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

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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Ed­i­tas and Cel­gene sub Juno are tack­ling hottest im­munother­a­py cells

As the first CRISPR-edited cancer patients watch their treatments unfold, one of the first CRISPR companies is rejigging a major oncology deal.

Editas Medicine is amending its long-running collaboration with Celgene and their subsidiary Juno Therapeutics. The new deal will expand the focus of their work to cover a subset of immune cells that have become an increasingly hot target for immunotherapy: gamma-delta cells.

Prakash Raman. Flagship

Flag­ship woos No­var­tis top deal­mak­er Prakash Ra­man in move to get the BD ball rolling ear­ly

Flagship Pioneering likes to be ahead of its times — so far ahead, perhaps, that it is often challenging to find partners for their startups while the scientific scaffolding is underway. But Prakash Raman is here to change that.

Raman, who most recently headed up business development at the Novartis Institutes for BioMedical Research, became Flagship’s first chief business development officer two weeks ago. By acting as a “central resource” for the 100 companies in the venture fund’s portfolio, he hopes to help entrepreneurs and management teams strategize about dealmaking to capture value beyond the near-term validation of their platform technologies, Raman told Endpoints News.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.
The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.
The insider take at the agency includes a note on two new safety signals seen in the big cardio outcomes study of the omega-3 fatty acid drug that shocked many analysts with a solid set of efficacy data. There’s a key concern over whether the use of mineral oil in the placebo skewed LDL levels in such a way that tilted the data in Amarin’s favor.
The FDA overview was written by John Sharretts, the acting deputy director in the Division of Metabolism and Endocrinology Products. 
On the safety side, the internal review focused on a 3.1% versus 2.1% rate of adjudicated events of atrial fibrillation or atrial flutter requiring hospitalization. But they also say a-fib shouldn’t confound the benefit-safety of the drug — given the improvement on MACE — or prevent its use. And then there was also a higher rate of bleeding events in the drug arm.

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

Solid Biosciences continues to be plagued by safety issues.

Close to 18 months after the gene therapy biotech was able to quickly shed an FDA hold on their lead Duchenne muscular dystrophy program for SGT-001, regulators have stepped back in to force another halt after another patient was hit hard by a set of serious adverse events remarkably similar to the first set.

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

With Bristol-Myers Squibb’s Celgene buyout all but complete, the BD teams are working in perfect synchrony now. The Celgene side is going back to Skyhawk, a darling of the crowd that set out to drug RNA, and they’re adding a suite of new programs that mesh perfectly with the new regime in charge.

Celgene is shelling out $80 million in a cash upfront to add oncology, immuno-oncology and autoimmune diseases to the initial roundup of neurological targets mapped early in Skyhawk’s existence.

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

Bardoxolone, like Reata’s other lead drug — omaveloxolone — is a small molecule engineered to bind to a gene called Keap1 to enhance the activity of the protein Nrf2 in order to defuse inflammation.

Kad­mon wax­es rhap­sod­ic on cGVHD re­sults as race with Jakafi heats up

A year ago, Kadmon piqued cautious interest and sent its stock up 20% when it announced positive results from a tiny proof-of-concept study on a new, chronic graft-versus-host-disease treatment. Now interim results are out on the pivotal, and not just the biotech’s executives are gushing about it.

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