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

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.

A USP­TO le­gal ad­vis­er is off con­tro­ver­sial Gilead HIV case af­ter ac­tivists al­lege tweets show bias

Last week, a top legal adviser in the US Patent and Trademark Office working on the high-profile Gilead HIV PrEP case tweeted at Sen Bernie Sanders (I-VT) “What proof????” and then at activists “Do facts even matter to you?”

Now, STAT reports, she’s off of the case.

Activists in the coalition PrEP4All filed a petition to the USPTO on December 9 asking longtime senior legal advisor Mary Till be removed from the Gilead case, saying her tweets showed a bias toward Gilead. PrEP4All requested earlier this month the agency reject Gilead’s three-year patent extension for TAF (tenofovir alafenamide), a component of one of the HIV prevention regimens often referred to as PrEP. They allege the pharma giant delayed developing the drug in order to “game” the system and hold off generics.