CSO Bill Lund­berg tran­si­tions to ad­vi­sor role at CRISPR Ther­a­peu­tics; Prothena los­es CMO Sarah Noon­berg; Sanofi vet Mark Nut­tall jumps to Kymera

Bill Lund­berg

→ Wrap­ping a three-year run marked by the first clin­i­cal tri­al ap­pli­ca­tions for CRISPR-based ther­a­pies, Bill Lund­berg is step­ping down as CSO of CRISPR Ther­a­peu­tics $CR­SP. He will stay with the com­pa­ny as the head of its sci­en­tif­ic ad­vi­so­ry board. This con­tin­ues a pe­ri­od of tran­si­tion af­ter Sam Kulka­rni took over from found­ing CEO Rodger No­vak in Oc­to­ber. Much of the sci­en­tif­ic lead­er­ship now falls up­on Tony Ho, head of R&D.

Su­jay Kan­go, the guy who led the launch of Kypro­lis while at Oynx Phar­ma, will help plan com­mer­cial op­er­a­tions for lus­pa­ter­cept as CCO at Ac­celeron Phar­ma $XL­RN. Cur­rent­ly in PhI­II de­vel­op­ment, lus­pa­ter­cept is a Cel­gene-part­nered ane­mia ther­a­py for dis­eases like myelodys­plas­tic syn­dromes and be­ta-tha­lassemia. Kan­go, who’s amassed some ex­pe­ri­ence at both Ab­b­Vie and In­fin­i­ty, will be “in­stru­men­tal” as Ac­celeron dri­ves the drug to mar­ket.

Abl­ynx $ABLX is switch­ing up its board of di­rec­tors again. Af­ter a mere month in the chair­man‘s seat — a month that saw the Bel­gian biotech get ac­quired by Sanofi no less — Bo Jes­per Hansen has re­signed from the board al­to­geth­er for per­son­al rea­sons. His suc­ces­sor is Rus­sell Greig, a for­mer GSK ex­ec who’s kept him­self busy with a num­ber of board ap­point­ments.

Sarah Noon­berg

→ Af­ter a brief stint at Prothena $PR­TA, Medi­va­tion vet and CMO Sarah Noon­berg has re­signed from the pro­tein im­munother­a­py biotech. Noon­berg’s de­par­ture deals an­oth­er blow to the rare dis­ease play­er, which has al­ready suf­fered a short at­tack from Ker­ris­dale Cap­i­tal’s Sahm Ad­ran­gi as the PhI­II da­ta on its AL amy­loi­do­sis drug looms. The Dublin biotech, which has US of­fices in South San Fran­cis­co, will count on for­mer CMO Mar­tin Koller’s con­sul­ta­tion while it search­es for Noon­berg’s re­place­ment.

→ A top R&D ex­ec on Genen­tech’s Tecen­triq crew has jumped ship to join Hous­ton-based Bel­licum as its chief med­ical of­fi­cer. William Gross­man had led “the glob­al clin­i­cal de­vel­op­ment of Tecen­triq in gas­troin­testi­nal can­cers and of can­cer im­munother­a­py com­bi­na­tions across all sol­id tu­mor types.” He joins Bel­licum on the heels of a clin­i­cal hold for the com­pa­ny’s lead­ing cell ther­a­py.

Selvi­ta, a Pol­ish drug dis­cov­ery com­pa­ny look­ing to build a clin­i­cal port­fo­lio, has re­cruit­ed Mer­ck KGaA vet Stef­fen Heeger to stew­ard that ef­fort. As CMO, Heeger will take charge of all clin­i­cal, med­ical and reg­u­la­to­ry af­fairs, with a spe­cial eye on SEL24, a dual PIM/FLT3 ki­nase in­hibitor cur­rent­ly in Phase I/II stud­ies for acute myeloid leukemia. Selvi­ta has been feed­ing drug can­di­dates emerg­ing from their dis­cov­ery plat­forms in­to its pipeline, bring­ing in part­ners such as Italy’s Menar­i­ni Group and the US’ Leukemia and Lym­phoma So­ci­ety along the way. The hir­ing of Heeger, who spent the past four years head­ing clin­i­cal de­vel­op­ment at Mor­phosys, fits right in­to that de­vel­op­ment strat­e­gy.

