8:30 am Check-In Opens & Light Breakfast
9:00 am Chair’s Opening Remarks
9:30 am Workshop A
Navigating Existing Standards & Regulatory Requirements for Analytical Development of mRNA Vaccines to Ensure a Streamlined Approval
Synopsis
Reviewing standards and regulatory requirements is critical for mRNA vaccines. In order to do so, we can look at the entire process from research and development to clinical trials and postmarket surveillance. This includes evaluating the manufacturing process, assessing the safety and efficacy of the vaccine, and monitoring for any adverse events. Additionally, it’s important to consider the ethical implications of vaccine distribution and ensure that access is equitable. Ultimately, a thorough review of standards and regulatory requirements is necessary to ensure that mRNA vaccines are both safe and effective in protecting public health.
Join this session to discuss:
- Delving into the quality issues regarding mRNA vaccines and how we can overcome them
- Discussing what is expected by the regulatory agencies for the clinical and non-clinical requirements
- Understanding the regulatory guidelines for CMC’s and manufacturing testing to allow a streamline approval
- Exploring the advances of having a platform approach for vaccines to allow a more rapid approval of your mRNA vaccines
12:30 pm Lunch Break & Networking
1:30 pm Workshop B
Optimising Analytics for Next Generation Nucleic Acid-Based Therapeutics to Better Understand RNA & Achieve Successful Applications Towards Effective mRNA Therapeutics
Synopsis
Nucleic acid-based therapeutics have emerged as a promising avenue for treating various diseases, including genetic disorders, cancers, and infectious diseases. With recent advancements in technology and understanding of nucleic acid biology, there is a growing need for advanced analytics techniques to optimize the development and efficacy of these therapeutics. This workshop aims to provide participants with an in-depth understanding of advanced analytics methodologies tailored specifically for next-generation nucleic acid-based therapeutics.
Join this session to discuss:
- Discuss implications of DNA templates and circular RNA in mRNA therapeutic development
- Navigate the current advancements in techniques for analyzing nucleic acid structure, stability, and enzymatic degradation
- Deep dive into key impurities and purification challenges specific to nucleic acid analysis, with a focus on toxicology aspects
- How we can align RNA technologies with mRNA analytical methods to create more effective and efficient treatments for a variety of diseases