→ Days af­ter Ku­ra On­col­o­gy an­nounced the de­par­ture of co-founder An­to­nio Gual­ber­to, we fi­nal­ly know where he wound up. Ei­sai sub­sidiary H3 Bio­med­i­cine has re­cruit­ed him as CMO to find­ing the right pa­tients to its four clin­i­cal-stage small mol­e­cule as­sets hit­ting ge­nom­ic dri­vers of can­cer.

“Chal­lenges of these and many oth­er pre­ci­sion med­i­cine ap­proach­es are on one hand tech­ni­cal — a need for ro­bust and pre­cise di­ag­nos­tics — and on the oth­er hand de­rived by the chal­lenge to al­ter stan­dard clin­i­cal prac­tice in set­tings where pa­tient screen­ing, e.g. by tu­mor DNA se­quenc­ing, is not stan­dard prac­tice,” he wrote to End­points News on his way back to Boston from Ei­sai’s Tokyo of­fices. “On­ly com­pelling clin­i­cal ac­tiv­i­ty can dri­ve clin­i­cians and pathol­o­gists to mod­i­fy stan­dard clin­i­cal prac­tice.”

Gual­ber­to was cred­it­ed with fig­ur­ing out the mech­a­nism of ac­tion for Ku­ra’s far­ne­syl trans­ferase in­hibitors and steer­ing them to the clin­ic. By dis­cov­er­ing CX­CL12 as a tar­get of their lead drug, tip­i­farnib, he an­swered a ques­tion that had been “unan­swered for more than a decade.”

“Tip­i­farnib is a great ex­am­ple of clin­i­cal dis­cov­ery that start­ed with the ob­ser­va­tion from tri­al da­ta from the pri­or Janssen pro­gram that AML pa­tients with high bone mar­row tu­mor bur­den and low cir­cu­lat­ing blasts were par­tic­u­lar­ly sen­si­tive to tip­i­farnib,” he said.

His pre­vi­ous stints span EMD Serono, Take­da and Pfiz­er.

→ Sea­soned drug hunter Siegfried Re­ich has left eF­FEC­TOR, the biotech he co-found­ed to dis­cov­er se­lec­tive trans­la­tion reg­u­la­tors, to take up the CSO role at Turn­ing Point Ther­a­peu­tics.

“I have fol­lowed the progress Turn­ing Point has made, and was drawn to its fo­cus on drug dis­cov­ery and its work to ad­vance the pipeline,” Re­ich told End­points. “I was al­so im­pressed by the depth of its man­age­ment team and board, many of whom I have worked with be­fore.”

Turn­ing Point re­cent­ly got some val­i­da­tion in its next-gen­er­a­tion ki­nase in­hibitor plat­form in the form of an im­pres­sive over­all re­sponse rate among TKI-naïve ROS1+ non-small cell lung can­cer pa­tients, al­though there were lin­ger­ing safe­ty con­cerns.

Re­ich, an in­ven­tor of the TKI In­ly­ta from his Agouron days who’s al­so worked in the an­tivi­ral space at Pfiz­er (in­vent­ing the pro­tease in­hibitor Vira­cept) and lat­er jumped to Lil­ly Biotech Cen­ter, said he would hit the ground run­ning to iden­ti­fy new tar­gets and churn out new projects on the macro­cyclic plat­form.

He will build on four drug can­di­dates in the San Diego start­up’s pipeline that tar­get ROS1/TRK, MET/CSF1R/SRC, RET/SRC and ALK, re­spec­tive­ly.

— Am­ber Tong

→ Gilead has snagged for­mer Bris­tol-My­ers Squibb on­col­o­gy ex­ec Michael Quigley as SVP, re­search bi­ol­o­gy. In ad­di­tion to his time at Bris­tol-My­ers, Quigley al­so held po­si­tions at Janssen and Med­Im­mune. At the same time, the com­pa­ny has pro­mot­ed Lin­da Hig­gins, who joined the com­pa­ny in 2010, to the po­si­tion of SVP and head of ex­ter­nal in­no­va­tion.

Géral­dine Hon­net Bio­ther­a­pies In­sti­tute

→ French biotech Sen­so­ri­on — fo­cused on the treat­ment of hear­ing loss dis­or­ders — has tapped Géral­dine Hon­net as CMO. Hon­net joins the com­pa­ny from Généthon, where she was al­so CMO. Pre­vi­ous­ly, Hon­net held posts at Parex­el In­ter­na­tion­al, Janssen-Cilag (John­son & John­son) and Trans­gene.

