Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since Jan­u­ary 2020, the clin­i­cal tri­als ecosys­tem has quick­ly evolved to man­age road­blocks im­ped­ing clin­i­cal tri­al in­tegri­ty, and pa­tient care and safe­ty amid a glob­al pan­dem­ic. Closed bor­ders, re­duced air traf­fic and de­layed or can­celed flights dis­rupt­ed glob­al dis­tri­b­u­tion, re­veal­ing how flex­i­ble lo­gis­tics and sup­ply chains can se­cure the time­ly de­liv­ery of clin­i­cal drug prod­ucts and ther­a­pies to sites and pa­tients.

Over the past sev­er­al months, the in­dus­try wit­nessed changes in clin­i­cal tri­al dis­tri­b­u­tion mod­els to in­crease the re­silien­cy of the sup­ply chain. Many clin­i­cal tri­al sup­ply chains adopt­ed di­rect-to-pa­tient (DTP) mod­els and home health care ser­vices to ad­dress trav­el re­stric­tions, vul­ner­a­ble pa­tient pop­u­la­tions and sites can­cel­ing or de­lay­ing in-per­son ap­point­ments. As pa­tient en­gage­ment in clin­i­cal tri­als con­tin­ues to evolve, 34–52 per­cent of clin­i­cal tri­al in­ves­ti­ga­tors ex­pect clin­i­cal tri­al de­cen­tral­iza­tion ap­proach­es — such as new site mod­els, on­line re­cruit­ment, home nurs­ing and DTP tri­al sup­ply — to in­crease.¹

This trend of spon­sors and in­ves­ti­ga­tors widen­ing the scope of their clin­i­cal sup­ply chain strat­e­gy — there­by mo­bi­liz­ing their abil­i­ty to piv­ot, when re­quired, to the needs of the prod­uct, pa­tient and en­vi­ron­ment — is key to quick­ly re­solv­ing po­ten­tial dis­rup­tions. To achieve re­silience in un­cer­tain times, phar­ma and biotech com­pa­nies are en­cour­aged to es­tab­lish a part­ner­ship with a clin­i­cal sup­ply chain so­lu­tions com­pa­ny that of­fers a flex­i­ble clin­i­cal tri­al dis­tri­b­u­tion strat­e­gy with DTP so­lu­tions in com­bi­na­tion with a state-of-the-art de­pot net­work. Such a part­ner­ship would al­so help com­pa­nies iden­ti­fy pos­si­ble risks along the en­tire clin­i­cal jour­ney.

A flex­i­ble dis­tri­b­u­tion net­work for an evolv­ing tri­al ecosys­tem

More specif­i­cal­ly, a part­ner with a glob­al net­work to ad­dress cur­rent chal­lenges — such as bor­der clo­sures and a re­duced num­ber of com­mer­cial flights — would have the re­sources to get pre­con­di­tioned pack­ag­ing so­lu­tions, clin­i­cal tri­al prod­ucts and equip­ment to dif­fi­cult-to-reach labs and pa­tients around the world.

Since the be­gin­ning of the pan­dem­ic, Marken has played a key role in en­abling ur­gent flow paths, in ad­di­tion to mon­i­tor­ing ship­ments and es­tab­lish­ing con­tin­gency ac­tions through­out the clin­i­cal tri­al ecosys­tem. Lever­ag­ing the strength and reach of the UPS Health­care net­work makes it pos­si­ble for Marken to de­liv­er clin­i­cal drugs via flights, de­spite halt­ed or sus­pend­ed com­mer­cial in­ter­na­tion­al air traf­fic. The strength of the Marken-UPS net­work en­sures de­pots are part of a seam­less sup­ply chain, al­low­ing for stored clin­i­cal tri­al ma­te­ri­als and drug prod­ucts to be de­liv­ered quick­ly and with less risk for in­ter­rup­tion, there­fore im­prov­ing the abil­i­ty to shift strate­gies mid-tri­al, as re­quired.

With tem­po­rary clo­sures of sites and pa­tient sched­ul­ing changes due to quar­an­tine guide­lines, many clin­i­cal tri­als re­quired piv­ot­ing to a de­cen­tral­ized ap­proach, in­clud­ing ini­ti­at­ing re­gion­al de­pot strate­gies to en­sure suf­fi­cient sup­plies and drugs are on hand when need­ed. De­cen­tral­ized dis­tri­b­u­tion, in­clud­ing DTP, widens the scope of the sup­ply chain strat­e­gy.

