An up­date on the End­points busi­ness mod­el — and how your com­pa­ny can di­rect­ly sup­port it

Pic­tured: The print-op­ti­mized ver­sion of End­points’ 2018 New Drug Ap­provals re­port. All paid sub­scribers will re­ceive a di­rect link to down­load the PDF + a copy of all our Q1 pay­wall sto­ries in print­able form, too.

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I want to give read­ers an up­date on the busi­ness front at End­points News, which is strong.

Two and a half years in — we’re prof­itable, about 14 peo­ple on the team and grow­ing, and 75,000 unique bio­phar­ma read­ers con­sume our news across all plat­forms on a week­ly ba­sis. Of that, 31,000 are what we con­sid­er “ba­sic sub­scribers” who re­ceive our dai­ly email re­ports and have opened or clicked on them in the last month, but haven’t up­grad­ed to paid sta­tus. And at the top we have 8,300 pre­mi­um sub­scribers who ei­ther di­rect­ly sup­port the work or are em­ployed at a com­pa­ny that does.

We reg­u­lar­ly scrub our email read­er­ship, too.

We’ve built a glob­al events fran­chise and con­vened over 2,000 at­ten­dees over the last 12 months in San Fran­cis­co, Boston, Lon­don, and Shang­hai. Lat­er this month we’ll be an­nounc­ing venues and dates for our en­tire 2019 line­up.

John Car­roll speaks at the US-Chi­na Bio­phar­ma In­no­va­tion and In­vest­ment Sum­mit in Shang­hai on Oc­to­ber 23, 2018

Click on the im­age to see the full-sized ver­sion


And we’ve done all of this with­out rais­ing any VC cash.

End­points is built to with­stand the storms en­velop­ing dig­i­tal me­dia to­day thanks to the di­rect sup­port of our En­ter­prise and In­sid­er sub­scribers.  We’re hir­ing new jour­nal­ists, plan to dou­ble the au­di­ence, and have moved in­to a new head­quar­ters in Lawrence, Kansas that’ll serve as the nerve-cen­ter for End­points’ next stage of in­no­va­tion. New hires in mar­ket­ing, sales, and op­er­a­tions are in the works now to sup­port that. There’s a web­site re­vamp on tap. And there’s just so much more news we’d like to cov­er in trans­la­tion­al sci­ence and out­sourc­ing.

Most im­por­tant­ly: Our fi­nan­cial in­cen­tives are tied to pro­duc­ing a jour­nal­ism prod­uct that serves the core bio­phar­ma read­er.

Haven’t joined yet? Now is a great time and you can see one of the ben­e­fits above: a print (yes, print!) ver­sion of the 2018 class of new drug ap­provals. You’ll al­so get ac­cess to the lat­est edi­tion of bio­phar­ma’s top 100 VCs, and the en­tire pay­wall li­brary.

The most im­por­tant way you can di­rect­ly sup­port End­points is hav­ing your com­pa­ny sub­scribe to our $1,000/year flat-rate En­ter­prise plan (signup link). That’s an “un­lim­it­ed li­cense” for every em­ploy­ee un­der your cor­po­rate ban­ner. All of your col­leagues get ac­cess to pay­wall con­tent, reprint rights, PDF ex­port, and your HR team gets two pre­mi­um job post­ings at End­points Ca­reers. We have a VIP sup­port team who’ll work with you to get End­points set up for the rest of your team, too.

It’s a great val­ue, and you’re sup­port­ing the most im­por­tant part of our mod­el. The pric­ing is trans­par­ent and so is our re­new­al process.

For in­di­vid­u­als, we of­fer the In­sid­er plan at $200/year. Ex­tra ben­e­fits on top of the pay­wall ac­cess in­clude dis­count­ed rates to our ma­jor glob­al events line­up.

We’re al­so start­ing a se­ries of sub­scriber-on­ly net­work­ing mix­ers for In­sid­ers. The very first one will be in Durham, NC on Thurs­day Feb­ru­ary 21 at 6pm. I’ll be there along with our VP/Part­ner­ships Mike Peck. In­sid­ers will get an email next week with signup de­tails on this one and our fu­ture slate.

Grow­ing Plans

We’re go­ing through a ma­jor plat­form over­haul this year.

The look and feel of End­points hasn’t changed since we launched in June 2016. The orig­i­nal goal of our de­sign is to de­liv­er news with­out un­nec­es­sary or­na­ments, with a user ex­pe­ri­ence that feels fa­mil­iar no mat­ter what de­vice you’re on. But we’ve pub­lished over 5,000 news ar­ti­cles and near­ly 700 dai­ly re­ports now in the End­points style, and with that ex­pe­ri­ence we’ve iden­ti­fied a num­ber of ar­eas we can im­prove on. Some of it will be in­cre­men­tal like bet­ter search and im­prov­ing the archives. Oth­ers will be more vis­i­ble and feel like brand new fea­tures.

Ad­ver­tis­ing

Sub­scrip­tions are the lifeblood of this com­pa­ny. But in or­der to de­vel­op a sus­tained im­pact be­fit­ting a ma­jor news or­ga­ni­za­tion, ar­ti­cles must be able to trav­el far and wide, eas­i­ly dis­cov­er­able by new au­di­ences. Oth­er­wise, we run the risk of be­com­ing an in­sid­ers-on­ly re­port.

That is where ad­ver­tis­ing comes in. But noth­ing we do there is tra­di­tion­al.

I don’t be­lieve in squeez­ing web pages hard for lit­tle juice. That’s es­sen­tial­ly what many news pub­lish­ers do when you see pro­mot­ed links and ads that are at best ir­rel­e­vant and at worst have fol­lowed you around the In­ter­net to sell you some­thing you searched on ear­li­er. That kind of ap­proach cheap­ens the qual­i­ty of the con­tent sur­round­ing it, in my view. It has no place on a busi­ness news web­site.

Every ad unit you see on End­points is pur­chased in-house. These are high qual­i­ty im­pres­sions that are rel­e­vant to bio­phar­ma, brought to you by ad­ver­tis­ers that have been vet­ted. Our busi­ness team is led by Mike Peck, who comes to End­points af­ter serv­ing as a VP at Forbes and the New York Times. Mar­ket­ing pros can reach him at mike@end­pointsnews.com.

Busi­ness Mod­el

Sub­scrip­tions, events, ad­ver­tis­ing — in or­der of im­por­tance, that is the End­points busi­ness mod­el. Our mis­sion is to pro­duce the best dai­ly news re­port in bio­phar­ma, writ­ten for our core read­ers, but to make it as wide­ly avail­able as pos­si­ble so it has an im­pact and is dis­cov­er­able by new read­ers.

If you need End­points, we def­i­nite­ly need you. Again the best way to sup­port us is hav­ing your com­pa­ny sub­scribe to our $1,000/year flat-rate En­ter­prise plan (signup link). In­di­vid­u­als can signup for In­sid­er here.

To all of you who’ve joined — thank you. We’re build­ing some­thing to­geth­er.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Emmanuel Hanon (Viome)

Glax­o­SmithK­line’s head of vac­cine R&D is jump­ing to a well­ness com­pa­ny con­cen­trat­ing on the mi­cro­bio­me as re­ports of an ex­o­dus start to spread

Back in the fall of 2019, GlaxoSmithKline vaccine R&D chief Emmanuel Hanon had plenty of good things to say about a wellness company called Viome and CEO Naveen Jain. He was particularly interested in Viome’s technology for analyzing the gut microbiome and how that could intersect with new vaccine research.

Today, Hanon is jumping ship to join his collaborator as R&D chief as reports circulate of an exodus at GSK’s big vaccine group.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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