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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.