Pre Conference Workshop Day
Tuesday May, 16 | Boston, MA
Workshop A
Reshaping CMC Strategies to Increase Regulatory Success of Next Generation RNA Therapeutics
9am - 11am
As the unprecedented efficacy of RNA in the treatment of various diseases has catapulted RNA-based therapeutics into the limelight, it is crucial to design robust protocols for scaling and manufacturing the therapeutic drugs for regulatory approvals and commercial use. With streamlined chemistry, manufacturing and control (CMC) strategies, next generation RNA-therapeutics can be manufactured more efficiently and efficaciously to accelerate the development and manufacturing timeline.
This workshop aims to explore:
- Optimizing streamlined CMC strategies to ensure quality manufacturing standards are established
- Obtaining a comprehensive understanding of which steps and variables need to be controlled in the manufacturing process
- Ensuring consistency of specificity, safety, stability and strength of the therapeutic drugs in both a clinical trial and commercial setting
- Driving R&D success by minimizing bottlenecks in process development, manufacturing scale-up, qualification and validation, quality assurance and quality control approaches
- Improving CMC strategies to increase chances of regulatory success
Workshop Leader:
Dimki Patel
RNA Vaccines CMC Lead,
GSK
Workshop B
Navigating Immunogencity Hurdles to Attain Efficacious Next Generation RNA Therapeutics with Improved Safety & Immunogenicity
11:30am - 1:30pm
The field of next generation RNA therapeutics is progressing at a rapid Workshop Leaders: rate, with the promise of many candidate therapeutics being testament to the industry’s effort in improving standards of care and revolutionizing personalized medicine. Consequently, the field needs to sustain momentum and expedite successful candidates through the clinic. As momentum continues building in the clinic for next generation RNA therapeutics, the industry must be aware of the immunogenicity challenges that need to be surmounted as their therapeutics enter the pipeline.
This workshop aims to delve deep into:
- Reviewing immune response challenges from first-generation RNA therapeutics
- Understanding and overcoming the immune response bottlenecks from next generation RNA therapeutics
- Evolving the approaches of improving safety and immunogenicity of the therapeutics
Workshop Leaders:
Yashu Liu
Head of Bioanalytical
Laronde
Michael Mingueneau
Head of Immunology
Laronde
Workshop C
Leveraging Computational Modeling to Accelerate the Discovery of Next Generation RNA Therapeutics
2:30 - 4:30pm
With the advancement of next generation sequencing techniques, machine Workshop Leaders: learning-based approaches have become more powerful and crucial to the discovery of RNA modifications and diverse associations between RNA molecules and complex diseases. Computational modelling approaches have been transforming the optimization and acceleration of the drug discovery process and the exploration of RNA molecules as potential therapeutic targets. As next generation RNA therapeutics are being catapulted into the limelight, it is important to work in parallel and advance the technologies used throughout the pipeline.
This workshop aims to leverage the importance of computational approaches for drug discovery by exploring:
- How computational innovations are applying AI for RNA drug design
- How computational modelling gives insights into RNA stability and structure and how it can improve them
Workshop Leaders:
Peng Yue
Co-Founder & CEO
ReviR Therapeutics
Xing Tang
Director, Computational Biology
ReviR Therapeutics