Dal­cor taps new CEO Fouzia Laghris­si-Th­ode as piv­otal PhI­II looms; Kel­ly Mar­tin set­tles in at No­van; Ed­ward Stew­art takes over Com­mense

Fouzia Laghris­si-Th­ode

As­traZeneca vet Fouzia Laghris­si-Th­ode will be lead­ing Dal­Cor Phar­ma­ceu­ti­cals through pa­tient en­roll­ment in­to its piv­otal Phase III tri­al. The new­ly mint­ed CEO has her work cut out for her — Lon­don-based Dal­Cor is try­ing to prove that dal­cetrapib, a CETP in­hibitor Roche aban­doned, has a strong car­dio ben­e­fit for a sub­group of pa­tients with a cer­tain geno­type by test­ing it in 6000 peo­ple. Laghris­si-Th­ode be­gan tack­ling this field at Roche, where she was a fran­chise leader for sev­er­al drugs.

→ Af­ter more than 15 years play­ing sup­port­ive ex­ec roles at Mer­ri­mack, Ed­ward “Tad” Stew­art is tak­ing the helm of a con­tro­ver­sial PureTech Health start­up fo­cused on the mi­cro­bio­me. Stew­art had been work­ing as CBO at Crescen­do Bi­o­log­ics since Mer­ri­mack be­came part of Ipsen in 2017, flex­ing the busi­ness mus­cles he gained in Mer­ri­mack’s jour­ney from pre­clin­i­cal to com­mer­cial stage. His new com­pa­ny, Boston-based Com­mense, stirred some crit­i­cism when it launched with an ex­plic­it goal to im­prove in­fants’ health by swab­bing new­borns with mi­crobes from their mom’s vagi­na — a prac­tice al­so known as “vagi­nal seed­ing.” It is now Stew­ard’s du­ty as pres­i­dent and CEO to lead the re­sult­ing ther­a­peu­tics to fruition, con­vinc­ing in­vestors and part­ners along the way.

Kel­ly Mar­tin

No­van did not find a per­ma­nent re­place­ment for Kel­ly Mar­tin af­ter all, so the CEO will take the “in­ter­im” tag off his ti­tle af­ter 10 months in the job. Mar­tin is al­so tasked with in­spir­ing faith in ex­ist­ing and po­ten­tial in­vestors to­ward No­van’s $NOVN ni­tric ox­ide plat­form, es­pe­cial­ly as the biotech mounts a come­back for its lead ac­ne drug. The com­pa­ny has al­so of­fi­cial­ly in­stalled An­drew No­vak, for­mer­ly se­nior di­rec­tor of re­port­ing and analy­sis, as VP and chief ac­count­ing of­fi­cer in an ef­fort to set the lead­er­ship struc­ture in place. Sup­port­ing them on the clin­i­cal de­vel­op­ment side will be new SVP of clin­i­cal op­er­a­tions Eliz­a­beth Messer­smith, whose com­bined ex­pe­ri­ence at Quark Phar­ma, Bal­ance Ther­a­peu­tics and Elan Phar­ma shaped her up to over­see the di­verse pro­grams at No­van.  

→ Less than a year af­ter the ac­tivist in­vestors at ven­Bio crashed a $2 bil­lion col­lab­o­ra­tion deal with Seat­tle Ge­net­ics on the lead drug at Im­munomedics $IM­MU, the new crew in charge has wooed the top I/O re­search ex­ec at As­traZeneca to take a lead­ing de­vel­op­ment role as chief med­ical of­fi­cer and R&D chief. Robert Ian­none played a top role in the de­vel­op­ment of Imfinzi (dur­val­um­ab), the PD-L1 check­point star at As­traZeneca/Med­Im­mune. Now he’s jump­ing in­to biotech, tak­ing the lead­ing re­search role at a com­pa­ny with a mar­ket cap of $2.4 bil­lion. He’ll now be fo­cused on sac­i­tuzum­ab govite­can (IM­MU-132), a late-stage drug for metasta­t­ic triple neg­a­tive breast can­cer look­ing for an ac­cel­er­at­ed ap­proval.

Ken­neth New­man is end­ing his three-year CMO tenure at res­pi­ra­to­ry dis­ease com­pa­ny Verona Phar­ma $VR­NA to pur­sue oth­er op­por­tu­ni­ties. His fi­nal month at the biotech was marked by pos­i­tive da­ta from two Phase II tri­als, for cys­tic fi­bro­sis and chron­ic ob­struc­tive pul­monary dis­ease, re­spec­tive­ly. The Lon­don-based com­pa­ny has yet to find a re­place­ment.  

