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Opinion: Secrecy: A demon of gene therapy’s past bedevils its future

STAT News

Twenty-three years ago, the field of gene therapy was bursting with the promise of breakthrough treatments. Then it was almost instantly derailed by the death of an 18-year-old clinical trial volunteer named Jesse Gelsinger after he received a genetically engineered virus that had been developed to treat his rare liver condition.

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Enabling the next wave of innovative drug therapies with speciality enzymes

Pharmaceutical Technology

For cell and gene therapy applications, you need a variety of speciality enzymes of the highest purity, specificity, and consistency. Novozymes has a long legacy of enzyme discovery and the ability to genetically engineer these speciality enzymes to be superior. And it’s within the family – Novozymes!”.

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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 Does an IBC Review?

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Nick Spittal Comments on Velocity’s Membership With Advarra’s Gene Therapy Ready Site Network

Velocity Clinical Research

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 clinical research safely.”

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Leading innovators in transcription factors for AAV for the pharmaceutical industry

Pharmaceutical Technology

Innovation S-curve for the pharmaceutical industry Transcription factors for AAV is a key innovation area in pharmaceutical Adeno-associated virus (AAV) vectors are widely used for gene therapy. There are two main genes in the AAV genome, rep and cap, which encode nine different proteins.

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How Centralized IBC Review Can Benefit Gene Therapy Research

Advarra

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. Defining the Boom in Gene Therapy Research The gene therapy field is experiencing explosive growth in today’s competitive research environment.

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The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

Advarra

Genetically engineered products often require additional safety practices to ensure the infectious agents do not endanger participants, study staff, or the broader environment where such agents are administered. How can I protect myself from exposure? What should I do if I’m exposed?