Gene Therapy Roundup: What To Know Now From The Lab To The FDA
Gene therapy continues to evolve rapidly - from the science to the regulatory requirements. To give you a greater perspective on recent developments, this panel discussion brings together gene therapy experts across assay development, regulatory submissions, and clinical trial strategy who will share observations from the front lines on a multitude of gene therapy and rare disease projects.
This event will be of interest to anyone involved in gene therapy clinical trial conduct, translational research, regulatory affairs – and anyone seeking to ensure successful gene therapy clinical development in the current climate.
Attendees will hear about:
- Advances in gene therapy assay development
- Validating gene therapy companion diagnostics--considerations for ensuring CDx approval
- Optimizing the likelihood of preclinical and clinical trial development success
- Winning strategies for rare disease trial design and regulatory submissions in the US and EU
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