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. 

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.

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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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 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.

Am­gen ax­es 149 of its staff in Cam­bridge of­fice; Evotec, Mil­li­pore­Sig­ma en­ter re­search pact

→ Amgen has submitted a Worker Adjustment and Retraining Act (WARN) — a warning of impending mass layoffs 60 days in advance of the date — to the state of Massachusetts in the wake of the company’s exodus from the neurosciences R&D sector. David Reese, the company’s R&D chief, said at the time that the company is cutting ties in the field to focus on other undisclosed areas. In its WARN notice, the Cambridge-based company stated that 149 of its employees would be affected — among the total 180 being let go. The terminations will take effect on December 31, 2019.