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19 May, 2025
What impact has Trump 2.0 had on biotech? And what comes next?
Biopharma’s elite are weighing in on Trump’s FDA overhaul and tariff impacts in our latest Endpoints 100 survey. Get the unfiltered analysis as John Carroll and industry leaders dissect what’s keeping executives up at night — and where they’re placing their bets despite the turbulence. Sign up today.
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Does your sup­ply chain hold up un­der pres­sure for high-risk tem­per­a­ture-crit­i­cal ship­ments?
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Jaimy Lee
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We’re getting ready to reveal the results of the latest Endpoints 100 survey, which largely focuses on the impact of the second Trump administration on biotech. Look out for John Carroll’s coverage and join us on Tuesday, May 20, at noon ET for a virtual discussion.

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Jaimy Lee
Deputy Editor, Endpoints News
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Does your sup­ply chain hold up un­der pres­sure for high-risk tem­per­a­ture-crit­i­cal ship­ments?
by Marken
5 Per­for­mance pil­lars that sep­a­rate strate­gic part­ners from stan­dard providers

In an era de­fined by geopo­lit­i­cal un­cer­tain­ty, cli­mate dis­rup­tion, and the re­lent­less pace of phar­ma­ceu­ti­cal in­no­va­tion, the mar­gin for er­ror in drug stor­age and dis­tri­b­u­tion has nev­er been nar­row­er. Imag­ine a life-sav­ing vac­cine, metic­u­lous­ly craft­ed and rig­or­ous­ly test­ed, ren­dered in­ef­fec­tive by a fleet­ing tem­per­a­ture ex­cur­sion dur­ing tran­sit - or a vi­tal gene ther­a­py strand­ed by a sud­den bor­der clo­sure. These are no longer hy­po­thet­i­cal risks but dai­ly re­al­i­ties for the glob­al phar­ma­ceu­ti­cal sup­ply chain.

The stakes are high: the bio­phar­ma in­dus­try los­es an es­ti­mat­ed $35 bil­lion an­nu­al­ly to tem­per­a­ture-con­trol fail­ures, with at least 20% of tem­per­a­ture-sen­si­tive prod­ucts sus­tain­ing dam­age in tran­sit. As the de­mand for ad­vanced bi­o­log­ics, per­son­al­ized ther­a­pies and di­rect-to-pa­tient mod­els ac­cel­er­ates, the ques­tion is not if your sup­ply chain will be test­ed, but when.

Pre­ci­sion lo­gis­tics, stor­age & dis­tri­b­u­tion providers are no longer just ven­dors — they are crit­i­cal part­ners in en­sur­ing pa­tient safe­ty, prod­uct in­tegri­ty and reg­u­la­to­ry com­pli­ance.

Here are five key ar­eas that sep­a­rate sup­ply chain ex­perts from every­one else:

1. Chain of cus­tody & tem­per­a­ture in­tegri­ty

Tem­per­a­ture con­trol is the foun­da­tion of phar­ma­ceu­ti­cal lo­gis­tics, par­tic­u­lar­ly for high-val­ue, tem­per­a­ture-sen­si­tive prod­ucts such as vac­cines, bi­o­log­ics, and cell and gene ther­a­pies. These prod­ucts de­mand rig­or­ous­ly con­trolled con­di­tions at every stage, from man­u­fac­tur­ing through last-mile de­liv­ery. Lead­ing providers de­ploy val­i­dat­ed mon­i­tor­ing that of­fer re­al-time vis­i­bil­i­ty in­to each ship­ment’s tem­per­a­ture, lo­ca­tion and se­cu­ri­ty sta­tus.

At Marken, we de­ploy a full suite of pre­ci­sion mon­i­tor­ing tools, in­clud­ing val­i­dat­ed da­ta log­gers, IoT sen­sors, GPS track­ing, blockchain tech­nol­o­gy and in­te­grat­ed dig­i­tal plat­forms to en­sure con­tin­u­ous over­sight of tem­per­a­ture, hu­mid­i­ty, light, shock and vi­bra­tion. As re­al-time vis­i­bil­i­ty be­comes an in­dus­try stan­dard, this lev­el of pre­cise over­sight en­ables proac­tive in­ter­ven­tion, ver­i­fies prod­uct au­then­tic­i­ty, de­liv­ers live da­ta-dri­ven in­sights and pro­tects against tem­per­a­ture ex­cur­sion, di­ver­sion or fraud. This shift to­ward prod­uct lev­el vis­i­bil­i­ty comes at a crit­i­cal time, as ad­vanced ther­a­pies, such as cell and gene treat­ments and ra­dio­phar­ma­ceu­ti­cals, move rapid­ly in­to main­stream adop­tion.

