SmartPharm focuses on technologies with reduced regulatory risk of barriers to clinical implementation
We have learned from our experience with multiple regulatory agencies (FDA, Health Canada, and China FDA) to avoid these approaches that will make it more difficult to achieve market approval with a gene-encoded therapeutic:
- Use of viral vectors or other approaches requiring pharmaceutical-based immune suppression
- The use of electroporation as a delivery technology
- Complex non-viral delivery technologies that face extensive regulatory hurdles
- Expensive or highly complex manufacturing processes
SmartPharm implements an accelerated development ecosystem
We also utilize an established network of best-in-class development partners to speed development of new therapeutics into clinical testing. We tap networks and approaches that have already proved to be able to move new candidates into clinical testing faster and less expensively than industry standards.