New­ly named Abeona chief Carsten Thiel boot­ed af­ter the board ac­cus­es him of mis­con­duct in­volv­ing col­leagues

Just 6 months af­ter land­ing the top job at Abeona Ther­a­peu­tics $ABEO, CEO Carsten Thiel has been un­cer­e­mo­ni­ous­ly boot­ed from the ex­ec­u­tive suite, ac­cused of un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny.

Ac­cord­ing to Abeona, a cell and gene ther­a­py start­up:

Dr. Thiel’s ter­mi­na­tion fol­lows an in­ves­ti­ga­tion by in­de­pen­dent mem­bers of the Com­pa­ny’s Board of Di­rec­tors and ex­ter­nal coun­sel in­to al­le­ga­tions of mis­con­duct to­wards col­leagues that the Board con­clud­ed vi­o­lat­ed the Com­pa­ny’s Code of Busi­ness Con­duct and Ethics and was in­con­sis­tent with its ex­pec­ta­tions for Abeona’s CEO.

And the sack­ing came with a lec­ture.

“We ex­pect all em­ploy­ees, re­gard­less of ti­tle or re­spon­si­bil­i­ty, to con­duct them­selves eth­i­cal­ly and in ac­cor­dance with com­pa­ny poli­cies, and are com­mit­ted to en­sur­ing an en­vi­ron­ment of re­spect, in­tegri­ty and eth­i­cal con­duct at Abeona,” said ex­ec­u­tive chair­man Steven Rouhan­deh in a pre­pared state­ment.

End­points News reached out to the com­pa­ny to see if we could round up some specifics of what hap­pened, but a spokesper­son was tight-lipped about the de­tails, stick­ing with the state­ment.

João Sif­fert

Thiel had been swept out of his job as com­mer­cial chief at Alex­ion in the spring of 2017 as the then new CEO Lud­wig Hantson cleaned house and brought in his own ex­ec­u­tive crew. Hantson’s ar­rival fol­lowed the de­par­ture of the pre­vi­ous Alex­ion CEO, who had been im­pli­cat­ed in an ethics scan­dal of his own af­ter ques­tions re­gard­ing the way they han­dled ad­vanced sales came up.

He’s be­ing re­placed on an in­ter­im ba­sis by an­oth­er new staffer: R&D chief João Sif­fert, who was brought in just a few weeks ago. Jef­feries notes that Sif­fert ap­pears to have the in­side track on the job, but adds that Abeona will look around for the best re­place­ment.

Pri­or to ABEO, Dr. Sif­fert was CMO at Cere­gene (ac­quired by SG­MO in 2013) and held lead­er­ship roles at AVNR and Av­era with his most re­cent role as Chief Sci­en­tif­ic and Med­ical of­fi­cer for Nes­tle Health Sci­ence. No­tably, he has Board lev­el per­spec­tive at AVXS (was ap­point­ed to the AVXS Board 4/19/17). In gen­er­al, he has ex­pe­ri­ence with neu­ro­log­i­cal drug and gene ther­a­py de­vel­op­ment. With ex­pe­ri­ence from pre­clin to drug ap­proval, Dr. Sif­fert brings a breadth of lead­er­ship-based qual­i­fi­ca­tions that should be rel­e­vant to ABEO’s cur­rent stage of growth. Though Dr. Sif­fert has a head start, ABEO has re­tained a search firm to look ex­ter­nal­ly too.

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.

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.

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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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

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.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

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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