In gene therapy, thoughtful planning cannot be overstated. Gene therapy developers encounter a multitude of challenges, from the lab to regulatory approval. However, there are proven strategies that can mitigate risks, reduce costs, and pave a smoother path to approval.
Join our panel of gene therapy experts with diverse perspectives and real-world experiences as they share these successful approaches and provide a roadmap for gene therapy development, CDx development, and commercialization.
Join the webinar to learn about:
- Recommended best practices throughout the development lifecycle for a gene therapy CDx
- Tools for successful CDx partner assessment and selection
- Regulatory requirements of an immunogenicity clinical trial assay, based on intended use (e.g. enrollment or stratification) in US and EU
- Registration requirements and timelines for a CDx, including premarket approvals (PMAs)
A live Q&A session will follow the presentation, offering you a chance to pose questions to the following expert panelists from Precision for Medicine:
- Deb Phippard, Ph.D., CSO
- Kennon Daniels, Ph.D. VP IVD Regulatory Consulting
- Travis Harrison, Ph.D., VP Bioassay Solutions
Register for FREE HERE