Biotech ex­ecs slam Trump’s trav­el ban, count­ing the high cost to a glob­al in­dus­try

A large ma­jor­i­ty of the biotech in­dus­try has ve­he­ment­ly re­ject­ed Don­ald Trump’s trav­el ban in no un­cer­tain terms.

We de­cid­ed to take the tem­per­a­ture of the in­dus­try in a snap poll emailed to in­dus­try sub­scribers Sun­day af­ter­noon. In just two hours, 600 of our near­ly 13,000 sub­scribers weighed in — the vast ma­jor­i­ty dead set against the ban, many an­gri­ly cit­ing the im­me­di­ate im­pact the ex­ec­u­tive or­der will have on the bio­phar­ma in­dus­try.

In our fi­nal tal­ly for the sur­vey Tues­day morn­ing, we had reg­is­tered more than 1,400 re­spons­es, with 1,226 op­posed (87%) to the ban and on­ly 188 in fa­vor of it. Three out of four felt that the ban is cer­tain to have a neg­a­tive im­pact on the in­dus­try, threat­en­ing di­ver­si­fied staffs, at­ten­dance at US con­fer­ences, and throt­tling back key re­cruit­ing ef­forts. Sev­er­al CEOs reached out to me to voice their con­cerns for staffers with green cards who come from out­side the 7 coun­tries cit­ed by Trump, but who are nonethe­less wor­ried about their fu­tures here. And in many cas­es, it was clear that quite a few ex­ecs in the in­dus­try were sim­ply out­raged by a move that they felt would tar­nish the coun­try’s rep­u­ta­tion for years to come.

We asked BIO for a com­ment, but have yet to hear back. We did hear from BIO Chair­man Ron Co­hen, though, and added it up top.

Some ex­ec­u­tives sent di­rect state­ments. We’ve in­clud­ed them be­low. Be­low that you’ll see re­spons­es from our biotech read­ers, di­rect­ly from the poll. We’ll con­tin­ue to gath­er re­spons­es and post up­dates on our poll through Mon­day. Please spread the word if you get a chance.

Acor­da Ther­a­peu­tics CEO and BIO Chair­man Ron Co­hen:

I ap­pre­ci­ate your ef­forts in tak­ing and pub­lish­ing the re­sults of the sur­vey. Frankly, I am dis­mayed that as many as 13% of re­spon­dents ac­tu­al­ly min­i­mize the im­por­tance bio­phar­ma of the re­cent events. That’s more than 1 in 8. I be­lieve what they miss more than any­thing is that this is not mere­ly an is­sue of 7 par­tic­u­lar coun­tries, which them­selves may not be in the van­guard of med­ical/sci­en­tif­ic re­search; it is an is­sue of the mes­sage that is be­ing sent across the plan­et, of the chill­ing ef­fect on would-be im­mi­grants every­where, who will now see Amer­i­ca as less wel­com­ing, more threat­en­ing, and many of whom will there­fore choose to ben­e­fit oth­er coun­tries with their tal­ents in­stead.
Even peo­ple who are al­ready in the US, in my own com­pa­ny, are ex­press­ing anx­i­ety. Il­lus­trat­ing my point above, the anx­i­ety ex­tends to green card hold­ers from West­ern Eu­ro­pean coun­tries, who trav­el to Eu­rope for both busi­ness and fam­i­ly rea­sons—al­though the let­ter of the Ex­ec­u­tive Or­der would seem not to be rel­e­vant to them, they have con­tact­ed me and our head of HR to ask if they should be con­cerned about get­ting back to the US if they leave for such a trip.

Je­re­my Levin, CEO of Ovid

Every na­tion has the right to de­ter­mine who comes across its board­ers. Every na­tion and par­tic­u­lar­ly Amer­i­ca, needs to be vig­i­lant in de­fend­ing against and hunt­ing down ter­ror­ists. The ac­tions tak­en by the ad­min­is­tra­tion how­ev­er were poor­ly con­ceived, ill planned and ill thought through. By these ac­tions the ad­min­is­tra­tion has raised deep fears and con­cerns across the em­ploy­ee base of the in­dus­try where di­ver­si­ty, the flow of ideas and peo­ple and in­clu­sion have been the main­stay of in­no­va­tion and mak­ing Amer­i­ca the pow­er­house of med­i­cine it is and should re­main. Not on­ly was this a fun­da­men­tal change in the way we and the out­side world in­ter­act, it was a blow to good busi­ness and a de­struc­tive at­tack on the core of what makes Amer­i­ca the great­est en­gine of in­no­va­tion.

