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New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of geneticengineering) 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.
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 clinicalresearch today also fall into this self-limiting class of recombinant therapeutics.
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.
The use of engineeredgenetic 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 engineeredgenetic materials.
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 clinicalresearch safely.”
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 geneticengineering have lessened over time.
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 engineeredgenetic materials to human research subjects.
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. Since then, however, certain geneticengineering technologies (e.g.,
The complexities in clinicalresearch in both Clinicalresearch for both biologics and small molecules involves complex processes that are crucial for demonstrating safety, efficacy, and quality before obtaining regulatory approval.
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 clinicalresearch , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.
This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. The project should also help clinicalresearch sponsors take advantage of various FDA pathways for accelerated review and approval.
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