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.
Sponsored by Precision ADVANCE, 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. This discussion will be moderated by Arsalan Arif (Founder & Publisher, Endpoints News), and include insights from Deborah Phippard (CSO, Precision for Medicine), Maham Ansari (Senior Director, Regulatory Affairs, Precision for Medicine), and Andy Kinley (VP, Innovation & Clinical Science, Precision for Medicine).
Key points to be discussed:
- 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