Al­ny­lam CEO John Maraganore:

At Al­ny­lam we live our val­ues and cel­e­brate many ben­e­fits from a di­verse work­force. Ac­cord­ing­ly, we re­ject all forms of dis­crim­i­na­tion and lim­i­ta­tions that pre­vent us from ben­e­fit­ing and grow­ing as a di­verse and in­clu­sive work­place. We have a num­ber of in­ter­na­tion­al em­ploy­ees work­ing legal­ly at our U.S. lo­ca­tions, and will con­tin­ue to sup­port them in every way we can.

David Schenkein, the CEO at Agios, sent me this:

I am first gen­er­a­tion Amer­i­can and on­ly here be­cause my par­ents es­caped the holo­caust and came to Amer­i­ca- this ban is hor­ri­ble and speaks against every­thing I be­lieve in.

Steve Holtz­man, CEO at the start­up Deci­bel, wrote:

Trump’s ban on im­mi­gra­tion and the no­tion of a re­li­gious test are deeply re­pug­nant to the fun­da­men­tal tenets and val­ues of not on­ly the Unit­ed States but al­so the biotech­nol­o­gy in­dus­try.
We are a sci­ence-based en­ter­prise built on the be­lief that the qual­i­ty of da­ta, not the po­si­tion of pow­er, pres­tige or re­li­gious or oth­er af­fil­i­a­tion of their pro­po­nent, are the source of their au­thor­i­ty.
So­cial ex­clu­sion is the moral equiv­a­lent of the ex­clu­sion of da­ta be­cause they con­tra­venes pop­u­lar be­lief.
We cher­ish all–re­gard­less of na­tion­al­i­ty, race, re­li­gious be­lief, sex­u­al ori­en­ta­tion or gen­der iden­ti­fi­ca­tion–who wish to join our in­dus­try’s bat­tle to com­bat hu­man dis­ease and ad­dress un­met hu­man needs.

Then we got this from Bassil Dahiy­at, CEO of Xen­cor:

To sum up, fright­en­ing and de­struc­tive. We are one of many com­pa­nies made up of a large per­cent­age of im­mi­grant staff, high­ly tal­ent­ed and trained. We cease to func­tion with­out im­mi­grants, pe­ri­od. Some now can­not leave the coun­try for fear of be­ing shut out. Those not im­pact­ed di­rect­ly have been scared on-and-off for months be­cause of the an­ti-im­mi­grant sen­ti­ment that was val­i­dat­ed by the elec­tion. They took ac­tion to change their sta­tus that they wouldn’t have oth­er­wise be­cause of fear. Per­son­al­ly, my par­ents im­mi­grat­ed from a coun­try ad­ja­cent to those banned. Are they next?
This move will have a neg­a­tive im­pact on the pro­duc­tiv­i­ty of the biotech in­dus­try if it stands. Tal­ent is hard to come by and clos­ing the door to any sources is bad.
And I hear the fear at Cal­tech, my grad school, is high among the large per­cent­age of for­eign stu­dents. They wor­ry that Amer­i­cans think they are tak­ing their jobs. Cam­paign rhetoric is lis­tened to. What on earth makes sense about re­ject­ing the best and bright­est from our coun­try?  Not to men­tion refugees.  My next door neigh­bors grow­ing up were Viet­namese refugees. I can say for sure they were a ben­e­fit to Amer­i­ca.

Here’s a small col­lec­tion of the huge re­sponse we’re track­ing, all tak­en from the poll.

