MD An­der­son­'s Patrick Hwu to helm Mof­fitt Can­cer Cen­ter; Af­ter Rock­well Med­ical ouster, Robert Chioi­ni gets an­oth­er chance to lead

Patrick Hwu

→ The Mof­fitt Can­cer Cen­ter in Tam­pa has found its next pres­i­dent and CEO af­ter the im­broglio sur­round­ing the de­par­ture of Alan List.

Patrick Hwu, the head of can­cer med­i­cine at MD An­der­son Can­cer Cen­ter, has been tapped to lead Mof­fitt al­most ex­act­ly 8 months fol­low­ing the mass res­ig­na­tions of List, cen­ter di­rec­tor Thomas Sell­ers and 4 oth­er re­searchers for con­flict of in­ter­est re­gard­ing their work in Chi­na, one of sev­er­al high-pro­file ex­am­ples that in­clude Har­vard pro­fes­sor Charles Lieber.

Hwu, who of­fi­cial­ly starts Nov. 10, spent 17 of his 33 years in on­col­o­gy at MD An­der­son in promi­nent lead­er­ship po­si­tions. Be­sides his most re­cent role, he chaired the De­part­ment of Sar­co­ma Med­ical On­col­o­gy and was the first chair of the De­part­ment of Melanoma Med­ical On­col­o­gy. Hwu was al­so co-di­rec­tor of the Cen­ter for Can­cer Im­munol­o­gy Re­search.

“I’m con­fi­dent that our col­lec­tive ef­forts will fur­ther el­e­vate Mof­fitt’s lead­er­ship in can­cer pa­tient care, re­search and ed­u­ca­tion,” Hwu said in a state­ment.

Robert Chioi­ni

Robert Chioi­ni made head­lines back in 2018 when he at­tempt­ed to un­fire him­self as CEO of Rock­well Med­ical, as­sert­ing that those who vot­ed against him vi­o­lat­ed fed­er­al se­cu­ri­ties laws. With that messy dis­missal be­hind him fol­low­ing a set­tle­ment deal, Chioi­ni is back in the sad­dle, tak­ing over as CEO of Toron­to life sci­ences com­pa­ny SQI Di­ag­nos­tics. Er­ic Brouw­er has sub­se­quent­ly stepped aside as in­ter­im CEO, but he will con­tin­ue on as CSO at SQI.

“I look for­ward to work­ing with the team to un­lock the po­ten­tial across our suite of clin­i­cal and point of care di­ag­nos­tic prod­ucts,” Choi­ni, who found­ed Rock­well Med­ical in 1995, said in a state­ment. “Now more than ever, we see the im­por­tance of ac­cu­rate, wide­ly avail­able, and rapid di­ag­nos­tic tests.”

Ravi Rao

→ Start­ing Sept. 1, So­bi is bring­ing in Ravi Rao as head of R&D af­ter the EMA spurned the Stock­holm phar­ma’s pitch for ema­palum­ab (which has al­ready been ap­proved in the US) in late Ju­ly. Be­fore link­ing up with Stock­holm-based So­bi, which fo­cus­es on hema­tol­ogy and im­munol­o­gy, Rao wrapped up a run as CMO of Ae­glea Bio­ther­a­peu­tics. His Big Phar­ma ex­pe­ri­ence ranges from his 5 years at Roche, where he was group med­ical di­rec­tor, im­munol­o­gy clin­i­cal de­vel­op­ment, to 7 years as a VP at GSK, where he led the im­munol­o­gy and spe­cial­ty med­i­cine fran­chise up­on his de­par­ture to Ae­glea.

James Hussey has been around the block ei­ther as a pres­i­dent or CEO, and now he’s at the helm of Seneca Ther­a­peu­tics, look­ing to push its on­colyt­ic virus SVV-001 in­to clin­i­cal tri­als some­time in 2021. Hussey, who got his ca­reer go­ing at Bris­tol My­ers in the 1980s, has been the CEO of NeoPharm and NanoInk as well as the pres­i­dent of Sagent Phar­ma­ceu­ti­cals. Among his most re­cent roles, Hussey has been act­ing US pres­i­dent of Mor­phoSys and EVP of Athenex.

