Gene Therapy
Bacteriophage Therapy: A Promising Solution to Antibiotic Resistance
Get to know about one possible solution to antibiotic resistance: bacteriophages: viruses that infect bacteria.
The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering
A formal hazard communication or IBC SOP is critical to ensure clinical personnel understand the risks involved with genetically engineered investigational products.
How Gene Therapy Will Move Rare Disease Research at Warp Speed
There is great potential for research surrounding rare diseases. Uncover various types of gene delivery and its impact on diverse populations in the U.S.
How Centralized IBC Review Can Benefit Gene Therapy Research
Understand the risks and regulatory requirements for gene therapy research and how a biosafety review can benefit this type of research.
Improving Study Activation Time for Gene Therapy Research
With the growing popularity of gene therapy research and genetically engineered vaccines, sites need to understand study activation impacts
Navigating Key Complexities in the Development of Cell and Gene Therapies
Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Advarra Achieves 1,000+ Site Milestone for its Gene Therapy Ready Network
Research involving gene therapy-based treatments can start more quickly with Advarra’s growing network of registered research sites.
FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products
Our IBC experts authored “FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products” in Applied Biosafety.
A Guide for Successful Cell and Gene Therapy Research
Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.
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