'Ris­ing star' CEO re­counts path from pre-med to break­through meds; Den­dreon taps Big Phar­ma vet Ja­son O'Neill as CEO

Fresh­man year was a trans­for­ma­tive one for Aet­na Wun Tromb­ley.

Aet­na Wun Tromb­ley

Hav­ing en­rolled at the Uni­ver­si­ty of Cal­i­for­nia, San Diego think­ing she would be­come a pe­di­a­tri­cian some day, she got in­trigued by the chem­istry re­search projects she was in­tro­duced to in her first un­der­grad­u­ate chem­istry course. She joined the lab of the lec­tur­er, paving the way for her to drop pre-med and even­tu­al­ly com­plete a PhD at MIT.

But there was al­so a rea­son why the re­search — which fo­cused on in­or­gan­ic chem­istry more in the ma­te­r­i­al space — ul­ti­mate­ly wasn’t sat­is­fy­ing enough. Af­ter her first year in col­lege, her fa­ther quite abrupt­ly passed away from liv­er can­cer.

“The most dif­fi­cult thing for me to un­der­stand — and I think it’s still true to­day — was that there were no good treat­ments for some­one like him,” Tromb­ley, the new­ly in­stalled CEO at Ly­cia Ther­a­peu­tics, told End­points News. “It was metasta­t­ic at the time, but even — I mean, where are we now? Many years lat­er, decades lat­er, we still don’t have re­al­ly good treat­ments for he­pa­to­cel­lu­lar car­ci­no­ma.”

The de­sire to ap­ply her prob­lem solv­ing an­a­lyt­i­cal skills to biotech led her to the Pa­lo Al­to of­fice of McK­in­sey, where she got ac­quaint­ed with both Big Phar­ma and small biotechs on the West Coast. It was al­so there that she met col­leagues who would go on to take up roles at Ver­sant Ven­tures.

“We knew from that time that she was a ris­ing star,” Clare Oza­wa, a Ver­sant man­ag­ing di­rec­tor who’s al­so on Ly­cia’s board, said. “To be hon­est, she’s been on our radar screen for some time. As soon as she seemed to be in the right place for her­self, per­son­al­ly and pro­fes­sion­al­ly, to make a move to CEO, we want­ed to try to grab her.”

Not that Tromb­ley has ever re­al­ly want­ed to take the helm com­pa­ny — es­pe­cial­ly af­ter serv­ing as chief of staff to Joe Jimenez at No­var­tis’ Basel head­quar­ters.

“See­ing what a CEO does, and what they bear, in terms of all the re­spon­si­bil­i­ty and ac­count­abil­i­ty, at the time it seemed so daunt­ing,” she said. “There’s fires that we would have to deal with.”

If there’s one thing that stood out, though, it might be the hu­man el­e­ment to the role.

Find­ing great peo­ple to work with and dri­ve sci­ence for­ward, she not­ed, is rare. So just as she grasped the op­por­tu­ni­ty to join Bill Rieflin — a for­mer boss and ear­ly men­tor — to build NGM nine years ago, she jumped at the chance to re­al­ize Car­olyn Bertozzi’s ideas about next-gen de­graders that can send ex­tra­cel­lu­lar pro­teins to the lyso­some for dis­pos­al.

“She’s amaz­ing,” Tromb­ley said, re­call­ing her first meet­ing with the Stan­ford pro­fes­sor. “That was ev­i­dent in the first minute of the con­ver­sa­tion.”

Ly­cia cur­rent­ly leans on Ver­sant’s In­cep­tion Dis­cov­ery En­gine as its R&D mus­cle. One of Tromb­ley’s pri­or­i­ties now as the first and on­ly em­ploy­ee is to re­cruit a full-time team and cre­ate a cul­ture where they would want to stay. Set­ting ag­gres­sive goals is al­so im­por­tant, she added.

“Even if you don’t hit all of those goals — be­cause that’s just how sci­ence works some­times — but be­cause you re­al­ly fo­cused every­one on try­ing to achieve them, any progress that they would have made to such ag­gres­sive goals would be tremen­dous val­ue cre­ation for the com­pa­ny,” she said.

