Cell and gene ther­a­pies (CAGT) have trans­formed what is pos­si­ble in med­i­cine. What once seemed out of reach—treat­ing, slow­ing, or even cur­ing dev­as­tat­ing ge­net­ic, on­co­log­ic, and rare dis­eases—has be­come re­al­i­ty for pa­tients who pre­vi­ous­ly had few or no op­tions. From CAR‑T ther­a­pies re­shap­ing hema­to­log­ic on­col­o­gy to gene ther­a­pies of­fer­ing sin­gle‑ad­min­is­tra­tion so­lu­tions for life­long con­di­tions, CAGT has re­de­fined both clin­i­cal am­bi­tion and pa­tient ex­pec­ta­tions.

The pace of in­no­va­tion shows no signs of slow­ing. The glob­al cell and gene ther­a­py mar­ket is pro­ject­ed to ex­ceed $146 bil­lion by 2032, fu­eled by ex­pand­ing pipelines, sec­ond ‑gen­er­a­tion plat­forms, and in­creas­ing reg­u­la­to­ry clar­i­ty. For bio­phar­ma or­ga­ni­za­tions com­mit­ted to this space, the op­por­tu­ni­ty is pro­found: trans­form pa­tient lives while en­ter­ing one of the most promis­ing and com­pet­i­tive ther­a­peu­tic mar­kets in bio­phar­ma.

Yet de­spite sci­en­tif­ic break­throughs, a fun­da­men­tal con­straint threat­ens to lim­it the im­pact—and the re­turn—of these ther­a­pies. It is no longer sci­ence that stands in the way. It is ac­cess.

Parex­el en­sures the CAGT ecosys­tem keeps pace with sci­ence by help­ing de­vel­op­ment teams re­think mod­els be­fore the first pa­tient is en­rolled—bring­ing deep sci­en­tif­ic, reg­u­la­to­ry, and op­er­a­tional ex­per­tise to de­sign tri­als that work across di­verse care set­tings with­out com­pro­mis­ing safe­ty or qual­i­ty.

As CAGT in­no­va­tion ac­cel­er­ates, drug de­vel­op­ers are be­ing forced to re­think where and how tri­als can be de­liv­ered—and what it will take to ex­pand ac­cess be­yond to­day’s tra­di­tion­al mod­els. At the same time, pa­tients out­side ma­jor aca­d­e­m­ic cen­ters of­ten re­main ex­clud­ed from tri­als al­to­geth­er. Ge­o­graph­ic bar­ri­ers, trav­el bur­den, so­cioe­co­nom­ic fac­tors, and re­fer­ral lim­i­ta­tions mean that many pa­tients nev­er have the op­por­tu­ni­ty to par­tic­i­pate—de­spite be­ing clin­i­cal­ly el­i­gi­ble and high­ly mo­ti­vat­ed. The re­sult is slow­er en­roll­ment, less di­verse datasets, and ther­a­pies that may not ful­ly re­flect re­al ‑world pop­u­la­tions.

The fol­low­ing key take­aways set the stage for why the field is reach­ing an in­flec­tion point.

The field has reached a clear in­flec­tion point. The ques­tion fac­ing drug de­vel­op­ers is no longer whether cell and gene ther­a­pies will suc­ceed—it is how to en­sure that de­vel­op­ment mod­els evolve quick­ly enough to keep pace with in­no­va­tion.

Meet­ing the grow­ing de­mand for CAGT re­quires a fun­da­men­tal shift in how, where, and with whom these tri­als are con­duct­ed. Ex­pand­ing de­vel­op­ment be­yond tra­di­tion­al cen­ters is not sim­ply about in­creas­ing en­roll­ment—it is about un­lock­ing the full val­ue of these ther­a­pies across their en­tire life­cy­cle.

Or­ga­ni­za­tions that act now can:

• Ac­cel­er­ate de­vel­op­ment time­lines by re­duc­ing com­pe­ti­tion for sites and pa­tients
• Strength­en reg­u­la­to­ry and pay­er con­fi­dence through more rep­re­sen­ta­tive ev­i­dence
• Lay the ground­work for fu­ture com­mer­cial­iza­tion by build­ing ac­cess ear­li­er

Or­ga­ni­za­tions that do not act risk falling be­hind com­peti­tors who are al­ready re­think­ing the de­liv­ery mod­el.

For­ward-think­ing lead­ers should see that shift­ing CAGT re­search from sole­ly spe­cial­ized AM­Cs to a broad­er pop­u­la­tion that in­cludes com­mu­ni­ty hos­pi­tals and clin­ics as a sig­nif­i­cant com­pet­i­tive op­por­tu­ni­ty.

