Zosano Phar­ma CEO pass­es ba­ton down to suc­ces­sor; James Sapirstein takes the helm at Azur­Rx

→ Two years af­ter Zosano Phar­ma re­port­ed pos­i­tive Phase III da­ta for its mi­cronee­dle patch sys­tem for de­liv­er­ing an old mi­graine drug — set­ting up a cam­paign to file an NDA — the com­pa­ny has brought on Steven Lo to the helm as pres­i­dent and CEO. Lo will be suc­ceed­ing John Walk­er, who is re­tir­ing af­ter 48 years in the health­care in­dus­try. Walk­er will re­main as the chair­man of the board of di­rec­tors. Lo most re­cent­ly served as the CCO at Puma Biotech­nol­o­gy, where he helped with the launch of the com­pa­ny’s first prod­uct, Ner­l­ynx — whose Q1 sales fell un­com­fort­ably short of Wall Street es­ti­mates. In ad­di­tion, Lo was the CCO of Cor­cept Ther­a­peu­tics, where he led the es­tab­lish­ment of their first prod­uct, Ko­r­lym, a treat­ment for Cush­ing’s syn­drome. Ear­li­er in his ca­reer, Lo held stints at Genen­tech and As­traZeneca. Lo’s ap­point­ment comes a few weeks af­ter the com­pa­ny wel­comed Dushyant Pathak as SVP of busi­ness de­vel­op­ment. 

James Sapirstein Busi­ness Wire

→ Gas­troin­testi­nal dis­ease-fo­cused Azur­Rx Bio­Phar­ma has a new face run­ning the com­pa­ny af­ter CEO Thi­js Spoor an­nounced his res­ig­na­tion. James Sapirstein is join­ing the com­pa­ny as the new CEO af­ter a stint in the same po­si­tion at Con­traVir Phar­ma­ceu­ti­cals (now He­p­i­on Phar­ma­ceu­ti­cals). Sapirstein has par­tic­i­pat­ed in 23 prod­uct launch­es and he’ll bring this ex­pe­ri­ence to help with the com­pa­ny’s lead prod­uct can­di­date, MS1819-SD — a re­com­bi­nant li­pase for ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy. Pri­or to Con­traVir, Sapirstein served as the CEO of Alli­qua Ther­a­peu­tics, the found­ing CEO of To­bi­ra Ther­a­peu­tics and as EVP, meta­bol­ic en­docrinol­o­gy at Serono Lab­o­ra­to­ries. His oth­er stints in­clude roles at Gilead Sci­ences and Bris­tol-My­ers Squibb. Spoor will re­main on the com­pa­ny’s board of di­rec­tors. 

CRO Pharm-Olam has tapped Robert Davie to suc­ceed David Grange — who has been with the com­pa­ny since April 2017 — as CEO. Grange will re­main a di­rec­tor and vice chair­man of the com­pa­ny’s board of di­rec­tors. Davie brings ex­pe­ri­ence from his time as vice pres­i­dent and gen­er­al man­ag­er, glob­al clin­i­cal de­vel­op­ment at Co­v­ance, where he man­aged the over­sight of clin­i­cal op­er­a­tions in 60 coun­tries with more than 6,000 em­ploy­ees un­der his guid­ance. Pri­or to his time at Co­v­ance, Davie served at Proc­ter & Gam­ble in OTC Health­care. Be­fore jump­ing in­to biotech, Davie fo­cused on the study of GI phys­i­ol­o­gy, in­clud­ing met­al ion trans­port and the trans­port of bile acids in pa­tients with in­flam­ma­to­ry bow­el dis­ease. 

→ At the same time that it pre­sent­ed new da­ta for two of its clin­i­cal stud­ies, Pre­ci­sion Di­a­betes has tapped Er­ic But­ton to the helm as CEO. But­ton is the cur­rent pres­i­dent of Neo­Mark Ven­tures and has pre­vi­ous­ly served as head of di­ag­nos­tics at Metabolon. Some of his oth­er stints in­clude SVP of new prod­uct strat­e­gy at True Health Di­ag­nos­tics and as pres­i­dent and founder of both Gly­co­Mark and Am­plis­tar.