Kristof Ver­cruysse

Per­somed, a Bel­gian con­sor­tium look­ing to scale up de­vel­op­ment of per­son­al­ized can­cer vac­cines, has named Abl­ynx vet Kristof Ver­cruysse as their CEO. Most re­cent­ly he has been the chief de­vel­op­ment of­fi­cer and CMO at TargED Bio­phar­ma­ceu­ti­cals, for­mer­ly known as IO­VA. Ver­cruysse was di­rec­tor of clin­i­cal op­er­a­tions at Abl­ynx from 2007-13.

Matt Brokaw has been cho­sen to take the helm as pres­i­dent and CEO of med­ical de­vice com­pa­ny Aerin Med­ical, which aims to pro­vide non-in­va­sive pro­ce­dures for treat­ing chron­ic nasal air­way con­di­tions. Brokaw has pre­vi­ous­ly held lead­er­ship po­si­tions in mar­ket­ing at com­pa­nies with ENT port­fo­lios, such as Smith+Nephew (which just ac­quired Tusker Med­ical in Jan­u­ary) and Stryk­er. Along with Brokaw’s ap­point­ment, Aerin Med­ical al­so re­vealed the close of their $48 mil­lion eq­ui­ty fi­nanc­ing.

→ Fo­cused on the re­peatome in drug de­vel­op­ment, ROME Ther­a­peu­tics has brought on Den­nis Za­ller to be their CSO. A for­mer ex­ec­u­tive di­rec­tor at Mer­ck and Cel­gene/BMS, Za­ller has col­lab­o­rat­ed in the past with ROME’s pres­i­dent, CEO and co-founder, Rosana Kapeller. On Wednes­day our Max Gel­man spoke with Za­ller and Kapeller, which you can read here.

→ Long­time phar­ma ex­ec Paul Ko­rner is head­ed to Prince­ton, NJ women’s health­care com­pa­ny Ag­ile Ther­a­peu­tics as their CMO. Ko­rner has held a va­ri­ety of ex­ec­u­tive ti­tles, in­clud­ing SVP of US de­vel­op­ment at Fer­ring Phar­ma­ceu­ti­cals, which has made women’s health one of its ar­eas of fo­cus. He just com­plet­ed a more than year-and-a-half run as Ax­o­vant’s SVP, clin­i­cal de­vel­op­ment & med­ical af­fairs, and from 2005-08, Ko­rner was Bay­er’s VP of med­ical af­fairs, women’s health.

Al­ka Chaubey

Al­ka Chaubey has made her way to San Diego-based gene se­quenc­ing play­er Bio­nano Ge­nomics as their first CMO. A well-known fig­ure through­out the mol­e­c­u­lar di­ag­nos­tics and cy­to­ge­net­ics com­mu­ni­ties, Chaubey is cur­rent­ly the head of cy­toge­nomics for PerkinElmer Ge­nomics, and she al­so spent 10 years at South Car­oli­na’s Green­wood Ge­net­ic Cen­ter, in­clud­ing 7 years as their di­rec­tor.

→ Bio­mark­er-dri­ven Ike­na On­col­o­gy has turned to Big Phar­ma vet Ser­gio San­til­lana to be their CMO. San­til­lana al­so led med­ical op­er­a­tions at Mer­ri­mack Phar­ma­ceu­ti­cals and ARI­AD Phar­ma­ceu­ti­cals pri­or to join­ing Boston-based Ike­na. He’s al­so held a num­ber of on­col­o­gy clin­i­cal de­vel­op­ment lead­er­ship roles at Eli Lil­ly (2002-06), GSK (2006-14) and Take­da (2014-16), where he was their se­nior med­ical di­rec­tor, on­col­o­gy clin­i­cal re­search.

