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Path to the market: from an investigator initiated study to global MAA success

Path to the market: from an investigator initiated study to global MAA success

A private European biotech company reached out to SMS-oncology for assistance on an investigator initiated study with their lead molecule, a cancer diagnostic tool, to be repurposed to also deliver treatment.

This Phase I/II study with a radiolabeled protein in neuroendocrine tumors has not been easy for the drugmaker, due to technical problems including the quality of data collection, the study was significantly delayed than initially planned. In this project SMS-oncology was asked to take over the study, and was responsible for performing data management and site management services for over 1200 patients to enable the drug for MAA. Through the professional expertise of SMS-oncology with DM and PM services, the company successfully received both FDA and EMA approvals and brought its lead to clinics.

From a CERN spin-off 15 years ago, increasing its valuation the company has been recently acquired by a global pharmaceutical company.