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

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.

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.