Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

Jef­frey Hat­field

→ San Diego pro­tein degra­da­tion start­up Vi­vid­ion Ther­a­peu­tics has made a change at the top with Jef­frey Hat­field tak­ing the helm as CEO, re­plac­ing Diego Mi­ralles six months af­ter Roche forked over $135 mil­lion to col­lab­o­rate with Vi­vid­ion on their small mol­e­cule de­graders. Hat­field is chair­man of the board at mi­Ra­gen Ther­a­peu­tics and pre­vi­ous­ly held the CEO job at Zaf­gen and Vi­tae Phar­ma­ceu­ti­cals. He al­so had a se­ries of lead­er­ship roles at Bris­tol My­ers Squibb from 1996-2004, in­clud­ing SVP, im­munol­o­gy and vi­rol­o­gy di­vi­sions.

Launched in Feb­ru­ary 2017 and chaired by Rich Hey­man, Vi­vid­ion fol­lowed with an $82 mil­lion Se­ries B two years lat­er.

Bill Haney’s folks at Drag­on­fly Ther­a­peu­tics — wheel­ing and deal­ing with Bris­tol My­ers Squibb on a $475 mil­lion pact in Au­gust — have brought on Alex Lu­gov­skoy as chief op­er­at­ing of­fi­cer. A Bio­gen vet in drug dis­cov­ery, Lu­gov­skoy spent five years as Mor­phic Ther­a­peu­tic’s chief de­vel­op­ment of­fi­cer be­fore set­tling in at Drag­on­fly. Be­fore that, he had a six-year run as VP of ther­a­peu­tics at Mer­ri­mack Phar­ma­ceu­ti­cals.

Drag­on­fly al­so gave Rob Her­sh­berg a spot on their sci­en­tif­ic ad­vi­so­ry board. Her­sh­berg was EVP and head of busi­ness de­vel­op­ment & glob­al al­liances at Cel­gene un­til the 2019 Bris­tol My­ers buy­out.

Hugh Samp­son

→ It’s been a try­ing year for DBV Tech­nolo­gies with the FDA’s re­jec­tion of their peanut al­ler­gy skin patch along with em­ploy­ee lay­offs while wait­ing to hear from the agency. CFO Ramzi Be­na­mar and chief com­mer­cial of­fi­cer Kevin Trapp bolt­ed in Oc­to­ber. And this week, CSO Hugh Samp­son has ten­dered his res­ig­na­tion ef­fec­tive Dec. 1, head­ing back to the lab at the Jaffe Food Al­ler­gy In­sti­tute at Mount Sinai. Samp­son had been DBV’s chief sci­en­tist for five years, but he’s not leav­ing for good: He will be sci­en­tif­ic ad­vis­er to CEO Daniel Tassé and chair­man of their sci­en­tif­ic ad­vi­so­ry board.

Maky Zan­ganeh

→ Biotech bil­lion­aire Bob Dug­gan is fill­ing out his ex­ec­u­tive team at Sum­mit Ther­a­peu­tics with long­time col­league Maky Zan­ganeh as chief op­er­at­ing of­fi­cer, two weeks af­ter she joined the an­tibi­otics biotech’s board of di­rec­tors. Zan­ganeh has worked with Dug­gan be­fore as VP of busi­ness de­vel­op­ment at Robert Dug­gan & As­so­ci­ates and as COO at Phar­ma­cyclics. She’s al­so a board mem­ber at Pulse Bio­Sciences and Ren­ovoRx.

→ Lon­don-based Mereo Bio­Phar­ma has been pop­ping up in Peer Re­view reg­u­lar­ly, ap­point­ing a CFO and CSO among oth­er ex­ecs. The on­col­o­gy and rare dis­ease out­fit isn’t fin­ished in 2020, nam­ing Su­ba Kr­ish­nan SVP of clin­i­cal de­vel­op­ment. Kr­ish­nan had been glob­al pro­gram head of im­muno-on­col­o­gy at Gen­mab for the last year, hav­ing just spent the year be­fore as clin­i­cal lead in a Phase II Lyn­parza study at Mer­ck. She’s al­so tak­en on lead­er­ship roles at Bris­tol My­ers Squibb and Shire. Mereo is tar­get­ing TIG­IT with a $70 mil­lion pri­vate place­ment they an­nounced in June.

Pen­rose Ther­a­peuTx — fo­cused on the de­vel­op­ment of small mol­e­cule ther­a­pies for the treat­ment of can­cer — has tapped Mark de Souza as its CEO. De Souza joins the com­pa­ny af­ter his most re­cent stint as CEO of cannabis health and well­ness com­pa­ny Rev­o­lu­tion Glob­al.

