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Proactive risk management to obtain regulatory approvals and FPI in record time

Proactive risk management to obtain regulatory approvals and FPI in record time

A public biotech  selected SMS-oncology for the implementation of the phase I/II study in several European countries with their immuno-oncology antibody for the treatment of solid tumors.

Shortly after the kick-off meeting it became apparent that the presentation of certain pre-clinical results of the antibody was delaying the finalization of the study protocol. This indicated a challenge for the operational team at SMS-oncology in reaching the clinical trial application (CTA) submission deadlines, which could have a major impact on the sponsor’s milestones, such as first-patient-in (FPI).

As we at SMS-oncology thrive on cooperating towards the milestones and goals of our sponsors via proactive rather than reactive execution, our operational teams develop risk management plans to identify foreseeable risks and contingencies to avoid lengthy and difficult decisions at critical times. Among the possible issues, a delay in approval of the study in the initial planned country Belgium was predicted. To mitigate this risk, an accelerated submission process was followed in two additional Nordic countries simultaneously. A great challenge in time and workload, however achievable through a flexible and dedicated team.

The operational team at SMS-oncology had a two-week window for the initial submission in Norway and a very tight one-week deadline to perform submissions in Belgium and Denmark after finalization of the protocol. Strategic and seamless organizational set-up and a team effort with can-do mentality resulted in successful CTA submissions in line with the short deadlines. Approvals in the two Nordics countries were obtained within 9 and 10 weeks. The first cohort (3 patients) was closed in a record time by the Nordic centers, only 2 weeks after performing site initiation visits (SIVs).

The sponsor appreciated the “hard work and excellent results” to reach their important FPI milestone!