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 45^th 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.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.