FDA EIR - Sesen Bio, Inc. - June 03, 2021

Sesen Bio, Inc. was subject to a high-priority FDA Bioresearch Monitoring (BIMO) inspection from May 24 to June 3, 2021, focusing on its responsibilities as the sponsor for an Investigational New Drug (IND) study. Although this particular inspection did not result in an FDA Form 483, management was presented with several significant issues, some of which echoed problems previously identified at two clinical investigator sites and a contract research organization (CRO) involved in the same study that had received 483s.Key issues raised during the inspection included challenges in providing complete and timely documentation, the absence of Sesen's clinical operations Standard Operating Procedures (SOPs) until 2019, and a lack of vendor oversight SOPs. The FDA also noted gaps in meeting minutes between Sesen and its CRO, limited clinical operations staffing, and turnover of medical officers. Furthermore, data listings lacked essential dates, and certain source records were missing from the pharmacovigilance system.The inspection highlighted poor quality monitoring by the CRO, which prompted Sesen to implement a Remediation Plan and a Re-Monitoring Plan. These plans addressed concerns about missing safety data and disorganized site records, which collectively presented a significant risk to data quality and patient safety. It was also noted that a data management plan for long-term follow-up was not in place prior to data collection commencing.Sesen's President and CEO acknowledged these discussion items, committing to review and address them, including improving documentation, ensuring procedural plans are established proactively, and reinforcing overall oversight.