RNA Clinical Trials Videos
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Designing Effective Multivalent mRNA Therapies: Key Regulatory Considerations
6/24/2025
How many mRNAs are too many in a multivalent therapy? In this clip, Eliquent Life Science’s Tiffany Lucas and CureVac’s Ulrike Jägle delve into this question, emphasizing the factors that are essential for regulatory success and patient benefit.
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From Crisis To Confidence: Ensuring Smooth Regulatory Submissions
10/8/2024
Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.
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How A Sponsored CMC Platform Accelerates mRNA Projects Into The Clinic
1/31/2023
Developing a client-sponsored Target Product Profile (TPP) and Analytical Target Profile (ATP) is critical to move your drug product to clinic efficiently and meet acceptance criteria.
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How Is mRNA "Shaking Up" Our Regulatory Interactions & Operations Today?
5/10/2024
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
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Go/No Go Decisions Based On Early Phase Oncology Trials
9/22/2022
In this webinar, gain insight into the latest regulatory and clinical developments in the field of oncology in China.
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R&D & CMC Priorities For LNPs Beyond Cell-Specific Delivery
12/4/2024
It goes without saying that achieving cell-specific delivery is the most often discussed challenge facing the RNA-LNP field near- and long-term. However, as these three LNP experts share in this Advancing RNA Live clip, they have a whole list of additional R&D and CMC priorities we must address/accomplish to improve RNA-LNPs’ efficacy in personalized and gene therapy approaches.
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Capstan Therapeutics' CEO Laura Shawver On In Vivo Cell Engineering
11/10/2022
Capstan Therapeutics' CEO, Laura Shawver, Ph.D., talks us through the company's in vivo CAR therapies and what led to the in vivo cell engineering breakthrough that has been decades in the making. Shawver explains the promise of harnessing mRNA and targeted LNP delivery to train a patient’s body to make CAR-T cells in vivo. She also details best practices to garner funding and investment partnership.
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Goldilocks & The 3…CQAs? Finding "Just Right" With LNP Optimization
12/4/2024
Three LNP experts from Sanofi, Hopewell Therapeutics, and BioNTech collectively discuss how far we’ve come in understanding the structure of our LNPs while also shedding light on the variables that have the greatest potential of causing shifts in our products’ structure/function.
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Approving The World's First saRNA Vaccine: Arcturus' Regulatory Experience
5/10/2024
Explore the behind-the-scenes best practices of the company implemented that led to the approval of the world’s first saRNA vaccine in Japan.
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Development And Regulatory Strategy For US And China
9/22/2022
This webinar discusses the expansion of International Market for Ensartini and RNAi Therapeutics in Oncology, from Skin Cancers to Liver Cancers.