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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