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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Diem Nguyen tapped to lead 'point of in­flec­tion' at Xalud Ther­a­peu­tics; Di­ana Es­co­lar dances her way to Avro­bio CMO

Diem Nguyen considers herself a “point of inflection seer.”

Helping businesses strategize and scale up is “where my sweet spot is,” the Pfizer veteran said. So when she was tapped to take the helm at gene therapy-focused Xalud Therapeutics, she knew it would be a great fit.

Xalud, founded in 2009 and headquartered in New York City, is working on non-viral gene therapies to treat pathologic inflammation. The company’s lead candidate, XT-150, is a locally injectable plasmid DNA gene therapy expressing Interleukin 10 (IL-10) — an upstream modulator for many pro-inflammatory and anti-inflammatory mediators.