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Experiment Reveals Human Genes Can Be Controlled With Electricity

AuroBlog - Aurous Healthcare Clinical Trials blog

New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly. Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals.

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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. Synthetic mRNA-based therapeutics used in clinical research today also fall into this self-limiting class of recombinant therapeutics.

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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 also reviews to confirm a comprehensive risk mitigation plan is in place prior to starting the research.

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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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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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Why do Community Members Need to Participate in IBC Review Meetings?

WCG Clinical

The NIH Guidelines also stipulate that at least two members of each IBC come from the surrounding community and be unaffiliated with the institution where the research is occurring apart from their membership on the IBC. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time.

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How Centralized IBC Review Can Benefit Gene Therapy Research

Advarra

Defining the Boom in Gene Therapy Research The gene therapy field is experiencing explosive growth in today’s competitive research environment. Gene therapy involves the transfer of engineered genetic materials to human research subjects.