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Blog

IBC vs. IRB: What’s the Difference?

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).

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White Paper

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.

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Blog

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.

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Blog

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.

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Webinar

Is Your Site Ready for an FDA Inspection?

Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.

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E-Book

Trend Report: 2023 Trends Impacting Clinical Research

This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.

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Blog

Regulatory Trends in Cell and Gene Therapies

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

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News

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.

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Abstract

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.

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Webinar

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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Blog

Safe Sharps Handling When Dispensing Investigational Products

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

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Blog

Clean Bench vs Biosafety Cabinet: What’s the Difference?

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

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