In­dus­try lead­ers need to speak out now more than ever

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

The House im­peach­ment man­agers pre­sent­ed a grip­ping, vis­cer­al case two weeks ago in pros­e­cut­ing the 45th pres­i­dent for in­cite­ment of mob vi­o­lence to stop the cer­ti­fi­ca­tion of a free and fair US elec­tion.

Yet nev­er has a case so damn­ing pre­saged an ac­quit­tal so fore­gone. Sev­en brave sen­a­tors crossed the aisle to do the right thing and vote for a re­pub­lic, if we can keep it.

Just be­cause the im­peach­ment tri­al is over does not mean the threat to our de­mo­c­ra­t­ic norms is. The Sen­ate ac­quit­tal comes with a long-term cost: the hy­per­vig­i­lance of the Amer­i­can peo­ple. It is up to all of us to de­ter­mine what the for­mer pres­i­dent’s con­duct means for our na­tion’s fu­ture.

In biotech­nol­o­gy, our day job is to dis­cov­er and de­vel­op in­no­v­a­tive, ground­break­ing ther­a­pies and see that they get de­liv­ered fair­ly to the world’s pa­tient pop­u­la­tions. My com­pa­ny, Nkar­ta Ther­a­peu­tics, is com­mit­ted to re­al­iz­ing the po­ten­tial of the body’s nat­ur­al killer cells to treat can­cer. As CEOs, in­ten­sive fo­cus on our day jobs does not ex­cuse us from the role that our boards and col­leagues re­ly on us to play, which is to lead. Lead­er­ship, at its core, means call­ing out bad be­hav­ior and stand­ing up for what is right.

In the 2020 elec­tion, the Amer­i­can peo­ple vot­ed for a new ad­min­is­tra­tion com­mit­ted to sci­en­tif­ic in­tegri­ty, so­cial jus­tice, racial rec­on­cil­i­a­tion and eco­nom­ic re­new­al. How­ev­er, I be­lieve that the last four years un­leashed malev­o­lent forces in our so­ci­ety; how quick­ly, and if, Pan­do­ra’s box can be closed is an open ques­tion.

Emerg­ing biotech com­pa­nies re­cruit top sci­en­tists from every race, cul­ture and back­ground. For me, build­ing an in­clu­sive cul­ture that tru­ly cel­e­brates our dif­fer­ences means that si­lence is not an op­tion. I once had an in­vestor call me and fret that he had Googled my com­pa­ny name and saw as many ar­ti­cles on the first screen about so­cial jus­tice as he did about break­through sci­ence. I asked him if he had any doubts that I am do­ing every­thing in my pow­er to suc­ceed sci­en­tif­i­cal­ly and fi­nan­cial­ly. “None what­so­ev­er,” he said.

“That makes me hap­py to hear,” I replied. “Those ar­ti­cles you saw — and the com­pa­ny val­ues they rep­re­sent — are a big rea­son why the team is work­ing so hard on the sci­ence and feels as in­vest­ed in this com­pa­ny as you do.”

His­tor­i­cal­ly, many bio­phar­ma­ceu­ti­cal CEOs have been care­ful to watch our words so we do not alien­ate the par­ty that be­lieves in the free mar­kets up­on which our suc­cess ul­ti­mate­ly de­pends. How­ev­er, I have be­come in­creas­ing­ly out­spo­ken in my be­lief that biotech CEOs need to be more out­spo­ken in their be­liefs.

In to­day’s po­lit­i­cal en­vi­ron­ment, I be­lieve it is more im­por­tant than ever that we show the par­ty in pow­er our hearts, our true val­ues and our com­mit­ment to pa­tients. For me, that starts with speak­ing out against a new breed of cult-of-per­son­al­i­ty pop­ulism that dis­dains sci­en­tif­ic knowl­edge, traf­fics in racism and vi­o­lent ri­ots and un­der­mines democ­ra­cy.

Amer­i­can lead­ers across gov­ern­ment, in­dus­try, me­dia, ed­u­ca­tion and be­yond have a spe­cial re­spon­si­bil­i­ty to use our voic­es to de­fend shared val­ues that should tran­scend par­ti­san af­fil­i­a­tion. The free­doms too many Amer­i­cans take for grant­ed can be in­stant­ly lost, and tra­di­tion­al al­lies of con­ser­v­a­tives like the bio­phar­ma­ceu­ti­cal in­dus­try are unique­ly sit­u­at­ed to de­mar­cate un­cross­able lines.

