Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular […]
Biosafety
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug
Clean Bench vs Biosafety Cabinet: What’s the Difference?
Institutional biosafety committees (IBCs) frequently receive questions about the proper type of hood for use with biological materials and the
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with
mRNA Clinical Trials: Key Regulatory Considerations
Over the past two years, Operation Warp Speed brought mRNA-based vaccines into the spotlight, as organizations like Moderna and Pfizer/BioNTech
Advarra’s Support for Institutions
As clinical research sites face more challenges than perhaps ever before, it’s increasingly important to provide sites with proper support
The Advantages of Outsourcing IRB and IBC Reviews to One Partner
Gene therapy studies are a relatively recent addition to the world of clinical research. As a result, the unique requirements
Does This Study Require IBC Review?
Gene therapy research is highly regulated due to associated risks, often leading to confusion among professionals new to its regulatory requirements.
Reflections from Cell and Gene Meeting on the Mesa 2021
I recently had the privilege of both presenting at and attending the 2021 Alliance for Regenerative Medicine (ARM) Annual Cell
Why Institutions Should Consider an Externally Administered IBC
Clinical trials for gene therapy are booming, especially in the fields of oncology, infectious diseases, rare diseases, and regenerative medicine.