The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Antibiotic resistance is an emerging problem. Some have argued bacteria are developing antibiotic resistance faster than we can research, develop,
Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their
Ensuring the safe and secure transport of investigational products (IP) is a core part of biosafety. This critical task requires
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
Cannabis use has become widespread. As such, we are seeing an uptick in research examining the therapeutic effects of cannabis
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.
