Peer Re­view: Don Hay­den com­mits to CEO role at Wind­MIL; X4 nabs new CMO Lynne Kel­ley from His­to­gen­ics ex­ile

→ Since leav­ing a 25-year ca­reer and the pres­i­dent of glob­al phar­ma­ceu­ti­cals ti­tle at Bris­tol-My­ers Squibb in 2005, Don Hay­den has kept him­self busy as a con­sul­tant and ad­vis­er to bio­phar­ma com­pa­nies, some­times jug­gling sev­en or eight board ap­point­ments. But af­ter a few months as in­ter­im CEO of Wind­MIL Ther­a­peu­tics, he’s ready to “sub­stan­tial­ly pull back” on all those com­mit­ments as he tran­si­tions to a full-time role.

Don Hay­den

“Every now and then in one’s ca­reer you come across a com­bi­na­tion of cir­cum­stances that con­vince you you just want to be a part of it, and that’s re­al­ly what hap­pened at Wind­MIL,” he told me.

The Bal­ti­more-based start­up was spun out of Johns Hop­kins and got its name, in part, from mar­row in­fil­trat­ing lym­pho­cytes, or MILs. These mem­o­ry T cells re­sid­ing in the bone mar­row have an in­nate abil­i­ty to rec­og­nize tu­mors, ren­der­ing them a po­tent can­cer killing agent both on its own and as a “base” for oth­er treat­ments like CAR-T.

His fo­cus now, Hay­den said, is to po­si­tion the com­pa­ny for a “very big year” in 2020, when the first da­ta read­out from a mul­ti­ple myelo­ma tri­al is due. Wind­MIL al­so plans to delve deep­er in­to sol­id tu­mor, fol­low­ing a non-small cell lung can­cer tri­al (in PD-1 re­frac­to­ry/re­lapsed pa­tients) it hopes to start this year.

Gra­ham Kel­ly

→ In prepa­ra­tion for a Nas­daq list­ing, Aus­tralian drug­mak­er Nox­opharm has re­as­signed some hats in top lead­er­ship. Founder Gra­ham Kel­ly is mov­ing up to the ex­ec­u­tive chair­man role, tap­ping Greg van Wyk — the cur­rent CMO — to dou­ble as chief ex­ec­u­tive. This way, the com­pa­ny says, Kel­ly can spend more time “look­ing to raise the com­pa­ny’s pro­file in the US cap­i­tal mar­kets,” where he’s led two IPOs al­most two decades ago.

No­var­tis’ Vas Narasimhan has raid­ed Glaso­SmithK­line’s se­nior ex­ec­u­tive crew for his new San­doz chief. Richard Saynor is mak­ing the leap from his last post as SVP clas­sic & es­tab­lished prod­ucts, com­mer­cial & dig­i­tal plat­forms at a time spec­u­la­tion about the fu­ture of San­doz has been ram­pant. But he may have some ideas on what can be done bet­ter. Ac­cord­ing to his LinkedIn page, he’s been at GSK for close to 9 years — af­ter jump­ing over from San­doz.

Jim Robin­son

→ Af­ter a stint at Alk­er­mes $ALKS that took him to Boston area for a lit­tle over a year, Jim Robin­son is mov­ing home. Re­port­ing at Paragon Bio­sciences’ Chica­go of­fice this week, Robin­son keeps the same ti­tle: pres­i­dent and chief op­er­at­ing of­fi­cer. But in­stead of over­see­ing one en­ti­ty, he will run a host of func­tion­al ser­vices to sup­port Paragon’s six and count­ing port­fo­lio com­pa­nies.

X4 Phar­ma­ceu­ti­cals $XFOR has re­cruit­ed Lynne Kel­ley to steer a Phase III pro­gram for a rare ge­net­ic, pri­ma­ry im­mun­od­e­fi­cien­cy dis­ease known as WHIM syn­drome. The new CMO is one of the His­to­gen­ics ex­ecs who were dis­band­ed af­ter the mi­cro­cap es­sen­tial­ly sold its shell to Ocu­gen in a re­verse merg­er.

John Cur­nutte

John Cur­nutte is hang­ing up his R&D boots at Por­to­la Phar­ma­ceu­ti­cals $PT­LA, trad­ing a lead role for a con­sul­tant po­si­tion. His re­tire­ment comes al­most a year af­ter that of ex-CEO William Lis, which put Cur­nutte in charge briefly as a co-pres­i­dent. In their time, the two ex­ecs shep­herd­ed Beyvexxa — an an­ti­co­ag­u­lant — and An­dexxa — an an­ti-an­ti­co­ag­u­lant — to FDA ap­provals, de­spite some hic­cups along the way. Pamela Con­ley, a 15-year vet­er­an of the com­pa­ny and cur­rent SVP of re­search, will take over the re­search team while Jeff My­ers serves as in­ter­im CMO.

