Aligning mRNA Progress With Regulatory Streamlining

In this exclusive BioPharm International Peer Exchange video series, Chris Spivey, Director of Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of mRNA scientific and commercial progress as it intersects with compliance and regulatory streamlining, potentially as a “platform” pathway.

EP. 1: The Benefits of Working with mRNA for Therapeutics

July 3rd 2024

The panelists discuss the advantages of rapid development, versatile applications, and precise dosing, and how they combine to signal a promising future for mRNA therapeutics.

EP. 2: Public Perception and Communicating the Potential and Safety of mRNA

July 3rd 2024

Experts discuss the critical need for cultivating public trust as mRNA technology makes promising advancements in treating a range of diseases.

EP. 3: Lessons from Vaccine Development and Future Possibilities

July 18th 2024

The panel discusses the rapid development of mRNA vaccines, the opportunities for mRNA technology to revolutionize drug discovery and gene therapy, and the need for regulatory collaboration to enable efficient review and access to these innovative treatments.

EP. 4: Streamlining Rare Disease Drug Development

July 18th 2024

The discussion explores how the principles of Operation Warp Speed can be applied to expedite rare disease therapeutic development through a new FDA pilot program aimed at streamlining the drug development process.

EP. 5: Navigating Challenges and Embracing Opportunities to Optimize mRNA Therapies

July 18th 2024

The discussion covers the challenges of optimizing mRNA therapies, including the diverse behaviors of mRNA in biological systems, as well as the opportunities presented by emerging mRNA technologies like circular and self-amplifying RNAs, and the role of regulators in ensuring quality control of these novel products.

EP. 6: Overcoming Delivery Challenges of mRNA Therapeutics

July 18th 2024

The key to advancing mRNA therapeutics lies in developing more efficient and versatile delivery systems that can overcome challenges around stability, targeting, and safety.

EP. 7: The Future of Manufacturing, Safety, and Collaboration

July 18th 2024

The panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.

EP. 8: Key Takeaways from the Peer Exchange Discussion “Aligning mRNA Progress with Regulatory Streamlining”

October 2nd 2024

There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.