Jo Varshney, VeriSIM Life CEO

Biosim­u­la­tion out­fit nets $15M Se­ries A in push to make pre­clin­i­cal R&D more pre­dictable

VeriSIM Life has been work­ing on cre­at­ing a biosim­u­la­tion plat­form since its found­ing in 2017 — and af­ter more than four years and a pre-seed and seed round, the Cal­i­for­nia soft­ware firm now has a Se­ries A un­der its belt.

The $15 mil­lion round, led by Mor­pheus Ven­tures and sup­port­ed by new in­vestors De­bio­pharm In­no­va­tion Fund and Col­or­con Ven­tures, in­cludes ex­ist­ing in­vestors OCA Ven­tures, In­tel Cap­i­tal, Ser­ra Ven­tures and Susa Ven­tures. The round will fund VeriSIM Life for the next 2 to 2½ years.

The R&D com­pa­ny, found­ed and led by first-time CEO Jo Varsh­ney and lo­cat­ed in San Fran­cis­co, has about 15 full-time em­ploy­ees, Varsh­ney told End­points News. With the Se­ries A, Varsh­ney said, the com­pa­ny can dou­ble its em­ploy­ees over the next 18 months and in­crease its in­fra­struc­ture, ex­pand­ing cur­rent part­ner­ships and po­ten­tial­ly open­ing the door to new ones.

The firm’s plat­form, called BIOiSIM, tries to com­bine AI and ma­chine learn­ing to more ac­cu­rate­ly pre­dict which drug can­di­dates are most like­ly to suc­ceed in an­i­mals and ul­ti­mate­ly hu­mans.

Varsh­ney — orig­i­nal­ly a vet­eri­nar­i­an by train­ing be­fore get­ting her PhD in com­par­a­tive on­col­o­gy and ge­nomics — said that close to 90% of drugs that pass an­i­mal test­ing do not pass test­ing in clin­i­cal tri­als in hu­mans. And in her mind, that num­ber can be changed.

“And we want to re­duce that num­ber. Even 20 to 30% in­creas­es and im­proves the chances of bet­ter R&D de­ci­sions, as well as bet­ter clin­i­cal pa­tient en­roll­ment pro­to­cols,” Varsh­ney said.

What makes VeriSIM’s plat­form unique, ac­cord­ing to Varsh­ney, is that its plat­form in­te­grates ma­chine learn­ing and deep learn­ing meth­ods in physics-based mod­el­ing, which she says al­lows VeriSIM Life to sim­u­late and more ac­cu­rate­ly pre­dict po­ten­tial clin­i­cal out­comes. That plays in­to trans­lata­bil­i­ty and in her words, “de-risk­ing R&D.”

“So for ex­am­ple, we want to de-risk the ef­fi­ca­cy end­points, we want to de-risk what the best route of ad­min­is­tra­tion would look like, what the dos­ing could look like,” Varsh­ney said. “And we’ve in­cor­po­rat­ed all that in a uni­fied or cen­tral­ized ar­chi­tec­ture that en­ables a cen­tral­ized learn­ing of our sys­tem to print to have bet­ter ac­cu­ra­cy pre­dic­tions, but al­so over­all learn­ing about a sys­tem.”

Be­yond VeriSIM Life, it has a sub­sidiary: Pul­moSIM Ther­a­peu­tics, which from Varsh­ney’s view, is val­i­da­tion of VeriSIM Life’s plat­form. So far, the biotech has two can­di­dates in its pipeline: one is for pul­monary ar­te­r­i­al hy­per­ten­sion, which al­ready has or­phan drug des­ig­na­tion, and the sec­ond is for id­io­path­ic pul­monary fi­bro­sis.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.