Pri­or to the pan­dem­ic, DTP was emerg­ing as a pa­tient-cen­tric strat­e­gy for de­liv­er­ing drugs to pa­tients, en­abling few­er site vis­its and de­creas­ing bur­dens on clin­i­cal tri­al par­tic­i­pants. Yet, ac­cord­ing to an analy­sis from No­vem­ber 2019, few­er than 40 per­cent of com­pa­nies ex­pect­ed vir­tu­al tri­als to be a ma­jor com­po­nent of their port­fo­lio.1 Now, for phar­ma com­pa­nies fac­ing the chal­lenge of dis­trib­ut­ing clin­i­cal prod­ucts to home-bound pa­tients, in­cor­po­rat­ing DTP so­lu­tions will be a ne­ces­si­ty to keep pa­tients en­rolled in tri­als and stud­ies on track.

Marken ad­vis­es phar­ma com­pa­nies to add DTP to pro­to­cols dur­ing tri­al set-up for in­creased agili­ty and im­ple­men­ta­tion when need­ed. Marken’s project man­age­ment and op­er­a­tions teams are trained in more than 80 coun­tries across EMEA, APAC, the U.S. and LATAM to not on­ly pro­vide DTP so­lu­tions, but al­so to bal­ance and lever­age re­gion­al and cen­tral dis­tri­b­u­tion strate­gies with­in Marken’s de­pot net­work or es­tab­lished cen­tral phar­ma­cies, de­pend­ing on coun­try reg­u­la­tions. As the sit­u­a­tion con­tin­ues to evolve, Marken con­tin­ues to meet chang­ing reg­u­la­to­ry frame­work, in­dus­try de­mand, and tri­al and pa­tient lev­el needs.

In­creas­ing agili­ty for fu­ture re­silience

Each clin­i­cal tri­al has its own sup­ply chain with its own chal­lenges. Whether phar­ma and biotech com­pa­nies are op­er­at­ing on a do­mes­tic or glob­al lev­el, as men­tioned pre­vi­ous­ly, re­silience in man­ag­ing the im­pact of the cur­rent cri­sis starts with a part­ner that can im­ple­ment a flex­i­ble sup­ply chain strat­e­gy. The abil­i­ty to ex­e­cute rapid de­ci­sions and im­ple­ment so­lu­tions with crit­i­cal ship­ments dur­ing a cri­sis re­quires agili­ty. Sup­ply chain agili­ty can be cen­tralised, re­gion­al or DTP, with de­pot net­works adapt­ed to sup­port mul­ti­ple so­lu­tions.

Fo­cused on mit­i­gat­ing dis­rup­tion, Marken was the first to in­vest in the com­bi­na­tion of DTP ser­vices, re­gion­al sup­plies and dis­tri­b­u­tion, as well as smart pack­ag­ing so­lu­tions to pow­er clin­i­cal tri­als through­out the COVID-19 pan­dem­ic. Marken con­tin­ues to source glob­al al­ter­na­tives, in­clud­ing the UPS net­work and lo­cal com­mer­cial car­ri­ers, in and out of im­pact­ed coun­tries to en­sure that hos­pi­tals and pa­tients re­ceive their crit­i­cal drug sup­ply with­in the nec­es­sary time and tem­per­a­ture re­quire­ments.

Com­pa­nies that act quick­ly to tack­le cur­rent chal­lenges and turn them in­to op­por­tu­ni­ties will make them­selves more ef­fi­cient and re­silient, not on­ly to to­day’s COVID-19 pan­dem­ic, but al­so to fu­ture crises and po­ten­tial threats. Marken’s flex­i­ble clin­i­cal tri­al dis­tri­b­u­tion strat­e­gy, and ad­vanced de­pot and lo­gis­tics net­work can help phar­ma­ceu­ti­cal and biotech­nol­o­gy com­pa­nies avoid clin­i­cal tri­al dis­rup­tion now and in the fu­ture.

Ref­er­ences:
  1. Xue, J, et al. (2020). Clin­i­cal tri­al re­cov­ery from COVID-19 dis­rup­tion. Na­ture Re­views Drug Dis­cov­ery 19, 662-663 doi: https://doi.org/10.1038/d41573-020-00150-9

AUTHOR

Nina Vas

Vice President, Clinical Distribution, Cell and Gene Supply Chain