Quita Highsmith, Genentech chief diversity officer (Credit: Genentech)

Genen­tech paves path to in­creased clin­i­cal tri­al di­ver­si­ty as a ‘busi­ness im­per­a­tive’

Genen­tech is aim­ing to lead the charge for clin­i­cal tri­al di­ver­si­ty in the phar­ma in­dus­try and it’s us­ing a mix of reg­u­la­to­ry com­mit­ments, tri­al site part­ner­ships and com­mu­ni­ty ac­tivism to get there.

Genen­tech has al­ready filed 20 di­ver­si­ty ac­tion plans for Phase 3 stud­ies with the FDA ahead of the agency’s fi­nal rul­ing, which it be­lieves is the most in the in­dus­try. The FDA guid­ance is tied to the Food and Drug Om­nibus Re­form Act of 2022 (FDO­RA), which re­quires phar­ma com­pa­nies to sub­mit di­ver­si­ty ac­tion plans to the agency ahead of piv­otal tri­als.

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