→ Can­cer test­ing start­up Grail — which had a top ex­ec change up, when then CEO Jen­nifer Cook stepped down for fam­i­ly health rea­sons and left the com­pa­ny in the hands of Hans Bish­ophas named Matthew Young as COO and CFO. Young joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where he served as EVP and CFO. Pri­or to his time at Jazz, Young hed po­si­tions at Bar­clays Cap­i­tal, Cit­i­group Glob­al Mar­kets and Lehman Broth­ers

AEON Bio­phar­ma — a com­pa­ny fo­cused on the ther­a­peu­tic tox­in mar­ket — has re­cruit­ed Chris Carr as CFO and Scott Akamine as gen­er­al coun­sel. Carr most re­cent­ly served as CFO, EVP of fi­nance and IT and board mem­ber of Den­dreon Phar­ma­ceu­ti­cals. Pri­or to that, he held stints at Ab­bott Lab­o­ra­to­ries, PerkinElmer and Gen­zyme. Akamine jumps over af­ter a stint as vice pres­i­dent and as­so­ciate gen­er­al coun­sel at Core­L­og­ic. Be­fore that, Akamine worked at In­ci­pio, Al­ler­gan and the law firm Lath­am & Watkins

→ Oph­thalmic phar­ma­ceu­ti­cal com­pa­ny Aerie Phar­ma­ceu­ti­cals — fo­cused on the treat­ment of pa­tients with open-an­gle glau­co­ma and oth­er reti­nal dis­eases — has brought a new face aboard with the ap­point­ment of Char­lene Davis as vice pres­i­dent and chief com­pli­ance of­fi­cer. Davis makes the jump af­ter a stint at Sun Phar­ma­ceu­ti­cal In­dus­tries

Amer­i­can BriV­i­sion — fo­cused on the de­vel­op­ment of ther­a­pies in on­col­o­gy/hema­tol­ogy, CNS and oph­thal­mol­o­gy — has wel­comed Chih­liang “Andy” An as CFO. An joins from a stint as man­ag­ing di­rec­tor of the in­vest­ment team at Yinyai In­vest­ment in Hong Kong. Pri­or to his time at Yinyai, An served as a se­nior di­rec­tor of sales and op­er­a­tions at Go­ertek and as a con­sul­tant and di­rec­tor of fi­nance at BioKey. In ad­di­tion, he’s al­so held stint at Flex­tron­ics, Chardan Cap­i­tal and Op­to­plex

An­ish Suri Cue

Cue Bio­phar­ma — work­ing on in­jectable bi­o­log­ics to se­lec­tive­ly en­gage and mod­u­late tar­get­ed T cells with­in the body — has named An­ish Suri pres­i­dent in ad­di­tion to his cur­rent role as CSO of the com­pa­ny. Pri­or to join­ing the com­pa­ny in Ju­ly 2018, Suri held stints at Janssen Phar­ma­ceu­ti­cal, Bris­tol-My­ers Squibb and was as­sis­tant pro­fes­sor of pathol­o­gy and im­munol­o­gy at Wash­ing­ton Uni­ver­si­ty School of Med­i­cine. In ad­di­tion to Suri’s ap­point­ment, the com­pa­ny plans to bring in a num­ber of new hires through 2020 in light of the re­cent clear­ance of the com­pa­ny’s lead drug can­di­date, CUE-101, in­to clin­i­cal de­vel­op­ment.

An­gela Jus­tice TCR²

→ Can­cer-fo­cused TCR² Ther­a­peu­tics has wel­comed An­gela Jus­tice to the com­pa­ny as chief peo­ple of­fi­cer. Jus­tice hails from Surgery Part­ners, where she served as EVP and chief hu­man re­sources of­fi­cer. Pri­or to that, she served as se­nior di­rec­tor of glob­al med­ical af­fairs, as well as the chief learn­ing of­fi­cer at Bio­gen, where she cre­at­ed and led a cen­tral­ized learn­ing or­ga­ni­za­tion sup­port­ing 14,000 peo­ple across all de­part­ments and ge­o­gra­phies. Her oth­er stints in­clude roles at EMD Serono, the Na­tion­al MS So­ci­ety and as a man­age­ment con­sul­tant at McK­in­sey & Com­pa­ny.