Neomed Ther­a­peu­tics 1 has tapped ex­pe­ri­enced tri­al in­ves­ti­ga­tor Frank Giles as its first chief med­ical of­fi­cer, re­spon­si­ble for both in-house de­vel­op­ment and col­lab­o­ra­tions and part­ner­ships of its epi­ge­net­ics-mod­u­lat­ing can­cer ther­a­peu­tics. Giles joins Mon­tre­al-based Neomed from a brief stint at Ac­tu­ate Ther­a­peu­tics, which he jug­gled with his di­rec­tor roles at North­west­ern Uni­ver­si­ty.

→ With a Phase III tri­al of ef­gar­tigi­mod set to launch this year, ar­genx $ARGX has ap­point­ed Kei­th Woods as COO to run ear­ly com­mer­cial plan­ning for that as­set, which spans mar­ket­ing, mar­ket­ing ac­cess, pro­gram man­age­ment and sup­ply chain op­er­a­tions. Ef­gar­tigi­mod will first be test­ed for myas­the­nia gravis, a chron­ic au­toim­mune dis­or­der re­sult­ing in mus­cle weak­ness. Woods’ pre­vi­ous roles at Alex­ion have sent him run­ning busi­ness on both sides of the At­lantic. Be­fore that, he’s spent a com­bined 20 years at Roche, Am­gen and Ei­sai.

→ Gene ther­a­py com­pa­ny Gen­prex $GN­PX has liked COO Julien Pham’s work since he joined in 2016, and they now want him to bring On­co­prex, its im­muno­gene ther­a­py for non-small cell lung can­cer, to mar­ket as the com­pa­ny’s new pres­i­dent. A clin­i­cian in train­ing, Pham takes over from chair­man and CEO Rod­ney Varn­er. He is now tasked with grow­ing strate­gic part­ner­ships in ad­di­tion­al to lead­ing the clin­i­cal pro­gram at the in­ter­sec­tion of on­col­o­gy and non-vi­ral gene ther­a­py. The Austin-based com­pa­ny be­lieves that On­co­prex can bol­ster both tar­get­ed ther­a­pies and im­munother­a­pies when used in com­bos.

At­las-backed Gen­er­a­tion Bio has brought on two new ex­ecs to cham­pi­on its non-vi­ral ap­proach to gene ther­a­py. Will Mc­Carthy is join­ing as chief busi­ness of­fi­cer from the same role at Igny­ta, where he be­came fa­mil­iar with ge­net­i­cal­ly de­fined can­cers. Be­fore that, he’s held po­si­tions at ge­nom­ic di­ag­nos­tics com­pa­ny Foun­da­tion Med­i­cine and can­cer biotech Halozyme. Jen­nifer El­liott, mean­while, takes on the role of head of le­gal af­fairs and in­tel­lec­tu­al prop­er­ty. For­mer­ly di­rec­tor of IP at the Broad In­sti­tute and as­so­ciate gen­er­al coun­sel at Genen­tech, El­liot brings a back­ground in patent ap­pli­ca­tion to the Cam­bridge, MA biotech as it ex­plores a wide range of ther­a­peu­tic ap­pli­ca­tions with a $100 mil­lion Se­ries B.  

→ Cana­da’s In­Med has wooed a sea­soned ex­ec­u­tive to es­tab­lish the com­pa­ny’s pres­ence in the emerg­ing field of cannabi­noid-based drugs. Hav­ing served as CFO at fel­low cannabi­noid drug­mak­er Ther­a­pix and liv­er dis­ease com­pa­ny Galmed, Joshua Blach­er joins In­Med as CBO, with a man­date to raise its pro­file in the cap­i­tal mar­kets in ad­di­tion to ex­e­cut­ing fi­nan­cial and BD ini­tia­tives.

Rober­to Cu­ca — the CFO and SVP — an­nounced that he is re­sign­ing from Treve­na $TRVN, just a week af­ter found­ing CEO Max­ine Gowen tapped Car­rie Bour­dow to be her suc­ces­sor. The for­mer lawyer and one-time an­a­lyst had been with the com­pa­ny for al­most five years.  

