Mer­ck’s women’s health spin­off Organon looks for phar­ma­ceu­ti­cals, di­ag­nos­tics, de­vices to fill out its pipeline

San­dra Mil­li­gan, Organon’s head of R&D, some­times wish­es the women’s health spin­off was an on­col­o­gy com­pa­ny.

In can­cer, the reg­u­la­to­ry path is well-trod­den. There are es­tab­lished end­points and bio­mark­ers in ad­di­tion to ac­cel­er­at­ed tracks to ap­proval. But in women’s health, the path is far less clear.

“We have to go dis­cov­er end­points, val­i­date end­points and get them ap­proved by the agency,” Mil­li­gan said. “It’s a tough road.”

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