RNA Clinical Trials Videos

1. 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.

2. ICH E6(R3): Practical Steps For Implementation 12/14/2023

   Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

3. Who's In Charge? How To Ensure Effective Trial Oversight, Leadership 3/19/2025

   Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Early Phase Excellence: Navigating B Cell Therapies In Autoimmune Conditions 12/2/2025

    Follow along as expert panelists share insights into the most critical considerations for navigating early-phase clinical development and designing studies that reliably translate mechanisms into meaningful patient outcomes.