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This Founder Could­n't Find His Own Clin­i­cal Tri­al. Now He's En­rolling Hun­dreds of Pa­tients for Phar­ma's Biggest Names
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top stories
1. Lilly to buy Kelonia for $3.25B upfront, underlining its in vivo CAR-T strategy
2. Gilead declines another Arcus option after Phase 3 TIGIT fail
3.
news briefing
Merck partner reveals bispecific data; Biogen pays $100M for antibody rights
4. UCB plots epilepsy expansion with $650M Neurona cell therapy acquisition
5. KRAS drugmakers take another, better swing at lung cancer
6. Updated: Novo Nordisk’s sickle cell therapy hits in Phase 3, but data lag expectations
7. Odyssey Therapeutics will try again to IPO, this time in a warmer market
8. Nektar’s long-term mid-stage alopecia data fuel Phase 3 plans
more stories
 
Karen Weintraub
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On choosing the target for the first-ever gene therapy, now a Breakthrough Prize winning discovery: “It chose us; we didn’t choose it.” Ryan Cross has a fascinating Q&A here with the winners about how they got Luxturna over the finish line and what’s next for them and for gene therapy.

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Karen Weintraub
Deputy Editor, Endpoints News
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This Founder Could­n't Find His Own Clin­i­cal Tri­al. Now He's En­rolling Hun­dreds of Pa­tients for Phar­ma's Biggest Names
by Bryan Manning

Bryan Man­ning built Clin­i­cal En­roll­ment af­ter a late-phase tri­al for his rare dis­ease failed to find him. Now his firm is de­liv­er­ing what al­go­rithms alone can't: pa­tients who ac­tu­al­ly show up.

I found out the tri­al had failed from a newslet­ter.

I was sit­ting at my desk at Two Blind Broth­ers, the cause-dri­ven ap­par­el com­pa­ny I'd co-found­ed, scrolling through a reti­nal dis­ease re­search roundup when I saw the head­line. A late-phase in­her­it­ed reti­nal dis­ease study had col­lapsed. Not be­cause the sci­ence failed. Be­cause en­roll­ment did.

One of the clin­i­cal sites was on the West Side High­way. I'd dri­ven past it three times while the tri­al was ac­tive­ly re­cruit­ing. It was half a mile from my reti­na spe­cial­ist's of­fice.

I was fu­ri­ous. How does a tri­al that costs hun­dreds of mil­lions of dol­lars — that could have treat­ed my Star­gardt's dis­ease — not find me?

The more I re­searched, the more I re­al­ized my sto­ry was­n't an out­lier. Too many pa­tients are be­ing side­lined from life-al­ter­ing re­search be­cause the sys­tem is bro­ken. I built Clin­i­cal En­roll­ment to fix it.

The prob­lem has­n't got­ten bet­ter. It's got­ten worse.

When we start­ed Clin­i­cal En­roll­ment in 2022, about 80% of clin­i­cal tri­als were miss­ing en­roll­ment mile­stones by at least six months. To­day that num­ber has­n't budged, even with more tools, more tech, and more au­toma­tion.

The rea­son is sim­ple: while tools can ac­cel­er­ate re­fer­rals, it's hu­man con­nec­tion that ac­tu­al­ly dri­ves en­roll­ment.

And yet the in­dus­try keeps bet­ting on tech­nol­o­gy like it's the sil­ver bul­let. Voice agents. Al­go­rith­mic out­reach. Pre­dic­tive mod­el­ing. All of it use­ful, but none of it enough.

I knew this from day one be­cause I'd al­ready built one of the fastest-grow­ing cause-dri­ven e-com­merce com­pa­nies in the coun­try. Two Blind Broth­ers had do­nat­ed over $2.5 mil­lion to reti­nal re­search, land­ed on Forbes 30 Un­der 30, and been fea­tured on Ellen. My team un­der­stood so­cial ad­ver­tis­ing bet­ter than any­one. We knew how to move peo­ple on­line.

But more im­por­tant­ly, I knew what it felt like to be on the oth­er side — to be the pa­tient the sys­tem could­n't find.

Pa­tient-first is in our DNA, and it's why we de­signed Clin­i­cal En­roll­men­t's mod­el to break every in­dus­try stan­dard.

We on­ly get paid when we prove we can de­liv­er.

As a pa­tient, I know what it feels like to be treat­ed like a num­ber in a data­base. As a busi­ness own­er, I be­lieve that if you promise to do some­thing, you should on­ly get paid when you de­liv­er.

That's why Clin­i­cal En­roll­ment op­er­ates on suc­cess-based pric­ing. We on­ly get paid on qual­i­fied re­fer­rals and pa­tients who end up sign­ing ICFs and en­rolling. And we de­fer pay­ment un­til we've proven we can de­liv­er.

