Col­in Fre­und takes new CEO job at Mod­ra Phar­ma; Com­pass re­cruits Pfiz­er, Bio­gen vets to C-suite

Col­in Fre­und

→ Am­s­ter­dam-based Mod­ra Phar­ma­ceu­ti­cals has tapped a per­ma­nent CEO to guide its pipeline of oral chemother­a­pies as it wraps up a Phase Ib/IIa study for the lead pro­gram — a tablet for­mu­la­tion of do­c­etax­el. Col­in Fre­und comes with fresh CEO ex­pe­ri­ence at Que On­col­o­gy as well as a pre­vi­ous stints at Trangene and GPC Biotech. Er­ic van der Put­ten, the Agla­ia Bio­med­ical Ven­tures part­ner who was fill­ing the role ad in­ter­im, will re­cede to a board di­rec­tor role. Mean­while Ed­win De Wit has al­so joined the com­pa­ny as head of on­col­o­gy de­vel­op­ment.

No­var­tis’ in­sis­tence on cen­tral­iz­ing top ex­ecs in its Swiss head­quar­ters has cost the phar­ma gi­ant a key leader: Liz Bar­rett has put in her no­tice just 10 months af­ter tak­ing on the on­col­o­gy chief role.

“Af­ter much per­son­al re­flec­tion, it be­came clear that my fam­i­ly would be un­able to re­lo­cate to Basel where the on­col­o­gy head­quar­ters is based,” Bar­rett said in a state­ment.

Su­sanne Schaf­fert, pres­i­dent of No­var­tis sub­sidiary Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, is re­plac­ing Bar­rett as CEO of the on­col­o­gy busi­ness unit. Bar­rett is mov­ing to the helm of a US-based biotech, though she told End­points she can’t say which just yet.

Or­biMed– and Thiel-backed Com­pass Ther­a­peu­tics has scooped Pfiz­er’s head of ear­ly clin­i­cal de­vel­op­ment, Yu Liu, to over­see the slate of pro­grams gen­er­at­ed from its an­ti­body dis­cov­ery plat­form. The new CMO will have a chance to work on tar­gets in can­cer, in­flam­ma­tion and au­toim­mune dis­ease. lever­ag­ing a di­verse range of ex­pe­ri­ence ac­crued over the years at Bio­gen, Bris­tol-My­ers Squibb, Es­sen­tialis Ther­a­peu­tics and Am­gen. Fel­low Bio­gen vet Lynne Sul­li­van — who al­so han­dled tax­es for Mer­ck KGaA is com­ing on board as CFO.

No­var­tis may still have big plans for CAR-T, but the phar­ma gi­ant con­tin­ues to bleed top tal­ent from the group ex­pect­ed to car­ry out the work. Cam­bridge, MA-based Sem­ma Ther­a­peu­tics — which is de­vel­op­ing a hoped-for stem cell cure for Type 1 di­a­betes — said that they have re­cruit­ed No­var­tis CAR-T chief David Leb­wohl as their new chief med­ical of­fi­cer. Sem­ma has al­so re­cruit­ed David DiGius­to as chief tech­nol­o­gy of­fi­cer and Ann Dar­da as head of hu­man re­sources. Last fall in­vestors put up $114 mil­lion to fund a pi­o­neer­ing hu­man study that will put a new de­liv­ery tech to the test in di­a­betes.

Daphne Qui­mi just got a pro­mo­tion at Am­i­cus Ther­a­peu­tics $FOLD, where she will be­come CFO in the be­gin­ning of next year as Chip Baird leaves for a new job. The hand­off caps the first year Am­i­cus be­came a com­mer­cial com­pa­ny with a con­tro­ver­sial OK for its Fab­ry dis­ease drug Galafold. Sev­er­al oth­er ex­ecs are get­ting new roles: Al­iba­ba alum­nus David Clark has been ap­point­ed chief peo­ple of­fi­cer; Ellen Rosen­berg has been pro­mot­ed to chief le­gal of­fi­cer; An­drew Mul­berg is now SVP, glob­al reg­u­la­to­ry af­fairs; and An­tho­ny Sileno will be SVP, clin­i­cal op­er­a­tions and trans­la­tion­al sci­ences.

Sono­ma Phar­ma­ceu­ti­cals, a spe­cial­ty phar­ma now fo­cused on der­ma­tol­ogy, has hired Fred­er­ick (Bub­ba) Sand­ford to ex­e­cute the com­pa­ny’s turn­around plan. He will take the roles of both CEO Jim Schutz and CFO Bob Miller, who re­signed from the com­pa­ny $SNOA.