Tan­isha Co­ri­na

→ Af­ter an­a­lysts were blind­sided last month with the sur­prise ex­it of Alex­ion‘s CFO, Paul Clan­cy — who was be­ing re­placed by Arad­hana Sarin as strat­e­gy and busi­ness chief — the com­pa­ny has brought on Tan­isha Cari­no as EVP and chief cor­po­rate af­fairs of­fi­cer. In ad­di­tion, she will serve on the com­pa­ny’s ex­ec­u­tive com­mit­tee. Pri­or to jump­ing on board Alex­ion, Cari­no served as the ex­ec­u­tive di­rec­tor of Faster­Cures, a cen­ter of the Milken In­sti­tute. Be­fore that, she served in roles at GSK and Avalere Health.

→ Toron­to-based Cycli­ca — of­fer­ing a drug dis­cov­ery plat­form fo­cused on polyphar­ma­col­o­gy — has an­nounced the ap­point­ment of Vern De Bi­asi as VP, glob­al head of strate­gic part­ner­ships. Pri­or to jump­ing aboard Cycli­ca, De Bi­asi held var­i­ous roles at GSK, in­clud­ing head of emerg­ing plat­forms, head of dig­i­tal da­ta and an­a­lyt­ics and head of plat­form tech­nol­o­gy and sci­ence at GSK R&D, Asia in Shang­hai. 

→ Lon­don-based cell ther­a­py play­er Au­to­lus Ther­a­peu­tics has made changes to its lead­er­ship team. The com­pa­ny an­nounced that Jim Faulkn­er, SVP, head of prod­uct de­liv­ery, and Neil Bell, SVP, head of clin­i­cal op­er­a­tions, will be hit­ting the ex­it. The two will be suc­ceed­ed by David Brochu and Vishal Mehta, re­spec­tive­ly. Brochu pre­vi­ous­ly held the po­si­tion of vice pres­i­dent of tech­ni­cal op­er­a­tions at Au­to­lus and pri­or to join­ing the com­pa­ny held po­si­tions at Kedri­on, Tale­cris Bio­Ther­a­peu­tics (for­mer­ly Bay­er Health­care) and Bay­er. Mehta joined Au­to­lus at the be­gin­ning of the year from Cel­gene, where he led the plan­ning and ex­e­cu­tion of mul­ti­ple clin­i­cal stud­ies for CAR T prod­ucts in B cell ma­lig­nan­cies and mul­ti­ple myelo­ma. Pri­or to Cel­gene, Mehta had stints at No­var­tis and ICON.

→ The med­ical der­ma­tol­ogy com­pa­ny Ver­ri­ca Phar­ma­ceu­ti­cals has ap­point­ed Eu­gene Scav­ola as EVP, tech­ni­cal op­er­a­tions. Most re­cent­ly, Scav­ola was a man­ag­ing part­ner at PBM Cap­i­tal Group. In ad­di­tion, Scav­ola has served in var­i­ous po­si­tions at Wyeth/Pfiz­er.

Karl Brad­shaw Metabolon

Metabolon — fo­cused on, you guessed it, metabolomics — has ap­point­ed Karl Brad­shaw as VP of bio­phar­ma strat­e­gy and part­ner­ing, who joins the com­pa­ny af­ter a stint as se­nior di­rec­tor of cor­po­rate strat­e­gy and de­vel­op­ment at As­traZeneca. Pri­or to his time there, Brad­shaw was vice pres­i­dent of eq­ui­ty and re­search at Mor­gan Stan­ley

Flem­ming Orn­skov

→ A week pri­or to win­ning FDA ap­proval for its top­i­cal retinoid cream, tri­farotene, in the use of ac­ne — dif­ferin mak­er Gal­der­ma made some new ad­di­tions to its ex­ec­u­tive team with the ap­point­ments of Shire vets Flem­ming Orn­skov as CEO and Thomas Dit­trich as CFO. Orn­skov as­sumes the po­si­tion as CEO from Stu­art Raet­z­man, who is mov­ing to a po­si­tion on the com­pa­ny’s board. Dur­ing his time at Shire, Orn­skov helped grow the com­pa­ny from a $4 bil­lion rev­enue busi­ness to $15 bil­lion in five years, be­fore the com­pa­ny was ac­quired by Take­da. Dit­trich held the same po­si­tion of CFO at Shire. In ad­di­tion to the new ex­ecs, the com­pa­ny has wel­comed for­mer CEO of No­var­tis Thomas Ebel­ing as chair­man of its board of di­rec­tors and for­mer CEO of Avon Prod­ucts and for­mer vice chair­man of John­son & John­son, Sheri Mc­Coy as di­rec­tor of the com­pa­ny. 

