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Webinar - On Demand

Gene Therapy Assays: Achieving Regulatory Compliance with a Unified Immunogenicity Strategy

Date: 11/19/2024

Duration: 60 Minutes

In this webinar, industry experts from Precision for Medicine will provide actionable insights into designing immunogenicity assays that comply with both European IVDR and US FDA regulations. Our discussion will focus on the challenges and strategies for integrating these regulatory requirements into clinical trial plans, ensuring your assays are both effective and compliant.

We will explore the nuances of assay customization, revealing how targeted design can streamline your path to regulatory approval. Whether you’re grappling with the complexities of integrating regulatory demands into clinical trials or seeking ways to optimize assay effectiveness across multiple regions, this session offers the insights you need to stay ahead.

Topics covered:

  • Critical importance of tailored assays: Discover why customized assays are essential in gene therapy to effectively determine immunogenicity and enhance therapeutic outcomes.
  • Navigating dual regulatory requirements: Gain strategic insights into harmonizing European IVDR and US FDA regulations within your clinical trial framework.
  • Regulatory compliance: Learn best practices for developing assays that are compliant across multiple regions, minimizing the need for redundant assay development and testing.
  • Strategic planning for assay development: Understand how to approach assay development with a global mindset, focusing on efficiency and regulatory alignment.

Register to Watch Webinar On Demand

Speakers

  • Maham_Ansari

    Maham Ansari

    Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh

  • Deb Phippard

    Deborah Phippard, PhD, Chief Scientific Officer

    Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.