Newsletter | June 19, 2024

06.19.24 -- What Can mRNA Learn From The Oligo Regulatory Paradigm?

Welcome to the Advancing RNA newsletter, delivering weekly insights on RNA therapy development. Based on your interest in the recent webinar Deciphering mRNA Immunogenicity: The What, Why, And How Of Early Assessment Of Human Immune Response Of Your Molecule Candidate (from our sister newsletter Outsourced Pharm), we thought you’d find Advancing RNA useful for addressing the analytical, formulation, manufacturing, outsourcing, and supply chain challenges you face in this rapidly evolving space. If not, you can unsubscribe at any time.


Clinical Research As A Delicate Ecosystem

Making the right outsourcing decision can significantly contribute to the success and growth of your program, providing essential support and resources that empower it to thrive in its objectives and endeavors. Trust that your program is in hands you can rely on, where integrity is paramount, and excellence is the standard.


Multidisciplinary mRNA: What Can We Learn From Other CGTs?

Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.


Streamline Process Characterization For Successful Validation Campaigns

Explore how a stepwise approach for process characterization can help target the right experimental design and be tailored for different programs based on prior knowledge and experience.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

Potent Immune Response With Vernal's LNP-mRNAs

As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.

Insights Into GMP Manufacturing Of RNA-LNP Drug Products

Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.

Staying On Top Of Changing FDA Regulations To Avoid Clinical Holds

As the biotech industry has grown exponentially, so has the number of FDA clinical holds. Biotech companies need strategic planning to avoid or quickly resolve costly clinical holds.

Navigating The Regulatory Maze: Fundamentals For Drug Development

Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey. 


What Can mRNA Learn From The Oligonucleotide Regulatory Paradigm?

ReciBioPharm’s Melanie Cerullo shares where mRNA needs to “catch up” to its oligonucleotide “cousin” molecules and where regulatory differences may be emerging between modalities.

Gene Therapy: Global Market Trends & Notable Developments

New market research about the gene therapy market from Markets And Markets reveals insights into macro trends, delivery methods, therapeutic areas, and more.