Rhon­da Chicko

→ With an IND in sight for its spinal mus­cu­lar dy­s­tro­phy treat­ment, Schol­ar Rock has named Iron­wood vet Rhon­da Chicko its new CFO along­side a slate of ap­point­ments and pro­mo­tions. Chicko brings fresh mem­o­ry and skills need­ed in an ear­ly-stage op­er­a­tion from Ed­i­tas Med­i­cine, where she built the fi­nance team. Oth­er new em­ploy­ees at the Cam­bridge, MA com­pa­ny are Ryan Iar­robi­no, VP of clin­i­cal op­er­a­tions and Cather­ine Hu, ex­ec­u­tive di­rec­tor of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Mean­while in recog­ni­tion of their work to ad­vance the pro­tein growth fac­tors plat­form, Gre­go­ry Car­ven has been pro­mot­ed to SVP of an­ti­body dis­cov­ery and pro­tein sci­ences; At­suko Polzin to VP of in­tel­lec­tu­al prop­er­ty; and Dodzie So­gah to VP of cor­po­rate de­vel­op­ment and strat­e­gy.

Dirk Ehlers is the new COO at di­ag­nos­tics com­pa­ny Cen­to­gene, which spe­cial­izes in de­tect­ing rare dis­ease ge­net­ics. Ehlers had gone in and out of the di­ag­nos­tics busi­ness through­out his ca­reer in life sci­ences, fea­tur­ing an ex­ec role at Roche years ago.

→ Waltham, MA-based Ave­dro, an oph­thalmic phar­ma and med­ical de­vice com­pa­ny, has ap­point­ed James Schuer­mann as CBO. The medtech vet­er­an will be busy over­see­ing all as­pects of com­mer­cial­iza­tion, in­clud­ing gov­ern­ment af­fairs, re­im­burse­ment, sales, com­mu­ni­ca­tions and field ser­vice.

→ The team of neu­ro­log­ic ex­perts at BioAx­one has re­cruit­ed Ronald Gold­stein to strength­en the com­pa­ny’s fi­nan­cial un­der­pin­nings. Cam­bridge, MA-based BioAx­one is part­nered with Ver­tex on its lead ther­a­py for spinal cord in­jury, cur­rent­ly in PhI­Ib/PhI­II de­vel­op­ment. With his back­ground in pub­lic ac­count­ing and bank li­ai­son, Gold­stein is ex­pect­ed to keep the com­pa­ny on track as it grows.

→ DNA test­ing spe­cial­ist Nat­era $NTRA has tapped dec­o­rat­ed schol­ar Paul Billings as its CMO. A ge­nom­ic ex­pert who con­sult­ed for Ther­mo Fish­er Sci­en­tif­ic, Billings has served on the sci­en­tif­ic ad­vi­so­ry boards of sev­er­al gov­ern­ment agen­cies in­clud­ing the FDA.

→ The change mas­ter of biotech is knock­ing at Iron­wood Phar­ma­ceu­ti­cals’ front door. And he wants in with plans to stay for awhile. Alex Den­ner, known for forc­ing out old CEOs and forc­ing through new buy­outs, has now set his sights on the long­time Boston/Cam­bridge play­er guid­ed by found­ing CEO Pe­ter Hecht, who launched the com­pa­ny 20 years ago with a plan for the long haul. In an un­usu­al move, Iron­wood put out word of Den­ner’s move to join the board in a press re­lease Mon­day. And the com­pa­ny took the op­por­tu­ni­ty to point­ed­ly praise the board Hecht has al­ready as­sem­bled, which in­cludes 8 in­de­pen­dent di­rec­tors on the 9-mem­ber group. It’s clear that Den­ner is out to shake things up at Iron­wood, a com­pa­ny best known for its fran­chise drug Linzess and a pipeline of ther­a­pies in the same space. Sev­er­al an­a­lysts think the com­pa­ny could do bet­ter on the stock price, and Den­ner is all about val­ue cre­ation — with a big ap­petite for prof­it­ing from tur­bu­lence.

→ As Tam­pa, FL-based In­tezyne ramps up in-house de­vel­op­ment ef­forts, Brad­ford Sul­li­van and Adam Curie were hand­ed in­creased re­spon­si­bil­i­ties for the an­ti-can­cer ther­a­pies it’s de­vel­op­ing. Sul­li­van will as­sume di­rec­tor­ship of chem­istry, man­u­fac­tur­ing and con­trols of ex­ist­ing poly­mers and APIs, while Curie will fo­cus on prod­uct de­vel­op­ment for po­ten­tial new can­di­dates.

