Matt Roe (Verana)

Fresh off $100M round, GV-backed re­al-world da­ta start­up woos Duke re­searcher as CMO

Days ago Ve­r­ana Health closed $100 mil­lion to ex­pand its re­al-world da­ta sys­tem and get ready for “reg­u­la­to­ry-grade.” What’s left un­said was that they’ve al­so found the guy to help them do it.

The San Fran­cis­co start­up has re­cruit­ed Matt Roe from Duke Uni­ver­si­ty to be its chief med­ical of­fi­cer, over­see­ing the it­er­a­tive process of gen­er­at­ing clin­i­cal da­ta and de­riv­ing sci­en­tif­ic in­sight from prospec­tive re­search. His job is al­so to work with oth­er stake­hold­ers such as aca­d­e­m­ic cen­ters and the FDA to map out more use cas­es for re­al-world da­ta.

By part­ner­ing with pro­fes­sion­al so­ci­eties to build out their reg­istries, Ve­r­ana of­fers a cen­tral­ly cu­rat­ed da­ta source that can aid physi­cians in treat­ing pa­tients, whether through show­ing them in­sights or con­nect­ing them with clin­i­cal tri­al in­for­ma­tion, Roe said.

“That’s some­thing that I didn’t re­al­ly have as a clin­i­cian when I was in prac­tice for 20 years,” Roe, a car­di­ol­o­gist by train­ing, told End­points News.

But for the past six years he’s delved in­to elec­tron­ic health records, work­ing with the na­tion­al ini­tia­tive known as PCOR­net to co­or­di­nate a tri­al test­ing dif­fer­ent dos­es of as­pirin for pa­tients with chron­ic car­dio­vas­cu­lar dis­ease. Dubbed ADAPT­ABLE, the tri­al was hailed by for­mer FDA com­mis­sion­er Robert Califf as “a mod­el of ev­i­dence gen­er­a­tion to an­swer crit­i­cal, prag­mat­ic ques­tions quick­ly.”

The ex­pe­ri­ence opened Roe’s eyes to the dif­fer­ent EHR sys­tems be­ing de­ployed at clin­i­cal sites across the coun­try. It al­so showed him the the im­por­tance of unit­ing the in­for­mat­ics ex­perts who de­sign the da­ta net­works and clin­i­cal tri­al in­ves­ti­ga­tors who re­cruit­ed pa­tients.

That kind of co­or­di­na­tion will be crit­i­cal as he works with the FDA on the kind of da­ta in­fra­struc­ture that’s “dy­nam­ic and evolves over time” but still in­forms reg­u­la­tor de­ci­sions.

“The con­cerns that most peo­ple have about EHR da­ta, which I be­lieve are the foun­da­tion for the re­al world da­ta sources, are re­lat­ed to the da­ta qual­i­ty and suit­abil­i­ty for re­search pur­pos­es. So when we look at that, the three ma­jor do­mains are the com­plete­ness of the da­ta, the ac­cu­ra­cy and then the trace­abil­i­ty of the da­ta,” he said. “And so I think where EHR da­ta are go­ing is hav­ing the right or the most mod­ern tech­niques to cu­rate and trace the EHR da­ta back to the source, and un­der­stand the qual­i­ty and things we could do to im­prove the qual­i­ty.”

Mov­ing for­ward, he al­so wants to lay the ground­work for link­ing EHR da­ta with those from oth­er sources such as claims, dig­i­tal health ap­pli­ca­tions and pa­tient-re­port­ed out­comes. And the goal is less to re­place ran­dom­ized, con­trolled stud­ies but to take ad­van­tage of what’s new­ly pos­si­ble.

“We should all work to change the tone of the con­ver­sa­tion and say we’re not just talk­ing about do­ing non-ran­dom­ized stud­ies,” he said. “We’re talk­ing about do­ing a whole spec­trum of re­search in a new and dif­fer­ent way.”

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

No­var­tis los­es biosim­i­lar ap­peal as court up­holds a 31-year mo­nop­oly by Am­gen's En­brel

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.