READ: ARW ON RNA

71. Beyond Moderna's Regulatory Legacy: (Re)defining The mRNA Regulatory “Norm” 3/22/2023

    It’s unlikely we will need to burn nearly as much “midnight oil” as Moderna and the regulatory bodies did during the pandemic. However, I share Moderna's unique experiences because they’re a great reminder that the mRNA therapeutics industry is set to face a much different regulatory challenge moving forward.

72. Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance 3/22/2023

    We may no longer be living in the fast-and-furious days of Emergency Use Authorization, nor are we all working strictly on mRNA vaccines. But after listening to Moderna’s Director of Regulatory CMC Chris Kelly share his whirlwind regulatory experiences, there were still several broad takeaways for companies navigating this nascent space.

73. Metaphorical mRNA: An Argument For (More) Creativity In RNA Therapeutics 1/25/2023

    In putting together my mRNA outlook presentation for November's 2022 AGC CDMO Summit, I realized there is one opportunity that should be top of mind for the RNA therapeutics industry in the years to come. We all, regardless of our functional area in the industry (i.e., manufacturing, quality, R&D, commercial), need to figure out how we can make this important science more accessible to populations around the world. 

74. Defining The RNA Therapeutics Industry In 2023 1/16/2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

75. Overcoming CGT Potency Assay Woes: 4 Best Practices 12/21/2022

    Here, I share a few of the actionable takeaways I walked away with from the ARM/ASGCT potency assay working session in the hopes they will be a complementary exploration of the analytical challenge impacting every ATMP company.

76. CGT Potency Assays: When Will We Wake Up From The Nightmare? 12/12/2022

    Here, I offer my biggest takeaways from a recent ARM/ASGCT workshop on one of the most popular topics to gossip about both in and outside the analytical labs: Potency assays. In part one of this two-part article, I start by unpacking what I see as the most prominent knowledge gaps and questions underpinning the industry’s potency assay challenge.

77. mRNA & RNA Therapeutics In 2023: Where Do We Go From Here? 12/7/2022

    To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.

78. A (More) Mature mRNA Therapeutics Industry: 4 Best Practices To Get There 9/27/2022

    Throughout the two-day mRNA Therapeutics Summit, there were four key takeaways that clearly demonstrated how the mRNA industry could incrementally achieve one speaker's industry prediction that, within the next 10 years, every person in the world will have had the opportunity to benefit from mRNA.

79. Equitable mRNA Therapies Demands Multi-Faceted Understanding Of Access & Innovation 9/19/2022

    This article is the final installment in a four-part series unpacking several of the best practices shared during the mRNA Therapeutics Summit, which took place in Boston on July 27 & 28, 2022. 

80. mRNA Delivery Is More Than Just The Vehicle: Think Outside — & Inside — The LNP 9/14/2022

    This article is part three of a four-part series unpacking my biggest takeaways from the mRNA Therapeutics Summit, which took place in Boston on July 27 & 28, 2022.