RWE chal­lenges for to­day's bio­phar­ma

The rapid de­vel­op­ment of tech­nol­o­gy — and the re­sult­ing avalanche of da­ta — are cat­a­lysts for sig­nif­i­cant change in the bio­phar­ma­ceu­ti­cal in­dus­try. This trans­lates in­to ur­gent pres­sures for to­day’s bio­phar­ma, in­clud­ing a need to quick­ly and af­ford­ably de­vel­op prod­ucts with proven ther­a­peu­tic ef­fi­ca­cy and val­ue. This ur­gency is ex­pe­dit­ed by the growth of val­ue-based con­tract­ing, where ac­cess to re­im­burse­ment and prof­it de­pends on these abil­i­ties.

Bio­phar­mas can­not stay com­pet­i­tive by spend­ing mil­lions of dol­lars and sev­er­al ex­tra months to gen­er­ate in­flex­i­ble, siloed da­ta that fails to de­liv­er im­por­tant in­sights of what is hap­pen­ing in the re­al world. In re­sponse to these chang­ing de­mands, more com­pa­nies are turn­ing to re­al-world ev­i­dence (RWE) to pro­vide en­ter­prise val­ue across both clin­i­cal and com­mer­cial use cas­es, while si­mul­ta­ne­ous­ly dri­ving in­creased time and cost ef­fi­cien­cies.

To ex­plore the state of the in­dus­try and iden­ti­fy RWE use trends, SHYFT An­a­lyt­ics, a Me­di­da­ta com­pa­ny, com­mis­sioned in-depth in­ter­views with 20 RWE de­ci­sion-mak­ers across large, mid-size, and small bio­phar­ma com­pa­nies.

Our re­search re­vealed a few key in­sights:

• All re­spon­dents be­lieve that RWE use will con­tin­ue to in­crease, and that their or­ga­ni­za­tions are poised for more growth and de­vel­op­ment in the space.
• Ex­cept for a few large firms, most com­pa­nies lack cen­tral­ized de­ci­sion-mak­ers for RWE.
• Small and mid-size bio­phar­ma re­spon­dents wor­ry about their abil­i­ty to use a ro­bust, end-to-end plat­form in an ef­fec­tive man­ner.
• Most pre­fer a “plat­form and ser­vices” mod­el and a col­lab­o­ra­tive ap­proach when work­ing with RWE con­sul­tants and ven­dors.
• Most cit­ed that RWE chal­lenges are, in large part, RWD chal­lenges, in­clud­ing process­es and best prac­tices for da­ta iden­ti­fi­ca­tion, sourc­ing, val­i­da­tion, cen­tral­iza­tion, analy­sis, and ap­pli­ca­tion.

There is a mas­sive and grow­ing sup­ply of RWD com­ing from the health­care ecosys­tem to­day. While this in­flux of po­ten­tial­ly valu­able in­for­ma­tion of­fers op­por­tu­ni­ty, it al­so presents a ma­jor chal­lenge for bio­phar­ma com­pa­nies that lack the ca­pa­bil­i­ties and re­sources to con­sis­tent­ly meet in­dus­try fit­ness as­sess­ments for RWD and sub­se­quent RWE.

While RWE is ex­pe­ri­enc­ing ex­cep­tion­al growth, com­pa­nies still face many ob­sta­cles on their path to more ef­fi­cient op­er­a­tions. Our study re­vealed that the ma­jor­i­ty of RWE chal­lenges are deeply-root­ed at an or­ga­ni­za­tion­al and struc­tur­al lev­el. Apart from a small seg­ment of large com­pa­nies, most bio­phar­mas lack the in­ter­nal knowl­edge, ex­per­tise, and re­sources to ef­fec­tive­ly lever­age RWE to im­prove busi­ness and re­search out­comes.

When asked about their or­ga­ni­za­tion’s top chal­lenges in lever­ag­ing RWE, the ma­jor­i­ty of re­spon­dents in­di­cat­ed that RWE ob­sta­cles start with RWD. These chal­lenges span the en­tire life­cy­cle of the da­ta man­age­ment process, from col­lect­ing and val­i­dat­ing trust­wor­thy da­ta, to cen­tral­iz­ing and in­te­grat­ing that da­ta in­to their or­ga­ni­za­tion, to an­a­lyz­ing and ap­ply­ing it across spe­cif­ic use cas­es. Fig­ure 1 shows the top-re­port­ed chal­lenges among all re­spon­dents.

Top-re­port­ed chal­lenges in lever­ag­ing RWE

35% of re­spon­dents cit­ed dif­fi­cul­ty ac­cess­ing qual­i­ty da­ta due to bar­ri­ers like da­ta pri­va­cy laws and the speed of da­ta ac­qui­si­tion. An­oth­er 30% re­port­ed chal­lenges in de­ter­min­ing how to use RWD to de­vel­op and im­ple­ment ev­i­dence strate­gies that meet the needs of their prod­ucts, busi­ness, or stake­hold­ers.

This dilem­ma in­cludes the se­lec­tion of the da­ta sets them­selves — 25% of re­spon­dents felt ill-equipped to choose the right da­ta from the over­whelm­ing amount avail­able.

Oth­er im­por­tant find­ings in­clude is­sues with:

• Da­ta man­age­ment and in­te­gra­tion, in­clud­ing stan­dard­iz­ing, or­ga­niz­ing, and en­sur­ing new da­ta is suc­cess­ful­ly in­te­grat­ed in­to ex­ist­ing da­ta prac­tices (20%)
• Lack of in­ter­nal knowl­edge and ex­per­tise to ro­bust­ly an­a­lyze da­ta and gen­er­ate mean­ing­ful in­sights (20 %)

The val­ue of RWE is com­ing in­to fo­cus and the po­ten­tial is great, but many chal­lenges re­main. While dif­fer­ent bio­phar­ma com­pa­nies take dif­fer­ent ap­proach­es to re­al­iz­ing the val­ue of RWE, SHYFT’s re­search re­veals a com­mon theme across to­day’s in­dus­try:

“Re­gard­less of whether they have a ro­bust in­ter­nal team or a com­plete re­liance on part­ners, bio­phar­mas are in search of a col­lab­o­ra­tive and dy­nam­ic “plat­form and ser­vices” RWE mod­el — one that pro­vides da­ta col­lec­tion, ag­gre­ga­tion, and an­a­lyt­ics ca­pa­bil­i­ties that are on­ly pro­vid­ed by an or­ga­ni­za­tion that spe­cial­izes in RWE.”

This mod­el helps to solve up­stream RWD chal­lenges such as col­lect­ing, val­i­dat­ing, man­ag­ing, and cen­tral­iz­ing da­ta, while en­sur­ing that or­ga­ni­za­tions re­ceive guid­ance in da­ta analy­sis, gen­er­a­tion of mean­ing­ful RWE, and ap­pro­pri­ate ap­pli­ca­tion and mon­i­tor­ing across use cas­es.

The mar­ket per­spec­tive re­port, The State of Re­al-World Ev­i­dence in Bio­phar­ma, con­tex­tu­al­izes the find­ings from this re­search in an ef­fort to pro­vide a snap­shot of where the in­dus­try is now, where it is head­ing, and how com­pa­nies are al­lo­cat­ing their re­sources to adapt and grow.