Ralph Passarella, Reify Health CEO

A uni­corn bags an­oth­er $220M to fund its plans to up­end the clin­i­cal tri­al process

The fo­cus on de­cen­tral­ized tri­als amid the pan­dem­ic has led in­vestors to make some big bets on com­pa­nies promis­ing to shake up the con­tract re­search space. Reify Health is the lat­est, com­ing away with $220 mil­lion to end what it calls the “sit and wait” pe­ri­od dur­ing tri­al en­roll­ment.

“What we’re do­ing, and the fu­ture of clin­i­cal tri­als over­all, goes be­yond de­cen­tral­ized tri­als,” ex­ec­u­tive chair­man Michael Lin said in a state­ment. “We need to have a glob­al health­care sys­tem proac­tive­ly reach­ing out to pa­tients every­where and mo­bi­liz­ing the re­sources nec­es­sary to bring tri­als to them.”

Coat­ue Man­age­ment led the hefty Se­ries C round, bring­ing Reify’s val­u­a­tion to $2.2 bil­lion, the com­pa­ny said on Tues­day morn­ing. The mon­ey will sup­port its two en­ti­ties, StudyTeam and Care Ac­cess, which are fo­cused on op­ti­miz­ing pa­tient re­cruit­ment and run­ning de­cen­tral­ized tri­als, re­spec­tive­ly.

“If we want to con­sis­tent­ly en­roll tri­als in three to four months in­stead of 18 months, there are two key things we must achieve,” CEO Ralph Pas­sarel­la said in a state­ment. “First, we must be able to rapid­ly iden­ti­fy enough in­ter­est­ed pa­tients. Sec­ond, we have to make it fea­si­ble for those pa­tients to par­tic­i­pate in the rel­e­vant tri­al.”

In 2015, the com­pa­ny be­gan build­ing more than 60 new re­search sites and lat­er brought on mo­bile site ve­hi­cles to spread their reach. To help op­ti­mize re­cruit­ment, they launched StudyTeam, which promis­es to save study spon­sors an av­er­age of six weeks in pa­tient en­roll­ment. The tech plat­form is used by some of the big play­ers, like Am­gen, Eli Lil­ly and As­traZeneca, ac­cord­ing to Reify.

ICONIQ Growth, Adams Street Part­ners, Sier­ra Ven­tures and Bat­tery Ven­tures al­so chipped in on the round.

Reify is one of many com­pa­nies look­ing to rev­o­lu­tion­ize clin­i­cal tri­als. Just two months ago, Gold­man Sachs made a $230 mil­lion eq­ui­ty in­vest­ment in 4G Clin­i­cal, a ser­vices firm that pro­vides cloud-based ran­dom­iza­tion and clin­i­cal tri­al ser­vices. Hobo­ken, NJ-based Cas­tor raised a mod­est $45 mil­lion for its de­cen­tral­ized ap­proach last month. And in May, Leaps by Bay­er led a $200 mil­lion ven­ture round for Hu­ma Ther­a­peu­tics and its dig­i­tal “hos­pi­tal at home” tech. And those are just a few of the con­tenders in that space.

“We’ve now op­er­at­ed mas­sive and com­plex tri­als in ways that, just five years ago, would have felt like sci­ence fic­tion,” said Ah­mad Nam­var­go­lian, CEO of Care Ac­cess. “The fu­ture of clin­i­cal tri­als is here.”

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Róbert Wessman, Alvotech chairman and founder

Ice­landic bil­lionare's biosim­i­lar com­pa­ny rais­es $450M, preps for Nas­daq launch with SPAC merg­er

As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.

While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.

Gary Glick, Odyssey Therapeutics founder

Al­ways busy, Gary Glick re­cruits Or­biMed in a mas­sive $218M Se­ries A for enig­mat­ic da­ta sci­ence biotech

Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet.

Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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