Ver­i­ly scoops up a fel­low soft­ware mak­er as Amy Aber­nethy scales its clin­i­cal tri­als plat­form

Amy Aber­nethy

Amy Aber­nethy now has a whole new set of tools to tap in­to as she scales up the clin­i­cal tri­al man­age­ment plat­form at Ver­i­ly.

The life sci­ences out­fit — now of­fi­cial­ly a sub­sidiary of Al­pha­bet on equal foot­ing with Google — has ac­quired Sig­nal­Path for an undis­closed amount, giv­ing it ac­cess to a sys­tem of dig­i­tal so­lu­tions that make it eas­i­er to run clin­i­cal tri­als, and promise to si­mul­ta­ne­ous­ly boost qual­i­ty and ef­fi­cien­cy.

“It’s our goal to mod­ern­ize the way clin­i­cal tri­als are con­duct­ed for pa­tients, re­searchers and spon­sors alike,” said Aber­nethy, who left a top lead­er­ship po­si­tion at the FDA to be­come Ver­i­ly’s pres­i­dent of clin­i­cal stud­ies plat­forms.

Ver­i­ly has built a clin­i­cal tri­al sys­tem and ev­i­dence gen­er­a­tion plat­form it calls Base­line, which of­fers da­ta ag­gre­ga­tion and an­a­lyt­ics tools, as well as da­ta col­lec­tion op­tions (think sen­sors and bio­mark­ers) de­signed with de­cen­tral­ized and hy­brid tri­als in mind. As part of that ef­fort, it’s gath­ered a com­mu­ni­ty of 500,000 peo­ple who have ex­pressed in­ter­est in join­ing clin­i­cal tri­als pro­mot­ed on Base­line.

With a sim­i­lar goal, Sig­nal­Path was found­ed in 2014 to de­vel­op and sell a cloud-based port­fo­lio to any­one who’s tasked with man­ag­ing a clin­i­cal tri­al. Al­though no dol­lar fig­ure was tied to the deal, Ver­i­ly says it marks its first ma­jor ac­qui­si­tion.

Brad Hirsch

The team will stay in Raleigh, NC even as they be­come Ver­i­ly em­ploy­ees.

Sig­nal­Path CEO Brad Hirsch said in­te­grat­ing its suite of soft­ware with­in Ver­i­ly’s busi­ness “ac­cel­er­ates our abil­i­ty to scale these so­lu­tions and make them avail­able to a larg­er group of sites as well as pro­vide en­tire­ly new op­por­tu­ni­ties to our net­work.”

The ac­qui­si­tion comes as the FDA re­cent­ly shot down an at­tempt by Ver­i­ly to add a vir­tu­al mo­tor ex­am for Parkin­son’s dis­ease with the Google smart­watch. In its re­jec­tion let­ter, the FDA said the mo­tor ex­am and Ver­i­ly’s al­go­rithm, which sought to as­sess the mo­tor symp­tom sever­i­ty in adults who have been di­ag­nosed with the de­bil­i­tat­ing dis­ease, are “lim­it­ed in their ca­pac­i­ty to eval­u­ate mean­ing­ful as­pects of con­cepts of in­ter­est that are rel­e­vant to the pa­tients’ abil­i­ty to func­tion in day-to-day life.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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