Gilead­'s ex-in­vestor re­la­tions chief takes CFO job at Sang­amo; For­mer GE Health­care ex­ec takes the helm at Vec­tura Group

And so the ex­o­dus con­tin­ues. Sung Lee, who had been Gilead‘s head of in­vestor re­la­tions, was named CFO of Sang­amo Ther­a­peu­tics, a cell and gene ther­a­py com­pa­ny. Lee had al­so helmed Gilead’s fi­nan­cial plan­ning and analy­sis di­vi­sion. Lee is just the lat­est in a slew of ex­its that have fol­lowed John Mil­li­gan‘s sud­den res­ig­na­tion from the CEO role in Ju­ly 2018. He had worked there for 14 years.

Will Down­ie Busi­ness Wire

UK-based res­pi­ra­to­ry drug de­vel­op­er Vec­tura Group has tapped for­mer GE Health­care ex­ec Will Down­ie as CEO. Down­ie will take over the reins from in­ter­im CEO Paul Fry — who took over the role in June at the de­par­ture of James Ward-Lil­ley. Fry will re­sume his du­ties as CFO. Pri­or to join­ing the com­pa­ny, Down­ie spent a decade as SVP at Catal­ent lead­ing the com­mer­cial ef­fort for glob­al sales and mar­ket­ing ac­tiv­i­ties. Be­fore that, he served as vice pres­i­dent and gen­er­al man­ag­er at GE Health­care and vice pres­i­dent of sales at Amer­sham Health.

→ Robin Bhat­tacher­jee has tak­en over the reins from re­tir­ing Glyn Parkin as CEO at Ac­timed Ther­a­peu­tics — a com­pa­ny fo­cused on the treat­ment of cachex­ia. Bhat­tacher­jee joins the com­pa­ny af­ter a stint as Acte­lion’s gen­er­al man­ag­er for the UK and Ire­land. Pri­or to that, he was the gen­er­al man­ag­er of CV Ther­a­peu­tics Eu­rope — which he joined af­ter serv­ing as head of mar­ket­ing at Sanofi-Syn­thélabo UK. Bhat­tacher­jee be­gan his ca­reer at Bay­er, serv­ing the com­pa­ny for 16 years in var­i­ous roles, such as UK mar­ket­ing man­ag­er and di­rec­tor in glob­al strate­gic mar­ket­ing. 

Af­ter an­nounc­ing plans for an $86 mil­lion IPO in June and pric­ing $75 mil­lion in Ju­ly, liv­er dis­ease-fo­cused Mirum Phar­ma­ceu­ti­cals has named Ed Tuck­er as the com­pa­ny’s CMO. Tuck­er comes from Ac­er­ta Phar­ma, where he served as chief op­er­at­ing of­fi­cer — re­spon­si­ble for the busi­ness and op­er­a­tional ac­tiv­i­ties with­in the com­pa­ny’s heme-on­col­o­gy pipeline and help­ing with the US ap­proval and launch of Calquence in 2017. Pri­or to that, Tuck­er held var­i­ous stints at Bay­er, Janssen Phar­ma­ceu­ti­ca and Genen­tech.

Af­ter bag­ging $46 mil­lion cash and leap­ing out of stealth mode in Sep­tem­ber, Arch-backed Bound­less Bio is on the hunt to build out a pipeline of ecD­NA-tar­get­ing ther­a­peu­tics. The com­pa­ny has snagged Chris­t­ian Has­sig as CSO to help with that job. Has­sig served in the same role at Sier­ra On­col­o­gy be­fore join­ing Bound­less. Has­sig was the VP of drug dis­cov­ery at San­ford Burn­ham Pre­bys Med­ical Dis­cov­ery In­sti­tute and held a stint at Ka­lyp­sys. Has­sig be­gan his ca­reer at the Scripps Re­search In­sti­tute.

Chris­t­ian Has­sig Bound­less Bio

→ James Wil­son’s gene ther­a­py start­up, Pas­sage Bio — which re­cent­ly brought in bil­lion­aire Len Blavat­nik to help fund a $110 mil­lion Se­ries B round — has ap­point­ed Richard Mor­ris as CFO. Mor­ris joins from Con­text Ther­a­peu­tics where he served as EVP and CFO. Pri­or to that, Mor­ris was CFO at Vi­tae Phar­ma­ceu­ti­cals (ac­quired by Al­ler­gan in 2016). Be­fore that, Mor­ris was the VP, glob­al fi­nan­cial plan­ning and strat­e­gy at Vi­roPhar­ma — help­ing lead to team to its ac­qui­si­tion by Shire.

