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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The company calls it “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” the Boston Globe reported, quoting a spokesperson.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

John Quisel, Disc Medicine CEO

Disc Med­i­cine goes pub­lic in re­verse merg­er with strug­gling Gem­i­ni Ther­a­peu­tics

After licensing a failed Roche schizophrenia drug last year, Disc Medicine is going public via a reverse merger with Gemini Therapeutics.

The combined company, while still named Disc Medicine, will trade under the stock symbol $IRON, in reference to Disc’s lineup of therapies for blood iron disorders. Alongside the merger, Disc has secured $53.5 million in another financing round, building on the $90 million Series B it raised in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,500+ biopharma pros reading Endpoints daily — and it's free.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.