When im­ple­ment­ed in­ten­tion­al­ly and re­spon­si­bly, com­mu­ni­ty‑based re­search un­locks three pow­er­ful ben­e­fits:

• Un­locks new pa­tient pop­u­la­tions: Com­mu­ni­ty health­care set­tings pro­vide ac­cess to pa­tients who are of­ten un­der­rep­re­sent­ed in aca­d­e­m­ic tri­als—pa­tients who may be ear­li­er in their dis­ease jour­ney, more re­flec­tive of re­al ‑world prac­tice, and high­ly mo­ti­vat­ed to par­tic­i­pate when tri­als are avail­able clos­er to home. By re­duc­ing trav­el bur­den and lo­gis­ti­cal bar­ri­ers, tri­al teams can ac­cel­er­ate en­roll­ment and im­prove re­ten­tion while reach­ing pop­u­la­tions that AM­Cs alone can­not serve.
• Gen­er­ates rich­er, more durable ev­i­dence: Da­ta gen­er­at­ed from a wider ge­o­graph­ic and de­mo­graph­ic foot­print strength­ens clin­i­cal and re­al‑world ev­i­dence pack­ages. More di­verse en­roll­ment sup­ports reg­u­la­to­ry de­ci­sion‑mak­ing, en­hances safe­ty and ef­fec­tive­ness in­sights, and pro­vides pay­ers with greater con­fi­dence in how ther­a­pies will per­form post‑ In a mar­ket where dif­fer­en­ti­a­tion in­creas­ing­ly de­pends on val­ue demon­stra­tion, ev­i­dence breadth mat­ters.
• Se­cures long-term mar­ket ad­van­tage: As com­pe­ti­tion for ex­pe­ri­enced sites in­ten­si­fies, ear­ly in­vest­ment in com­mu­ni­ty ac­cess es­tab­lish­es crit­i­cal in­fra­struc­ture for fu­ture tri­als and com­mer­cial­iza­tion. Or­ga­ni­za­tions that build trust, ca­pa­bil­i­ty, and pres­ence be­yond AM­Cs po­si­tion them­selves as lead­ers in ex­pand­ing ac­cess—earn­ing good­will with pa­tients, providers, reg­u­la­tors, and health sys­tems alike.

For many de­vel­op­ment teams, the idea of mov­ing cell and gene ther­a­py tri­als in­to com­mu­ni­ty set­tings can feel daunt­ing. Con­cerns around in­fra­struc­ture readi­ness, qual­i­ty over­sight, reg­u­la­to­ry scruti­ny, and op­er­a­tional com­plex­i­ty of­ten slow de­ci­sion ‑mak­ing. Yet many of these bar­ri­ers are root­ed in out­dat­ed as­sump­tions.

The re­al­i­ty is that the ecosys­tem is evolv­ing.

Reg­u­la­to­ry agen­cies are in­creas­ing­ly sup­port­ive of prag­mat­ic, qual­i­ty‑dri­ven frame­works that pri­or­i­tize pa­tient safe­ty while en­abling broad­er ac­cess. Health sys­tems are in­vest­ing in ad­vanced ca­pa­bil­i­ties, and pi­o­neer­ing in­sti­tu­tions are al­ready demon­strat­ing that com­mu­ni­ty‑based CAGT de­liv­ery can be done safe­ly, ef­fi­cient­ly, and com­pli­ant­ly.

What sep­a­rates suc­cess from hes­i­ta­tion is ex­per­tise. Drug de­vel­op­ment com­pa­nies that part­ner with teams who un­der­stand both the sci­en­tif­ic com­plex­i­ty and op­er­a­tional re­al­i­ties of CAGT can move for­ward with con­fi­dence—turn­ing per­ceived risk in­to a strate­gic ac­cel­er­a­tor.

Cap­i­tal­iz­ing on the promise of ad­vanced ther­a­pies re­quires more than am­bi­tion, it re­quires the right part­ner with the vi­sion and ex­per­tise to nav­i­gate this new fron­tier.

At Parex­el, our ded­i­cat­ed team helps you de­sign pro­to­cols that can be op­er­a­tional­ized across di­verse set­tings and builds com­mu­ni­ty-based op­tions di­rect­ly in­to your site se­lec­tion strat­e­gy. We pre­pare sites for suc­cess with re­sources like our Train­ing Acad­e­my and pro­vide cross-func­tion­al ex­per­tise – in­clud­ing for­mer FDA reg­u­la­tors and ex­perts in EMA and MHRA. We are ready to help you ex­pand your reach and ac­cel­er­ate your ther­a­py’s jour­ney to the pa­tients wait­ing.

Learn more about how our ex­perts can help you: Cell and Gene Ther­a­pies CRO Ser­vices | Parex­el

Dai­ichi Sankyo is bet­ting on its on­col­o­gy fran­chise to push it past 3 tril­lion Japan­ese yen ($19 bil­lion) in 2030 rev­enues.

The drug­mak­er pub­lished a...