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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Alex Martinez, Intrinsic Medicine CEO

They with­drew their IPO. Then, they broke off their SPAC merg­er. Now what?

If at first an IPO doesn’t succeed, try, try a SPAC. But what happens when that fails too?

Intrinsic Medicine and its blank-check partner Phoenix Biotech Acquisition Corp. called off their reverse merger Tuesday night, citing “current market conditions” as the reason it went kaput. The pair decoupled just weeks after agreeing to combine in late October as investors’ appetite for new IPOs and SPACs has been limited, at best.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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