Mark Nut­tall

→ Af­ter two decades in Big Phar­ma, Mark Nut­tall is switch­ing gears to do busi­ness for a lit­tle biotech hunt­ing for ground­break­ing pro­tein degra­da­tion drugs. At­las-backed Kymera emerged from stealth mode just last Oc­to­ber, and Nut­tall — com­ing from the near­by of­fice of Sanofi Gen­zyme — is one of a dozen new staff that CEO Lau­rent Au­doly plans to hire this year. As chief busi­ness of­fi­cer, Nut­tall is tasked with ex­plor­ing new part­ner­ships and col­lab­o­ra­tions — some­thing he’s had plen­ty of ex­pe­ri­ence with while at Sanofi and J&J. In the spir­it of wel­com­ing, the Cam­bridge, MA-based com­pa­ny has al­so ap­point­ed Nim­bus CEO Don Nichol­son to its board of di­rec­tors.

→ As Liq­uidia Tech­nolo­gies ad­vances the first prod­uct can­di­date en­gi­neered from its own tech plat­form, it has tapped Kevin Gor­don to lead fi­nance op­er­a­tions and cor­po­rate de­vel­op­ment as pres­i­dent and CFO. Most re­cent­ly the COO and EVP of con­tract re­search gi­ant Quin­tiles, Gor­don helped ex­e­cute the Quin­tiles-IMS merg­er that gave life to IQVIA.

→ In an­oth­er ex­pres­sion of its dogged faith in Afrez­za, MannKind has en­list­ed di­a­betes ex­pert David Kendall’s help in achiev­ing the growth po­ten­tial that they be­lieve the in­haled in­sulin still has. Even though Sanofi pulled out of a mar­ket­ing part­ner­ship af­ter de­cid­ing the mar­ket isn’t there, Kendall — who joins from Eli Lil­ly — can still see the meal­time in­sulin be­com­ing the stan­dard of care for di­a­bet­ics.

Marc Beer has re­signed from the board chair­man role at Min­er­va Neu­ro­sciences $NERV, trig­ger­ing the el­e­va­tion of CEO Rémy Luthringer to ex­ec­u­tive chair­man­ship. Join­ing him at the board will be William Doyle, ex­ec­u­tive chair­man of Novo­cure, who’s been ap­point­ed as lead in­de­pen­dent di­rec­tor. The change­up hap­pens at a time the cen­tral ner­vous sys­tem spe­cial­ist is look to piv­ot to com­mer­cial stage with its lead drug, MIN-101, cur­rent­ly in PhI­II test­ing for schiz­o­phre­nia.

Ac­er Ther­a­peu­tics $AC­ER, the biotech look­ing to mar­ket a rare dis­ease drug that some fear would be the next Em­flaza, has an­nounced four ad­di­tions to the ex­ec­u­tive ranks. John Klopp is the VP of man­u­fac­tur­ing; Ter­rie Kellmey­er, VP of clin­i­cal sci­ence; Ja­son Knee­land, VP of fi­nance and con­troller; and Kim Thar­ald­sen, se­nior di­rec­tor of mar­ket­ing. Klopp is the star hire here, hav­ing worked on or­phan drug de­vel­op­ment at Bio­Marin and Ul­tragenyx for a decade. The ex­pan­sion of the man­age­ment team is part of a big­ger dri­ve to build a com­mer­cial op­er­a­tion in an­tic­i­pa­tion of the NDA fil­ing for Ed­si­vo (celipro­lol), a drug for vas­cu­lar Ehlers-Dan­los syn­drome bought cheap­ly out­side the US.

Pan­na Shar­ma has stepped down as CEO and pres­i­dent of Can­cer Ge­net­ics, the Ruther­ford, NJ-based out­sourc­ing group that spe­cial­izes in di­ag­nos­tic and test­ing ser­vices for per­son­al­ized on­col­o­gy treat­ment. COO Jay Roberts will take the helm in the in­ter­im.

Po­sei­da Ther­a­peu­tics, an up­start look­ing to catch up in the CAR-T field with a suite of gene en­gi­neer­ing tech­nolo­gies, has tapped Mar­tin Giedlin to lead tech­ni­cal op­er­a­tions as a vice pres­i­dent. A Sang­amo vet, Giedlin’s claim to fame is di­rect­ing the man­u­fac­tur­ing process in sup­port of Kym­ri­ah while he’s at No­var­tis. Po­sei­da’s most ad­vanced cell ther­a­py, for mul­ti­ple myelo­ma, is still in Phase I, but the San Diego biotech is hop­ing Giedlin’s ex­per­tise in process de­vel­op­ment will give them an edge in as­sem­bling its wide-rang­ing pipeline.

→ With the res­ig­na­tion of CFO Robert Dick­ey IV, co-founder and long­time board mem­ber Jonathan Gold is step­ping in as his tem­po­rary re­place­ment at Mo­tif Bio $MTFB. The UK an­tibi­ot­ic de­vel­op­er has gar­nered some at­ten­tion with its plans to re­sub­mit iclaprim, a drug that has been re­ject­ed by the FDA and changed hands a cou­ple times since.

