Ver­i­ly joins up with Duke, Stan­ford to en­list an army of con­sumers to put its next-gen sen­sor tech to the test — and in the pub­lic eye

Ver­i­ly Study Watch via Ver­i­ly

What can a new gen­er­a­tion of wear­able tech and biosen­sors teach us about dis­ease?

Ver­i­ly, for­mer­ly Google Life Sci­ences, is de­vel­op­ing and mar­ket­ing this tech. And it’s putting the com­pa­ny right at the cross­roads be­tween the bio­phar­ma in­dus­try and the pub­lic.

With con­sid­er­able fan­fare it’s an­nounc­ing a new pro­gram with Duke Uni­ver­si­ty and Stan­ford to re­cruit 10,000 par­tic­i­pants in a study to an­swer that ques­tion — us­ing this new tech to gath­er da­ta to pro­vide a base­line of in­for­ma­tion on healthy sub­jects and how they tran­si­tion to a dis­ease.

Each of the par­tic­i­pants will have their genome se­quenced and then tracked for at least four years, with their health da­ta col­lect­ed and stored in the Google cloud (nat­u­ral­ly).

Andy Con­rad, Ver­i­ly

So what does this mean to bio­phar­ma? Po­ten­tial­ly, quite a lot is at stake here af­ter Ver­i­ly has struck up deals with a num­ber of ma­jor phar­mas on dis­ease man­age­ment.

There’s a re­cent ven­ture formed with Sanofi — On­duo — to use mi­cro­elec­tron­ics to man­age di­a­betes, a core dis­ease fo­cus for the French phar­ma gi­ant. Glax­o­SmithK­line jumped in­to a $713 mil­lion joint ven­ture with Ver­i­ly to cre­ate new nan­otech-based bio­elec­tron­ic ther­a­peu­tics in a start­up called Gal­vani Bio­elec­tron­ics. And oth­ers have been in dis­cus­sions on how Ver­i­ly’s wear­able tech can track the course of a dis­ease like, say schiz­o­phre­nia, to help map a ther­a­peu­tic reg­i­men for pa­tients.

In this new pop­u­la­tion health project, in­ves­ti­ga­tors plan to gath­er in­for­ma­tion on bio­mark­ers linked to dis­ease de­vel­op­ment, all prime tar­gets for new drug de­vel­op­ment. And they’ll be us­ing Ver­i­ly’s new “Study Watch,” un­veiled a few days ago and re­viewed by An­to­nio Re­gal­a­do at MIT Tech­nol­o­gy Re­view, which in­cludes an elec­tro­car­dio­gram to study heart rhythms.

This new project not on­ly show­cas­es the tech­nol­o­gy Ver­i­ly is sell­ing to a world of con­sumers avid­ly in­ter­est­ed in mon­i­tor­ing their health. It can pro­vide in­sights on pa­tients in clin­i­cal tri­als and help di­rect re­searchers to new ther­a­pies in emerg­ing fields like the mi­cro­bio­me.

Ver­i­ly is do­ing this with a more prac­ti­cal ap­proach to health man­age­ment. In­stead of talk­ing about moon shots, Ver­i­ly’s chief — the col­or­ful Andy Con­rad — is fo­cused on tak­ing one care­ful step at a time to­ward a big new mar­ket.

Now it’s all about “set­ting the goal and then get­ting down to the day-to-day prac­ti­cal drudgery,” Con­rad told Bloomberg. “If you ex­am­ine the re­al moon­shot close­ly, you’ll see a dude whose job is to riv­et and a la­dy whose job is to do some wiring.”

They’re just do­ing it in a way sure to at­tract the at­ten­tion of every me­dia op­er­a­tion in the coun­try.

Ver­i­ly is al­ready deeply en­gaged with the in­dus­try on pol­li­nat­ing R&D and drug use with its tech­nol­o­gy. Now they want to get the pub­lic’s at­ten­tion. Ear­ly re­views would sug­gest that they’re off to a strong start.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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