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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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