The Background

A manufacturer of biosimilar medicines partnered with a large global pharmaceutical company to conduct the pivotal clinical trial with the aim of applying for global marketing licences for a new oncology biosimilar product.

The Problem

Both companies in the joint venture (JV) agreed that wherever possible the activities would be outsourced and only a skeleton team from each company would be provided to oversee the outsourced service providers. The trial (including safety monitoring and reporting) was outsourced to a contract research organisation (CRO). However, complaints from regulatory agencies were received and it soon became clear that safety monitoring by the CRO was limited. The contract did not include in-house surveillance of the safety profile and the CRO could not support them through the regulatory application process. The people assigned to the JV were charged with looking for a suitable provider to support with these critical elements of patient safety.

The Solution

Pharmora provided a small, experienced team of staff to function as the entire safety department, working alongside the JV team. This included the Head of Patient Safety, the Safety Management Team (SaMT) Leader and a Global Safety Physician (GPS).

During the study period the GPS monitored all Serious Adverse Event (SAE) reports and ensured these were entered fully and accurately. He also provided company causality and expectedness assessments, facilitated regulatory expedited reporting decisions, reviewed the data coming from literature and supported MedDRA coding. The SaMT Leader organised regular meetings to assess the safety data sent from the CRO and wrote the Development Safety Update Reports (DSURs).

At the end of the study the Pharmora safety team helped to analyse the safety data and write the safety documents for submission to regulatory agencies. Pharmora also wrote the standard operating procedures (SOPs) and documentation in preparation for regulatory Inspection, leading to the Pharmacovigilance Systems Master File (PSMF) in readiness for commercialisation of the product.

The Pharmora team represented the JV in regulatory interactions during the submission process, including face to face meetings in Japan and (due to COVID lockdowns) meetings by videoconference.

Pharmora only charged for the hours used for each of the activities, and when the JV requested changes in scope (e.g. from safety surveillance during the study to preparing for and supporting regulatory approvals) Pharmora reacted quickly and efficiently, providing experienced team members with suitable expertise for the tasks.

The Outcome

The Pharmora safety team led patient safety on behalf of the JV throughout clinical development, to the final regulatory responses and inspections, resulting in successful global regulatory approvals for a new biosimilar oncology product.