Mer­ck vet John Renger is climb­ing up the lead­er­ship lad­der at Pur­due Phar­ma, where he’s just been named VP, head of R&D and reg­u­la­to­ry af­fairs. Where­as he was fo­cused on neu­ro­sciences, his new role will put him in charge of the over­all sci­en­tif­ic di­rec­tion and strat­e­gy.

→ An­tibi­ot­ic mak­er Spero Ther­a­peu­tics $SPRO has hired Ian Critch­ley to head clin­i­cal mi­cro­bi­ol­o­gy, trust­ing him to not on­ly steer the late-stage tri­als planned for the year but al­so build up a clin­i­cal port­fo­lio to ad­dress mul­tidrug-re­sis­tant bac­te­ria. That wouldn’t be new to Critch­ley, who had man­aged pre­clin­i­cal and clin­i­cal stud­ies on sev­er­al an­ti-in­fec­tives com­pounds dur­ing a three-year run at Al­ler­gan.

→ As Re­zo­lute read­ies its or­phan drug for con­gen­i­tal hy­per­in­su­line­mia, RZ358, to en­ter Phase IIb, it is bring­ing in Chris­tine Fer­rara as di­rec­tor of clin­i­cal de­vel­op­ment with a pri­ma­ry fo­cus on the pro­gram.

→ An­tic­i­pat­ing an NDA for Ro­cla­tan lat­er this year, Aerie Phar­ma­ceu­ti­cals has ap­point­ed for­mer UCB staffer Scott Laran­jo to plan for its mar­ket­ing.

Michael Moore has added Macrophage Phar­ma to the list of boards he’s chair­ing. Moore, who served as the founder chair­man of Tril­li­um Ther­a­peu­tics and PsiOx­is Ther­a­peu­tics, said he’s im­pressed by the po­ten­tial of Macrophage’s im­mune mod­u­la­tion plat­form tech in can­cer and be­yond.

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?

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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The FDA will hus­tle up an ex­pe­dit­ed re­view for As­traZeneca’s next shot at a block­buster can­cer drug fran­chise

AstraZeneca paid a hefty price to partner with Daiichi Sankyo on their experimental antibody drug conjugate for HER2 positive breast cancer. And they’ve been rewarded with a fast ride through the FDA, with a straight shot at creating another blockbuster oncology franchise.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

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CSL ac­cus­es ri­val Pharm­ing of par­tic­i­pat­ing in a scheme to rip off IP on HAE while re­cruit­ing se­nior R&D staffer

Pharming has landed in the middle of a legal donnybrook after recruiting a senior executive from a rival R&D team at CSL. The Australian pharma giant slapped Pharming with a lawsuit alleging that the Dutch biotech’s new employee, Joseph Chiao, looted a large cache of proprietary documents as he hit the exit. And they want it all back.
Federal Judge Juan Sanchez in the Eastern District Pennsylvania court issued an injunction on Tuesday prohibiting Chiao from doing any work on HAE or primary immune deficiency in his new job and demanding that he return any material from CSL that he may have in his possession. And he wants Pharming to tell its employees not to ask for any information on the forbidden topics.
For its part, Pharming fired off an indignant response this morning denying any involvement in extracting any kind of IP from CSL, adding that it’s cooperating in the internal probe that CSL has underway.

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Eli Lil­ly’s first PhI­II show­down for their $1.6B can­cer drug just flopped — what now?

When Eli Lilly plunked down $1.6 billion in cash to acquire Armo Biosciences a little more than a year ago, the stars seemed aligned in its favor. The jewel in the crown they were buying was pegilodecakin, which had cleared the proof-of-concept stage and was already in a Phase III trial for pancreatic cancer.

And that study just failed.

Lilly reported this morning that their cancer drug flopped on overall survival when added to FOLFOX (folinic acid, 5-FU, oxaliplatin), compared to FOLFOX alone among patients suffering from advanced pancreatic cancer.

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UP­DAT­ED: Alex­ion pays $930M to buy out Achillion and its promis­ing com­pan­ion drug to Soliris

After a series of stock-crunching setbacks over the years, Achillion enjoyed a turn in the sun a few weeks ago as the FDA blessed their lead drug danicopan (ACH-4471) — a complementary therapy for PNH patients taking Alexion’s Soliris — with a breakthrough drug designation after taking a look at some solid supporting Phase II data.

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