Ton Berkien

Ton Berkien has been in­stalled as CBO at Nor­we­gian can­cer biotech Ul­ti­movacs, which re­port­ed pos­i­tive Phase I da­ta last month for their pep­tide-based vac­cine UV1 in pa­tients with non-small cell lung can­cer. Be­fore the switch to Ul­ti­movacs, helmed by Car­los de Sousa af­ter his run end­ed at Swe­den-based Im­mu­nicum, Berkien was Am­gen’s di­rec­tor of busi­ness de­vel­op­ment and worked in M&A at Take­da as their act­ing head of cor­po­rate de­vel­op­ment.

→ When last we saw Tarus Ther­a­peu­tics here, the New York biotech had added David Ep­stein and David Nichol­son to the board of di­rec­tors. Now they’ve brought on Bri­an Schwartz as act­ing CMO and head of their sci­en­tif­ic ad­vi­so­ry board. Schwartz was pre­vi­ous­ly CMO at ar­Qule from 2008 un­til Mer­ck bought the com­pa­ny for $2.7 bil­lion, and he had al­so been ar­Qule’s head of R&D since 2013. From 2006-08, the Bay­er vet held dual roles (CMO and SVP, clin­i­cal and reg­u­la­to­ry af­fairs) at Zio­pharm On­col­o­gy.

Alas­tair Maxwell

→ Look­ing to cor­ner the sleep-dis­or­dered break­thing mar­ket with eX­ci­teOSA for mild ob­struc­tive sleep ap­nea and snor­ing, Sig­ni­fi­er Med­ical Tech­nolo­gies has ap­point­ed Alas­tair Maxwell as CFO. Maxwell, a Mor­gan Stan­ley and Gold­man Sachs alum, heads to Sig­ni­fi­er af­ter de­cid­ing not to re­lo­cate to Greece with the rest of se­nior man­age­ment at GasLog and GasLog Part­ners, where he was the group’s CFO.

→ Along with the news of their col­lab­o­ra­tion with cell ther­a­py equip­ment man­u­fac­tur­er BioS­pher­ix, mi­to­chon­dr­i­al dis­ease-fo­cused Mi­novia Ther­a­peu­tics has pegged David O’Don­nell as their glob­al head of man­u­fac­tur­ing and sup­ply chain. O’Don­nell makes the move from be­lea­guered Unum Ther­a­peu­tics (since re­named Co­gent Bio­sciences), where he was their di­rec­tor of tech­nol­o­gy op­er­a­tions. The Agenus vet has al­so been Ova­Science’s se­nior di­rec­tor of op­er­a­tions.

Robert Wal­ter­mire

→ An­tibi­otics-fo­cused Ve­na­torx Phar­ma­ceu­ti­cals out of Malvern, PA has en­list­ed Bris­tol My­ers Squibb vet Robert Wal­ter­mire as SVP, chem­istry, man­u­fac­tur­ing & con­trols (CMC). Wal­ter­mire spent more than 18 years at BMS, in­clud­ing the last 4 years as VP, chem­i­cal & syn­thet­ic de­vel­op­ment. He heads to Ve­na­torx af­ter a brief stint at Palatin Tech­nolo­gies as SVP, prod­uct de­vel­op­ment.

Urvi Rand­har

Prime Ther­a­peu­tics has re­cruit­ed Urvi Rand­har as SVP, chief in­for­ma­tion tech­nol­o­gy and da­ta man­age­ment and an­a­lyt­ics ar­eas; Sam Mo­han­ty as VP and chief da­ta of­fi­cer; and Sarah Tay­lor as VP and chief an­a­lyt­ics of­fi­cer. Rand­har joins the com­pa­ny from Healog­ics, while Mo­han­ty hops aboard af­ter stints at Unit­ed Air­lines and CVS Health. Mean­while, Tay­lor comes to the team with ex­pe­ri­ence at Unit­ed Health­care.

Jayson Dal­las, the for­mer CEO of Aim­mune Ther­a­peu­tics (ac­quired by Nestlé Health Sci­ence), is hop­ping aboard the board of di­rec­tors at Copen­hagen-based Galec­to, which filed for a $100 mil­lion IPO ear­ly last month. Dal­las is cur­rent­ly a mem­ber of the board at Are­na Phar­ma­ceu­ti­cals and has ex­pe­ri­ence from his stints at Pfiz­er, No­var­tis, Roche and Ul­tragenyx Phar­ma­ceu­ti­cals.

