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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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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.

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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

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? Replication-incompetent Agents Many viral vectors used in clinical trials today are genetically engineered with safeguards to render them replication-incompetent.

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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 Centralized IBC Review Can Benefit Gene Therapy Research

Advarra

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.

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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.