Fred­er­ic Pla en­list­ed as COO at the Park­er In­sti­tute; For­mer Alk­er­mes ex­ec named CMO at Seres Ther­a­peu­tics

Fred­er­ic Pla Park­er In­sti­tute

→ The Park­er In­sti­tute for Can­cer Im­munother­a­py has wel­comed Fred­er­ic Pla aboard as COO. Pri­or to his ap­point­ment, Pla served as COO at Ge­nom­ic Health. Pla has held ap­point­ments at Life Tech­nolo­gies — as VP, cor­po­rate busi­ness de­vel­op­ment — and GE Health­care. He be­gan his ca­reer at the NASA Glenn Re­search Cen­ter. PI­CI, found­ed by bil­lion­aire Sean Park­er, con­tin­ues to search for a new CEO in the wake of Jef­frey Blue­stone’s de­par­ture to launch a new biotech com­pa­ny.

Lisa von Moltke

Lisa von Moltke has stepped in as EVP and CMO at Seres Ther­a­peu­tics, whose SER-109 pro­gram is in Phase III de­vel­op­ment for re­cur­rent C. dif­fi­cile in­fec­tion. She comes to Seres af­ter 5 years at Alk­er­mes, where she most re­cent­ly had been SVP and head of clin­i­cal de­vel­op­ment. She’s al­so been VP, clin­i­cal and ex­plorato­ry phar­ma­col­o­gy at Sanofi and se­nior di­rec­tor of trans­la­tion­al med­i­cine at Take­da.

Af­ter bid­ding adieu to its then-CEO Michael Pehl more than a year ago, along with a sur­prise com­plete re­sponse let­ter from the FDA, Im­munomedics has en­list­ed No­var­tis On­col­o­gy vet Harout Se­mer­jian as CEO. Se­mer­jian’s ap­point­ment comes just in time for him to steer the com­pa­ny to a new PDU­FA date in June. Most re­cent­ly, Se­mer­jian served as EVP, CCO at Ipsen. Dur­ing his time at No­var­tis On­col­o­gy, Se­mer­jian held var­i­ous roles, cul­mi­nat­ing in his last role as SVP, glob­al head of Ri­bo­ci­clib. With his ap­point­ment, Scott Canute will step down from his role as ex­ec­u­tive di­rec­tor and re­sume his role as board mem­ber.

Gade­ta — fo­cused on hema­to­log­i­cal can­cers and sol­id tu­mors — has tapped Mar­co Lon­dei as CEO. Lon­dei’s ap­point­ment comes at a time in which the com­pa­ny is tran­si­tion­ing from a pre­clin­i­cal stage com­pa­ny to a clin­i­cal stage com­pa­ny. Lon­dei hops aboard af­ter a stint as CMO and chief de­vel­op­ment of­fi­cer of Anap­tys­Bio. In ad­di­tion, Lon­dei held posts at No­var­tis and Bris­tol My­ers Squibb.

Gail McIn­tyre has stepped up as CEO of Ar­a­vive af­ter the res­ig­na­tion of Rekha Hem­ra­jani. McIn­tyre joined Ar­a­vive in 2016 and most re­cent­ly served as the com­pa­ny’s CSO. In ad­di­tion, the board ap­point­ed the founder of Es­hel­man Ven­ture Fred Es­hel­man as chair­man of the board. Jay Shep­ard, Srini­vas Akkara­ju and Robert Hoff­man have all re­signed from the board of di­rec­tors.

Harout Se­mer­jian

→ British bank Bar­clays has ap­point­ed JP Mor­gan vet Khaled Habayeb as man­ag­ing di­rec­tor in health­care eq­ui­ty cap­i­tal mar­kets (ECM). Habayeb will be based in New York. Habayeb joins the com­pa­ny from Deutsche Bank and pre­vi­ous­ly served as man­ag­ing di­rec­tor and head of health­care ECM at UBS.

→ Changes at Ar­ix Bio­science have been plen­ti­ful re­cent­ly. In March, it was Rober­to Ia­cone join­ing Ar­ix; in April, they’re do­ing a big­ger shuf­fle. Co-founder Joe An­der­son will step down ef­fec­tive im­me­di­ate­ly, while Naseem Amin, cur­rent­ly non-ex­ec­u­tive di­rec­tor, will step in as ex­ec­u­tive chair­man. The board of di­rec­tors al­so will have a new look as Jonathan Pea­cock, co-founder and chair­man, and Art Pap­pas, non-ex­ec­u­tive di­rec­tor, will ex­it the board at the Lon­don biotech’s An­nu­al Gen­er­al Meet­ing.