Yasir Al-Wa­keel

Nor­bert Bischof­berg­er has been busy all sum­mer bol­ster­ing his ex­ec­u­tive lead­er­ship at Kro­nos Bio, and this week is no dif­fer­ent as Yasir Al-Wa­keel heads to the biotech as their CFO and head of cor­po­rate de­vel­op­ment af­ter a 3-year run as CFO and head of strat­e­gy at Neon Ther­a­peu­tics. Al-Wa­keel held the same ti­tles at Mer­ri­mack Phar­ma­ceu­ti­cals as he does now at Kro­nos, which gob­bled up two of Gilead’s SYK in­hibitors in Ju­ly. We fea­tured him in our 2018 re­port on the un­der-40 crowd mak­ing a mark in biotech.

→ San Diego im­munother­a­py play­er Fate Ther­a­peu­tics has en­list­ed Cel­gene vet Ed­ward Du­lac as their new CFO. Du­lac start­ed at Cel­gene in 2012 as their di­rec­tor of glob­al mar­ket­ing and rose to VP, busi­ness de­vel­op­ment and strat­e­gy be­fore jump­ing over to Fate, which de­vel­ops off-the-shelf cell prod­ucts with its pro­pri­etary in­duced pluripo­tent stem cell (iP­SC) prod­uct plat­form.

→ British Co­lum­bia-based Xenon Phar­ma­ceu­ti­cals, tar­get­ing neu­ro­log­i­cal dis­or­ders, has tapped Chris Von Seg­gern as chief com­mer­cial of­fi­cer. Dur­ing a tenure of near­ly 12 years at ClearView Health­care Part­ners, most of Von Seg­gern’s en­er­gy was geared to­ward or­phan dis­eases and trans­for­ma­tion­al tech­nolo­gies.

Richard Katz has an­nounced his res­ig­na­tion as CFO at Liq­uidia Tech­nolo­gies, which is look­ing to go toe-to-toe with stan­dard-of-care Ty­va­so in the de­vel­op­ment of their drug LIQ861 for pul­monary ar­te­r­i­al hy­per­ten­sion. Steven Bariahtaris is step­ping in as in­ter­im CFO at the Re­search Tri­an­gle phar­ma un­til the po­si­tion is filled. Bariahtaris was a long­time J&J ex­ec in sev­er­al ca­pac­i­ties, leav­ing the phar­ma gi­ant ear­ly this year as their chief au­dit ex­ec­u­tive. While at J&J, he was al­so their CFO & VP of fi­nance for Janssen Amer­i­c­as.

Ju­lianne Aver­ill

Ju­lianne Aver­ill has tak­en on the CFO post at Bay Area in­fec­tious dis­ease di­ag­nos­tic tech start­up Alveo Tech­nolo­gies, which an­nounced a col­lab­o­ra­tion with Janssen Phar­ma­ceu­ti­cals in April to bring its be.well test­ing sys­tem to mar­ket. A De­loitte vet, Aver­ill hails from Black­Thorn Ther­a­peu­tics, where she was their VP, fi­nance since Jan­u­ary 2019.

→ Rare dis­ease biotech San­i­fit — which raised near­ly $81 mil­lion last June in Spain’s largest-ever pri­vate biotech fundraise — has made the ad­di­tion of Adam Levy as CFO. Most re­cent­ly, Levy served as CBO of Brick­ell Biotech and has pre­vi­ous ex­pe­ri­ence with mi­Ra­gen Ther­a­peu­tics, Mer­rill Lynch and Jef­feries Group among oth­ers.

→ San Diego-based biotech Zai Lab has snapped up Ty Ed­mond­son as chief le­gal of­fi­cer. Ed­mond­son hails from Bio­gen, where he served as SVP, chief cor­po­ra­tion coun­sel and as­sis­tant sec­re­tary. Pri­or to Bio­gen, Ed­mond­son served in roles at Sepra­cor, Sum­it­o­mo Dainip­pon Phar­ma, Ei­sai and Bris­tol My­ers Squibb among oth­ers.

