Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

Mark Mc­Clel­lan

→ On the same day it an­nounced a $17.5 mil­lion Se­ries C, life sci­ences and health da­ta com­pa­ny Seer un­veiled that it had lured for­mer FDA com­mis­sion­er and ex-CMS ad­min­is­tra­tor Mark Mc­Clel­lan on to its board. “Mark’s deep un­der­stand­ing of the health care ecosys­tem and vi­sion­ary in­sights on pol­i­cy re­form will be cru­cial in in­form­ing our think­ing as we work to bring our liq­uid biop­sy and life sci­ences prod­ucts to mar­ket,” said Seer chief and founder Omid Farokhzad in a state­ment.

→ Re­mem­ber when Her­cules Cap­i­tal part­ed ways with Manuel Hen­riquez af­ter the CEO had been sin­gled out as a prin­ci­pal play­er in the big col­lege cheat­ing scan­dal known as Op­er­a­tion Var­si­ty Blues? Scott Bluestein, then chief in­vest­ment of­fi­cer, stepped up to as­sume the du­ties ad in­ter­im. Four months lat­er, the firm has de­cid­ed to make that ap­point­ment per­ma­nent, leav­ing him in charge of an in­vest­ment op­er­a­tion that’s been known for its in­volve­ment with um­brel­la-style biotech groups like Vivek Ra­maswamy’s My­ovant and Neil Ku­mar’s Bridge­Bio.

Scott Bluestein

→ Hav­ing built Pan­dion Ther­a­peu­tics up from a $58 mil­lion Se­ries A through an ear­ly R&D strat­e­gy to the cusp of clin­i­cal stud­ies, An­tho­ny Coyle is pass­ing the reins on. Rahul Kakkar, the new CEO, will work shoul­der-to-shoul­der with Jo Viney, who’s adding pres­i­dent to her cur­rent CSO ti­tle. Viney and Coyle are both founders of the Cam­bridge, MA-based biotech, which is work­ing on bis­pe­cif­ic an­ti­bod­ies de­signed to treat au­toim­mune dis­eases via tar­get­ed, lo­cal­ized mod­u­la­tion of the im­mune sys­tem. Bring­ing some fresh start­up ex­pe­ri­ence from Cor­vidia Ther­a­peu­tics, Kakkar will now lead the tran­si­tion in­to the next stage. SR One alum Vikas Goy­al is al­so join­ing as SVP of busi­ness de­vel­op­ment, hav­ing tak­en a deep look at the com­pa­ny on the in­vestor side of the ta­ble. 

→ For­mer Im­munomedics CEO Michael Pehl has emerged on the oth­er side of the At­lantic, tak­ing on an­oth­er can­cer chal­lenge as the new chief of GEMoaB. From the biotech’s head­quar­ters in Dres­den, Ger­many, Pehl will steer the de­vel­op­ment of its next-gen im­munother­a­pies de­signed to tone down tox­i­c­i­ties by fine-tun­ing the cells. Be­fore his ill-fat­ed stint at Im­munomedics — taint­ed by an FDA re­jec­tion and re­ports about a breach of da­ta in­tegri­ty — Pehl en­joyed a sol­id run as Cel­gene’s pres­i­dent of on­col­o­gy.

→ As Copen­hagen-based Or­p­hazyme gets se­ri­ous about fil­ing its Nie­mann-Pick dis­ease type C treat­ment for ap­proval, it’s looped in a new leader well versed in drug launch­es. Kim Strat­ton takes over from An­ders Hins­by, who’s been lead­ing the biotech as CEO since co-found­ing it a decade ago. A No­var­tis vet, Strat­ton was most re­cent­ly the in­ter­na­tion­al com­mer­cial head Shire’s spe­cial­ty and rare dis­ease port­fo­lio — giv­ing her in­sight in­to or­phan drug de­vel­op­ment across the UK, US, Eu­rope and emerg­ing mar­kets. The suc­ces­sion will of­fi­cial­ly take place in Oc­to­ber.

