In­sti­tu­tion­al re­search is flawed. I'm team­ing with End­points to help de­moc­ra­tize it

As some­one who con­sumes a lot of re­search, it has be­come in­creas­ing­ly clear to me that this is an in­dus­try reach­ing on­ly a frac­tion of its full po­ten­tial. The re­search mar­ket is ripe for dis­rup­tion.

Con­sid­er the fol­low­ing:

  • Sell-side re­search (Wall Street re­search) is not al­ways in­de­pen­dent and can be in­flu­enced by bank­ing re­la­tion­ships a firm has with the com­pa­nies it cov­ers.
  • Most re­search is on­ly avail­able to in­vestor clients of the spe­cif­ic bank. Many po­ten­tial con­sumers are be­ing shut out. Com­pa­nies with no bank­ing needs, foun­da­tions, and oth­er in­sti­tu­tions want ac­cess to first-rate re­search as well. Those who don’t trade stocks and gen­er­ate re­sult­ing fees need not be left out.
  • There are many in­de­pen­dent KOL’s who bring unique ex­per­tise to a spe­cif­ic re­search top­ic that would be valu­able if shared wide­ly. How­ev­er, most do not have the dis­tri­b­u­tion net­work avail­able to make it pos­si­ble.
  • The re­search busi­ness is go­ing through im­por­tant fun­da­men­tal change. A new law im­ple­ment­ed in Eu­rope re­quires that clients pay for re­search di­rect­ly rather than through trad­ing fees. This means that the con­sump­tion of re­search and the val­ue placed on it in the fu­ture will be more close­ly aligned with the qual­i­ty of con­tent (as it should be). It al­so means that by tak­ing the trad­ing desk re­la­tion­ship out of the equa­tion, the brand name of the in­sti­tu­tion be­hind it mat­ters much less…if at all. Con­tent is king.

All of this can be done a bet­ter way. That is why I want­ed to team up with an in­de­pen­dent me­dia or­ga­ni­za­tion like End­points News to cre­ate a plat­form that can de­moc­ra­tize and change the re­search busi­ness. End­points is a first-class pub­lish­er with a unique fo­cus on biotech who shares this vi­sion of chang­ing re­search for the bet­ter.


Vis­it End­points Ex­change

To­geth­er via End­points Ex­change, we will make it pos­si­ble for any­one with unique ex­per­tise to cre­ate ex­cel­lent re­search for in­sti­tu­tion­al con­sump­tion and get it in the hands of all who are will­ing to pay. For con­sumers out there, all are wel­come here…no bank­ing re­la­tion­ship re­quired. We are re­mov­ing the in­ef­fi­cien­cies and bi­as­es of the cur­rent sys­tem out of the equa­tion and de­moc­ra­tiz­ing it on both sides. This will be re­search by the biotech com­mu­ni­ty for the biotech com­mu­ni­ty.

If you are an ex­pert in a par­tic­u­lar field, please reach out to us if you would like to share your in­sights with the biotech world. We want to help max­i­mize your ex­po­sure and im­pact. How­ev­er, End­points Ex­change will have a rig­or­ous eval­u­a­tion process and ac­cep­tance pol­i­cy. We cur­rent­ly plan to make avail­able on­ly one re­port at a time be­cause our goal is to show­case on­ly the best of the best. This il­lus­trates our qual­i­ty com­mit­ment to con­sumers and will al­so ben­e­fit pub­lish­ers who make the cut by giv­ing them the strongest spot­light pos­si­ble.

And if you are one of those un­der­served con­sumers, we hope you en­joy what our ex­perts have to share. Hav­ing the high­est stan­dards and a rig­or­ous qual­i­ty fil­ter­ing process is a top pri­or­i­ty. We will be very thought­ful about what re­ports find a home here so you can be con­fi­dent that this will be a place of ex­cel­lence. Our com­mit­ment to you is that any re­port that makes End­points Ex­change will be wor­thy your valu­able at­ten­tion.

We hope you en­joy End­points Ex­change and that it will be­come a valu­able new as­set for the biotech com­mu­ni­ty. Please al­ways let us know how we can im­prove this plat­form over time to bet­ter fit your needs.

Brad Lon­car is an in­de­pen­dent biotech­nol­o­gy in­vestor and an­a­lyst. He can be reached on Twit­ter at @brad­lon­car.

AUTHOR

Brad Loncar

CEO, Loncar Investments

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.