fund. Her last post was as CEO of Proclara, which op­er­at­ed in a sim­i­lar field: neu­rode­gen­er­a­tion. Tia­ki has tar­get­ed im­mune cells of the brain — mi­croglia — in an at­tempt to ad­dress in­flam­ma­to­ry-dri­ven CNS dis­or­ders and pro­tect cog­ni­tive func­tion.

Kim Bran­son

GSK R&D chief Hal Bar­ron is aim­ing high for the phar­ma gi­ant’s crew for ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing. The phar­ma gi­ant poached their new chief of the AI/ML group from Genen­tech, tap­ping that tal­ent-rich tech zone in South San Fran­cis­co which Bar­ron — long based in the Bay Area — al­ways in­tend­ed to re­cruit from. Kim Bran­son — who was head of AI, ear­ly clin­i­cal de­vel­op­ment at Genen­tech — adds to Bar­ron’s list of lo­cal re­cruits, which in­cludes BD chief Kevin Sin. Bran­son’s glob­al team in­cludes Je­re­my Eng­land, a for­mer as­so­ciate pro­fes­sor at MIT fo­cused on the cross­roads of bi­ol­o­gy and physics. 

→ For the lat­est in his se­ries of biotech start­up gigs, Jay Mohr has opt­ed for the COO and CBO role at AZTher­a­pies as the com­pa­ny en­ters the fi­nal clin­i­cal stretch with a treat­ment for ear­ly Alzheimer’s dis­ease. Mohr, a found­ing mem­ber and part­ner emer­i­tus at Lo­cust Walk, had re­cent­ly left a pres­i­dent and CEO po­si­tion at Diri­go Ther­a­peu­tics. His ex­pe­ri­ence with part­ner­ships and prod­uct com­mer­cial­iza­tion, CEO David El­maleh said, is es­pe­cial­ly help­ful at a time reg­u­la­to­ry fil­ings loom large. AZTher­a­pies’ idea is to slow the pro­gres­sion of Alzheimer’s — an ail­ment that’s de­feat­ed vir­tu­al­ly every at­tempt to rein it in  — by tamp­ing down the neu­roin­flam­ma­tion that leads to neu­ronal death.

→ Ahead of a piv­otal read­out, NASH play­er Madri­gal Phar­ma is pro­mot­ing Re­bec­ca Taub to pres­i­dent of R&D, a new po­si­tion that gives her more over­sight over the pipeline. Taub, a founder and for­mer CEO of Madri­gal pri­or to its merg­er with Syn­ta, has been steer­ing resme­tirom (MG-3196) in the clin­ic as CMO.

San­jay Keswani

An­nex­on Bio­sciences has made sev­er­al re­cruit­ments to ex­pand its se­nior lead­er­ship team to help ad­vance its two mon­o­clon­al an­ti­body prod­uct can­di­dates, ANX005 and ANX007 — used for the treat­ment of au­toim­mune and neu­rode­gen­er­a­tive dis­or­ders. The com­pa­ny wel­comed San­jay Keswani as CMO, Jen­nifer Lew as CFO and Les­ley Stolz as CBO. 

Keswani brings over 20 years of ex­pe­ri­ence to the po­si­tion, hop­ping over to the com­pa­ny af­ter a brief, 10-month stint as CEO of Rheos Med­i­cines. Ear­li­er he had done a stint at Roche as their SVP and glob­al head of neu­ro­science, oph­thal­mol­o­gy and rare dis­eases re­search & de­vel­op­ment. Pri­or to Roche, he served in se­nior roles at Bris­tol-My­ers Squibb and Eli Lil­ly.

Jen­nifer Lew

Lew, who served as trou­bled Aduro Biotech’s CFO, is cred­it­ed with play­ing a lead role in the prepa­ra­tion and ex­e­cu­tion of their IPO which raised $119 mil­lion in 2015. Stolz hopped over from J&J In­no­va­tion where she helped run their West Coast JLABS busi­ness.

→ Ex-Genen­tech star and 23andMe vet Richard Scheller jumped over to join Neil Ku­mar’s new com­pa­ny, Bridge­Bio, as their chair­man in R&D. Bridge­Bio re­cent­ly fin­ished off a stel­lar IPO, which has left the com­pa­ny with a $3.3 bil­lion mar­ket cap. Scheller com­mit­ted to stay­ing with 23andMe for 4 years and now leaves his po­si­tion in the hands of Ken­neth Hillan, the for­mer CEO of Achao­gen, which went bank­rupt and liq­ui­dat­ed in a fire sale 