Nel­lo Main­olfi

Nel­lo Main­olfi is step­ping up his lead­er­ship role at Kymera Ther­a­peu­tics, as Lau­rent Au­doly pur­sues an­oth­er ven­ture idea. With the pro­mo­tion to pres­i­dent, Main­olfi — a co-founder and the cur­rent CSO — is on­ly as­sum­ing half of Au­doly’s job. The com­pa­ny is search­ing for a new CEO while al­so wel­com­ing West­field man­ag­ing part­ner Bruce Ja­cobs as CFO. The shake­up comes weeks af­ter Au­doly and Main­olfi inked a $70 mil­lion deal with Ver­tex to de­ploy the small­er play­er’s pro­tein degra­da­tion tech for vague but de­cid­ed­ly next-gen us­es. The duo had found­ed the start­up to­geth­er with the bless­ing of At­las Ven­ture, where Au­doly was en­tre­pre­neur-in-res­i­dence.

Nav­i­tor is ready to send its mTORC path­way ac­ti­va­tors in­to the clin­ic, and James “Randy” Owen will be their man for the task. As the biotech’s first CMO, Owen is first tasked with clin­i­cal and reg­u­la­to­ry de­vel­op­ment NV-5138 for treat­ment-re­sis­tant de­pres­sion. In the same role at Aca­dia Phar­ma, he’d helped ad­vance the Parkin­son’s psy­chosis drug known as Nu­plazid, or pi­ma­vanserin — an ex­pe­ri­ence he’s ex­pect­ed to lever­age in his new gig.

David Chang

Ca­balet­ta Bio — fo­cused on the dis­cov­ery and de­vel­op­ment of cell ther­a­pies for B cell-me­di­at­ed au­toim­mune dis­eases — wel­comes au­toim­mune clin­i­cal drug de­vel­op­ment ex­pert, David Chang, in­to its ranks as the com­pa­ny’s CMO. Chang hops on board af­ter a stint as SVP and head of in­flam­ma­tion, au­toim­mu­ni­ty and neu­ro­science, glob­al med­i­cines de­vel­op­ment at As­traZeneca. He was the vice pres­i­dent and head of im­muno-in­flam­ma­tion, clin­i­cal de­vel­op­ment at GSK and has served at Mer­ck and Wyeth ear­li­er in his ca­reer. 

Vac­citech brings Mariem Charafed­dine on board as its CMO to over­see the de­vel­op­ment of its grow­ing clin­i­cal pipeline of T Cell-in­duc­ing vi­ral vec­tor vac­cines. Charafed­dine joins the com­pa­ny af­ter a six-year stint at Ab­b­vie as their med­ical di­rec­tor for phar­ma­covig­i­lance and pa­tient safe­ty sci­ences, in­fec­tious dis­eases and neu­ro­sciences. Pri­or to her time at Ab­b­vie, Charafed­dine served at Hoff­mann-La Roche/Genen­tech.

Mariem Charafed­dine

Parvus Ther­a­peu­tics — fo­cused on the de­vel­op­ment and com­mer­cial­iza­tion of Navacim ther­a­peu­tics tar­get­ing au­toim­mune and oth­er in­flam­ma­to­ry dis­eases — added some new faces to its board of di­rec­tors and lead­er­ship team. Hugh Young Rien­hoff joined as the com­pa­ny’s chair­man of the board, Charles John­son was ap­point­ed to the board and Alain Del­cayre hopped on as se­nior vice pres­i­dent of re­search. 

Rien­hoff is the CEO of Ima­go Bio­sciences, his fourth start-up. Pri­or to his po­si­tion at Ima­go, Rien­hoff was the CEO of Fer­roKin Bio­sciences (lat­er ac­quired by Shire in 2012). He has al­so served as the di­rec­tor at Abing­worth Man­age­ment in Lon­don and as a part­ner at New En­ter­prise As­so­ci­ates. John­son, most re­cent­ly, served as the CMO of Neu­rotech and pri­or to that was the vice pres­i­dent of glob­al med­ical af­fairs at Ver­tex. He’s al­so had stints at In­spire Phar­ma­ceu­ti­cals, APT Phar­ma­ceu­ti­cals and Genen­tech. Del­cayre is cred­it­ed as VP of re­search and de­vel­op­ment at Anosys with the co-dis­cov­ery of Ex­o­some Dis­play — a tech­nique to ma­nip­u­late ex­o­some pro­tein con­tent — with his team.

