Clinical Research Compliance Gene Genetic Engineering 
Advarra
JUNE 13, 2024
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.
Advarra
MARCH 31, 2023
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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WCG Clinical
NOVEMBER 17, 2023
It also establishes the role of the Institutional Biosafety Committee (IBC) in providing local oversight of such research. At the time this change was implemented, methods used to deliver rsNA to cells or research participants typically involved the use of viral vectors that were subject to the NIH Guidelines.
Advarra
JANUARY 11, 2024
The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.
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. The IBC’s membership roster is therefore unique to the individual research location it oversees.
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