RNA Clinical Trials Videos

1. Overcoming Regulatory, Safety/Efficacy, And Toxicity Hurdles 11/28/2022

   In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss what industry challenges should be top of mind for experts as it relates to the regulatory paradigm, toxicity/safety, and in vivo modeling.

2. A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor 1/23/2024

   In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.

3. Proactive Partnerships: Engaging FDA And EMA During mRNA Process Development 6/24/2025

   Panelists Tiffany Lucas and Ulrike Jägle address an audience question about when and how to approach the regulatory agencies for mRNA process development. In addition to listing the different FDA and EMA meeting opportunities available to sponsors, Jägle reminds us of one critical best practices sponsors shouldn’t forget when approaching the agencies.

4. 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.

5. The Scientific Underpinnings Of mRNA/LNPs 11/28/2022

   In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, share their thoughts on the scientific-research and CMC-related reasons that have made the lipid nanoparticle the “darling” of the delivery world for mRNA/RNA products today.

6. What Have We Learned About Our LNP's Function In Vitro In 2024? 12/4/2024

   BioNTech’s Ben Muir shares a high-level overview of the LNP preclinical research advances that are the most exciting/promising today — while also reminding us of a few important caveats that accompany early-stage research. 

7. 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.

8. 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.

9. What Innovations Could Help Us Overcome Preclinical Model Limitations For RNA-LNPs? 12/4/2024

   In this Advancing RNA Live clip, BioNTech’s Ben Muir and Hopewell Therapeutics’ Kate Zhang share their perspectives on the most exciting novel screening methods, innovative preclinical models, and next-gen technologies they hope can/will eventually help us bridge the translation gap between preclinical models and the clinic.

10. Michelangelo Meets mRNA | ARW on RNA Ep04 5/4/2023

    Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 4, Welch explores the parallels that exist between the oft-overlooked history of Michelangelo's David and the mRNA therapeutics sector's own R&D history, as well as where the mRNA space hopes to move in the future.