Am­ber Tong


Ja­son O’Neill

Den­dreon Phar­ma­ceu­ti­cals, de­vel­op­ers of the pi­o­neer­ing drug Provenge used by men with ad­vanced prostate can­cer, has tapped Ja­son O’Neill as CEO. You name it, O’Neill’s been there: Start­ing out at Pfiz­er, he then moved to Scher­ing-Plough and Bris­tol My­ers Squibb in the 1990s. O’Neill spent nine-and-a-half years in a hand­ful of roles at Sanofi, was briefly at Genen­tech and was the glob­al ther­a­peu­tic area head, im­munol­o­gy & oph­thal­mol­o­gy at Roche. O’Neill was the gen­er­al man­ag­er, rheuma­tol­ogy unit at Mallinck­rodt be­fore be­com­ing the CEO of Irid­i­um Ther­a­peu­tics in 2017.

Pre­ston Klassen will now helm Metacrine — co-found­ed by Rich Hey­man and in the clin­ic with po­ten­tial treat­ments for NASH — as pres­i­dent and CEO. Klassen, an Am­gen vet, was for­mer­ly the EVP, head of R&D for Are­na Phar­ma­ceu­ti­cals and the CMO at Lab­o­ra­toris San­i­fit SL. Ad­di­tion­al­ly, Metacrine an­nounced that As­sem­bly Bio­sciences pres­i­dent and CEO John McHutchi­son will lend his ex­per­tise to the San Diego bio­phar­ma’s board of di­rec­tors.

Franck Brinkhaus

→ Adding to his list of ti­tles at im­muno-on­col­o­gy biotech Epi­cen­tRx, which raised $35 mil­lion last sum­mer in a Se­ries D round, Franck Brinkhaus has been named pres­i­dent of the com­pa­ny. Brinkhaus had been CFO at Epi­cen­tRx, lo­cat­ed in the Tor­rey Pines area of San Diego, since De­cem­ber. Be­fore his ar­rival, Brinkhaus found­ed and was the CEO of Biotech Al­liances In­ter­na­tion­al.

→ UK-based an­ti-ag­ing biotech Ju­ve­nes­cence has wel­comed Ellen Don­nel­ly to the fray as CEO of the epi­ge­net­ics di­vi­sion of the com­pa­ny while al­so helm­ing its port­fo­lio com­pa­ny Sou­vien Bio. Don­nel­ly most re­cent­ly served as CEO of Modus Ther­a­peu­tics AB and has pre­vi­ous­ly held posts at Pfiz­er.

Jef­frey Humphrey is re­plac­ing Adri­an Senderow­icz as CMO of Cam­bridge, MA epi­ge­net­ics play­er Con­stel­la­tion Phar­ma­ceu­ti­cals. Senderow­icz will tran­si­tion to se­nior ad­vi­sor, which will go in­to ef­fect June 22. Be­fore his ar­rival at Con­stel­la­tion, Humphrey was the chief de­vel­op­ment of­fi­cer at Ky­owa Kirin. He’s al­so held se­nior man­age­ment po­si­tions at Pfiz­er, Bay­er and Bris­tol My­ers Squibb.

Yael Hay­on

Pro­tal­ix Bio­Ther­a­peu­tics, which filed a BLA in May for their Fab­ry Dis­ease treat­ment, pe­gu­ni­gal­si­dase al­fa, is bring­ing on Yael Hay­on as VP of R&D. Hay­on will get the ball rolling at Pro­tal­ix af­ter be­ing VP of clin­i­cal af­fairs at Syqe Med­ical in Tel Aviv. Pri­or to that  she led Log­icBio‘s Is­raeli-based R&D fa­cil­i­ty.

→ Cam­bridge, Mass­a­chu­setts-based X4 Phar­ma­ceu­ti­cals — run­ning a Phase III tri­al for its lead drug ma­vorix­afor for the treat­ment of WHIM syn­drome, has pro­mot­ed Re­na­to Skerlj to CSO. Skerlj is one of the sci­en­tif­ic founders of X4. Skerlj hopped aboard the com­pa­ny last Sep­tem­ber as SVP, re­search and de­vel­op­ment. Pri­or to join­ing the com­pa­ny, Skerlj held posts at Lyso­so­mal Ther­a­peu­tics and was head of small mol­e­cule dis­cov­ery at Gen­zyme.

