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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Tri­fec­ta of sick­le cell dis­ease ther­a­pies ex­tend life ex­pectan­cy, but are not cost-ef­fec­tive — ICER

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.