Jai Pandey

Jai Pandey

Company: Sanofi

Job title: Head, Global Device Regulatory for IVD/CDx and Digital Health


Ask the Experts: Navigating the Paradigm Shift: The Role and Regulation of Companion Diagnostics (CDx) in Precision Medicine 2:00 pm

Join us for an open-to-the-floor Q&A session on the evolving landscape of CDx. This session will feature industry experts discussing the paradigm shift in precision oncology drug development and clinical practice, evolving regulatory landscape, and the future direction of CDx. We’ll explore the challenges, new regulations, and practical considerations for CDx in clinical practice and…Read more

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Assessing Challenges in Existing Regulatory Frameworks for Rare Diseases to Facilitate CDx Approval Across Diverse Therapeutic Domains & Navigating the Complex Landscape of Diagnostics in Gene Therapies 2:45 pm

What are the critical challenges associated with obtaining patient samples for rare diseases to meet the validation requirements for regulatory approval? Navigating innovative approaches in overcoming evidentiary hurdles specific to rare diseases within the CDx regulatory framework- a shift from oncology, evolving global regulatory landscape, decision on centralized versus point of care testing Analysing the…Read more

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Panel Discussion: Overcoming Challenges in a Shifting Regulatory Landscape to Gain CDx Approval Across Diverse Markets 9:30 am

Discussing the dynamic nature of the regulatory landscape and strategies for adapting to changes, ensuring successful CDx approvals across different markets How can we strive towards a unified regulatory framework – where could regulatory bodies collaborate to drive harmonious efforts in CDx regulation? Exploring the advantages and disadvantages of different approaches to CDx regulation Standardization…Read more

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