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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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