Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clin­i­cal stud­ies back on track amid the pan­dem­ic, Med­able re­turned to the ven­ture well for the sec­ond time this year, bag­ging a $91 mil­lion Se­ries C to build out its vir­tu­al tri­al plat­form.

The soft­ware provider re­cent­ly launched three new apps for de­cen­tral­iz­ing clin­i­cal tri­als, and saw a 500% rev­enue spike this year. And it isn’t alone. Back in Au­gust, Sci­ence 37 se­cured a $40 mil­lion round for its vir­tu­al tri­al tech, with sup­port from No­var­tis, Sanofi Ven­tures and Am­gen. Pa­tients and re­searchers are tak­ing a lik­ing to the on­line ap­proach, sug­gest­ing reg­u­la­tors could al­low it to be­come a new nor­mal even af­ter the pan­dem­ic is over.

“The pan­dem­ic has made the world aware of the im­por­tance of clin­i­cal drug de­vel­op­ment,” Med­able CEO Michelle Long­mire said in a state­ment.

De­cen­tral­ized tri­als are sim­ply more con­ve­nient — vol­un­teers can pick up a phone to par­tic­i­pate, rather than risk­ing a vis­it to a clin­i­cal tri­al site, many of which are op­er­at­ing un­der re­stric­tions amid the pan­dem­ic.

Ac­cord­ing to a Glob­al­Da­ta poll post­ed in Sep­tem­ber, 67% of health ex­perts sur­veyed said they plan on con­duct­ing de­cen­tral­ized clin­i­cal tri­als due to Covid-19. Ac­cord­ing to Med­able, its cus­tomers are re­port­ing faster pa­tient en­roll­ment and in­creased re­ten­tion rates.

Parax­el, an­oth­er vir­tu­al tri­al play­er, said tri­als us­ing “pa­tient-cen­tric de­signs” take less time to re­cruit the first 100 pa­tients — an av­er­age of 4 months ver­sus 7 for all tri­als.

“Many da­ta sources re­port that pa­tients trav­el, on av­er­age, 30 miles to their re­search clin­ic, which adds a sig­nif­i­cant time and ef­fort bur­den, which is fur­ther am­pli­fied for frag­ile and vul­ner­a­ble pa­tients,” Med­able SVP of mar­ket­ing David Swanger said in an emailed state­ment. “As we have all be­come more com­fort­able with man­ag­ing oth­er as­pects of our lives on­line, such as bank­ing and shop­ping, then it is rea­son­able we would like to ex­tend that abil­i­ty and con­ve­nience to health­care par­tic­i­pa­tion, par­tic­u­lar­ly clin­i­cal tri­als.”

This year, the Pa­lo Al­to, CA-based com­pa­ny launched Tele­Vis­it, which con­nects pa­tients with site co­or­di­na­tors and in­ves­ti­ga­tors; Tele­Con­sent, which al­lows pa­tients to vir­tu­al­ly con­sent and re-con­sent to clin­i­cal tri­als; and Tele­COA, which com­bines elec­tron­ic Clin­i­cal Out­come As­sess­ments (eCOAs) with Tele­Vis­its. It al­so struck part­ner­ships with Data­vant, AliveCor and MRN.

“We’re ex­cit­ed to break down yet an­oth­er bar­ri­er, and stream­line the path to greater par­tic­i­pant di­ver­si­ty, ac­cess, and en­gage­ment,” Long­mire said.

Since its found­ing in 2015, Med­able has raised more than $136 mil­lion. The Se­ries C was led by Sap­phire Ven­tures, with a hand from GSR Ven­tures and Stream­lined Ven­tures — the lat­est and like­ly not the last in­vestors to bet on a vir­tu­al fu­ture for clin­i­cal tri­als.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.