Ash Shehata, KPMG

As sup­ply chain wor­ries ease up, Big Phar­ma CEOs have a new top con­cern: re­cruit­ing and keep­ing em­ploy­ees

As the in­dus­try goes through a boom, Big Phar­ma’s CEOs seem to have re­al­ized one thing above the rest: It’s time to re­ward the peo­ple do­ing the leg work.

KP­MG, a Big Four ac­count­ing net­work, has com­piled a busi­ness con­fi­dence re­port for phar­ma CEOs for the past few years, and while 2020’s re­port had top ex­ec­u­tives soul-search­ing for an­swers and pre­dic­tions amidst a chaot­ic time, it ap­pears that some nor­mal­cy, cou­pled with the sky­rock­et­ing growth of the in­dus­try, has re­stored con­fi­dence lev­els at the top.

Af­ter a year filled with de­mands for high­er wages, bet­ter work­ing con­di­tions and a more flex­i­ble ap­proach to the work­place across near­ly every sec­tor of busi­ness, Big Phar­ma CEOs seem to have got­ten the mes­sage. Across the world, 43% of those sur­veyed said that how the com­pa­ny re­wards and in­cen­tivizes peo­ple is go­ing to be the com­pa­ny’s top pri­or­i­ty over the next three years.

In 2020, just 4% of those sur­veyed said that was a pri­or­i­ty, tied with train­ing and learn­ing op­por­tu­ni­ties for em­ploy­ees for the low­est pri­or­i­ty out of eight op­tions pro­vid­ed. Re­cruit­ing peo­ple and as­sess­ing em­ploy­ee per­for­mance was the run­away pri­or­i­ty last year, with 25% of CEOs say­ing so, fol­lowed close­ly by al­lo­cat­ing cap­i­tal and com­mu­ni­cat­ing to in­vestors and share­hold­ers.

Pres­sure sur­round­ing in­creased wages and the in­fla­tion that could come with it is among the top un­cer­tain­ties for CEOs, ac­cord­ing to Ash She­ha­ta, a part­ner at KP­MG, as well as the ques­tions sur­round­ing a re­turn to the of­fice.

“It re­al­ly is around all in­dus­tries…and I think you can’t have a CEO out­look con­ver­sa­tion with­out in­volv­ing the out­look on the phys­i­cal en­vi­ron­ment, how peo­ple were go­ing back to the of­fice, the new ways of work­ing,” She­ha­ta said in a call with End­points News. “So I’d say that to me, that’s one of the biggest ar­eas of op­por­tu­ni­ties, and al­so un­cer­tain­ty. You’re start­ing to see poli­cies around vac­ci­na­tion re­quire­ments, and cer­tain­ly en­cour­ag­ing peo­ple to go back in­to the of­fice, or of­fer­ing some com­bi­na­tion, a hy­brid.”

The top dogs al­so have an ap­petite for merg­ers and ac­qui­si­tions, with just 4% say­ing that it is un­like­ly the com­pa­ny will make an ac­qui­si­tion, and 45% say­ing that the like­li­hood is high, out­pac­ing last year’s 38% of CEOs who said the same.

But per­haps the most in­ter­est­ing por­tion of the re­port is the part in which CEOs talk about their great­est risks go­ing for­ward. Last year, amidst the chaos that came with the start of the pan­dem­ic, sup­ply chain risk and a re­turn to ter­ri­to­ri­al­ism were flagged as the two most press­ing risks to Big Phar­ma’s progress. As the phar­ma­ceu­ti­cal in­dus­try’s sup­ply chain has large­ly held strong through­out one of the in­dus­try’s biggest booms, wor­ry among CEOs has eased up, but not to­tal­ly gone away. About 17% of those sur­veyed list­ed the sup­ply chain as a risk, com­pared to 25% in 2020.

“In the past, we would man­age risks quar­ter to quar­ter, event by event. Now we’re man­ag­ing events by the lat­est vari­ant, and the im­pact it has on our com­mu­ni­ty, and we are start­ing to see some sup­ply chain peak and wane based on the en­vi­ron­ments sur­round­ing Covid,” She­ha­ta said. “I think the is­sue we’re go­ing to track over the next year … the dy­nam­ic of re­gion­al­ism is re­al­ly im­pact­ing our busi­ness. So you might see a peak in the south­ern states, and that might af­fect over­all vol­umes to pa­tients pro­ce­dures, but you might see the west­ern states not have that same amount of im­pact.”

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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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.

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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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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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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