FDA Finalizes Guidance on Conducting Studies for Drugs Based on Bacteria and Viruses

September 1, 2015

Biologics makers developing drugs based on bacteria and viruses should conduct preclinical and clinical studies to determine if infection could be unintentionally transmitted from treated patients to other individuals, the FDA says.

While product-based viruses and bacteria are generally not as infectious or virulent as the parent strain, transmission can occur, and sponsors should design a sampling plan to collect shedding data in clinical studies, according to final guidance that contains only minor changes from a 2014 draft.

The collection should begin in Phase 1 trials for virus or bacteria-based gene therapy products and oncolytic products classified as replication competent. Sponsors may need to continue collecting shedding data during Phase 2 and Phase 3, since replication competent products have a higher likelihood of releasing infectious viruses or bacteria, the FDA says.

For products based on bacteria or viruses that can infect a host but not spread, the data can be collected later in drug development, such as Phase 2 studies, after determining dose and regimen.

BLAs should include a comprehensive shedding report with background information on the product, preclinical study findings, rationale for the study design, data collection plan, a description of assays, analysis of the data and an estimate of potential transmission to untreated individuals.

Read Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products here: www.fdanews.com/8-15-FDA-SheddingStudies.pdf. — Jonathon Shacat