Liz Hen­der­son

Mer­ck KGaA has made Liz Hen­der­son re­gion­al VP of Mer­ck Bio­phar­ma Asia Pa­cif­ic (APAC), based in Sin­ga­pore. A Pfiz­er and Am­gen vet, Hen­der­son has spent the last 18 months in Lon­don as Mer­ck’s man­ag­ing di­rec­tor and GM, Mer­ck UK & Re­pub­lic of Ire­land and has been at Mer­ck since 2009. In her new role, she will cov­er 11 APAC coun­tries across the phar­ma’s 4 ther­a­py ar­eas: on­col­o­gy, fer­til­i­ty, neu­rol­o­gy and im­munol­o­gy, and gen­er­al med­i­cine and en­docrinol­o­gy.

Tyme Tech­nolo­gies — fo­cused on the de­vel­op­ment of can­cer me­tab­o­lism-based ther­a­pies — has named John Roth­man as EVP, prod­uct de­vel­op­ment. Roth­man pre­vi­ous­ly served in roles at Scher­ing-Plough, Roche and Ad­vax­is.

Lori Hoff­man has moved to Prince­ton, NJ-based Slay­back Phar­ma as their head of al­liance man­age­ment af­ter lead­ing Fron­ti­da’s al­liance man­age­ment func­tion the last 3 years. Be­fore Fron­ti­da, Hoff­man spent more than 9 years at Sagent Phar­ma­ceu­ti­cals, the ma­jor­i­ty of which was spent as their se­nior di­rec­tor, busi­ness de­vel­op­ment.

Ted Love

Seat­tle Ge­net­ics has reeled in Glob­al Blood Ther­a­peu­tics pres­i­dent and CEO Ted Love to its board of di­rec­tors. Love brings a wealth of ex­pe­ri­ence from Onyx Phar­ma­ceu­ti­cals, Nu­velo, Ther­a­vance and Genen­tech.

Be­yond­Spring is mak­ing a big splash with the ad­di­tion of Ravin­dra Ma­jeti to its board of di­rec­tors. Ma­jeti co-found­ed Forty Sev­en out of Stan­ford in 2016, be­fore the com­pa­ny was ac­quired by Gilead in a $4.9 bil­lion buy­out. Af­ter snag­ging $123 mil­lion from the deal, Ma­jeti cur­rent­ly serves as chief, di­vi­sion of hema­tol­ogy at Stan­ford Uni­ver­si­ty.

Gar­ry Men­zel

TCR² Ther­a­peu­tics CEO Gar­ry Men­zel has been giv­en a seat on ge­net­ic dis­ease biotech Stoke Ther­a­peu­tics’ board of di­rec­tors. Men­zel is al­so a found­ing di­rec­tor at Black Di­a­mond Ther­a­peu­tics.

Michael Cham­bers has been se­lect­ed to the board of di­rec­tors at Calviri, a can­cer-fo­cused spin­out of the Biode­sign In­sti­tute at Ari­zona State. Cham­bers left his CEO post at Alde­vron but re­mains their chair­man.

Liz Kwo

Flex­ion Ther­a­peu­tics, which struck a deal in April to de­vel­op and com­mer­cial­ize Zil­ret­ta in Chi­na, has brought on Liz Kwo as a mem­ber of their board of di­rec­tors. Kwo is the staff VP, clin­i­cal da­ta an­a­lyt­ics at An­them.

Jakob Dupont, for­mer CMO at Gos­samer Bio, has joined Apex­i­gen‘s board of di­rec­tors. Dupont cur­rent­ly serves as EVP, head of glob­al re­search and de­vel­op­ment at Atara Bio­ther­a­peu­tics and was pre­vi­ous­ly at Genen­tech/Roche and On­coMed Phar­ma­ceu­ti­cals.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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

→ 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.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.