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Nick Spittal Comments on Velocity’s Membership With Advarra’s Gene Therapy Ready Site Network

Velocity Clinical Research

As Nick Spittal states in this Advarra press release, membership in the Gene Therapy Ready (GTR) site network “allows Velocity to start studies over a month faster and provides a meaningful credential and important validation that increases sponsors’ confidence in our specialized capabilities to conduct complex clinical research safely.”

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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Advarra

Genetically engineered products often require additional safety practices to ensure the infectious agents do not endanger participants, study staff, or the broader environment where such agents are administered. How can I protect myself from exposure? What should I do if I’m exposed?

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Genetically engineered T cells could lead to therapies for autoimmune diseases

Scienmag

A new study has found that a novel T cell genetically engineered by University of Arizona Health Sciences researchers is able to target and attack pathogenic T cells that cause Type 1 diabetes, which could lead to new immunotherapy treatments.

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Opinion: Secrecy: A demon of gene therapy’s past bedevils its future

STAT News

Twenty-three years ago, the field of gene therapy was bursting with the promise of breakthrough treatments. Then it was almost instantly derailed by the death of an 18-year-old clinical trial volunteer named Jesse Gelsinger after he received a genetically engineered virus that had been developed to treat his rare liver condition.

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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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AGC and RoosterBio partner for cell and exosome therapy manufacturing

Pharmaceutical Technology

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets.

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Q&A: A decade on, what’s next for CAR-T therapies?

Pharmaceutical Technology

But while companies continue studying allogeneic CAR-T therapies, including for their coveted use in solid tumours, such advancements remain challenging. More broadly however, several advancements are on the horizon for cell and gene therapies in 2023. AZ: Cell and gene therapies often come with a high price.