John Maraganore, Jeremy Levin, Ron Cohen and Steven Holtzman

Biotech lead­ers ral­ly be­hind Chi­nese sci­en­tists in US, calls for 'mea­sured' poli­cies in wake of purges

A slate of biotech ex­ec­u­tives, ven­ture cap­i­tal­ists and aca­d­e­m­ic re­searchers have lent their voic­es to Chi­nese sci­en­tists work­ing in the US bio­med­ical field, am­pli­fy­ing con­cerns that re­cent sanc­tions could “cre­ate a cli­mate of fear and un­cer­tain­ty.”

The let­ter — draft­ed by Steven Holtz­man, Ron Co­hen, Je­re­my Levin and John Maraganore and signed by well over 100 in­dus­try fig­ures — cau­tions against vil­i­fy­ing or ex­clud­ing an eth­nic group at the ex­pense of the uni­ver­sal ef­fort to fight dis­ease. Levin cur­rent­ly chairs BIO, while Co­hen and Maraganore are past heads of the trade group.

High-pro­file ter­mi­na­tions of three Asian re­searchers at MD An­der­son in April first jolt­ed biotech lead­ers to­ward a re­al­iza­tion that their in­dus­try is not im­mune from na­tion­al vig­i­lance about over­seas in­flu­ence. Sub­se­quent con­tro­ver­sy at Emory in­volv­ing two promi­nent neu­ro­sci­en­tists of Chi­nese ori­gin fur­ther fu­elled wor­ries that re­searchers were be­ing pun­ished for con­duct­ing trans-Pa­cif­ic col­lab­o­ra­tive work that they were pre­vi­ous­ly en­cour­aged to do.

Feng “Franklin” Tao KU

Sig­nal­ing a tough crack­down against aca­d­e­m­ic es­pi­onage, the De­part­ment of Jus­tice has in­dict­ed a Uni­ver­si­ty of Kansas pro­fes­sor of fed­er­al fraud. Feng “Franklin” Tao, who works on sus­tain­able tech­nol­o­gy, was ac­cused of hid­ing his em­ploy­ment with a Chi­nese uni­ver­si­ty while con­duct­ing gov­ern­ment-fund­ed re­search in the US.

In their let­ter, Holtz­man, Co­hen, Levin and Maraganore (CEOs of Deci­bel, Acor­da, Ovid and Al­ny­lam, re­spec­tive­ly) em­pha­sized that they are for ac­tions against for­eign es­pi­onage and IP theft.

But ac­tions must not evolve in­to broad lim­i­ta­tions on col­lab­o­ra­tions be­tween Chi­nese and Amer­i­can sci­en­tists, as it would de­ter Chi­nese sci­en­tists from stay­ing in the US or even com­ing in the first place and thus be “dele­te­ri­ous to our na­tion­al in­ter­ests.”

Echo­ing opin­ions al­ready pub­lished by the ed­i­tors of Na­ture, Na­ture Biotech­nol­o­gy and for­mer NIH di­rec­tor (and ex-Sanofi R&D chief) Elias Zer­houni, they added:

(We) ad­vo­cate for mea­sured poli­cies that will both pro­tect U.S. in­tel­lec­tu­al prop­er­ty and con­tin­ue to fos­ter the di­ver­si­ty and col­lab­o­ra­tion that fu­el our abil­i­ty to ad­vance sci­ence and cure dis­ease. At a min­i­mum, uni­ver­si­ties must ef­fec­tive­ly com­mu­ni­cate and con­sis­tent­ly ap­ply their rules gov­ern­ing sci­en­tif­ic col­lab­o­ra­tions and IP oblig­a­tions, and they, as well as gov­ern­ment agen­cies, must clear­ly jus­ti­fy their ac­tions when they ac­cuse sci­en­tists of malfea­sance or seek to dis­miss them from their po­si­tions.

Last month, Zer­houni point­ed out in his op-ed that US pol­i­cy­mak­ers had ad­vo­cat­ed for sci­en­tif­ic ex­changes with Chi­na for years and in­sti­tu­tions had tac­it­ly sup­port­ed their re­searchers’ in­volve­ment in Chi­na’s Thou­sand Tal­ents Pro­gram.

Elias Zer­houni Sanofi

“The ‘rules,’ now pre­sent­ed and en­forced as se­vere vi­o­la­tions of U.S. ethics and in­tel­lec­tu­al prop­er­ty reg­u­la­tions, were not rig­or­ous­ly im­ple­ment­ed by of­fi­cials at many U.S. in­sti­tu­tions,” he wrote. “The con­ster­na­tion, sense of tar­get­ed dis­crim­i­na­tion, and fear in the Chi­nese-Amer­i­can sci­en­tif­ic com­mu­ni­ty are thus un­der­stand­able.”

While a re­cent sur­vey of End­points read­ers sug­gests a lack of con­sen­sus on the threat that Chi­nese-Amer­i­can sci­en­tif­ic com­mu­ni­ty faces, key play­ers are ap­par­ent­ly ea­ger to speak up be­fore the brain drain hap­pens in earnest.

Check out the full list of sig­na­to­ries here.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.