MSK's José Basel­ga steps off Bris­tol-My­er­s' board as the in­dus­try de­bates the con­tro­ver­sy over in­dus­try ties

The dam­age re­port from the con­tro­ver­sy sur­round­ing Memo­r­i­al Sloan Ket­ter­ing’s chief physi­cian José Basel­ga keeps mount­ing.

Late on Fri­day came word from Bris­tol-My­ers Squibb that Basel­ga had re­signed from the big biotech’s board of di­rec­tors.

“Bris­tol-My­ers Squibb $BMY is com­mit­ted to the high­est stan­dards of ethics, com­pli­ance and in­tegri­ty,” not­ed the com­pa­ny in a brief state­ment. “These prin­ci­ples are cen­tral to the Com­pa­ny’s mis­sion and our abil­i­ty to de­liv­er in­no­v­a­tive med­i­cines to pa­tients with se­ri­ous dis­ease.”

Basel­ga had on­ly joined the board 5 months ago.

That res­ig­na­tion came sev­er­al days af­ter The New York Times and ProP­ub­li­ca re­port­ed that the renowned can­cer re­searcher had rou­tine­ly failed to fol­low the rules and cite his many fi­nan­cial ties with bio­phar­ma com­pa­nies in jour­nal ar­ti­cles and at con­fer­ences, forc­ing his ouster at Memo­r­i­al Sloan Ket­ter­ing.

Late Thurs­day word spread that the ar­ti­cle had set off a storm of con­tro­ver­sy, trig­ger­ing a chain re­ac­tion of alarm at MSK that prompt­ed the sci­en­tist to turn in his let­ter of res­ig­na­tion. In it, he wrote:

I fear my con­tin­ued role lead­ing clin­i­cal care and re­search will be­come too much of a dis­trac­tion to the hos­pi­tal and its re­mark­able team of physi­cians, re­searchers and staff.

Basel­ga, the once high­ly sought af­ter physi­cian-in-chief at MSK, al­so ac­cept­ed re­spon­si­bil­i­ty for his fail­ures to dis­close his many ties to phar­ma and biotech com­pa­nies, adding that those links were al­so well known and care­ful­ly re­port­ed to MSK it­self.

The news trig­gered a fren­zy of com­ments on Twit­ter, with a mix of views on the sud­den down­fall of a wide­ly cel­e­brat­ed re­searcher. If noth­ing else, it will put a spot­light on the grow­ing fi­nan­cial con­nec­tions be­tween re­searchers and the in­dus­try — and like­ly trig­ger a rush to fill in any gaps on dis­clo­sures in the com­ing weeks.

Quite a few peo­ple felt that forc­ing Basel­ga out at MSK was ex­ces­sive. But it’s al­so clear that prop­er­ly re­port­ing these ties is a se­ri­ous con­cern for the in­dus­try. We put up a poll for peo­ple at the be­gin­ning of the week, and drew more than a few harsh re­bukes for what he had failed to do.

Out of 447 re­spons­es, 330 — 74% — felt his fail­ure to re­port fi­nan­cial ties was a sig­nif­i­cant is­sue. On­ly 26% felt it was not. Sig­nif­i­cant, though, meant dif­fer­ent things to dif­fer­ent peo­ple. 

Here’s a sam­pling of the com­ments we heard:

It’s un­ac­cept­able and un­eth­i­cal. It hurts a lot the al­ready bad rep­u­ta­tion of phar­ma in­dus­try and of all the hon­est peo­ple and ex­cel­lent pro­fes­sion­als who work in clin­i­cal de­vel­op­ment. I am spe­cial­ly touched by his un­eth­i­cal be­hav­ior as I work in phar­ma/CROs and try to do my job as best as pos­si­ble with the high­est eth­i­cal stan­dards I can and have.
Not dis­clos­ing un­der­mines the goal of the en­tire process. The in­for­ma­tion should be pro­vid­ed and avail­able. Whether it in­flu­ences a stake­hold­er’s de­ci­sion one way or an­oth­er is sec­ondary to the fun­da­men­tal dis­clo­sure process. – John Cial­lel­la, Charles Riv­er Labs
Sig­nif­i­cant enough to call him out and have the dis­clo­sures cor­rect­ed but not wor­thy of a ma­jor ex­pose or alarm. He’s not the first or last re­searcher who didn’t dis­close some­thing. Don’t con­done it but lets not over­re­act ei­ther. Just set clear guide­lines and en­force them.
I’d de­fine sig­nif­i­cance as ris­ing to a crim­i­nal, civ­il or eth­i­cal breach. And that breach de­pends on in­tent. It is fair­ly clear that his in­tent was not to de­ceive and this was an over­sight. He made an er­ror. What is much more sig­nif­i­cant was the shod­dy ‘gotcha’ jour­nal­ism that im­plied ma­lign in­tent with­out prov­ing it. – David Weis­man, MD
I don’t think this par­tic­u­lar fail­ure to dis­close con­flicts was sig­nif­i­cant since Basel­ga’s con­sult­ing agree­ments/ad board mem­ber­ships are pret­ty much pub­lic knowl­edge. How­ev­er, this should be a sign to jour­nals, con­fer­ences and oth­er pub­lish­ing en­ti­ties to im­prove their process­es to al­ways en­sure au­thors ad­here to their dis­clo­sure agree­ments. For piv­otal stud­ies, FDA col­lects fi­nan­cial dis­clo­sure forms for all pri­ma­ry in­ves­ti­ga­tors *and* subin­ves­ti­ga­tors, which is sub­mit­ted with the clin­i­cal da­ta.
The re­la­tion­ship of trust be­tween pa­tients and doc­tors is fun­da­men­tal to our med­ical sys­tem. This sys­tem­at­ic fail­ure to com­ply with wide­ly-ac­cept­ed stan­dards of con­flict dis­clo­sure un­der­mines that foun­da­tion, while al­so pro­vid­ing a bad ex­am­ple to younger re­searchers and a good cov­er to un­scrupu­lous re­searchers. Why should any­one dis­close their con­flicts when some­one as ac­claimed as Dr. Basel­ga does not?

Im­age: José Basel­ga. AS­CO

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

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The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

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The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

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