Case study

Nascent technology barrier
clearance

Challenge

A cutting-edge cell and gene therapy company’s clinical trial was facing a delay due to additional FDA requirements for its newer technology. The company hired Catalyst to contextualize the regulatory environment, help progress its trial and prevent regulatory hurdles for its pipeline.

Strategy

  • Worked with the company to define and hone the regulatory challenges.  
  • Elevated the issue of trial delays within the industry.
  • Prepared a presentation for discussion with the Agency, posing potential solutions to specific challenges.
  • Socialized the need for early information sharing with FDA on nascent technologies to facilitate efficiency in future product development.

Impact

  • Within a few weeks, the client's trial was permitted to progress.
  • FDA created process enhancements to reduce future trial delays.

Interested?
Explore additional Catalyst capabilities.

Cross-functional strategic vision development and execution

View case study

Network expansion

View case study

Regulatory pathway strategies and submissions

View case study