→ As Johns Hop­kins spin­out Wind­MIL Ther­a­peu­tics opens a new of­fice to con­sol­i­date its cell ther­a­py work and at­tract tal­ent in Philadel­phia, two ex­ecs are join­ing the out­post. Monil Shah, chief de­vel­op­ment of­fi­cer, comes with a string of roles at Brook­lyn Im­munoTher­a­peu­tics, Ven­trus Bio­sciences, Cel­gene, Fi­bro­Gen, Am­gen and oth­ers on his re­sume. New VP of op­er­a­tions Patrick Dougher­ty was the chief of staff to the SVP of R&D at Glax­o­SmithK­line. Wind­MIL closed a $32.5 mil­lion round ear­li­er this year for its work on mem­o­ry T cells re­sid­ing in the bone mar­row and a “sig­nif­i­cant ex­pan­sion” of its team.

→ The first snap­shot of ef­fi­ca­cy for Avro­bio’s lead gene ther­a­py to treat Fab­ry dis­ease might have spooked in­vestors, but the Cam­bridge, MA-based biotech $AVRO is keen to re­gain their con­fi­dence with four new hires. Bir­gitte Vol­ck, a rare dis­ease ex­pert for­mer­ly of So­bi and GSK, has been tapped as pres­i­dent of R&D; Erik Os­trows­ki joins as CFO from the same role at Sum­mit Ther­a­peu­tics; for­mer FDA staffer Josie Yang is the new head of reg­u­la­to­ry af­fairs; while Bio­gen vet Steven Avruch be­comes gen­er­al coun­sel.

→ Parisian biotech Bio­phytis has pro­mot­ed Jean-Christophe Mon­tigny to COO, from his pre­vi­ous role of su­per­vis­ing all things fi­nan­cial and le­gal for the com­pa­ny. Mean­while, Bio­phytis has al­so named Daniel Schnei­der­man as CFO. Schnei­der­man, who served most re­cent­ly as VP of fi­nance and con­troller at Boston-based pre­ci­sion med­i­cine com­pa­ny Meta­S­tat, will be based at the com­pa­ny’s Cam­bridge of­fice in the Unit­ed States as Bio­phytis ex­pands its op­er­a­tions in the re­gion. “We plan to con­tin­ue build­ing…in­fra­struc­ture in Boston with ad­di­tion­al key hires in 2018 and 2019, as we ex­e­cute the clin­i­cal de­vel­op­ment of SAR­CO­NEOS through our…clin­i­cal phase 2b tri­al for the treat­ment of sar­cope­nia in both the Unit­ed States and Eu­rope, as well as progress SAR­CO­NEOS…in Duchenne mus­cu­lar dy­s­tro­phy (DMD) and MA­CU­NEOS…in dry age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), CEO Stanis­las Veil­let said. 

Ed Kaye has re­cruit­ed two for­mer Sarep­ta col­league to his team as he moves Stoke Ther­a­peu­tics in­to a larg­er R&D space in Bed­ford, MA. Shamim Ruff, pre­vi­ous­ly Sarep­ta’s chief reg­u­la­to­ry af­fairs of­fi­cer and SVP, head of qual­i­ty, will have the ti­tle SVP of reg­u­la­to­ry af­fairs and qual­i­ty. Nan­cy Wyant comes on board as VP, head of clin­i­cal op­er­a­tions af­ter con­sult­ing with Stoke for the past few months fol­low­ing stints at Idera and BeiGene.

→ Ahead of a Phase III read­out of its NSCLC treat­ment, OSE Im­munother­a­peu­tics has ap­point­ed for­mer Sanofi $SNY ex­ec­u­tive Julien Per­ri­er as chief com­mer­cial of­fi­cer. Per­ri­er most re­cent­ly served as the head of Ab­b­Vie’s $AB­BV im­munol­o­gy di­vi­sion in France, where he was in charge of the com­mer­cial op­er­a­tions for Hu­mi­ra, as well as prep­ping the launch of two oth­er im­munol­o­gy prod­ucts. “Julien’s ex­pe­ri­ence in im­munol­o­gy and bi­o­log­ics will al­so prove es­sen­tial as we plan next steps for FR104, a Phase 2-ready, first-in-class CD28 an­tag­o­nist with ex­cit­ing po­ten­tial to treat au­toim­mune dis­ease,” OSE chief Alex­is Pey­roles said.

Boehringer In­gel­heim’s Hen­ning Ger­schews­ki is head­ing over to an­oth­er Ger­man firm where he will serve as as vice pres­i­dent of man­u­fac­tur­ing, sci­ence and tech­nol­o­gy. The com­pa­ny, Rentschler Bio­phar­ma SE, fo­cus­es on con­tract de­vel­op­ment and man­u­fac­tur­ing for bio­phar­ma­ceu­ti­cal com­pa­nies.  


With con­tri­bu­tion by Na­tal­ie Grover.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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