→ Fol­low­ing up its ad­di­tion of Pe­ter Linde as CMO, Mor­phic Ther­a­peu­tic has named Marc Schegerin CFO and COO. Schegerin heads to the Waltham, Mass­a­chu­setts biotech from Ar­Qule, where he was CFO, trea­sur­er and head of strat­e­gy & com­mu­ni­ca­tions be­fore Mer­ck ac­quired the on­col­o­gy-fo­cused drug de­vel­op­er for $2.7 bil­lion. Else­where in the in­dus­try, he pre­vi­ous­ly held di­rec­tor­ships at Bio­gen and Sage.

Marc Schegerin Mor­phic

→ Swiss-based Polyneu­ron Phar­ma­ceu­ti­cals, which reeled in $22.6 mil­lion in Se­ries A fi­nanc­ing last year, has ap­point­ed De­bra Bark­er as CMO. Be­fore join­ing Polyneu­ron, which fo­cus­es on au­toim­mune dis­eases of the ner­vous sys­tem, Bark­er was chief med­ical and de­vel­op­ment of­fi­cer of Polyphor. She al­so had a num­ber of roles at No­var­tis, no­tably as glob­al pro­gram head, on­col­o­gy, as well as po­si­tions at GSK and Roche.

Cal­lid­i­tas Ther­a­peu­tics, known for its de­vel­op­ment of Ne­fe­con to po­ten­tial­ly treat the in­flam­ma­to­ry re­nal dis­ease IgA nephropa­thy (IgAN), has a new CMO. Richard Philip­son has al­most a quar­ter-cen­tu­ry of ex­pe­ri­ence in the in­dus­try and tran­si­tions from his CMO role at Trizell to the Stock­holm-based phar­ma. Philip­son’s pre­vi­ous stops in­clude Take­da as ex­ec­u­tive med­ical di­rec­tor and Glax­o­SmithK­line, where he round­ed out his near­ly 16-year tenure as dis­ease area head and act­ing CMO for the rare dis­eases unit.

→ Hous­ton-based Ar­a­vive is un­der­go­ing a shake­up at the top. Out goes CEO Rekha Hem­ra­jani, who’s be­ing re­placed at the helm by CSO Gail McIn­tyre. Jay Shep­ard, Srini­vas Akkara­ju and Robert Hoff­man have re­signed from the board of di­rec­tors while Fred Es­hel­man was named chair­man of the board.

De­bra Bark­er

Tim Adams has an­nounced his res­ig­na­tion as CFO of Ob­sE­va SA, a Swiss bio­phar­ma cen­tered on women’s re­pro­duc­tive health. He’ll be re­placed by Fa­bi­en de Ladon­champs, Ob­sE­va’s VP, cor­po­rate af­fairs & fi­nance. Adams seeks new op­por­tu­ni­ties af­ter be­ing CFO for three years.

Lara Hashimo­to has tak­en over as CMO at SOPHiA GE­NET­ICS, join­ing the da­ta-dri­ven med­i­cine biotech ef­fec­tive April 1. Pri­or to her ar­rival, Hashimo­to had been chief com­mer­cial of­fi­cer at Roche Se­quenc­ing So­lu­tions, and be­fore that, she was in charge of IVD (in vit­ro di­ag­nos­tic) de­vel­op­ment and com­mer­cial­iza­tion at Roche Di­ag­nos­tics.

In­cyte vet Richard Levy has leapt on­to the board of di­rec­tors at Con­stel­la­tion Phar­ma­ceu­ti­cals. Levy served as EVP and chief drug de­vel­op­ment and med­ical of­fi­cer at In­cyte and pre­vi­ous­ly served at Cel­gene and San­doz/No­var­tis.

Kevin O’Dono­van H.E.L

→ Chad Mirkin is step­ping down as chair­man of the board of di­rec­tors at Al­ler­gan-part­nered gene ex­pres­sion ex­pert Ex­i­cure. Tim­o­thy Wal­bert, CEO of Hori­zon Ther­a­peu­tics, has been named as his suc­ces­sor. Mirkin will re­main on the board.

Glob­al de­vel­op­er and man­u­fac­tur­er of lab­o­ra­to­ry tools H.E.L Group has wel­comed Kevin O’Dono­van as chair of the com­pa­ny’s board of di­rec­tors, tak­ing over from in­ter­im chair Jon An­drew. O’Dono­van was pre­vi­ous­ly the founder of Hy­baid, a mol­e­c­u­lar bi­ol­o­gy in­stru­men­ta­tion com­pa­ny.

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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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.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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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.

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.