FDA EIR - Joseph R. Lentino, M.D. - September 20, 2016

An FDA inspection conducted between August 8 and September 20, 2016, at Joseph R. Lentino, M.D., operating under Radiant Research in Chicago, IL, identified significant issues in the conduct of a clinical trial for HEPLISAV™ (BLA #STN 125428/0). The inspection was performed under the Bioresearch Monitoring-Clinical Investigators program (CPGM 7348.811). The inspection resulted in two main observations detailed in an FDA Form 483. First, Dr. Lentino failed to conduct the investigation in accordance with the approved plan (21 CFR 312.60). Specifically, protocol deviations for missed Week 24 injections and out-of-window Week 28 blood sample collections for re-engaged subjects were not consistently reported to the sponsor, potentially impacting data analysis. Second, there was a failure to prepare or maintain adequate case histories. This included not keeping contemporaneous copies of internet questionnaire responses and not documenting the investigator’s review of these responses at the time they were completed, instead printing a single final report at study end. Additionally, management was informed of concerns regarding the physical security of study supplies and records, the practice of obtaining informed consent via mail, and the inadequacy of a specific electronic program for FDA-regulated data capture and electronic signatures. Dr. Lentino committed to providing a written response addressing these objectionable conditions to the FDA.