RNA Clinical Trials Videos

1. 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.

2. Shaping Therapeutic Development With Cutting-Edge CRISPR Nucleases 6/4/2025

   Gain an understanding of how an advanced nuclease portfolio is designed to support CRISPR-based cell and gene therapy development, providing scientists with the best solutions for therapeutic success.

3. Adapting Clinical Strategies For Rapid Response 12/5/2024

   This presentation aims to equip sponsors, researchers, and stakeholders with the tools to enhance trial resilience and ensure continuity in today’s unpredictable global landscape.

4. Navigating The Early Oncology Landscape: Market Trends And Insights 5/14/2025

   Explore the evolving landscape of early-phase oncology clinical trials, including strategic insights to empower operations teams in optimizing study design, site selection, and recruitment.

5. PepGen's SVP Head Of Clinical Development On Delivery Of Oligonucleotide Therapies 10/27/2022

   PepGen, a Cambridge, MA-based biotech, is advancing oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases. SVP Head of Clinical Development Dr. Michelle Mellion explains PepGen's trial of PGN-EDO51, the company’s lead product candidate for the treatment of DMD patients whose mutations are amenable to an exon 51 skipping approach. She also explains how the delivery of oligonucleotide therapies differ from other techniques in genetic medicine, and much more.

6. 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.

7. Accelerating Development In Novel & Advanced Oncology Therapies 6/15/2023

   Hear from a panel of industry experts on dissecting the shift in early-phase oncology design, focusing on Bayesian Data.

8. 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.

9. 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.

10. 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.