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.

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 is 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 is 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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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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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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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.

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.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Up­dat­ed: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.

Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.

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Eli Lil­ly or­dered to pay roy­al­ties on block­buster di­a­betes drugs, though ex­act dam­ages are un­clear

A federal court found Eli Lilly in breach of a royalty agreement with an Arizona company, likely sending the case — which deals with Lilly’s blockbuster diabetes drugs — to a trial.

The Arizona District Court ordered Lilly to pay the royalties to Tucson, AZ-based Research Corporation Technologies, per an opinion delivered Tuesday, stemming from a 1990 agreement involving materials used in manufacturing Lilly’s insulin products. Lilly had agreed to pay a 2% royalty on worldwide sales, and the exact amount of damages will be determined in a trial, Judge Scott Rash wrote.