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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.