Opening The "Black Box" Of The mRNA Regulatory Paradigm

Though the linear mRNA COVID vaccines set the stage for the broader xRNA therapeutics industry, the industry’s push into next-generation encoding RNA modalities (i.e., saRNA and circRNA) and non-prophylactic therapeutic approaches necessitates many more conversations on what shape the future RNA therapeutics regulatory paradigm should take.

In this Advancing RNA panel discussion, we discussed the broad learnings therapeutics developers can adapt (or can’t adapt) from the previously approved mRNA vaccine products, and what an “ideal” RNA therapeutics regulatory paradigm could look like in the long-term. We also dig into best practices for working with regulators to usher encoding RNA products into the clinic, as well as current approaches for “platforming” product development.

Available on-demand thanks to the support of Roche CustomBiotech.

Don't have time to watch the full video? Check out these segments by topic:

• Approving The World's First saRNA Vaccine: Arcturus' Regulatory Experience
• Where Does The mRNA Vaccine Regulatory Paradigm Fall Short For Therapeutics?
• What Learnings Can mRNA Take From The Oligonucleotide Regulatory Paradigm?
• The Pre-IND "Diaries": What Can mRNA Makers Expect From Early FDA Engagement?
• A Snapshot Of The RNA Industry & Its Regulatory Progress
• In Which Specific Areas Do mRNA Makers Need More Regulatory Guidance?
• The FDA's "Platform" Provision: An Emerging Debate Among Regulators
• How Is mRNA "Shaking Up" Our Regulatory Interactions & Operations Today?
• Don't Ignore These Functional Areas In Your RNA Therapeutic's Regulatory Story
• An mRNA Wish-List: What Regulatory Developments Would Make Life "Easier?"