Clinical Research DNA Genetic Engineering 
Advarra
JUNE 13, 2024
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?
Advarra
JUNE 12, 2023
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. IBC membership must include involving two local community members who reside within 50 miles of the research site.
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Advarra
MARCH 31, 2023
This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.
WCG Clinical
AUGUST 27, 2024
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.
Advarra
AUGUST 10, 2023
However, recent advancements in the clinical use of recombinant DNA (rDNA) technology creates opportunities for changing this calculation and addressing a great, unmet medical need. “I The project should also help clinical research sponsors take advantage of various FDA pathways for accelerated review and approval.
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