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

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.