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