Com­bined with ad­vanced pack­ag­ing so­lu­tions, lane map­ping and ver­i­fi­ca­tion, risk man­age­ment and equip­ment val­i­da­tion, we de­liv­er both pas­sive and ac­tive pro­tec­tion un­der even the most chal­leng­ing con­di­tions — main­tain­ing an un­in­ter­rupt­ed, au­ditable chain of cus­tody from ori­gin to des­ti­na­tion.

2. Sus­tain­able stor­age and dis­tri­b­u­tion in­fra­struc­ture

Pre­ci­sion lo­gis­tics must be both glob­al, in­te­grat­ed and con­sis­tent. Frag­ment­ed ven­dor net­works in­tro­duce in­con­sis­ten­cy, in­crease lead times, and el­e­vate risk — ul­ti­mate­ly threat­en­ing pa­tient out­comes. Strate­gic part­ners elim­i­nate these vul­ner­a­bil­i­ties by of­fer­ing an en­ter­prise-wide in­fra­struc­ture that uni­fies drug sup­ply, stor­age, dis­tri­b­u­tion, and pa­tient ac­cess un­der one har­mo­nized net­work.

Marken’s ex­ten­sive glob­al net­work has syn­chro­nized SOPs, re­dun­dant con­di­tion­ing ca­pac­i­ty and ded­i­cat­ed teams man­ag­ing both com­mer­cial and clin­i­cal sup­ply. Whether it's stor­ing in­ves­ti­ga­tion­al prod­ucts, over­see­ing de­pot-to-site dis­tri­b­u­tion, or ex­e­cut­ing di­rect-to-pa­tient de­liv­er­ies, Marken en­sures op­er­a­tional con­sis­ten­cy and mea­sur­able per­for­mance at every step.

No longer a val­ue-add, but now an ex­pec­ta­tion, sus­tain­abil­i­ty is emerg­ing as a com­pet­i­tive dif­fer­en­tia­tor. Marken in­te­grates eco-friend­ly pack­ag­ing, biodegrad­able ma­te­ri­als, and en­er­gy-ef­fi­cient trans­porta­tion and stor­age in­to its lo­gis­tics so­lu­tions, low­er­ing our en­vi­ron­men­tal im­pact and sup­port­ing clients meet en­vi­ron­men­tal goals, with­out sac­ri­fic­ing per­for­mance.

3. Reg­u­la­to­ry ex­per­tise & qual­i­ty as­sur­ance

Through­out the sup­ply chain, com­pli­ance isn’t op­tion­al, it’s es­sen­tial. A trust­ed pre­ci­sion lo­gis­tics part­ner must op­er­ate with­in the high­est stan­dards of Good Man­u­fac­tur­ing Prac­tices (GMP) and Good Dis­tri­b­u­tion Prac­tices (GDP) stan­dards to en­sure qual­i­ty, safe­ty and full reg­u­la­to­ry align­ment at every step. This isn’t just about meet­ing re­quire­ments; it’s about build­ing trust with man­u­fac­tur­ers, reg­u­la­tors and pa­tients alike.

As drug modal­i­ties be­come more com­plex and reg­u­la­tions in­ten­si­fy across glob­al mar­kets, ex­pe­ri­enced part­ners bring the reg­u­la­to­ry in­sight and op­er­a­tional ex­per­tise need­ed to nav­i­gate an evolv­ing, mul­ti-ju­ris­dic­tion­al land­scape. En­sur­ing drug in­tegri­ty de­mands not on­ly rig­or­ous en­vi­ron­men­tal con­trols but a shared ded­i­ca­tion to the same high stan­dards as the man­u­fac­tur­ers them­selves.