The trav­el ban rais­es eth­i­cal, moral and pos­si­bly le­gal is­sues. It is re­gres­sive along the very di­men­sions that en­abled the US to be the founders and lead­ers of the biotech­nol­o­gy in­dus­try- in­no­va­tion, en­tre­pre­neur­ship, op­por­tu­ni­ty and fair­ness. As has been wide­ly re­port­ed, Steve Jobs of Ap­ple, was the bi­o­log­i­cal son of a Syr­i­an im­mi­grant, Ab­dul­fat­tah Jan­dali, and was raised by His adop­tive moth­er, Clara, an eth­nic Ar­men­ian whose par­ents es­caped Ot­toman Turkey and im­mi­grat­ed to the US. The cur­rent process for vet­ting refugees is ex­ten­sive and there has been no ev­i­dence pre­sent­ed that pre­vi­ous en­trants have posed a dan­ger. Our coun­try went in­to war in Iraq based on as­ser­tions of im­mi­nent dan­ger that were lat­er found to be un­true. We need to un­der­stand the fac­tu­al ba­sis be­hind such ex­treme and sud­den mea­sures in or­der to avoid re­peat­ing our mis­takes. To the ex­tent this di­rec­tive pre­vents or dis­rupts the abil­i­ty of green card hold­ers to re-en­ter the US, their rights would be af­fect­ed in a dis­crim­i­na­to­ry way and that seems il­le­gal. The biotech in­dus­try re­lies up­on im­mi­grants to a large ex­tent and ef­forts to cre­ate ad­di­tion­al bar­ri­ers than those al­ready in ef­fect would slow in­no­va­tion and progress. Noubar Afeyan

“Yes, the trav­el ban will have an im­pact on the bio­phar­ma in­dus­try. There are many visa and green card hold­ers from those coun­tries who are ei­ther study­ing to be­come a re­searcher or clin­i­cian or cur­rent­ly hold­ing those po­si­tions. How­ev­er, now they are un­able to see any of their fam­i­ly who might re­main in those coun­tries – which can have a dev­as­tat­ing emo­tion­al toll. In ad­di­tion, they are now un­able to trav­el out­side the US for med­ical meet­ings, busi­ness de­vel­op­ment, clin­i­cal tri­al site ini­ti­a­tion, etc. This es­sen­tial­ly blocks them from ad­vanc­ing re­search, as well as their own ca­reer. (Anony­mous)

Part of the strength of bio­med­ical re­search in the US is its abil­i­ty to re­cruit the bright­est and best from oth­er coun­tries to come to US for grad school or post-doc, which then feeds in­to biotech in­dus­try. Trump’s hos­tile stance to­ward rest of world is go­ing to di­min­ish this flow of tal­ent.  Tom Woi­wode

My CEO has dual UK/Iran­ian cit­i­zen­ship (he lives in the U.K.) and is thus un­able to trav­el to the USA at present. (Anony­mous)

“Suc­cess­ful biotech com­pa­nies need out­stand­ing, high­ly skilled peo­ple and they re­cruit from all over the world to get tal­ent. And they need re­li­a­bil­i­ty they can re­tain these peo­ple and not be afraid they may not re-en­ter the US be­cause some type of ban has been or­dered overnight. Even if your biotech com­pa­ny cur­rent­ly does not em­ploy cit­i­zen af­fect­ed by the cur­rent list of coun­tries that are banned…who’s next? This ad­min­is­tra­tion – with their un­rea­son­able and un­pre­dictable be­hav­iour – dam­ages biotech in­dus­try, dam­ages the US econ­o­my and en­dan­gers our free way of life.” — Harpreet Singh, CEO, Im­mat­ics US Inc., Hous­ton, TX

Any ban on any race or re­li­gion has an im­pact on our in­dus­try be­cause our in­dus­try is one of sci­ence and rea­son. Many of us are im­mi­grants, sons and daugh­ters of im­mi­grants or mar­ried to im­mi­grants ( I am gay and mar­ried to my im­mi­grant hus­band from Viet­nam who came here in 1980) . This ban has an im­pact on every de­cent hu­man in the world…a neg­a­tive im­pact. Plain and sim­ple, this is NOT who we are as an in­dus­try or as a peo­ple, pe­ri­od. Proud­ly signed, — Paul James Hast­ings, Chair and CEO, On­coMed Phar­ma­ceu­ti­cals

This is an in­dus­try that runs on brains. It needs the best, and they must be able to op­er­ate in a sup­port­ive en­vi­ron­ment, where they don’t fear for their safe­ty or face hos­til­i­ty. It is not for­tu­itous that over a third of the bio­phar­ma R&D work­force in the US is for­eign-born. Push­ing them out will evis­cer­ate in­no­va­tion. Bernard Munos, In­no­Think

