Out­side re­view con­firms top Memo­r­i­al Sloan Ket­ter­ing ex­ec­u­tives flout­ed con­flicts-of-in­ter­est poli­cies — re­port

The up­per ech­e­lons of the Memo­r­i­al Sloan Ket­ter­ing (MSK) Can­cer Cen­ter have been charged with cul­ti­vat­ing a cul­ture of putting prof­its be­fore re­search and pa­tients by per­sis­tent­ly breach­ing con­flict-of-in­ter­est poli­cies in a re­view con­duct­ed by an in­de­pen­dent body.

The re­sults of the re­view — re­port­ed by the New York Times and ProP­ub­li­ca — so­lid­i­fies a sweep­ing in­ves­ti­ga­tion by the two me­dia or­ga­ni­za­tions last year that found var­i­ous top ex­ec­u­tives and board mem­bers from the lead­ing New York-based can­cer re­search and treat­ment cen­ter had prof­it­ed from re­la­tion­ships with drug­mak­ers, oth­er re­search out­fits and cor­po­rate board mem­ber­ships.

In re­sponse to the in­de­pen­dent re­view, MSK on Thurs­day al­so broad­ened its con­flicts-of-in­ter­est pol­i­cy over­haul, in­clud­ing pub­lic dis­clo­sure of physi­cian ties to cor­po­ra­tions and lim­its on work out­side of MSK.

The con­tro­ver­sial rev­e­la­tions com­ing out of Memo­r­i­al Sloan Ket­ter­ing have al­so had an im­pact on oth­er high pro­file can­cer in­sti­tu­tions, in­clud­ing the Boston-based Dana-Far­ber Can­cer In­sti­tute and Seat­tle-based Fred Hutchin­son Can­cer Re­search Cen­ter — both of whose ex­ec­u­tives sit on cor­po­rate boards — and are re­assess­ing their norms re­lat­ed to fi­nan­cial ties, ac­cord­ing to NYT/ProP­ub­li­ca.

José Basel­ga

The NYT/ProP­ub­li­ca re­ports trig­gered the Sep­tem­ber ex­it of MSK chief med­ical of­fi­cer, José Basel­ga, who failed to dis­close the re­mu­ner­a­tions he re­ceived from a spate of bio­phar­ma firms he as­sist­ed — in terms of ar­ti­cles in med­ical jour­nals as well as or­ga­ni­za­tions like AS­CO, where he head­lined ma­jor pre­sen­ta­tions. Basel­ga al­so stepped down from the boards of Bris­tol-My­ers Squibb and Var­i­an Med­ical Sys­tems, on­ly to be hired by As­traZeneca to run the British drug­mak­er’s on­col­o­gy di­vi­sion this Jan­u­ary.

Craig Thomp­son

The re­portage al­so sparked the dis­en­tan­gle­ment of oth­er MSK re­la­tion­ships. MSK CEO Craig Thomp­son in Oc­to­ber re­signed from the boards of Charles Riv­er Lab­o­ra­to­ries and Mer­ck. In Jan­u­ary, the non­prof­it re­search in­sti­tute re­formed its con­flicts-of-in­ter­est pol­i­cy, by ban­ning its top ex­ec­u­tives from serv­ing on cor­po­rate boards of bio­phar­ma com­pa­nies.

The out­side in­ves­ti­ga­tion — con­duct­ed by the law firm De­bevoise & Plimp­ton — found that MSK of­fi­cials  “fre­quent­ly vi­o­lat­ed or skirt­ed their own poli­cies; that hos­pi­tal lead­ers’ ties to com­pa­nies were like­ly con­sid­ered on an ad hoc ba­sis rather than through rig­or­ous vet­ting; and that re­searchers were of­ten un­aware that some se­nior ex­ec­u­tives had fi­nan­cial stakes in the out­comes of their stud­ies,” the NYT/ProP­ub­li­ca re­port pub­lished on Thurs­day said.

Nev­er­the­less, the vi­o­la­tions were not the re­sult of “in­ten­tion­al mis­con­duct” but due to “in­ad­e­quate over­sight and a lack of es­tab­lished pro­to­cols for ex­am­in­ing whether em­ploy­ees’ and ex­ec­u­tives’ af­fil­i­a­tions with cor­po­ra­tions could re­sult in bi­ased re­sults that fa­vored a com­pa­ny’s prod­ucts,” the ar­ti­cle high­light­ed, cit­ing an MSK staff meet­ing held on Thurs­day.

Im­age: Memo­r­i­al Sloan Ket­ter­ing (MSK) Can­cer Cen­ter

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link. 

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

Fol­low­ing CAR-T pi­o­neer­s' foot­steps, Tes­sa launch­es Chi­na JV in $120M deal

These days just about every biotech se­ri­ous about glob­al de­vel­op­ment — and not just com­mer­cial­iza­tion — has a Chi­na strat­e­gy. Tes­sa Ther­a­peu­tics, a Bay­lor as­so­ci­at­ed out­fit based out of Sin­ga­pore, is no ex­cep­tion.

Tak­ing a page out of the CAR-T pi­o­neers’ play­book, Tes­sa is es­tab­lish­ing a joint ven­ture with Chi­na-Sin­ga­pore Guangzhou Knowl­edge City, which is ini­tial­ly putting down $40 mil­lion for a 13% stake with $40 mil­lion more to come in a sec­ond stage. The biotech, which now re­tains an 87% con­trol, is al­so rolling out its own con­tri­bu­tions in two phas­es, start­ing with $20 mil­lion and all its tech­nol­o­gy li­cense rights for Chi­na.

Bain’s biotech team has cre­at­ed a $1B-plus fund — with an eye to more Big Phar­ma spin­outs

One of the biggest investors to burst onto the biotech scene in recent years has re-upped with more than a billion dollars flowing into its second fund. And this next wave of bets will likely include more of the Big Pharma spinouts that highlighted their first 3 years in action.

Adam Koppel and Jeff Schwartz got the new life sciences fund at Bain Capital into gear in the spring of 2016, as they were putting together a $720 million fund with $600 million flowing in from external investors and the rest drawn from the Bain side of the equation. This time the external investors chipped in $900 million, with Bain coming in for roughly $180 million more.

They’re not done with Fund I, with plans to add a couple more deals to the 15 they’ve already posted. And once again, they’re estimating another 15 to 20 investments over a 3- to 5-year time horizon for Fund II.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.