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By AR Welch, Editorial & Community Director, Advancing RNA | Having read and reread the MHRA's guidance on personalized mRNA cancer immunotherapies, the following five takeaways will function somewhat as a mind-meld, combining a few of my own thoughts/takeaways with those of the MHRA. | |
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By Advancing RNA Live | Do we need more specific regulatory guidance for every RNA modality and therapeutic approach? We asked and the Advancing RNA Live audience answered… Here, panelists Tiffany Lucas and Ulrike Jägle address the audience’s responses, as well as share their thoughts on just how prescriptive the future of regulatory guidance for RNA therapeutics approaches could/should be. | |
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By Steven Grossman, FDA Matters | In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA. | |
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| The Future Of mRNA: Four Key Focuses For Industry | Article | Roche CustomBiotech | Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry. |
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| Regulatory Frameworks For mRNA Therapeutics | White Paper | MilliporeSigma | The RNA therapeutics and vaccines market has experienced rapid growth, driven by advancements in siRNA and mRNA technologies. Explore how these advancements are being applied to cancer vaccines and innovative therapeutics. |
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| Harnessing Chemistry For Scalable Manufacturing Of Lipids | White Paper | Curia | The widespread use of mRNA vaccines has accelerated the development of new LNP-based therapies. Discover how chemists are addressing challenges in lipid manufacturing and purification to bring these products to market. |
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| The 4th mRNA Process Development & CMC Summit returns to Boston (September 23-25) as the world’s only flagship forum dedicated to overcoming bottlenecks and helping mRNA therapeutic and vaccine developers deliver safer and more effective mRNA drugs to patients. Featuring insights from Sanofi, GSK, Moderna, AstraZeneca, CSL, BioNTech, CEPI, US Pharmacopeia, CureVac, Editas Medicines, and many more! |
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