Marken’s glob­al op­er­a­tions are built on har­mo­nized qual­i­ty sys­tems, and our reg­u­la­to­ry and trade com­pli­ance teams work proac­tive­ly with spon­sors to align with lo­cal and in­ter­na­tion­al au­thor­i­ties. This com­mit­ment en­sures seam­less de­liv­ery, mit­i­gates risk, and pro­tects both time­lines and pa­tient out­comes.

4. Op­er­a­tional re­silience un­der pres­sure

Over the past five years, the glob­al sup­ply chain has en­dured a re­lent­less se­ries of stress tests - from pan­demics and cli­mate dis­as­ters to la­bor short­ages and geopo­lit­i­cal up­heaval. Now, in 2025, the land­scape grows even more com­plex as shift­ing US pol­i­cy up­ends sup­ply chains and hints at the po­ten­tial for a glob­al eco­nom­ic down­turn. These mount­ing in­ter­na­tion­al ten­sions are once again chal­leng­ing the phar­ma­ceu­ti­cal sec­tor’s abil­i­ty to de­liv­er ther­a­pies con­sis­tent­ly and com­pli­ant­ly across bor­ders, de­mand­ing un­prece­dent­ed re­silience and adapt­abil­i­ty from every sup­ply chain stake­hold­er

In this en­vi­ron­ment, trust­ed part­ners stand apart by their abil­i­ty to an­tic­i­pate dis­rup­tion, adapt in re­al time, and main­tain con­ti­nu­ity. Whether rerout­ing ship­ments around bor­der clo­sures or ac­ti­vat­ing con­tin­gency pro­to­cols dur­ing a cri­sis, re­silience is not just about re­sponse, it’s about readi­ness. Pre­ci­sion lo­gis­tics providers have de­signed in­fra­struc­ture and pro­to­cols specif­i­cal­ly to with­stand volatil­i­ty, pow­ered by pre­dic­tive an­a­lyt­ics, AI-dri­ven route op­ti­miza­tion and decades of ex­pe­ri­ence man­ag­ing en­vi­ron­men­tal, po­lit­i­cal and op­er­a­tional chal­lenges.

5. Tech­no­log­i­cal in­no­va­tion & au­toma­tion

The fu­ture of bio­phar­ma lo­gis­tics is dig­i­tal and al­ready trans­form­ing the way crit­i­cal treat­ments move across the globe. From ware­house ro­bot­ics to AI-dri­ven fore­cast­ing, ma­chine learn­ing and route op­ti­miza­tion, tech­nol­o­gy is ac­cel­er­at­ing speed, ac­cu­ra­cy and con­trol across the sup­ply chain. Au­toma­tion, in­clud­ing ad­vanced stor­age and re­trieval sys­tems, stream­lines op­er­a­tions, re­duces the risk of hu­man er­ror and im­proves over­all ef­fi­cien­cy. In par­al­lel, ma­chine learn­ing and pre­dic­tive analy­sis en­able smarter, proac­tive de­ci­sion-mak­ing and en­hanced agili­ty – ca­pa­bil­i­ties that are mis­sion-crit­i­cal as ther­a­pies be­come more com­plex and per­son­al­ized.

This dig­i­tal in­fra­struc­ture helps pre­vent the in­fil­tra­tion of fake prod­ucts - an in­creas­ing threat un­der­scored by re­cent FDA warn­ings. Every Marken ship­ment is dig­i­tal­ly guard­ed, tracked, and pro­tect­ed, en­sur­ing coun­ter­feit prod­ucts do not in­fil­trate le­git­i­mate sup­ply chain chan­nels.

Nav­i­gat­ing the dis­tri­b­u­tion maze: From ori­gin to des­ti­na­tion

Every touch­point in the phar­ma­ceu­ti­cal jour­ney, from raw ma­te­r­i­al stor­age to last-mile de­liv­ery, de­mands metic­u­lous at­ten­tion and pre­ci­sion. Ef­fi­cient in­ven­to­ry man­age­ment, strict ad­her­ence to “First In, First Out” prin­ci­ples and val­i­dat­ed trans­porta­tion process­es en­sure that med­i­cines reach pa­tients safe­ly, time and with full com­pli­ance.

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Sam Sternberg (L) and David Liu
1
by Ryan Cross, Lei Lei Wu

Re­searchers have de­