“Di­ver­si­ty is the heart of biotech. Walk in­to any phar­ma or biotech and you will find peo­ple of all eth­nic­i­ties, re­li­gion, na­tions work­ing to­geth­er to solve health care prob­lems. To­day more than ever, if we are to main­tain our com­pet­i­tive­ness, we need the smartest peo­ple around the Globe to choose to come to Unit­ed States over oth­er coun­tries. A ban on im­mi­gra­tion, ban on refugees, even if tem­po­rary, sends the wrong sig­nal. — Sunil Joshi, Pres­i­dent & CEO, Gradalis

I am a biotech lawyer. Each of my clients, every shape and size, are for­tu­nate enough to have some of the world’s best and bright­est sci­en­tif­ic and busi­ness minds among their ranks. Many of them hail from out­side the US, in­clud­ing the coun­tries cov­ered by this ex­ec­u­tive or­der. Why would we want to lim­it our abil­i­ty to work to cure life-threat­en­ing dis­eases and con­di­tions? The drug dis­cov­ery busi­ness is hard enough as it is. Nev­er mind the fact that this is a heart­less act that flies in the face of this coun­tries most ba­sic tenets. (Anony­mous)

We re­ly on good sci­ence. We should at­tract the bright­est and best from around the world what­ev­er their coun­try of ori­gin. — Mike Grey

De­ploy sec­ond-or­der think­ing. This is on­ly a first step. Ex­trap­o­late for­ward. What this leads to. The best tal­ent goes else­where. — Praveen Tipir­neni

I have very ac­com­plished friends in our in­dus­try who are from those 7 coun­tries. (Anony­mous)

All but three of the ‘no im­pact’ votes (by 2:40 am) were anony­mous. And even in the mi­nor­i­ty of cas­es where no re­al im­pact was ex­pect­ed, you could al­so see op­po­si­tion to the move for big­ger rea­sons.

It will hit econ­o­my on­ly mi­nor if at all, phar­ma-biotech even less. But the im­age of US as leader of the free world goes down the riv­er. (Anony­mous)

But Trump has his loy­al sup­port­ers:

In the long term, firm­ness en­cour­ages re­spect. (Anony­mous)

Bio­phar­ma does not re­ly on any of the 7 coun­tries for em­ploy­ees, col­lab­o­ra­tions or busi­ness op­por­tu­ni­ties. (Anony­mous)

We have many tal­ent­ed re­searchers and sci­en­tists here in the USA that were in fact born and raised here. (Anony­mous)

This is a tem­po­rary pol­i­cy which im­pacts ar­eas not known for their con­nec­tion to bleed­ing-edge sci­en­tif­ic work. As­sum­ing the com­po­nent with green card hold­ers is worked out (and the court or­der around this ap­par­ent­ly has start­ed this), there will be min­i­mal im­pact on the in­dus­try over a 90 day pe­ri­od. (Anony­mous)

The coun­tries in­volved are hard­ly the heart­beat of biotech­nol­o­gy. To try and ex­trap­o­late this on tech­nol­o­gy laden sec­tors is a po­lit­i­cal ex­er­cise, not an ob­jec­tive or re­al­is­tic one. (Anony­mous)

And, of course, we got trolled, too. Anony­mous­ly.

You peo­ple are ut­ter dopes in need of a sto­ry. Trump “tem­porar­i­ly” banned en­try from a few na­tions…not all mus­lims, not all im­mi­grants. Get a clue. (Anony­mous)

By most ac­counts it seems that few CEOs of the Big Phar­mas have made any kind of com­ment on the ban, for or against.

For now, a spokesper­son for Mer­ck says that the phar­ma gi­ant is still as­sess­ing the sit­u­a­tion, adding:

We are com­mit­ted to our em­ploy­ees of all na­tion­al­i­ties and re­li­gions. We are ac­tive­ly reach­ing out to em­ploy­ees who may be af­fect­ed by the Ex­ec­u­tive Or­der to pro­vide le­gal ad­vice and oth­er as­sis­tance.

But a few high-pro­file ex­ecs have stepped up on Twit­ter.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to direct-to-consumer generic drugs, Mark Cuban has made another inroad in the ongoing battle over prescription drug prices. His cost-plus-15% generic drug company, frequently undercutting many competitors, now has its sights set on the employer healthcare market.

Cost Plus Drugs, which originally pledged to cut out PBMs, has now partnered with the PBM EmsanaRx, majority owned by the Purchaser Business Group on Health, to launch a supplemental drug discount program designed specifically for self-funded employers, the company announced Thursday.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.