In this free webinar, gain a clear understanding of the latest European Union (EU) regulatory requirements for conducting gene therapy (GMO) trials with companion diagnostics (CDx). The featured speakers will share strategic approaches to navigate complex European submission processes and ensure regulatory compliance. Attendees will learn key operational readiness factors that can impact trial execution from site selection to logistics. The speakers will also share essential insights for US-based sponsors looking to successfully conduct GMO trials in Europe.
TORONTO, April 24, 2025 /PRNewswire-PRWeb/ -- Discover an informative webinar that will deliver essential insights for biotech and specialty pharma companies planning gene therapy (GMO) trials with companion diagnostics (CDx) in the European Union (EU), as well as strategies for successful trial implementation.
In an era where precision medicine is revolutionizing rare disease treatment, one critical challenge remains: many patients still lack access to the CDx tests needed to guide targeted therapies.
While genetic biomarker testing has become a cornerstone of personalized medicine, significant barriers persist—particularly for those with rare and neurological conditions—limiting their ability to receive the most effective treatments.
This gap in real-world diagnostic accessibility, combined with the increasing sophistication of GMO trials, presents unprecedented challenges for trial sponsors navigating the complex intersection of GMO regulations and CDx requirements within the EU. As these requirements become increasingly stringent, understanding the nuanced European regulatory landscape has become crucial for ensuring successful trial planning and execution.
Through practical case studies and real-world examples, the expert speakers will explore the intricate regulatory pathways and operational considerations that impact trial readiness and timeline management, with a focus on rare diseases and the unique challenges faced in neurological indications. The key areas of focus include:
- A clear understanding of the latest EU regulatory requirements for conducting GMO trials with CDx
- Strategic approaches to navigate complex European submission processes and ensure regulatory compliance
- Key operational readiness factors that can impact trial execution from site selection to logistics
- Essential insights for US-based sponsors looking to successfully conduct GMO trials in Europe
This webinar is designed for regulatory and clinical leaders who need to confidently navigate the evolving European regulatory landscape while ensuring smooth and efficient trial execution. Attendees will examine actionable strategies to streamline submissions, maintain compliance and tackle operational hurdles in GMO trials with CDx—empowering them to drive successful outcomes in their gene therapy programs.
Register for this webinar today to unlock pivotal insights for biotech and specialty pharma companies embarking on gene therapy trials with companion diagnostics in the EU.
Join experts from TFS HealthScience, Mesfin James, Vice President, Head of Regulatory Affairs; and Lakshmi Guduri, Senior Director, Project Management, for the live webinar on Wednesday, May 14, 2025, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Mastering Gene Therapy and Companion Diagnostics Trials: The EU Regulatory Playbook.
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