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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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