→ Hav­ing qui­et­ly re­signed from Te­va, An­drew Boy­er is pop­ping up on the oth­er end at Am­neal Phar­ma, an­oth­er gener­ic mak­er about to merge with Im­pax Lab­o­ra­to­ries. Boy­er, who start­ed a decades-long ca­reer in gener­ics at Al­ler­gan, was the trou­bled Is­raeli gi­ant’s pres­i­dent and CEO of North Amer­i­ca. Now, he will lead com­mer­cial op­er­a­tions for the com­bined com­pa­ny as EVP.

→ Switzer­land’s Ad­dex Ther­a­peu­tics is wel­com­ing back Jean-Philippe Rocher to work on the com­pa­ny’s small mol­e­cule al­losteric mod­u­la­tor plat­form — which he helped build with Robert Lüt­jens — as the co-head of dis­cov­ery. “The team will ini­tial­ly fo­cus on de­liv­er­ing on our fund­ed re­search pro­grams which are be­ing con­duct­ed in col­lab­o­ra­tion with In­di­v­ior PLC and The Michael J. Fox Foun­da­tion for Parkin­son’s Re­search,” said Ad­dex CEO Tim Dy­er. The part­ner­ship with In­di­v­ior tar­gets ad­dic­tion treat­ments and car­ries up to $330 mil­lion in po­ten­tial mile­stones. Rocher, who was most re­cent­ly at Pierre Fab­re, will al­so over­see the pre­clin­i­cal port­fo­lio.

→ Af­ter a months-long hunt, Al­ler­gan $AGN has locked in Matthew Walsh as the suc­ces­sor of out­go­ing CFO Maria Tere­sa Hi­la­do, who an­nounced the de­sire to re­tire in Sep­tem­ber. Most re­cent­ly CFO at out­sourc­ing com­pa­ny Catal­ent, Walsh — al­so named EVP — is tasked with un­lock­ing growth po­ten­tial even as Al­ler­gan con­tends with the im­mi­nent gener­ic com­pe­ti­tion fac­ing its Resta­sis fran­chise. “Matt brings to Al­ler­gan a unique com­bi­na­tion of skills, in­clud­ing a tech­ni­cal back­ground, a deep un­der­stand­ing of the health­care in­dus­try, a rich ex­pe­ri­ence across fi­nan­cial dis­ci­plines, and the abil­i­ty to lead com­plex health care or­ga­ni­za­tions,” said CEO Brent Saun­ders in a state­ment. “I’m pleased to wel­come Matt to our team and look for­ward to part­ner­ing with him as we con­tin­ue to dri­ve strong fi­nan­cial per­for­mance and de­ploy our cap­i­tal to in­crease share­hold­er re­turn over the short- and long-term.”

→ Now that In­tel­lia Ther­a­peu­tics $INTL is sail­ing steadi­ly to­ward its first hu­man stud­ies with Ab­b­Vie vet John Leonard at the helm, Nes­san Berming­ham will of­fi­cial­ly re-join At­las Ven­ture as a ven­ture part­ner. Berming­ham had been CEO of the At­las-backed CRISPR/Cas-9 up­start (which he co-found­ed) for four years, lead­ing the com­pa­ny from seed in­vest­ment through an IPO to clin­i­cal de­vel­op­ment. Back in his ven­ture cap­i­tal­ist shoes, he will be scout­ing for new biotechs for the At­las plat­form.

→ Pre­clin­i­cal ser­vice provider Sin­clair Re­search has brought in Alex Wake­field, a dual Eli Lil­ly and Co­v­ance vet, as its first VP of re­search and op­er­a­tions.

Kai­ji Hu is the lat­est re­search sci­en­tist to join cannabi­noid-de­rived med­ica­tion de­vel­op­er Medipure Phar­ma­ceu­ti­cals, with a spe­cif­ic man­date to spear­head pso­ri­a­sis and fat­ty liv­er dis­ease/NASH project.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.

Eli Lil­ly-backed biotech grabs $100M to dis­patch an­ti­body-oligonu­cleotide con­ju­gates af­ter mus­cu­lar dy­s­tro­phy

Hold up your hand. Make a fist. Now open it. And again.

If you can do it fully and with ease, then the proteins in your hand are likely working properly. If you can’t then they may not be. In people with myotonic muscular dystrophy, something more atomic is going on.

In those folks, the problem is RNA. Certain base pairs repeat far beyond normal, up to 11,000 superfluous letters in some cases. The extended strands form “clumps.” Proteins misform and can’t function properly. They often allow one movement but not the reverse, a condition called myotonia that gives the dystrophy its name.