Why take the risk? Be­cause si­lence is a greater risk. Our in­dus­try de­pends on de­mo­c­ra­t­ic sta­bil­i­ty and the mar­ket con­fi­dence it in­spires. Sta­ble mar­kets are why biotech en­tre­pre­neurs can raise the enor­mous cap­i­tal re­quired to bring long­shot break­throughs to pa­tients. For this rea­son and many more, we can­not turn our heads at threats to the foun­da­tion of the U.S. po­lit­i­cal and eco­nom­ic sys­tem.

That’s why the bio­phar­ma­ceu­ti­cal in­dus­try de­cid­ed to re­con­sid­er po­lit­i­cal con­tri­bu­tions to mem­bers of Con­gress who sup­port­ed over­turn­ing the re­sults of a con­sti­tu­tion­al­ly prop­er and ex­haus­tive­ly ad­ju­di­cat­ed elec­tion. As the vice chair of the Biotech­nol­o­gy In­no­va­tion Or­ga­ni­za­tion (BIO), the largest biotech in­dus­try group, I was heart­ened that so many of my col­leagues on both sides of the aisle agreed that this was the right course of ac­tion.

But the best way to com­bat dis­crim­i­na­tion and in­val­i­date white su­prema­cy is to em­brace racial di­ver­si­ty and to reck­on with past so­ci­etal trans­gres­sions. In the health­care sys­tem, that means ac­knowl­edg­ing lega­cies of mis­treat­ment and mis­trust that have made mi­nori­ties dis­pro­por­tion­ate­ly skep­ti­cal about vac­cines and clin­i­cal tri­al par­tic­i­pa­tion.

Pfiz­er and Mod­er­na en­rolled an im­pres­sive 42% and 37% mi­nori­ties, re­spec­tive­ly, in their Phase III COVID-19 vac­cine clin­i­cal tri­als. Me­dia and pa­tient ad­vo­cates want to know if this is a flash in the pan or an on­go­ing com­mit­ment. CEOs must con­tin­ue to speak out and act af­fir­ma­tive­ly if we are to main­tain cred­i­bil­i­ty and car­ry that mo­men­tum over to di­ver­si­fy tri­als in oth­er dis­ease ar­eas. Pro­grams like BIO Equal­i­ty rep­re­sent a long-term, in­dus­try­wide ef­fort to fight for di­ver­si­ty, ac­cess and af­ford­abil­i­ty for all pa­tients. Nkar­ta is proud to be a BIO mem­ber.

My ap­proach to drug de­vel­op­ment is in­formed by my own ex­pe­ri­ence liv­ing with Crohn’s dis­ease and run­ning a pa­tient ad­vo­ca­cy group for chil­dren with bow­el and blad­der con­di­tions. I can speak the heresy that drug costs are, in fact, too high, be­cause I’m talk­ing about low­er­ing pa­tient out-of-pock­et costs, not slash­ing in­sur­ance and gov­ern­ment re­im­burse­ment rates that have en­abled us to in­no­vate life-sav­ing vac­cines and an­ti­bod­ies against COVID-19 with record speed.

I can agree with HHS Sec­re­tary De­signee Xavier Be­cer­ra that health care is a fun­da­men­tal right but strong­ly dis­agree that in­val­i­dat­ing patents is a smart strat­e­gy to help pa­tients ac­cess med­i­cine. I can be­lieve in the so­cial con­tract that al­lows new med­i­cines — whether small mol­e­cules, pro­teins, an­ti­bod­ies or cell ther­a­pies — to be priced for a re­turn on in­vest­ment ini­tial­ly so long as gener­ics en­ter the mar­ket with­out de­lay, un­nec­es­sary ne­go­ti­a­tion or com­pli­ca­tion once patents ex­pire.

I can agree that Rep. Katie Porter (D-CA) is a pa­tri­ot but dis­agree with her state­ment that Big Phar­ma com­pa­nies buy­ing up small­er ones some­how de­val­ues them. Ac­tu­al­ly, this dy­nam­ic churn frees sci­en­tists to start new com­pa­nies and in­no­vate anew, while large com­pa­nies — with their glob­al sales teams and armies of com­mer­cial pro­fes­sion­als and drug de­vel­op­ers — sell, mar­ket and dis­trib­ute new med­i­cines.

Fight­ing for de­mo­c­ra­t­ic ideals doesn’t mean fi­deli­ty to politi­cians from any par­tic­u­lar par­ty. For me, in these tu­mul­tuous times, it is about hav­ing a moral com­pass, do­ing what’s right and speak­ing up for pa­tients and sci­en­tists who rep­re­sent the glo­ri­ous di­ver­si­ty and great hope of our plan­et.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.