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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Advarra

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. How can I protect myself from exposure? What should I do if I’m exposed?

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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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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

At the time this change was implemented, methods used to deliver rsNA to cells or research participants typically involved the use of viral vectors that were subject to the NIH Guidelines. Since then, however, certain genetic engineering technologies (e.g.,

Genome 52
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mRNA Cancer Vaccines and Therapies: An Overview

Advarra

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. Only after these trials are successful can sponsors seek market approval for mRNA-based products.

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The New Frontier in Drug Development: Understanding Biologics and Small Molecules

Cloudbyz

The complexities in clinical research in both Clinical research for both biologics and small molecules involves complex processes that are crucial for demonstrating safety, efficacy, and quality before obtaining regulatory approval. Ensuring batch-to-batch consistency is a significant challenge.