Explore the Agenda
8:00 am Check-In, Coffee & Networking
Workshop A
Structuring RNA Design, Manufacturing & Regulatory Planning to Accelerate IND Timelines & Reduce Development Risk
Advancing novel RNA therapeutics requires early, aligned decisions that strengthen manufacturability and regulatory readiness. This workshop provides a practical framework for designing circular and self-amplifying RNA constructs, anticipating CMC risks and building streamlined development paths that reduce rework and accelerate IND timelines.
This workshop will gather experts to discuss:
- Accelerate IND timelines by applying structured design principles that cut construct development cycles and improve potency/durability.
- Prevent scale-up failures by identifying manufacturability and CMC risks early, ensuring GMP consistency and reducing costly rework.
- Minimize IND deficiencies by aligning regulatory expectations with analytical and CMC strategies, reducing late-stage surprises.
- Unify design, manufacturing, and regulatory teams to enable faster decision-making and reduce development bottlenecks.
This workshop is for:
R&D leaders, CMC teams, program directors, regulatory strategists and platform developers seeking a more predictable and accelerated path from sequence design to IND
12:00 pm Networking Lunch
1:00 pm Workshop B
Engineering Immunogenicity & Dosing Strategies to Enable Redosing & Expand Therapeutic Reach
Repeat-dose RNA therapeutics require careful engineering to reduce innate activation, expand the therapeutic window and support multi-dose regimens. This workshop provides a clear framework for understanding immunogenicity drivers, designing for tolerability and aligning dosing strategies with long-term clinical needs.
This workshop will gather experts to discuss:
- Reduce reactogenicity and strengthen safety margins by pinpointing innate immune activation pathways and integrating immunology, delivery, and regulatory considerations early in development
- Strategies to improve the potency of saRNA to drive lowered dosing and maximize the therapeutic window
- Differentiate the role of RNA design versus formulation and delivery in maximizing potency, durability, and dose efficiency
- Enable multi-cycle regimens by structuring redose-ready delivery and dosing strategies across diverse tissues and indications
This workshop is for:
Teams developing therapeutic RNA programs who need to overcome dose ceilings and enable safe, reliable redosing in autoimmune, oncology, neuromuscular or CNS applications