→ Cell ther­a­py com­pa­ny Im­mu­soft has man­aged to snag Am­gen’s $AMGN for­mer head of bi­o­log­ics Robert Hayes as its chief sci­en­tif­ic of­fi­cer. The Seat­tle-based firm has de­vel­oped a tech­nol­o­gy en­gi­neered to in­sert func­tion­al genes in­to im­mune cells us­ing a non-vi­ral vec­tor. Its lead ther­a­py is de­signed to help pa­tients with a rare, lethal child­hood ge­net­ic dis­ease that af­fects the body’s abil­i­ty to pro­duce an es­sen­tial en­zyme that helps to break down long-chain sug­ars in­side cells. 

Leslie Dan steps down from the board of di­rec­tors of Sesen Bio — fo­cused on the de­vel­op­ment of tar­get­ed fu­sion pro­tein ther­a­peu­tics for the treat­ment of pa­tients with can­cer — and in­to re­tire­ment. With his re­tire­ment the board will now con­sist of five di­rec­tors, four of whom are in­de­pen­dent. Dan start­ed his ca­reer in the phar­ma­ceu­ti­cal in­dus­try in 1964 as the founder of Novopharm, one of Cana­da’s largest gener­ic phar­ma­ceu­ti­cal com­pa­nies with about $750 mil­lion in rev­enue and over 3,000 em­ploy­ees (lat­er be­com­ing a part of Te­va Phar­ma­ceu­ti­cal in 2000). Af­ter Novopharm, Dan found­ed Viven­tia Bio, which was lat­er sold to Sesen in 2016. 

San­jay Pa­tel is step­ping up to suc­ceed Tama­ra Sey­mour, who has served as the in­ter­im CFO, as CFO at Im­mu­nic — a com­pa­ny fo­cused on the de­vel­op­ment of oral ther­a­pies for the treat­ment of chron­ic in­flam­ma­to­ry and au­toim­mune dis­eases. Pa­tel comes from the same po­si­tion at Pernix Ther­a­peu­tics, where he helped in sourc­ing and ex­e­cut­ing ac­qui­si­tions in ex­cess of $600 mil­lion and rais­ing more that $460 mil­lion in var­i­ous fi­nanc­ing trans­ac­tions. Pa­tel has had stints at Can­tor Fitzger­ald, the William J Clin­ton Foun­da­tion, and at Cowen and Com­pa­ny

Max Don­ley

Au­rinia — cur­rent­ly de­vel­op­ing its in­ves­ti­ga­tion­al drug, vo­closporin for the treat­ment of Lu­pus Nephri­tis, Fo­cal Seg­men­tal Glomeru­loscle­ro­sis and Dry Eye Syn­drome — strength­ened its se­nior man­age­ment team with the ad­di­tion of Max Don­ley as ex­ec­u­tive vice pres­i­dent of in­ter­nal op­er­a­tions and Glenn Schul­man as SVP of cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions. Most re­cent­ly, Don­ley led hu­man re­sources, in­for­ma­tion tech­nol­o­gy and fa­cil­i­ties at Senseon­ics. Pri­or to that, he served at Su­cam­po Phar­ma­ceu­ti­cals and Med­Im­mune. Schul­man jumps on board af­ter a stint as cor­po­rate com­mu­ni­ca­tions and in­vestor re­la­tions at Achillion Phar­ma­ceu­ti­cals and pre­vi­ous­ly, has served at Cura­Gen. 

→ Mary­land-based biotech­nol­o­gy com­pa­ny, Im­mu­nom­ic Ther­a­peu­tics, has ap­point­ed An­drew Eisen as VP, Clin­i­cal De­vel­op­ment. Eisen joined the com­pa­ny with ex­pe­ri­ence from roles at Rex­ahn Phar­ma­ceu­ti­cals, Acor­da Ther­a­peu­tics, Ei­sai On­col­o­gy Prod­uct Cre­ation Sys­tems, Dai­ichi-Sankyo Phar­ma De­vel­op­ment and Cura­Gen

Daniel Wal­lace has joined the board of di­rec­tors of Lu­pus Ther­a­peu­tics. Wal­lace is the med­ical di­rec­tor of the Wal­lace Rheumat­ic Study Cen­ter and as­so­ciate di­rec­tor of the Rheuma­tol­ogy Fel­low­ship Pro­gram at Cedars-Sinai in Los An­ge­les. Wal­lace has over 40 years of ex­pe­ri­ence and has been in­volved in more than 50 clin­i­cal tri­als and is cur­rent­ly con­duct­ing six tri­als.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.