→  In the storm of rapid ex­its of its top ex­ecs, Gilead’s CEO Daniel O’Day has brought on Genen­tech SVP of ear­ly clin­i­cal de­vel­op­ment, Mer­dad Parsey, on board as the com­pa­ny’s CMO. Parsey made his way to Genen­tech af­ter a de­tour as CEO of NASH drug de­vel­op­er 3V Bio­sciences (now known as Sagimet) for five years. Gilead has seen a clean sweep of its top ranks since CEO John Mil­li­gan stepped out along­side chair­man John Mar­tin, and not long af­ter oth­ers fol­lowed suit — CSO John McHutchi­son left for a new po­si­tion of CEO at As­sem­bly Bio­sciences, CMO An­drew Cheng left for the helm at Akero and re­search chief Nor­bert Bischof­berg­er left to run his own start­up

Han­dan He

→ Hong Kong-list­ed, Hangzhou-based As­cle­tis has wooed an­oth­er top phar­ma ex­ec from the US to Chi­na as it gets ready to show that its R&D team has what it takes to come up with some first-in-class drugs. In tak­ing up the CSO role Han­dan He is leav­ing be­hind a 22-year stint at No­var­tis, where her last ti­tle was glob­al head of com­pu­ta­tion­al, bio­phar­ma­ceu­tics and trans­la­tion­al PK/PD. Her ar­rival marks an­oth­er big get for CEO Jinzi Wu, who ear­li­er this year re­cruit­ed Mer­ck’s top drug de­vel­op­er in Chi­na as As­cle­tis’ CMO. But health and fam­i­ly con­cerns cut Zhengqing Li’s tenure short, forc­ing him to de­part af­ter on­ly five months. Days ago CFO Lin­di Tan al­so hand­ed in her pa­pers. As­cle­tis is known do­mes­ti­cal­ly for de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — with some help from Roche — but has made a point to be­come a glob­al play­er, not just in the an­tivi­ral space but al­so can­cer and liv­er dis­eases.

→ As Bio­Marin shoots for the first-ever ap­proval of a he­mo­phil­ia gene ther­a­py — and the multi­bil­lion-dol­lar rev­enue ex­pect­ed to fol­low — the com­pa­ny is pro­mot­ing CSO Lon Car­don to a po­si­tion where he can help sketch the next ren­di­tion of its rare dis­ease port­fo­lio. In the new­ly cre­at­ed role of chief sci­en­tif­ic strate­gic of­fi­cer, Car­don will look be­yond the re­search work that he’s been lead­ing for the past two years to “lead cross func­tion­al ac­tiv­i­ties to build our lead­er­ship po­si­tion in pre­ci­sion med­i­cine,” ac­cord­ing to Bio­Marin. Car­don held a 9-year tenure at GSK where he was the SVP of al­ter­na­tive dis­cov­ery and de­vel­op­ment — lin­ing up a $495 mil­lion al­liance with Aval­on Ven­tures to bankroll some star­tups and buy them out if the sci­ence stands up to due dili­gence.  

Bolt Bio­ther­a­peu­ticswho wel­comed their new CEO Randy Schatz­man last month — has made three ad­di­tions to its sci­en­tif­ic board of di­rec­tors: UCSF pro­fes­sor Lawrence Fong, as­so­ciate di­rec­tor of Yale Can­cer Cen­ter Roy Herb­st and Lip­i­tor in­ven­tor Bruce Roth

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Top Har­vard chemist caught up in FBI’s 'T­hou­sand Tal­ents' drag­net, ac­cused of ly­ing about Chi­nese con­nec­tions, pay

The FBI’s probe into the alleged theft of R&D secrets by Chinese authorities has drawn Harvard’s top chemist into its net.

The agency accused Charles M. Lieber, who chairs the university’s chemistry and chemical biology department, with lying about his involvement in China’s Thousand Talents campaign, which was established as a way of drawing in innovators from around the world. And the scientist, 60, was charged with making false statements about his ties to China.

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Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”