Strategies in AAV Gene Therapy for CDx and Assay Development – Webinar

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 for HERE

Thursday, December 7th 2023, 11:00 am ET | 5:00 pm CET
Precision for Medicine