→ Mar­i­nus Phar­ma­ceu­ti­cals saw its shares eclipsed in Ju­ly when it failed to com­pare on PPD in its Phase II tri­al for a ri­val IV for­mu­la­tion of Sage’s de­pres­sion drug Zul­res­so. Now the com­pa­ny has wooed Joe Huli­han, the for­mer glob­al med­ical af­fairs leader of neu­ro­science of J&J, to the po­si­tion of CMO. Huli­han will suc­ceed Lo­ri­anne Ma­suo­ka, who is re­tir­ing from the po­si­tion. Most re­cent­ly, Huli­han was prin­ci­pal at Par­a­digm Neu­ro­science. Pri­or to that, he served in var­i­ous neu­rol­o­gy and psy­chi­a­try-fo­cused roles at J&J, in­clud­ing VP, CNS med­ical af­fairs at Janssen. In ad­di­tion, he served as di­rec­tor, CNS re­search, clin­i­cal af­fairs at Or­tho-Mc­Neil Phar­ma­ceu­ti­cal.

An­tibi­otics-fo­cused En­ta­sis Ther­a­peu­tics — which is part­nered with GSK for a Phase III tri­al on the an­tibi­ot­ic zo­liflo­dacin to tar­get Neis­se­ria gon­or­rhoeae has named Mer­ck vet David Al­tarac as CMO, suc­ceed­ing re­tir­ing CMO Robin Isaacs. In his new role, Al­tarac will be re­spon­si­ble for lead­ing clin­i­cal de­vel­op­ment for the com­pa­ny’s lead pro­grams, sul­bac­tam-dur­lobac­tam and zo­liflo­dacin — both in Phase III tri­als. Most re­cent­ly, he served as SVP and head of glob­al reg­u­la­to­ry af­fairs, glob­al drug safe­ty and R&D qual­i­ty and com­pli­ance at Shire. Pri­or to that, he served as VP, reg­u­la­to­ry af­fairs at NeoStem.

→ Joanne Schindler is suc­ceed­ing Gabriela Ro­su as CMO at IMV. Schindler has served as VP, clin­i­cal de­vel­op­ment and ex­ec­u­tive med­ical di­rec­tor at H3 Bio­med­i­cine and as VP, clin­i­cal de­vel­op­ment at Con­stel­la­tion Phar­ma­ceu­ti­cals. Her pre­vi­ous stints in­clude roles at Syn­De­vRx, Im­muno­Gen and No­var­tis.

Cam­bridge, UK-based Bi­cy­cle Ther­a­peu­tics — which raised $61 mil­lion in a down­sized IPO in Mayhas brought on Nigel Crock­ett as CBO. Most re­cent­ly, Crock­ett served as a found­ing part­ner at Tukan Part­ners. He did a pre­vi­ous stint as VP, busi­ness de­vel­op­ment at As­tex Ther­a­peu­tics. In ad­di­tion, the com­pa­ny has ap­point­ed for­mer CEO and pres­i­dent of Medelle, Veron­i­ca Jor­dan, to its board of di­rec­tors, where she will serve as chair of the com­pen­sa­tion com­mit­tee. 

Af­ter re­cent­ly wel­com­ing a new CMO and VP of reg­u­la­to­ry af­fairs, Check­mate Phar­ma­ceu­ti­cals has ap­point­ed Kleem Chaud­hary as CBO. Chaud­hary joins the com­pa­ny af­ter serv­ing as head of busi­ness de­vel­op­ment & li­cens­ing at Bio­gen and as a trans­ac­tion leader in busi­ness de­vel­op­ment at Take­da. He has al­so held stints at No­var­tis and Gilead Sci­ences

Af­ter bag­ging $20 mil­lion in a fi­nanc­ing round in April, Penn-part­nered and James Wil­son co-found­ed Scout Bio — fo­cused on de­vel­op­ing gene ther­a­pies for pets — has brought on Boehringer In­gel­heim (BI) vet Anne Traas as chief de­vel­op­ment of­fi­cer. Most re­cent­ly Traas served as head of Saint Joseph phar­ma clin­i­cal R&D — where she was re­spon­si­ble for tar­get an­i­mal safe­ty and ef­fi­ca­cy stud­ies — at BI sub­sidiary Boehringer In­gel­heim An­i­mal Health. She has al­so served as as­so­ciate di­rec­tor of US bi­o­log­i­cal clin­i­cal de­vel­op­ment and as­so­ciate di­rec­tor of phar­ma­ceu­ti­cal clin­i­cal de­vel­op­ment at BI. Ear­li­er in her ca­reer, Traas was a res­i­dent in med­ical ge­net­ics and a clin­i­cal tri­als vet­eri­nar­i­an at the Uni­ver­si­ty of Penn­syl­va­nia. 

