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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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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This week in drug discovery (8-12 April) 

Drug Discovery World

The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. News round-up for 8-12 April by DDW Digital Content Editor Diana Spencer.

Drugs 52
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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

FDA Law Blog

labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. labeling of major food allergens in bulk foods, dietary supplements, protein-free ingredients, and foods produced through genetic engineering); and. 1, 2023, sesame.

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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

Originally released in 1976, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) serve as the foundation of biosafety-focused oversight of research involving recombinant or synthetic nucleic acids (rsNA). Since then, however, certain genetic engineering technologies (e.g.,

Genome 52
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Thinking About the Box: Considerations for Transport of Investigational Products

Advarra

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines. The containment must then prevent spills or leaks if the IP is dropped. Size matters.

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More efficient mouse model generation through informed founder selection

Drug Discovery World

This paid-for advertorial by Taconic appeared in DDW Volume 24 – Issue 3, Summer 2023 Overcoming challenges in model generation Genetically engineered mouse models are essential tools for biomedical research. In response, researchers often breed several founders.

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Trends in Human Health Management: A Journey through Time

Roots Analysis

Whether it was a common cold or a genetic disease, prayers and sacrifices to the gods were the only hope of a remedy at such times. It is possible that the legend of Big Foot may be based on an unfortunate person suffering from elephantiasis or gigantism or some other genetic predisposition that would have rendered him abnormal.