We often hear how interest in, and use of, RNA technology is growing because of the COVID-19 pandemic. One discussion at the TIDES USA conference had a unique perspective: how Moore’s Law may now apply to RNA technology.
The FDA recently released draft guidance on Investigational New Drug (IND) applications for Human Gene Therapy Drug Products Incorporating Human Genome Editing technology to edit human somatic cells. This much-anticipated draft highlights manufacturing, quality, and regulatory considerations for drug developers preparing IND filings for novel, gene-modified cell therapies.
Managing the H1N1 outbreak in 2009 was considered a practice run for the recent SARS-CoV2 pandemic and, over the last two years, we certainly learned a great deal in being prepared for the next virus to gain a foothold. That was the backdrop as we returned to the World Vaccine Congress in Washington, DC.
The American Biomanufacturing Summit, held in San Francisco in April, is a senior-level event attracting over 200 biopharmaceutical executives sharing the latest information from the industry. One top item consistently discussed was how the expectations of speed have been dramatically changed after how quickly COVID-19 vaccines were developed and moved to market, most particularly the mRNA vaccines.
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I’ve spent most of the last 30 years in marketing and sales for molecular biology research products. During that time, I’ve been responsible for software platforms and instrumentation, but my main focus has been on reagents and consumables – nucleic acid purification, PCR, cloning tools, and so forth.