→ Tay­lor Schreiber has tak­en over the reins as CEO at Take­da–part­nered I/O play­er Shat­tuck Labs, suc­ceed­ing Josi­ah Horn­blow­er. Schreiber, a co-founder of the com­pa­ny, was pre­vi­ous­ly CSO. Pri­or to Shat­tuck, Schreiber was the co-founder and sci­en­tif­ic ad­vi­sor of Pel­i­can Ther­a­peu­tics. Horn­blow­er will re­main with the com­pa­ny as ex­ec­u­tive chair­man of the board.

→ AskBio has en­list­ed AAV gene ther­a­py ex­pert An­na Tre­ti­ako­va as SVP of prod­uct de­vel­op­ment. Tre­ti­ako­va has spent near­ly a decade con­duct­ing re­search at the Uni­ver­si­ty of Penn­syl­va­nia Gene Ther­a­py Pro­gram, Pfiz­er Rare Dis­ease Re­search Unit and Swan­Bio Ther­a­peu­tics.

Pe­ter Hecht Cy­cle­ri­on

→ Nan­cy Thorn­ber­ry-led Kally­ope — fo­cused on the gut-brain ax­is — has wel­comed Pe­ter Hecht to the board of di­rec­tors. Hecht re­cent­ly left his po­si­tion as CEO of Iron­wood Phar­ma­ceu­ti­cals to head the com­pa­ny’s spin­out Cy­cle­ri­on Ther­a­peu­tics as CEO.

→ For­mer Foun­da­tion Med­i­cine CEO Troy Cox has hopped aboard the board of di­rec­tors at SOPHiA GE­NET­ICS as chair­man, re­plac­ing An­toine Duchateau, who will con­tin­ue to serve as a board mem­ber. Cox served as CEO for Foun­da­tion Med­i­cine be­gin­ning in 2017 up un­til the com­pa­ny was snatched up by Roche.

→ Af­ter scor­ing a new glau­co­ma drug ap­proval last March, Aerie Phar­ma­ceu­ti­cals has named Ni­na Ohara as di­rec­tor, mar­ket­ing. Most re­cent­ly, Ohara served at Ot­su­ka Phar­ma­ceu­ti­cals sub­sidiary Avanir Phar­ma­ceu­ti­cals. In ad­di­tion, the com­pa­ny wel­comed Gre­go­ry Jones as di­rec­tor, tax. Jones pre­vi­ous­ly served at De­loitte Tax.

Hee­hy­oung Lee

→ Bolt Ther­a­peu­tics has ap­point­ed Bris­tol-My­ers Squibb vet Nils Lon­berg to its sci­en­tif­ic ad­vi­so­ry board. Lon­berg cur­rent­ly serves as ex­ec­u­tive-in-res­i­dence at Canaan Part­ners.

→ Soft­ware de­vel­op­er for drug dis­cov­ery Optib­ri­um has ap­point­ed Tim Hohm as di­rec­tor of com­mer­cial busi­ness strat­e­gy and busi­ness de­vel­op­ment. Hohm hops over from No­vo Nordisk, where he was se­nior com­pet­i­tive in­tel­li­gence man­ag­er.

→ Ca­li­di Bio­ther­a­peu­tics — work­ing on on­colyt­ic virus-based im­munother­a­pies for can­cer — has en­list­ed Hee­hy­oung Lee to their board of di­rec­tors. Lee cur­rent­ly serves as a man­ag­ing part­ner at Lume­Bio and has held po­si­tions at Han­mi Phar­ma­ceu­ti­cals and Sor­ren­to Ther­a­peu­tics in the past.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

Like many who work in biopharma, Richard Paulson got started in the field because of a love of science.

Paulson had just finished business school and was looking to start a career that married his two passions. While looking for jobs, he thought of his grandmother who had struggled with Alzheimer’s disease, recalling how he saw first-hand what innovative medicines can do for patients. Ultimately, he started his first job in the space as a sales rep at Glaxo Wellcome, one of GlaxoSmithKline’s predecessors before its merger with SmithKline Beecham in 2000.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.