RNA Clinical Trials Videos

1. 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.

2. Q&A On LNP Cell-Specific Delivery 11/28/2022

   In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery for Strand Therapeutics, outline several examples of foundational research that could provide insights into how we attain more specific cellular uptake of LNPs.

3. 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.

4. 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.

5. Fly Fishing Meets mRNA | ARW On RNA Ep05 7/12/2023

   Hosted by Cell & Gene Collaborative Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 5, Welch dives into the separate — but strikingly similar — worlds of fly fishing and mRNA R&D. In particular, she explains how a fly fisherman’s strategies to catch a fish relate to the work of mRNA scientists as they strive to identify the most appropriate immunogenicity profiles for their mRNA vaccines or therapeutics.    

6. 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.

7. Mitigating Financial Risk Before Selecting An Outsourcing Vendor 9/25/2023

   Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.

8. 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.

9. A New Approach to Genome Engineering with Tessera Therapeutics' Dr. Michael Severino 9/11/2024

   Tessera Therapeutics' CEO, Dr. Michael Severino, joins Host Erin Harris to discuss Gene Writing, the biotech's genome engineering technology that writes therapeutic messages into the genome to treat diseases at their source. Severino discusses why delivery has always been a challenge for gene editing technologies and why Gene Writing is different when it comes to efficient delivery.

10. 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.