→ Af­ter kick­ing off its Phase III pro­gram, En­ta­sis Ther­a­peu­tics, the biotech spun out from As­traZeneca to house its an­tibi­otics group, is plan­ning for its com­mer­cial fu­ture — and hir­ing an ex­pe­ri­enced hand. Er­ic Kim­ble joins the biotech $ET­TX as the field is still rat­tling from Achao­gen’s bank­rupt­cy, yet an­oth­er stark re­minder of the grim con­di­tions that face an­tibi­otics de­vel­op­ers even when they man­age to bring their drugs to the mar­ket. Kim­ble, a Cu­bist Phar­ma alum who’s spent the past five years con­sult­ing for an­tibi­otics star­tups, said he wel­comes the chal­lenge.

→ A trou­bled Aduro has re­cruit­ed Pfiz­er can­cer R&D ex­ec to take the chief med­ical of­fi­cer’s job. Dim­it­ry Nuyten is mov­ing from his job as vice pres­i­dent and im­muno-on­col­o­gy clin­i­cal de­vel­op­ment leader to the biotech. His stint at Pfiz­er put Nuyten in charge of its Baven­cio work, part­nered with Mer­ck KGaA. “We are ex­treme­ly pleased to wel­come Dim­it­ry as we pre­pare to broad­en our de­vel­op­ment plans for STING ag­o­nist ADU-S100 and ini­ti­ate our first in hu­man study of an­ti-APRIL an­ti­body BION-1301 in IgA nephropa­thy,” not­ed CEO Stephen Isaacs in a state­ment.

→ The crew at Ju­ve­nes­cence has brought on David El­lam on their an­ti-ag­ing cru­sade. El­lam jumps from the same role at Lon­don-based Si­lence Ther­a­peu­tics, which he joined af­ter stints at Bio­Marin and Ark Ther­a­peu­tics. With over $110 mil­lion to spend on ex­ist­ing and fu­ture port­fo­lio com­pa­nies, El­lam will work along­side CEO Greg Bai­ley to build up Ju­ve­nes­cence’s in­fra­struc­ture and cor­po­rate gov­er­nance as it ex­plores “a list­ing on an in­ter­na­tion­al ex­change.”

Thomas Le­ung is the new CFO at Men­lo Park, CA-based Ad­verum Biotech­nolo­gies $AD­VM, play­ing a big role in shap­ing the com­pa­ny as it charts a clin­i­cal path for its gene ther­a­py for the eye. A for­mer VP at TPG Cap­i­tal, Le­ung’s most re­cent job was in busi­ness op­er­a­tions at a women’s health ge­net­ic test­ing com­pa­ny.

→ Keen on get­ting its wet age-re­lat­ed mac­u­lar de­gen­er­a­tion drug ap­proved around the world next year, Out­look Ther­a­peu­tics $OTLK has ap­point­ed Jen­nifer Kiss­ner as SVP clin­i­cal de­vel­op­ment. As CMO Ken­neth Bahrt heads out the door (with no re­place­ment planned), Kiss­ner will ef­fec­tive­ly take up the re­spon­si­bil­i­ty to work with con­tract­ed ser­vices to dri­ve ONS-5010 for­ward, lever­ag­ing lessons she learned at Al­con, Acucela and most re­cent­ly Clear­side Bio­med­ical.

→ Hav­ing learned the ins and outs of can­cer di­ag­nos­tics at Foun­da­tion Med­i­cine, Al­fred “Fred­di” Bowie is bring­ing his busi­ness skillset to Ve­r­a­cyte $VCYT. As VP, cor­po­rate and busi­ness de­vel­op­ment, Bowie is tasked with as­sess­ing and man­ag­ing part­ner­ships, li­cens­ing and ac­qui­si­tions. One of them will be a lung can­cer de­tec­tion project al­lied with J&J in an al­liance an­nounced this Jan­u­ary.

→ Rare dis­ease-fo­cused Log­icBio Ther­a­peu­tics $LOGC has hired five se­nior ex­ecs to help man­age its ex­pand­ed lab op­er­a­tions, from CMC and tech­nol­o­gy de­vel­op­ment to pro­gram and clin­i­cal man­age­ment. They in­clude Matthias Hebben, VP of tech­nol­o­gy de­vel­op­ment, jump­ing from Genethon; Marie Pay­ton, VP of clin­i­cal op­er­a­tions, for­mer­ly of Mil­len­ni­um; Sanofi Gen­zyme vet Car­ol Sher­ako, se­nior di­rec­tor, pro­gram man­age­ment; Sven Loe­brich, a CMC ex­pert with ex­pe­ri­ence at Im­muno­Gen; and Voy­ager’s Lau­ren Drouin, who will fo­cus on an­a­lyt­i­cal de­vel­op­ment. To­geth­er, they will push Log­icBio’s first drug in­to clin­i­cal de­vel­op­ment while re­fin­ing its gene edit­ing plat­form.

Yposke­si, a French CD­MO spe­cial­iz­ing in gene ther­a­py vi­ral vec­tor man­u­fac­tur­ing, has ap­point­ed Morad El Gued­dari as pro­duc­tion di­rec­tor of its core op­er­a­tion. A vet­er­an of Cell­for­Cure — now a No­var­tis sub­sidiary — El Gued­dari joins as the com­pa­ny is dou­bling its glob­al foot­print.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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