Seast­ead­er, drug lib­er­tar­i­an and now FDA Com­mis­sion­er? Pe­ter Thiel backs a rad­i­cal shift

Once Bloomberg broke the word that Pe­ter Thiel as­so­ciate Jim O’Neill was be­ing con­sid­ered for the top job at the FDA, re­porters start­ed to nose out the most out­ra­geous re­marks had made. And there are some doozies.

The busi­ness news ser­vice start­ed out with the most rel­e­vant: O’Neill has called for a new sys­tem that would ap­prove drugs that es­tab­lish a base­line on safe­ty, let­ting con­sumers sort out the ef­fi­ca­cy side of thing.

“We should re­form FDA so there is ap­prov­ing drugs af­ter their spon­sors have demon­strat­ed safe­ty — and let peo­ple start us­ing them, at their own risk, but not much risk of safe­ty,” O’Neill said in a speech two years ago at what was called Re­ju­ve­na­tion Biotech­nol­o­gy. “Let’s prove ef­fi­ca­cy af­ter they’ve been le­gal­ized.”

His own re­sume pro­vides some quick hits. 1. Not a doc­tor. 2. Not a sci­en­tist. And he’s on the board of the Seast­eading In­sti­tute, which hopes to set up float­ing towns free of gov­ern­ment in­ep­ti­tude.

The Yale grad got his ca­reer start­ed as a speech­writer at Health & Hu­man Ser­vices and was prin­ci­pal as­so­ciate deputy sec­re­tary un­der the George W. Bush ad­min­is­tra­tion.

STAT not­ed sources who say that it’s Thiel — the bil­lion­aire Face­book backer who broke with Sil­i­con Val­ley in sup­port­ing the pres­i­dent-elect — who’s pro­mot­ing the lib­er­tar­i­an for the top job at the FDA. O’Neill has worked at Thiel Cap­i­tal, helmed the Thiel Foun­da­tion and now runs Thiel-backed Mithril Cap­i­tal, which in­vest­ed in med tech — Au­ris Sur­gi­cal was a re­cent in­vest­ment — that the FDA reg­u­lates.

Among his many in­volve­ments in the R&D field, O’Neill is on the board at SENS Re­search Foun­da­tion, which is fo­cused on ag­ing R&D. And his 2014 speech in­clud­ed a claim that on­go­ing re­search would make it pos­si­ble to achieve hu­man im­mor­tal­i­ty in 40 years, ac­cord­ing to Bio­Cen­tu­ry. His bio at SENS in­cludes a note that he was on the steer­ing com­mit­tee at BAR­DA.

But now that word is out about his pos­si­ble se­lec­tion, his dig­i­tal re­sume is start­ing to dis­ap­pear. STAT notes that a speech has gone miss­ing overnight.

You can still hear him talk about seast­eading here.

He’s no shoe in. Scott Got­tlieb has long been con­sid­ered a kind of Re­pub­li­can shad­ow com­mis­sion­er for the FDA, and re­mains one of the most fre­quent­ly cit­ed can­di­dates for the post.

Since the elec­tion Trump has made two points re­lat­ed to biotech­nol­o­gy. He wants drug ap­provals to come faster and he wants drug prices to come down. There hasn’t been a word yet about how he plans to ac­com­plish the low­er drug prices, but the 21st Cen­tu­ry Cures Act pas­sage yes­ter­day gives him some ear­ly boasts to tout.

We’ll find out soon if his ideas about rad­i­cal change in gov­ern­ment ex­tend to the top job at the FDA.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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