Stephen Squin­to

Stephen Squin­to is step­ping in as chair­man of the board at hematopoi­et­ic stem prog­en­i­tor cell gene ther­a­py de­vel­op­er Genen­ta Sci­ence. Squin­to, the Alex­ion co-founder and Or­biMed ex­ec­u­tive part­ner, had more re­cent­ly been cho­sen as vice chair­man of bioAffin­i­ty Tech­nolo­gies. He was al­so in­ter­im CEO of Pas­sage Bio un­til he was suc­ceed­ed by Bruce Gold­smith a month be­fore their mas­sive IPO.

Kathy Reape

Taysha Gene Ther­a­pies is adding Kathy Reape and Mer­ck vet Lau­ra Sepp-Loren­zi­no to its board of di­rec­tors. Reape for­mer­ly served as CMO at Spark Ther­a­peu­tics, while Sepp-Loren­zi­no cur­rent­ly serves as CSO at In­tel­lia Ther­a­peu­tics. In ad­di­tion, Sepp-Loren­zi­no has held stints at Ver­tex and Al­ny­lam.

→ Cam­bridge, MA mi­cro­bio­me drug de­vel­op­er Vedan­ta Bio­sciences, which se­lect­ed Jef­frey Sil­ber as their CMO in Sep­tem­ber, has wel­comed Troy Ignelzi to their board of di­rec­tors. Ignelzi has been CFO at Karuna Ther­a­peu­tics since March 2019.

Ox­ford Bio­med­ica, which inked a CAR-T deal with Beam Ther­a­peu­tics in Au­gust, has reeled in Siya­mak Rasty as non-ex­ec­u­tive di­rec­tor of the board. Rasty cur­rent­ly serves as CEO and pres­i­dent of Platelet­Bio and has pre­vi­ous­ly served in roles at Ho­mol­o­gy, Shire, En­do Phar­ma­ceu­ti­cals and GSK.

Jen­nifer Mc­Nealey

→ A pair of new board mem­bers have been an­nounced at An­tibe Ther­a­peu­tics, a Toron­to-based biotech de­vel­op­ing an­ti-in­flam­ma­to­ries on a hy­dro­gen sul­fide plat­form. Robert Hoff­man re­cent­ly re­tired as CFO of Heron Phar­ma­ceu­ti­cals and is chair­man of Kin­tara Ther­a­peu­tics. Jen­nifer Mc­Nealey is the VP, in­vestor re­la­tions and strat­e­gy at Calithera Bio­sciences.

→ A trio of board mem­bers is glid­ing in­to Philadel­phia AAV gene ther­a­py play­er Swan­Bio Ther­a­peu­tics: Pat­ty Allen, Dan­ny Bar-Zo­har, and Alex Hamil­ton. Allen, the ex-Zaf­gen CFO, is al­so on the board of Anokion, In­ver­sa­go and Yu­man­i­ty. Bar-Zo­har just took the job at Mer­ck KGaA as glob­al head of de­vel­op­ment, while Hamil­ton is a part­ner at Syn­cona.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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No­vavax CFO Greg Covi­no makes a quick ex­it as lead­er­ship carousel keeps turn­ing; Kite ex­ecs fly away to a cell ther­a­py up­start team­ing up with Lyell

→ If it seems like Covid-19 vaccine bridesmaid Novavax is shuttling staffers in and out, you’re not alone. This week, Greg Covino announced he’s leaving the biotech after holding the CFO job for a blink-and-you-miss-it tenure. An advisory role within the company awaits for Covino, who came to Novavax just five months ago from Bristol Myers Squibb, while CCO and CBO John Trizzini juggles even more executive responsibility by taking on the interim CFO title.

J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Emmanuel Hanon (Viome)

Glax­o­SmithK­line’s head of vac­cine R&D is jump­ing to a well­ness com­pa­ny con­cen­trat­ing on the mi­cro­bio­me as re­ports of an ex­o­dus start to spread

Back in the fall of 2019, GlaxoSmithKline vaccine R&D chief Emmanuel Hanon had plenty of good things to say about a wellness company called Viome and CEO Naveen Jain. He was particularly interested in Viome’s technology for analyzing the gut microbiome and how that could intersect with new vaccine research.

Today, Hanon is jumping ship to join his collaborator as R&D chief as reports circulate of an exodus at GSK’s big vaccine group.

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