An­tho­ny Quinn ce­ments Ae­glea CEO spot; Hu­man Longevi­ty bumps David Karow up to the top

An­tho­ny Quinn

→ Af­ter prov­ing him­self in one year as in­ter­im CEO at Ae­glea Bio­Ther­a­peu­tics $AGLE, An­tho­ny Quinn is of­fi­cial­ly tak­ing on the post per­ma­nent­ly. Since he joined the Austin-based com­pa­ny as a board mem­ber in 2016, he’s seen it through an IPO and ini­ti­a­tion of sev­er­al Phase I tri­als for its rare dis­ease drug, AEB1102. A for­mer pro­fes­sor at Barts and the Lon­don School of Med­i­cine, Quinn pre­vi­ous­ly worked as CMO at Synage­va Bio­phar­ma un­til Alex­ion came along to snap it up. He will be helped at the helm by Bri­an Lawlis, Itero founder and ex-CEO, who’s just been ap­point­ed to the board.

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→ As Ape­iron Bi­o­log­ics’ found­ing CEO Hans Loib­n­er re­tires, Pe­ter Llewellyn-Davies has been pro­mot­ed from the dual CFO/CBO role to fill his shoes. Loib­n­er di­rect­ed the Aus­tri­an biotech’s piv­ot to im­muno-on­col­o­gy, which proved to be a boon lead­ing to two out-li­cens­ing deals and an ap­proved pe­di­atric can­cer drug named Qarz­i­ba. He will con­tin­ue to be an ad­vi­sor to Llewellyn-Davies, who joined the com­pa­ny on­ly months ago af­ter spend­ing some time in both biotech ex­ec and con­sult­ing roles. Mov­ing for­ward, the new CEO com­ment­ed, ex­pect to see Ape­iron ex­tend the de­vel­op­ment port­fo­lio, ex­pand their head­quar­ters in Vi­en­na and do more in­ter­na­tion­al­ly in way of part­ner­ships.

David Karow

→ At­tempt­ing to put a stop to the con­fus­ing se­ries of ex­ec­u­tive shake­ups, Hu­man Longevi­ty has pro­mot­ed chief of ra­di­ogenomics David Karow all the way to the top. To­geth­er with CTO/in­ter­im COO Scott Sorensen, Karow will over­see the an­ti-ag­ing com­pa­ny’s busi­ness strat­e­gy, try­ing to re­al­ize founder J. Craig Ven­ter’s vi­sion of “in­cor­po­rat­ing ge­nom­ic an­a­lyt­ics, ma­chine learn­ing and ad­vanced clin­i­cal imag­ing.” Ven­ter re­tired from the com­pa­ny about two months ago.

Ja­son Han­son has been tapped as CEO and pres­i­dent at gene ther­a­py com­pa­ny en­Gene, free­ing co-founder An­tho­ny Che­ung up for the chief tech­nol­o­gy of­fi­cer role. Fresh off a two-year run at the helm of Flag­ship-launched Ohana Bio­sciences (and equipped with plen­ty of op­er­a­tional, le­gal and strate­gic ex­pe­ri­ence from stints at the likes of GE Health­care and Medicis), Han­son is tasked with lead­ing the biotech’s oral gene de­liv­ery plat­form in­to clin­i­cal de­vel­op­ment.

→ Seat­tle biotech Presage Bio­sciences added some fresh cap­i­tal to its cof­fers Tues­day, al­low­ing the can­cer com­pa­ny to work on the de­sign of a de­vice it cre­at­ed to con­duct its ear­ly clin­i­cal work. At the same time, Presage an­nounced its CSO Rich Kling­hof­fer is tak­ing over as CEO, while for­mer CEO Nathan Caf­fo steps in­to an ad­vi­so­ry role. “When Nathan and I joined Presage as the first two em­ploy­ees of the com­pa­ny, it was be­cause we rec­og­nized the trans­for­ma­tive po­ten­tial of the CI­VO plat­form to en­able faster proof-of-con­cept stud­ies for ear­ly stage drug can­di­dates,” Kling­hof­fer said in a state­ment. “Giv­en the well-known lack of trans­la­tion of an­i­mal mod­els to the hu­man clin­ic, we are ex­cit­ed to pro­vide an ap­proach that al­lows our part­ners to test as­sets in the con­text where they are ul­ti­mate­ly in­tend­ed to be used – the hu­man can­cer pa­tient.”

→ Af­ter a brief stint as An­thera Phar­ma’s CEO, Craig Thomp­son is jump­ing to the same job at Neu­rana Phar­ma­ceu­ti­cals, div­ing in­to the new area of neu­ro­mus­cu­lar con­di­tions. As the San Diego com­pa­ny heads in­to Phase II with tolperisone — a wide­ly used drug in Eu­rope and Asia — it’s al­so hired Toni Fos­ter to run med­ical op­er­a­tions. The drug, which now tar­gets acute, painful mus­cle spasms, “has the po­ten­tial to be the first skele­tal mus­cle re­lax­ant with­out se­da­tion,” Thomp­son said in a state­ment.  

