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How Potential Changes to the NIH Guidelines Could Impact IBC Review

WCG Clinical

This change expanded the definition of HGT research to include research using nucleic acids that are able to replicate, be transcribed, translated into protein, and/or integrate into the host genome. If implemented, these changes would broaden the definition of HGT to include new gene editing and genome-modified products.

Genome 52
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Regulatory Trends in Cell and Gene Therapies

Advarra

The first is titled, Human Gene Therapy Products Incorporating Human Genome Editing , and provides recommendations on the information to include in IND filings for these therapies, including study design, safety, and manufacturing.

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Beyond the Pill: The Rise of Biologics and the Evolution of Pharmaceutical Therapies

Cloudbyz

Longer Lasting Effects: Many biologics have prolonged therapeutic effects, allowing for less frequent dosing regimens and improved patient compliance. As we continue to harness the power of biotechnology, genomics, and digital health, the potential for transformative breakthroughs in healthcare is virtually limitless.

Gene 99