Remove Clinical Research Remove Compliance Remove Gene Therapy Remove Genetic Engineering
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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Advarra

When working with an unfamiliar IP, clinical personnel are likely looking for answers to three main questions: What are the risks associated with this IP? Because these therapies often use live viral vectors, there is the risk of accidental transmission that is not encountered with non-biological drugs and therapeutics.

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Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Either way, occupational exposure to these gene delivery systems bears potential risks to the research staff.

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mRNA Cancer Vaccines and Therapies: An Overview

Advarra

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

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IBC vs. IRB: What’s the Difference?

Advarra

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. The IBC’s membership roster is therefore unique to the individual research location it oversees.