It's high­ly mo­ti­vat­ing, and it forces us to do what most firms won't: treat pa­tients like hu­man be­ings in­stead of con­ver­sion met­rics.

Since launch, we've ex­pand­ed in­to 17 ther­a­peu­tic ar­eas in­clud­ing on­col­o­gy, neu­rol­o­gy, oph­thal­mol­o­gy, chron­ic kid­ney dis­ease, COPD, der­ma­tol­ogy, rare dis­eases, and more. We're work­ing with five of the top 10 glob­al phar­ma com­pa­nies. We're av­er­ag­ing 34% of to­tal en­roll­ment on the tri­als we sup­port.

And we're do­ing it with a mod­el that mar­ries tech­nol­o­gy and hu­man­i­ty in a way most firms still don't un­der­stand.

Work with Clin­i­cal En­roll­ment

Speed mat­ters. But trust mat­ters more.

Here's where every­one else is get­ting it wrong. They're build­ing re­cruit­ment en­gines that op­ti­mize for speed and scale. We op­ti­mize for trust.

Yes, we use tech­nol­o­gy. We use it to un­der­stand pa­tient sen­ti­ment, an­a­lyze pro­to­cols, and launch tri­als with­in 48 hours. We use voice screen­ing to call can­di­dates with­in 90 sec­onds of ex­press­ing in­ter­est be­cause in­ter­est is fleet­ing, and min­utes mat­ter.

But au­toma­tion fails at the em­pa­thy lay­er.

It can't an­swer the ques­tion a pa­tient texts at 3 p.m. the day be­fore their site vis­it: "Is there some­where I can drop off my kids dur­ing the ap­point­ment?"

It can't send a mes­sage the night be­fore that says, "Hey, just check­ing in. Your ap­point­men­t's to­mor­row. Let me know if you need any­thing."

It can't build the kind of trust that makes a pa­tient ac­tu­al­ly show up.

En­ter Moth­er Goose.

The team that makes pa­tients feel like peo­ple, not pro­to­col sub­jects.

Af­ter a can­di­date pass­es our on­line screen­ing and phone pre-screen, they're hand­ed off to our Pa­tient Concierge team (which I lov­ing­ly re­fer to as our Moth­er Goose team), a group of sup­port ad­vo­cates whose on­ly job is to make pa­tients feel seen, com­fort­able, and ed­u­cat­ed.

Leslie was a teacher for 30 years be­fore join­ing us. Jo­lene has worked in clin­i­cal tri­als for 28 years. They text pa­tients the night be­fore site vis­its. They an­swer ques­tions at 2 a.m. about med­ica­tion washout pe­ri­ods. They re­mind pa­tients to bring their med­ica­tion list. They check in the day af­ter a site vis­it to see how it went. They fol­low up when a site is slow to call back.

And it works.

In­dus­try av­er­age for re­fer­ral-to-ICF ra­tio, the per­cent­age of re­ferred pa­tients who ac­tu­al­ly sign con­sent and en­roll, is un­der 5%.

We just wrapped up a re­cent tri­al at over 22%.

On av­er­age, our Moth­er Goose team speaks with a pa­tient 4.8 times be­fore they ever walk through a clin­i­cal site's front door. When we im­ple­ment­ed the Moth­er Goose mod­el, re­fer­ral-to-ICF ra­tios in­creased by more than 36 per­cent­age points.

Why does this work when oth­ers can't break 5%? Be­cause we're com­bin­ing speed with em­pa­thy. Tech­nol­o­gy flags who's ready to move for­ward. Moth­er Goose makes them feel safe enough to ac­tu­al­ly do it. Voice screen­ing qual­i­fies them in 90 sec­onds. Leslie makes sure they feel con­nect­ed be­fore they ever walk in­to a site. The al­go­rithm finds and qual­i­fies them. Our team builds the trust and con­vic­tion nec­es­sary for them to walk in­to a clin­i­cal site for screen­ing, en­roll, and stay in the study.

It's not mag­ic. It's what hap­pens when you stop treat­ing re­cruit­ment like a fun­nel and start treat­ing it like a re­la­tion­ship.

When Leslie texts a pa­tient the night be­fore their ap­point­ment, it's not a chat­bot pulling an an­swer from a data­base. It's a per­son who knows their name, un­der­stands their con­cerns, and is look­ing out for them the way a friend would.

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Kevin Friedman, Kelonia Therapeutics founder and CEO
1
by Elizabeth Cairns

Eli Lil­ly is go­ing big on in vi­vo CAR-T ther­a­py.

The com­pa­ny said Mon­day that it would