Af­ter re­cent­ly un­veil­ing 24-week da­ta from their OP­TIC tri­al of their ex­per­i­men­tal ther­a­py, AD­VM-022, Ad­verum Biotech­nolo­gies an­nounced the ap­point­ment of Pe­ter Soparkar as chief le­gal of­fi­cer. Soparkar joins the com­pa­ny from Coun­syl (ac­quired by Myr­i­ad Ge­net­ics), where he served in the same po­si­tion. Soparkar served as the VP and as­so­ciate gen­er­al coun­sel at Jazz Phar­ma­ceu­ti­cals — where he led the trans­ac­tions of the ten­der-of­fer of Cela­tor and the ac­qui­si­tions of Gen­tium, EU­SA Phar­ma and Azur Phar­ma. Ear­li­er in his ca­reer, Soparkar worked at Lath­am & Watkins.

Anne Traas

→ NGM Bio­phar­ma­ceu­ti­cals — which re­cent­ly tout­ed pos­i­tive Phase II NASH re­sults — has hired Va­lerie Pierce as SVP, gen­er­al coun­sel and chief com­pli­ance of­fi­cer. Pierce joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where she served as as­so­ciate gen­er­al coun­sel. Be­fore Jazz, Pierce was the VP and se­nior trans­ac­tion­al coun­sel at Amyris. Her pre­vi­ous stints in­clude roles at Sune­sis Phar­ma­ceu­ti­cals, OneWorld Health, Tu­larik and ALZA

→ Con­tin­u­ing to ex­pand in­to the US vi­ral vec­tor mar­ket – re­cent­ly ink­ing a deal with De­nali in Jan­u­ary to de­vel­op AAV vec­tors for ther­a­peu­tics in ar­eas such as Alzheimer’s, Parkin­son’s and Lou Gehrig’s dis­ease – Siri­on Biotech has an­nounced that Siri­on’s VP, US op­er­a­tions, Carl Chris­tel, has re­lo­cat­ed to the com­pa­ny’s Cam­bridge, MA of­fice. In ad­di­tion, the com­pa­ny has brought on vi­rol­o­gist Ra­jesh Pan­i­grahi and Boston Chil­dren’s Hos­pi­tal hema­tol­ogy and on­col­o­gy post­doc Ro­man Braun to fur­ther US op­er­a­tions. Both will serve as the com­pa­ny’s key ac­count man­agers.

→ Camp4 Ther­a­peu­tics — which inked a col­lab­o­ra­tion with RNAi trend­set­ter Al­ny­lam in Jan­u­ary — has named pres­i­dent and CEO of Deci­bel Ther­a­peu­tics, Steven Holtz­man, as the chair of their board of di­rec­tors and Paula Ra­gan, founder, pres­i­dent and CEO of X4 Phar­ma­ceu­ti­cals, as the di­rec­tor of its board. In ad­di­tion Uni­ver­si­ty of British Co­lum­bia pro­fes­sor Michael Hay­den has joined the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry board.

→ Rock­well Med­ical — fo­cused on im­prove­ments for pa­tients with ane­mia, with an ini­tial fo­cus on end-stage re­nal dis­ease — has wel­comed John McLaugh­lin as chair­man of its board of di­rec­tors. McLaugh­lin is the for­mer CEO of PDL Bio­Phar­ma and will be suc­ceed­ing Ben­jamin Wolin, who will re­main on the board.

Neu­rode­gen­er­a­tive dis­ease-fo­cused Neu­ro­pore Ther­a­pies has ap­point­ed for­mer Roche ex­ec Joseph Mc­Crack­en to its board of di­rec­tors. Mc­Crack­en cur­rent­ly serves as an ad­vi­sor of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment ini­tia­tives for sev­er­al bio­phar­ma­ceu­ti­cal com­pa­nies, in­clud­ing Modalis Ther­a­peu­tics and Savara Phar­ma­ceu­ti­cals

Biotech Ox­ford Bio­Dy­nam­ics — fo­cused on the de­vel­op­ment of epi­ge­net­ic bio­mark­ers based on reg­u­la­to­ry genome ar­chi­tec­ture — has ap­point­ed Uni­ver­si­ty of Glas­gow rheuma­tol­ogy pro­fes­sor Iain McInnes to the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry board. 

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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