Gene Therapy
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.
Reflections from Cell and Gene Meeting on the Mesa 2021
This blog recounts the 2021 Cell and Gene Meeting on the Mesa conference, including details on cell and gene therapy's growth and trajectory.
Why Institutions Should Consider an Externally Administered IBC
Gene therapy clinical trials require specialized oversight & expertise. Read how institutions can prep for the boom in gene therapy research.
Understanding the Current and Future States of Cell and Gene Therapy Research
This white paper focuses on gene therapy uses in oncology and looks at a successful program at an NCI-designated comprehensive cancer center.
Daniel Eisenman, Paul Gulig, and Adam Soloff Explore The Exponential Rise of Gene Therapy and Unlocking Its Potential Promise
In this podcast, Daniel Eisenmann talks with Adam Soloff and Paul Gulig for a discussion on the growth and the promise of gene therapy.
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
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