Ed Tourtellotte (CTO) and David Kelleher (CEO), 4G Clinical

Gold­man Sachs backs clin­i­cal tri­al ser­vices in the cloud with $230M eq­ui­ty play amid de­cen­tral­ized study craze

The fo­cus on de­cen­tral­ized clin­i­cal tri­als dur­ing the Covid-19 pan­dem­ic has shak­en up the con­tract re­search space and spurred some mas­sive val­u­a­tions and deals along the way. Now, a com­pa­ny work­ing in cloud-based tri­al ser­vices on the cut­ting edge of the field has snared a ma­jor in­vest­ment from a lead­ing Wall Street banker.

4G Clin­i­cal, a ser­vices firm that pro­vides cloud-based ran­dom­iza­tion and clin­i­cal tri­al ser­vices, has bagged a $230 mil­lion eq­ui­ty in­vest­ment from Gold­man Sachs as it looks to add jet fu­el to its glob­al ex­pan­sion plans, the com­pa­ny said in a re­lease.

4G’s been around for six years and has so far run tri­al ser­vices for around 100 clin­i­cal stud­ies for bio­phar­ma com­pa­nies, the firm said. The com­pa­ny’s plat­form can cut the time for first pa­tient en­roll­ment by 50%, it said, and is de­signed for in­creas­ing­ly com­plex tri­al de­sign, in­clud­ing de­cen­tral­ized stud­ies.

“As life sci­ences com­pa­nies strive for cre­ativ­i­ty and in­no­va­tion in tri­al de­signs, they can­not af­ford to be lim­it­ed by tech­nol­o­gy,” said 4G CTO Ed Tourtel­lotte said in a state­ment.

Gold­man Sachs’ in­vest­ment comes amid a spike in in­ter­est in com­pa­nies and ser­vices work­ing in de­cen­tral­ized clin­i­cal tri­als, a field that has seen rapid growth amid Covid-19.

In May, vir­tu­al tri­al soft­ware com­pa­ny Sci­ence 37 went pub­lic as part of a re­verse merg­er with LifeSci Ac­qui­si­tion II Corp that val­ued the com­pa­ny at $1.05 bil­lion. Sci­ence 37 got its start back in 2014 and struck a part­ner­ship with No­var­tis four years lat­er to launch 10 vir­tu­al clin­i­cal tri­als in which pa­tients could par­tic­i­pate via cell phone. The sys­tem can cap­ture and gen­er­ate da­ta from things like elec­tron­ic clin­i­cal out­comes as­sess­ments, eCon­sent and re­al-world ev­i­dence.

Mean­while, com­pa­nies like Lon­don-based Hu­ma are us­ing wear­able tech­nol­o­gy and a pa­tient app to help re­searchers pre­screen par­tic­i­pants, con­duct re­mote vis­its via tele­health, track med­ica­tion and col­lect re­al-life da­ta. The com­pa­ny says its plat­form can dou­ble clin­i­cal ca­pac­i­ty and re­duce hos­pi­tal read­mis­sions by over a third, with pa­tient ad­her­ence lev­els of over 90%. In May, the firm un­veiled a $130 mil­lion Se­ries C with back­ing from Leaps by Bay­er.

Mean­while, the rush in­to de­cen­tral­ized tri­als has al­so spurred a wave of M&A among the ma­jor con­tract re­search out­fits. In April, Ther­mo Fish­er ac­quired PPD for $17.4 bil­lion, ex­plic­it­ly paint­ing the deal as a boost to its tri­al ser­vices wing.

Two months ear­li­er, Dublin-based Icon bagged PRA Health Sci­ences for $12 bil­lion, a merg­er that cre­at­ed the sec­ond-largest glob­al CRO be­hind on­ly IQVIA in terms of 2020 rev­enue. PRA not­ed in its an­nounce­ment the growth in de­cen­tral­ized tri­als the pan­dem­ic has fu­eled.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

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FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

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Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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