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

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Another executive is migrating from the echelons of Big Pharma to the corridors of small biotech.

In April 2018, Badrul Chowdhury took his more than two decades of experience at the FDA to AstraZeneca, where he took on the role of senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

After about a year and a half in this role, Chowdhury is moving to a small Texas biotech called Savara, where he will serve as chief medical officer.

When Amazon developed a machine-learning tool to make its recruitment process more efficient — the man-made system absorbed the gender-bias of its human makers, and the project was aborted. In the field of biopharmaceuticals, the way researchers train their machine learning algorithms can skew the outcome of predictions. But before those predictions can be made, the engine must learn to read to make sense of explosive volume of knowledge out there.

As a former academic and a seasoned drug developer, Burt Adelman knew when he was recruited as a senior advisor to Novo Ventures in 2017 that one of his key priorities needs to be introducing the fund to the network he was so deeply embedded in.

“I was thinking long and hard on how can I, as a Boston insider, help Novo really get inside the ecosystem of Boston biotech?” he recalled in an interview with Endpoints News.

Wellington Management made some uncustomary waves at the beginning of the year when it threw its considerable weight against Bristol-Myers Squibb’s $74 billion Celgene buyout. But after Bristol-Myers’ biggest investor conceded that game to the influential proxy firms involved, they’re now going to end the year by rolling out a big new investment fund for a new stable of fledgling biotechs on the private side of the industry.