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.”

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

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In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

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Illustration: Kim Ryu for Endpoints News

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Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Samantha Du, Zai Lab CEO

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Joachim Kreuzburg, Sartorious CEO

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

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