→ Top­ping $90 mil­lion with its Se­ries C round in May, San Diego bio­phar­ma Am­plyx Phar­ma­ceu­ti­cals is adding to its lead­er­ship team with the ap­point­ments of Chris LeMas­ters as chief op­er­at­ing of­fi­cer and Car­los Sat­tler as se­nior vice pres­i­dent, clin­i­cal de­vel­op­ment. LeMas­ters had been EVP and CBO at Mi­rati Ther­a­peu­tics and was al­so the CEO at Pro­mo­some. Sat­tler was pre­vi­ous­ly VP, glob­al med­ical and sci­en­tif­ic af­fairs at Halosyme, and be­fore that, he was at San­doz from 2013-19.

Jo Ellen Schwein­le

→ New Jer­sey-based de­vel­op­er of au­tol­o­gous stem cell ther­a­pies Ren­o­vaCare has gained its first CMO with the ap­point­ment of Jo Ellen Schwein­le. Schwein­le comes with ex­pe­ri­ence from her time as for­mer se­nior med­ical of­fi­cer at the US De­part­ment of Health and Hu­man Ser­vices as well as ex­ec po­si­tions at Bay­er, GSK, and Ch­i­ron/No­var­tis, among oth­ers.

→ There are lead­er­ship moves aplen­ty at iTeos, which fo­cus­es on im­muno-on­col­o­gy and snapped up $125 mil­lion in Se­ries B2 fi­nanc­ing. Cel­gene and Gilead vet Matthew Gall is the new CFO, jump­ing to iTeos from Sarep­ta, where he was SVP of cor­po­rate de­vel­op­ment and trea­sur­er. Yvonne Mc­Grath is now VP of R&D and was pre­vi­ous­ly the chief sci­en­tif­ic of­fi­cer at Com­plix N.V. as well as the head of de­vel­op­ment at Im­muno­core. Mean­while, Philippe Bran­tegem, whose work in biotech be­gan at Sanofi Pas­teur, has signed on as VP of hu­man re­sources.

Justin Renz

Justin Renz has stepped in as CFO of Cal­i­for­nia-based Arde­lyx, which se­cured FDA ap­proval for IBS with Ib­srela in Sep­tem­ber. Renz was pre­vi­ous­ly pres­i­dent and CFO of Cor­re­vio Phar­ma, lead­ing the sale of the com­pa­ny to Ad­vanz Phar­ma in May. Be­fore he helmed Cor­re­vio, he was EVP, CFO and trea­sur­er of Karyopharm Phar­ma­ceu­ti­cals.

→ Ger­man biotech Af­fimed, al­lied with Genen­tech and en­rolling for stud­ies of can­cer drug can­di­dates AFM13 and AFM24, has reeled in An­gus Smith as CFO. Smith had been CFO at Rock­well Med­ical since No­vem­ber 2018, when he left Pernix Ther­a­peu­tics as their SVP, CBO and prin­ci­pal fi­nan­cial of­fi­cer.

TriSalus just in­tro­duced a new CFO in Ra­jesh Mis­try. Now the Den­ver com­pa­ny has a new chief tech­nol­o­gy of­fi­cer in Scott Davie, who will be the site lead for TriSalus’ fa­cil­i­ty in West­min­ster, CO and will over­see re­search and de­vel­op­ment of in­travas­cu­lar in­fu­sion sys­tems. Davie was a long­time pres­ence at Medtron­ic, leav­ing as the se­nior di­rec­tor of R&D.

→ Philadel­phia-based Xy­lo­Cor Ther­a­peu­tics, fo­cused on gene ther­a­py for car­dio­vas­cu­lar dis­ease, has snagged Alexan­der Gaidama­ka as SVP of tech­nol­o­gy, man­u­fac­tur­ing & qual­i­ty. His pre­vi­ous lead­er­ship role came at Am­pliPhi Bio­sciences as VP of chem­istry, man­u­fac­tur­ing & con­trols. He al­so served as CEO and CSO at Per­son­al­ized On­coTher­a­peu­tics.

Alexan­der Gaidama­ka

Ro­mesh Sub­ra­man­ian’s biotech start­up Dyne Ther­a­peu­tics, which is backed by At­las, has re­cruit­ed Daniel Wil­son as VP, head of in­tel­lec­tu­al prop­er­ty. Wil­son joins the Mass­a­chu­setts-based com­pa­ny from Cel­gene, where he served as se­nior cor­po­rate coun­sel. Pri­or to that, he was in­tel­lec­tu­al prop­er­ty coun­sel at Sunovion Phar­ma­ceu­ti­cals.

