Parex­el em­braces re­al world ev­i­dence, en­list­ing Data­vant to drill it in­to CRO work­flow

With the emer­gence of re­al-world ev­i­dence as a promis­ing way to cap­ture da­ta points out­side of clin­i­cal tri­als and speed up drug de­vel­op­ment, con­tract re­search or­ga­ni­za­tions — the stal­warts of tra­di­tion­al tri­al ex­e­cu­tion — are of­ten lead­ing the charge in adopt­ing new tech­nol­o­gy. Parex­el, a lead­ing play­er in the field, is step­ping up that com­mit­ment through a deal with Data­vant.

Jamie Mac­don­ald

Spawned by Vivek Ra­maswamy’s start­up fac­to­ry Roivant and led by Travis May, Data­vant has po­si­tioned it­self as a key ag­gre­ga­tor link­ing up the dis­parate datasets that ex­ist in health­care, of­ten in si­los. In the new part­ner­ship, its soft­ware will be in­te­grat­ed in­to Parex­el’s work­flow such that all the da­ta from their stud­ies will be con­nect­ed to re­al-world da­ta such as elec­tron­ic health records, claims and di­ag­nos­tics, as well as in­for­ma­tion re­lat­ing to ge­nomics, wear­able de­vices, so­cioe­co­nom­ic and be­hav­ioral da­ta and oth­ers.

All the da­ta gen­er­at­ed in the process are al­so quick­ly de-iden­ti­fied — one of Data­vant’s key pitch­es amid in­creas­ing con­cerns about pa­tient pri­va­cy.

“(O)ne of the most sig­nif­i­cant bar­ri­ers to gen­er­at­ing re­al-world ev­i­dence is over­com­ing lim­i­ta­tions of sin­gle da­ta sources,” Parex­el CEO Jamie Mac­don­ald said in a state­ment. “Part­ner­ing with Data­vant has pro­vid­ed Parex­el the abil­i­ty to link dis­parate da­ta sets to dri­ve the com­plex analy­ses nec­es­sary for pro­vid­ing in­no­v­a­tive sci­en­tif­ic and clin­i­cal da­ta strate­gies.”

Travis May

Mac­don­ald be­gan work­ing with Data­vant last Sep­tem­ber, a few months af­ter he took the helm. Af­ter ham­mer­ing out how best to in­cor­po­rate Data­vant’s tech in­to Parex­el’s way of de­sign­ing and con­duct­ing tri­als, the duo has agreed to for­mal­ly ex­pand the re­la­tion­ship in­to a mul­ti-year strate­gic pact.

The use of re­al-world ev­i­dence has gained steam as bio­phar­ma com­pa­nies look to trim the cost of clin­i­cal de­vel­op­ment and ad­vo­cate for a sort of pa­tient-cen­tric nar­ra­tive in which their day-to-day ex­pe­ri­ence with ther­a­pies can be tak­en in­to reg­u­la­to­ry ac­count. The FDA kick-start­ed its own pi­lot projects to eval­u­ate whether RWE can help pre­dict the re­sults of clin­i­cal tri­als that have yet to wrap up. The dis­cus­sion is still lim­it­ed to drugs al­ready on the mar­ket — for which de­vel­op­ers might be seek­ing la­bel changes — and ques­tions about da­ta qual­i­ty stan­dards re­main, but the mo­men­tum is there to cre­ate new ways to build a fran­chise treat­ment.

So­cial im­age: Jamie Mac­don­ald, Travis May

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Noubar Afeyan (Sebastien Micke/Paris Match/Contour by Getty Images)

As Mod­er­na rose, Flag­ship cashed in for $1.4B — with a lot more wealth still re­main­ing

For nearly a decade, Flagship poured record-setting levels of cash into Moderna, even as they faced setbacks on early programs and skeptics wondered whether the company’s science could ever match its hype.

Now that the science has delivered, Flagship is cashing in.

Over the last 13 months, since the World Health Organization declared a pandemic, Flagship has sold off Moderna shares worth $1.4 billion. The sales, first reported by Forbes, came as the Cambridge biotech’s shares soared from just under $20 per share on Jan. 3, 2020, to $169.50 when markets opened Thursday.

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Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

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Paul Wotton, Obsidian CEO

Ver­tex adds a new gene edit­ing part­ner, pay­ing Ob­sid­i­an $75M for con­trol­lable CRISPR sys­tem

When Paul Wotton became CEO of Obsidian Therapeutics two years ago, he asked his team to explore where they could apply the company’s technology beyond cancer.

Launched by Michael Gilman in 2017, the GV-backed company had been working on a way of controlling cell therapies after they’re administered to a patient, allowing doctors to modulate the potency of CAR-T and other drugs as you might volume on a television set. Wotton wanted to them look beyond cancer, into areas such as gene editing.