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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.
Pharmaceutical Technology
OCTOBER 26, 2022
Gene therapy uses DNA to manipulate cells and correct defective genes, whereas cell therapy is the infusion or transplantation of cells into a patient. Early gene therapy methods were proposed in the 1970s, and the first approved gene therapy clinical research in the US began in 1990. The future of cell and gene therapies.
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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.
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.
Drug Discovery World
JUNE 6, 2023
The only way we’re going to do that was improved diagnostic techniques.” At the meeting, Jordan says we are seeing improvements in circulating tumour DNA, circulating tumour cell diagnosis, as well as ways of detecting tumours before they are detectable through standard methodologies, such as CT scans. It’s a 1.5
Drug Discovery World
JULY 5, 2023
Decades of research on the cellular and molecular mechanisms of how the immune system detects and kills cancerous or pre-cancerous cells, known as immune surveillance, and the factors which modulate that response, have led to understanding how we can enable a patient’s own immune system to fight cancer more efficiently in different ways.
Drug Discovery World
AUGUST 10, 2022
But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Frontiers in Immunolology. 2018) 9(507).
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