→ 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.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.