Af­ter emerg­ing as the biggest win­ner yet dur­ing the pan­dem­ic IPO boom — fetch­ing $424 mil­lion — Leg­end Biotech has wel­comed some new faces to its board of di­rec­tors. The J&J-part­nered CAR-T de­vel­op­er has ap­point­ed ex Juno ex­ec Cora­zon Dat­ing Sanders, cur­rent CEO of Elpi­science Bio­phar­ma­ceu­ti­cals Dar­ren Ji and for­mer AMTD Group ex­ec Philip Yau.

Ca­r­ole Ho

→ Not long af­ter nam­ing Siob­han Nolan Mangi­ni as CFO, NGM Bio is strength­en­ing its board of di­rec­tors. Ca­r­ole Ho, the CMO and head of de­vel­op­ment at De­nali Ther­a­peu­tics since 2015, is jump­ing on to the board. Pri­or to her lead­er­ship roles at De­nali, Ho was VP of ear­ly clin­i­cal de­vel­op­ment at Genen­tech.

→ Af­ter pric­ing a $75 mil­lion IPO in April, ORIC Phar­ma­ceu­ti­cals has wooed Lori Kunkel to its board of di­rec­tors. Kunkel joins the San-Fran­cis­co-based can­cer biotech with ex­pe­ri­ence as act­ing CMO at Loxo On­col­o­gy and CMO at Phar­ma­cyclics and Pro­te­olix.

→ AAV biotech Affinia Ther­a­peu­tics, which raised a $60 mil­lion Se­ries A round that was an­nounced at the end of March, has wel­comed El­liott Si­gal to their board of di­rec­tors. The for­mer CSO and pres­i­dent of R&D at Bris­tol My­ers Squibb, Si­gal had al­so been on the board at Spark Ther­a­peu­tics.

Richard Bag­ger

→ Tiny Tonix Phar­ma­ceu­ti­cals, which has had its share of ups and downs, has en­list­ed Pfiz­er vet Richard Bag­ger to its board of di­rec­tors, re­plac­ing John Rhodes, who stepped down from the po­si­tion of com­pa­ny di­rec­tor. Along with his 16-year stint at Pfiz­er, Bag­ger served as EVP of cor­po­rate af­fairs and mar­ket ac­cess at Cel­gene un­til its ac­qui­si­tion by Bris­tol My­ers Squibb.

Rock­well Med­ical — whose for­mer CEO, Robert Chioi­ni, tried to un­fire him­self in 2018 be­fore reach­ing a set­tle­ment — has ap­point­ed kid­ney dis­ease ex­pert and UCLA emer­i­tus pro­fes­sor of med­i­cine Allen Nis­senson to its board of di­rec­tors. Nis­senson is emer­i­tus CMO of DaVi­ta Kid­ney Care and mem­ber of the board at An­gion Bio­med­ica.

Amolyt Phar­ma — fo­cused on the de­vel­op­ment of ther­a­peu­tic pep­tides for rare en­docrine and meta­bol­ic dis­eases — has tapped Pierre Legault as di­rec­tor and chair­man of its board of di­rec­tors. Legault comes with ex­pe­ri­ence from his time as chair­man of Bi­cy­cle Ther­a­peu­tics and lead di­rec­tor of Urovant Sci­ences, among oth­ers. Legault joins as the com­pa­ny pre­pares to move its first as­set in­to the clin­ic.

→AI-fo­cused twoXAR Phar­ma­ceu­ti­cals has wel­comed Howard Rosen to its board of di­rec­tors. Rosen’s pre­vi­ous stints in­clude roles at Gilead Sci­ences, Kala Phar­ma­ceu­ti­cals and ALZA Cor­po­ra­tion among oth­ers.

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.

Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: 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 subbleases are “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,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

Feud be­tween two biotechs left near­ly 12M dos­es of mon­key­pox an­tivi­ral on the ta­ble

As the US embarks on a new delivery strategy to stretch out its thinning supply of monkeypox vaccines, the need for treatments could pick up as cases of the virus rise. And the amount of courses of one potential antiviral, soon to be clinically tested for efficacy in humans, was almost 12 million more than it is today, according to SEC filings.

While not greenlit for treating monkeypox, SIGA’s FDA-approved smallpox antiviral, Tpoxx, can be requested by physicians under an expanded use program. As of Monday, HHS tells Endpoints News it had tapped into more than 15,000 of the 1.7 million courses of Tpoxx that have been stockpiled, but with cases climbing over the past few weeks, demand will likely not peter out in the near future, especially if the vaccine supply runs dry.

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