Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP

Get to know about one possible solution to antibiotic resistance: bacteriophages: viruses that infect bacteria.

As FDA CBER prepares to launch Operation Warp Speed for Rare Diseases, there is an expected rapid growth in gene therapy.

Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.

Find out which unexpected events you should report to the IBC during a clinical trial, and what to expect from the IBC's review.

Gene therapy research is full of promise, but because of the risks, it’s a highly regulated space requiring oversight by an institutional biosafety committee (IBC).

Care must be taken to avoid sharps-related injuries and exposures when preparing investigational products for clinic transportation.

Using hoods with biological materials depends on directional airflow, and specialized airflow is necessary when handling hazardous materials.

Responses to the most frequently asked questions regarding mRNA technology and clinical trial regulatory requirements.

While clinical research professionals are familiar with the role of the IRB to protect research subjects, most are unfamiliar with the added need for an Institutional Biosafety Committee (IBC).