Innovators developing gene therapies face a multitude of challenges, from the lab to the FDA. Yet a number of successful strategies are emerging that are mitigating the risks, reducing costs and smoothing out the road to approval. Listen to a panel of gene therapy experts with unique perspectives and real-world experiences share successful approaches in gene therapy development, CDx development and commercialization.
This panel discussion co-hosted by Endpoints Webinars and Precision for Medicine will be moderated by Arsalan Arif (Founder & Publisher of Endpoints News) and feature insights from Eugen Koren (Senior Scientific Advisor, Immunology at Precision for Medicine), Maritza Mcintyre (Chief Development Officer at StrideBio), Markus Peters (President & CEO of Aevitas Therapeutics), Deborah Phippard (Global Head, Research at Precision for Medicine), and Karen Richards (Senior Vice President, IVD regulatory & Quality Consulting at Precision for Medicine). It will be followed by an interactive Q & A session.
Attendees with hear:
- Factors in the NAb vs. TAb assay choice, including respective assay development challenges and agency outlooks
- How to make the most of early engagement and collaboration with regulatory agencies
- How to plan and prepare for CDx development from the beginning of assay development
- New approaches for CDx regulatory approval and commercialization
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