Remove DNA Remove Genetic Engineering Remove Regulation
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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. What do the Regulations Say about IBC Review? What do the Regulations Say about IBC Review?

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Why do Community Members Need to Participate in IBC Review Meetings?

WCG Clinical

1 This is an important requirement, as the NIH Guidelines were originally created partly in response to public concerns surrounding recombinant DNA and genetic engineering. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time.

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Gene Switch: A Novel Platform for Switching Genes On and Off

Roots Analysis

Gene switches can be regulatory proteins or specific DNA sequences that act to either switch on or off the expression of a gene. Basic Components of Gene Switch Gene switches are composed of noncoding DNA sequences and transcription factors. Negative Gene Regulation: Repressor is a protein molecule that initiates negative regulation.

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A history of blood cancer treatment

pharmaphorum

The following year, the regulator also approved Rituximab, a monoclonal antibody targeting CD-20 positive B-cells, as a companion treatment of chemotherapy in older diffuse large B-cell lymphoma patients. This was an entirely new approach to DNA research. 2002 – Emergence of CAR-T therapy. 2012 – The 100,000 Genomics Project begins.

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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

Advarra

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 Many rare diseases, like cystic fibrosis and sickle cell anemia, are monogenic in nature , caused by mutations to single genes.

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RNA Therapeutics: A Novel Approach to Treating Diseases

Roots Analysis

It is important to highlight that IVT mRNAs are structurally similar to natural mRNAs and can be used to express proteins through genetic engineering. In the last few years, researchers have become interested in using in vitro transcribed (IVT) mRNA as a drug delivery agent.

RNA 40
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Spotlighting Lupus Awareness Month: CAR-T Technology Creates New Avenues for Treatment of a Devastating Disease

WCG Clinical

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies.

In-Vivo 40