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.”

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.