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

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Michel Vounatsos, Getty Images

UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.