→ Fol­low­ing a rocky few months at Bel­licum Phar­ma­ceu­ti­cals $BLCM, the Hous­ton biotech an­nounced that CFO Alan Mus­so is ex­it­ing at the end of Au­gust, leav­ing VP of fi­nance and con­troller Rose­mary Williams in charge while the search for his suc­ces­sor takes place. This marks his fourth run at the top fi­nan­cial role, and it seems like­ly he’s head­ing to an­oth­er one. CEO Rick Fair em­pha­sized that Bel­licum is “well cap­i­tal­ized” to con­tin­ue ex­e­cut­ing on its lead cell ther­a­py, which is now back in de­vel­op­ment af­ter be­ing halt­ed for three months by a clin­i­cal hold.

→ Three months in­to his tenure, Cere­cor CEO Pe­ter Green­leaf is build­ing out his own man­age­ment team to help dri­ve the Bal­ti­more biotech to­ward the pe­di­atric busi­ness and push its cen­tral ner­vous sys­tem drugs in or­phan and spe­cial­ty in­di­ca­tions. He’s brought in Joe Miller as CFO, Per­ry Calias as CSO, and James Har­rell as EVP of mar­ket­ing and in­vestors re­la­tions. Both Miller and Calias are old col­leagues from Green­leaf’s Su­cam­po days, be­fore he led the com­pa­ny to a merg­er with Mallinck­rodt. Mean­while, Mari­am Mor­ris, the CFO who over­saw Cere­cor’s IPO and a cou­ple of BD deals, is out.

Sara Bon­stein

Sara Bon­stein is the new CFO and COO at On­coSec $ONCS, where she will have a broad man­date over fi­nan­cial and cap­i­tal mar­ket ac­tiv­i­ties, as well as ad­min­is­tra­tive func­tions and tech­ni­cal op­er­a­tions. Most re­cent­ly at Ad­vax­is — a bit of a mixed bag these days — Bon­stein be­gan her ca­reer in fi­nan­cial roles at J&J and branched out to project man­age­ment at Eli Lil­ly’s Im­clone. She suc­ceeds Richard Slanky.

Yann Maz­abraud

Tre­vi Ther­a­peu­tics has poached long­time Sanofi Gen­zyme ex­ec Yann Maz­abraud to head up its com­mer­cial strat­e­gy and in­ter­na­tion­al op­er­a­tions as chief com­mer­cial of­fi­cer. The New Haven, CT biotech is ap­proach­ing piv­otal tri­als for its syn­thet­ic opi­oid, Nal­buphine ER, in both of its pru­rit­ic pro­grams. And they are trust­ing Maz­abraud — most re­cent­ly US gen­er­al man­ag­er and North Amer­i­ca re­gion head for the French drug­mak­er — to build the sales and mar­ket­ing team from scratch.

→ Mov­ing up the lad­der at the CRO de­part­ment of Gen­e­sis Biotech­nol­o­gy Group, Ole­sia Buiako­va has been tapped as the CSO of Gen­e­sis Drug Dis­cov­ery & De­vel­op­ment. The move will re­quire her to step up from her cur­rent role as CSO of In­viv­otek, co­or­di­nat­ing pre­clin­i­cal plat­forms in on­col­o­gy, im­munol­o­gy, meta­bol­ic and oc­u­lar dis­eases.

Turn­stone Bi­o­log­ics is wel­com­ing a par­ty of five sea­soned ex­ecs in­to its lead­er­ship ranks, topped by the ap­point­ment of new CFO Jane Hen­der­son, who left Voy­ager Ther­a­peu­tics to take the role. Oth­er new hires are Kite Phar­ma vet Kristin Gustafson, SVP of hu­man re­sources and fa­cil­i­ties; Bris­tol-My­ers Squibb staffer Steve Bern­stein, SVP of clin­i­cal R&D; pro­fes­sor and re­searcher David Sto­jdl, SVP of dis­cov­ery re­search; and clin­i­cal op­er­a­tions pro Ad­i­na Pelu­sio, VP of clin­i­cal op­er­a­tions. Turn­stone is de­vel­op­ing a vi­ral ther­a­py that com­bines the func­tions of a on­colyt­ic virus and an im­mune stim­u­lat­ing T cell vac­cine.

→ Look­ing to emerge from the scan­dal that’s en­gulfed the com­pa­ny for weeks, MiMedx has in­stalled UCB vet Mark Graves as chief com­pli­ance of­fi­cer. Graves will now han­dle all reg­u­la­to­ry and le­gal com­pli­ance mat­ters re­lat­ed to risk man­age­ment, sales op­er­a­tions and fi­nan­cial re­port­ing — things that, if you re­call, got MiMedx $MXDG in­to trou­ble with the Jus­tice De­part­ment as well as in­vestors.

Avid Bioser­vices $CD­MO has brought in Daniel Hart, a fi­nan­cial pro­fes­sion­al whose em­ploy­ers have spanned med­ical de­vice, man­age­ment con­sult­ing and re­al es­tate, as its CFO. Look­ing to “ag­gres­sive­ly” grow and di­ver­si­fy its client base, the con­tract de­vel­op­ment and man­u­fac­tur­ing com­pa­ny has al­so ap­point­ed Michael Faugh­nan as the se­nior di­rec­tor of busi­ness de­vel­op­ment for the west­ern re­gion, cov­er­ing the US west coast as well as Cana­da. Faugh­nan jumps from WuXi Bi­o­log­ics.

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.