Les­ley Stolz

IDEAYA Bio­sciences strength­ens its lead­er­ship team with the ap­point­ments of Paul Stone as CFO, An­dres Ruiz Briseno as vice pres­i­dent, fi­nance and ten year Genen­tech vet Mick O’Quigley as vice pres­i­dent, de­vel­op­ment op­er­a­tions. Stone pre­vi­ous­ly served as the com­pa­ny’s SVP, gen­er­al coun­sel and head of op­er­a­tions. He will con­tin­ue his du­ties as the prin­ci­pal fi­nan­cial ac­count­ing of­fi­cer and over­see the le­gal func­tion as gen­er­al coun­sel. Stone joined the com­pa­ny from 5AMVen­tures. Ruiz Briseno re­cent­ly served as the com­pa­ny’s se­nior di­rec­tor, fi­nance and con­troller. He joined the com­pa­ny from Phar­ma­cyclics as their di­rec­tor of fi­nan­cial plan­ning and analy­sis. He was cred­it­ed with help­ing lead Phar­ma­cyclics’ fi­nance and op­er­a­tions ef­forts in sup­port of the suc­cess­ful launch of Im­bru­vi­ca through to its ac­qui­si­tion by Ab­b­Vie. O’Quigley has sup­port­ed the com­pa­ny in var­i­ous clin­i­cal op­er­a­tions. Pre­vi­ous­ly, he held var­i­ous clin­i­cal op­er­a­tion roles at Am­gen for twelve years.

Oc­u­lar Ther­a­peu­tix — a com­pa­ny fo­cused on the de­vel­op­ment of treat­ments for eye con­di­tions and dis­eases — wel­comed Christo­pher White as the com­pa­ny’s SVP, head of busi­ness and cor­po­rate de­vel­op­ment. Be­fore hop­ping on­board to Oc­u­lar, White was the COO at Sil­ver Creek Phar­ma­ceu­ti­cals — a pri­vate Bay Area biotech­nol­o­gy com­pa­ny fo­cused on the de­vel­op­ment of nov­el re­gen­er­a­tive med­i­cines. He’s al­so held roles as CBO of both En­ta­sis Ther­a­peu­tics and AM­AG Phar­ma­ceu­ti­cals. Be­fore join­ing the biotech in­dus­try, White worked as a part­ner at man­age­ment con­sult­ing firms Ac­cen­ture and A.T. Kear­ney

NeoPhore — a com­pa­ny de­vel­op­ing small mol­e­cule treat­ments for can­cer — wel­comed Matthew Bak­er to the ranks of its man­age­ment team as VP im­munol­o­gy. Cur­rent­ly, Bak­er serves as the non-ex­ec­u­tive di­rec­tor at Ox­ford Ge­net­ics. Pri­or to join­ing NeoPhore, Bak­er was the co-founder, CEO and CSO of An­ti­tope. Oth­er po­si­tions that he has served in­clude CSO of Abzena and co-founder and CSO of Den­cep­tor Ther­a­peu­tics. Be­fore co-found­ing, An­ti­tope in 2004, Bak­er held stints at Bio­va­tion, Cel­lu­lar Tech­nolo­gies and What­man Bio­Sciences

Lau­ra Edger­ly-Pflug

Lyra Ther­a­peu­tics — fo­cused on de­vel­op­ing treat­ments for ear, nose and throat (ENT) dis­eases — has added Lau­ra Edger­ly-Pflug as SVP of tech­ni­cal op­er­a­tions of the com­pa­ny. Edger­ly-Pflug joins right as their lead drug can­di­date, LYR-210 is en­ter­ing a Phase II clin­i­cal tri­al for the treat­ment of rhi­nos­i­nusi­tis. Edger­ly-Pflug joins from her pre­vi­ous post as vice pres­i­dent of tech­ni­cal op­er­a­tions at Adgero Bio­phar­ma­ceu­ti­cals. She brings over 25 years worth of ex­pe­ri­ence from sev­er­al biotech and phar­ma­ceu­ti­cal com­pa­nies, such as In­smed, Ova­tion Phar­ma­ceu­ti­cals (cur­rent­ly Recor­dati Rare Dis­eases), Bio­mi­ra (cur­rent­ly Seat­tle Ge­net­ics) and The Li­po­some Com­pa­ny

Start Codon, the start­up ac­cel­er­a­tor with a mis­sion to nur­ture ear­ly-stage health­care star­tups in the Gold­en Tri­an­gle, has added two ex­ecs to their sup­port team. Daniel Rooke, part­ner and head of op­er­a­tions, brings le­gal ex­per­tise and some re­cent in­sights gleaned at Cy­cle Phar­ma. Saku­ra Hol­loway leaps from a BD role at Mer­ck KGaA to be­come part­ner and head of dili­gence.

Jim Mel­lon’s ag­ing ven­ture Ju­ve­nes­cence — which in Jan­u­ary raised $46 mil­lion to crack the bi­o­log­i­cal bar­ri­ers of ag­ing to live un­til 150 — has tapped Col­in Watts as CEO of Ju­ve­nes­cence Life, which is fo­cus­ing on the com­mer­cial­iza­tion of health sup­ple­ments, nu­traceu­ti­cals and med­ical foods that can im­prove hu­man longevi­ty and qual­i­ty of life. Watts comes from a back­ground in the health­care, re­tail, con­sumer prod­ucts, food, and well­ness in­dus­tries and most re­cent­ly served as CEO of The Vi­t­a­min Shoppe

With con­tri­bu­tion by Am­ber Tong

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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