As spot­light trains on bio­phar­ma di­ver­si­ty, most com­pa­nies kept their C-suites ex­act­ly the same in 2020 — re­port

The past year has cast a harsh spot­light on the bio­phar­ma in­dus­try’s lack of di­ver­si­ty. And though most com­pa­nies list di­ver­si­ty and in­clu­sion as one of their key val­ues, a whop­ping 67% of com­pa­nies saw lit­tle or no change in rep­re­sen­ta­tion by race or eth­nic­i­ty at the ex­ec­u­tive lev­el, ac­cord­ing to a re­cent BIO sur­vey.

As part of its sec­ond an­nu­al di­ver­si­ty re­port, BIO part­nered with Co­qual (for­mer­ly known as Cen­ter for Tal­ent In­no­va­tion) to sur­vey 100 com­pa­nies from Oc­to­ber to De­cem­ber 2020. They re­ceived or­ga­ni­za­tion-lev­el di­ver­si­ty da­ta from 18 com­pa­nies, and ex­ec­u­tive-lev­el di­ver­si­ty da­ta from 16. Sev­en­ty per­cent of re­spon­dents list­ed D&I as one of their stat­ed val­ues, BIO said. But on­ly 13% ac­tu­al­ly in­creased rep­re­sen­ta­tion for ex­ec­u­tives of col­or by at least 5%.

Two-thirds of com­pa­nies en­act­ed lit­tle or no mean­ing­ful change at the ex­ec­u­tive lev­el, and one in five com­pa­nies ac­tu­al­ly saw a de­crease of more than 5% in di­ver­si­ty in the C-suite, BIO said.

“For more than a year, the biotech­nol­o­gy in­dus­try and the world have faced a pub­lic health cri­sis. BIO’s mem­ber com­pa­nies have re­spond­ed tremen­dous­ly, demon­strat­ing the pow­er of col­lab­o­ra­tion and in­no­va­tion to cre­ate life-sav­ing vac­cines and ther­a­pies,” Michelle Mc­Mur­ry-Heath, CEO of BIO, wrote. “But the cri­sis al­so high­light­ed the health­care dis­par­i­ties fac­ing Black and Brown com­mu­ni­ties.”

On av­er­age, em­ploy­ees of col­or ac­count for 32% of the to­tal work­force, but just 21% of ex­ec­u­tives and 24% of CEOs, BIO re­port­ed. Black pro­fes­sion­als ac­count for 7% of the to­tal work­force and 3% of ex­ec­u­tive teams, de­spite rep­re­sent­ing about 12% of the US adult pop­u­la­tion. Sim­i­lar­ly, Lat­inx pro­fes­sion­als make up a mere 4% of the work­force and ex­ec­u­tive teams, de­spite ac­count­ing for 16% of the coun­try’s adult pop­u­la­tion.

In­dige­nous pro­fes­sion­als are “all but miss­ing from the biotech in­dus­try,” ac­cord­ing to BIO, with Na­tive Amer­i­can, Alaskan Na­tive, Na­tive Hawai­ian and Pa­cif­ic Is­landers com­pris­ing 0.3% or less of re­port­ed em­ploy­ee and ex­ec­u­tive com­po­si­tion this year and last.

Bio­phar­ma’s di­ver­si­ty prob­lems ex­tend far be­yond the work­force, with clin­i­cal tri­als his­tor­i­cal­ly leav­ing out com­mu­ni­ties of col­or. Of the 53 drugs ap­proved in 2020, Black pa­tients rep­re­sent­ed about 8% of par­tic­i­pants in the tri­als reg­u­la­tors based their de­ci­sions on (and for which da­ta on race was col­lect­ed).

“The way in which bio­med­ical re­search works is con­t­a­m­i­nat­ed by struc­tur­al racism,” NIH di­rec­tor Fran­cis Collins said at a Milken In­sti­tute event ear­li­er this year.

That isn’t to say com­pa­nies aren’t lis­ten­ing. Ac­cord­ing to BIO’s cal­cu­la­tions, the re­spon­dents were 2.5 times as like­ly to have a D&I pro­gram this year com­pared to last year’s sam­ple. And one in five re­spon­dents saw sig­nif­i­cant progress in gen­der rep­re­sen­ta­tion at the ex­ec­u­tive lev­el (with one in four achiev­ing what BIO deemed mod­er­ate progress).

Women ac­count for 47% of to­tal em­ploy­ees in the in­dus­try — and be­tween this year and last, 36% of re­spon­dents saw an in­crease of at least 5% in fe­male em­ploy­ees. That num­ber shrinks the high­er up you look, though, with women rep­re­sent­ing 31% of ex­ec­u­tives and 23% of CEOs.

On­ly 18% of re­spon­dents said their or­ga­ni­za­tion has hir­ing tar­gets for women and pro­fes­sion­als of col­or, with larg­er com­pa­nies more than twice as like­ly to have them. And just 7% of com­pa­nies re­port­ed hav­ing blind­ed re­sume re­views (up from 3% last year).

When asked to de­scribe the pro­grams they be­lieve have had the great­est im­pact in di­ver­si­ty, eq­ui­ty and in­clu­sion at their or­ga­ni­za­tions, re­spon­dents came forth with a va­ri­ety of an­swers:

“We do not post a job open­ing and wait for ap­pli­cants. We di­rect­ly con­tact the sci­en­tists and lead­ers that we want who are [women] or [peo­ple of col­or],” one re­spon­dent wrote.

An­oth­er said: “We do not shy away from talk­ing about the un­rest in the world right now. We talk about it in our month­ly cor­po­rate up­dates with every em­ploy­ee. We have an anony­mous link peo­ple can use to send in ques­tions to cov­er at the meet­ing.”

BIO is­sued a set of rec­om­men­da­tions for com­pa­nies to im­prove, in­clud­ing col­lect­ing and track­ing da­ta, com­mit­ting and fol­low­ing through on pay eq­ui­ty, pi­lot­ing spon­sor­ship ini­tia­tives, and sup­port­ing a cul­ture of feed­back.

“There is no one-size-fits all ap­proach to DEI strat­e­gy,” BIO wrote, adding lat­er: “The speed of growth in the in­dus­try is rea­son enough for com­pa­nies to view DEI as an im­per­a­tive to­day, not an is­sue to be ad­dressed down the line.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.