Bou­tique biotech agency guar­an­tees re­cruit­ment to drug spon­sors

KEY TAKE­AWAYS:

• Bou­tique biotech agency Clin­i­cal En­roll­ment is of­fer­ing a guar­an­tee to drug spon­sors that CE’s pa­tient en­roll­ment goals will be met
• The un­prece­dent­ed move al­so in­cludes a first-ever eq­ui­ty po­si­tion re­cruit­ment op­tion for cash-strapped drug spon­sors, en­sur­ing that spon­sors are able to re­tain much-need­ed cap­i­tal to in­crease drug de­vel­op­ment prob­a­bil­i­ties of suc­cess
• Clin­i­cal En­roll­ment’s unique re­cruit­ment ef­forts are out­per­form­ing tra­di­tion­al meth­ods by more than 200%
• They place a strong fo­cus on mak­ing di­ver­si­ty ac­tion plan­ning more straight­for­ward, re­sult­ing in more di­verse pa­tient co­horts, which are dif­fi­cult to achieve with tra­di­tion­al meth­ods

Clin­i­cal tri­als are un­pre­dictable based on the nu­mer­ous vari­ables that can’t be con­trolled, like safe­ty is­sues or drug ef­fi­ca­cy. How­ev­er, with a ground­break­ing move, a bou­tique biotech agency has re­moved one un­cer­tain vari­able by pro­vid­ing a guar­an­tee to drug spon­sors that Clin­i­cal En­roll­ment will hit their pa­tient re­cruit­ment mile­stones.

You read that right — a guar­an­tee. Full stop.

In a first-ever move of its kind, Char­lottesville-based pa­tient re­cruit­ment agency Clin­i­cal En­roll­ment, helmed by dig­i­tal mar­ket­ing vet­er­an Bryan Man­ning, has tak­en screen fail rates and un­der-en­roll­ment off the ta­ble as rea­sons why a drug ther­a­py wouldn’t make it to mar­ket. So con­fi­dent is Man­ning and his team at CE at the ef­fi­ca­cy of their care­ful­ly-honed re­cruit­ment ap­proach that they are cur­rent­ly of­fer­ing drug spon­sor clients as­sur­ances that no pay­ments will be due un­til CE hits their guar­an­teed num­ber of pa­tients.

And in a land­scape where rough­ly 1 in 4 Phase III clin­i­cal tri­als fail due to lack of fund­ing, that type of safe­ty net means spon­sors have noth­ing to lose, in­clud­ing much-need­ed cap­i­tal.

“Is it a bit of an au­da­cious move? Yes, but on­ly for us. From a spon­sor stand­point, it’s as much of a ‘sure thing’ as ex­ists in biotech,” says Man­ning. “Ul­ti­mate­ly, this in­cen­tive could be a game-chang­er for help­ing en­sure that po­ten­tial­ly life-al­ter­ing ther­a­pies get in­to the hands of pa­tients who need them, so we’re com­fort­able mak­ing these as­sur­ances.” And by “these,” he’s in­clud­ing Clin­i­cal En­roll­ment’s oth­er mav­er­ick move: be­ing the first-ever agency to of­fer eq­ui­ty po­si­tion re­cruit­ment for cash-strapped spon­sors. The nev­er-been-done-be­fore “dis­count” of sorts pro­pos­es that spon­sors can main­tain enough cap­i­tal to get their drug to mar­ket by bar­ter­ing a nom­i­nal eq­ui­ty po­si­tion which would on­ly be trig­gered up­on cer­tain mile­stones like drug ap­proval or takeover.

So, how does Clin­i­cal En­roll­ment plan on pulling off this one-two punch? For starters, the struc­ture is built in­to their busi­ness mod­el. “We’ve al­ways of­fered a 5-pa­tient ran­dom­iza­tion eval­u­a­tion pe­ri­od for clients, where we don’t get paid un­til we’ve hit that bench­mark. So this guar­an­tee is just up­ping the ante a bit more,” says Man­ning. “Al­so, clin­i­cal tri­al re­cruit­ment in­cludes a bi­na­ry met­ric for suc­cess: In­formed Con­sent forms and en­roll­ments. We don’t get paid un­til we send pa­tients — the right pa­tients — down the fun­nel, get them to the sites, and pro­vide these tri­al teams the re­sources they need to keep hum­ming.”

How can CE be so con­fi­dent they’ll find these pa­tients? Their ap­proach works. The proof is in the num­bers. Cur­rent­ly, CE is able to boast be­tween 30% and 50% of over­all pa­tient re­cruit­ment at­trib­uted to their team’s ef­forts, which out­per­forms the in­dus­try norm by more than 200%. And with the FDA’s di­ver­si­ty guid­ance emerg­ing in 2023, CE has made di­ver­si­ty ac­tion plan­ning more straight­for­ward and op­ti­mized right along with it. Their team of world-class con­tent cre­ators mar­ry their back­grounds in ecom­merce, lifestyle mar­ket­ing and dig­i­tal sto­ry­telling with their ex­per­tise in clin­i­cal tri­als, pa­tient psy­chol­o­gy, and dis­ease states to achieve a more com­pre­hen­sive overview of the re­cruit­ment land­scape.

Their metic­u­lous­ly tar­get­ed ap­proach doesn’t just en­sure that po­ten­tial pa­tients be­come aware of these tri­als, but that they con­nect with them emo­tion­al­ly and are spurred to ac­tion.

Ac­cord­ing to Man­ning, “It’s not enough to just have our clin­i­cal tri­als be seen. You need to let pa­tients feel seen in the mes­sag­ing they en­counter.”

Man­ning has knowl­edge of that nu­ance on a per­son­al lev­el, which is why his re­cruit­ment of­fer is dri­ven by a larg­er sense of pur­pose. “Any­one who knows our ori­gin sto­ry knows that, as a pa­tient my­self with a de­gen­er­a­tive reti­nal dis­ease, I un­der­stand the im­por­tance of not on­ly get­ting vis­i­bil­i­ty for these clin­i­cal tri­als, but al­so see­ing po­ten­tial­ly life-chang­ing treat­ments ac­tu­al­ly earn FDA ap­proval. Find­ing pa­tients is the first hur­dle. But the drugs need to ac­tu­al­ly make it to mar­ket, and for a lot of spon­sors, that de­ter­min­ing fac­tor is hav­ing enough par­tic­i­pants — and enough mon­ey — to get it over the fin­ish line.” For now, at least, while the Clin­i­cal En­roll­ment guar­an­tee is be­ing of­fered, it ap­pears that for drug spon­sors, the gaunt­let has been thrown.

Learn more about Clin­i­cal En­roll­ment and their re­cruit­ment prac­tices here.