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Gene therapy assays: Achieving regulatory compliance with a unified immunogenicity strategy

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.

Key Takeaways:

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.

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Deborah Phippard

Chief Scientific Officer, Precision for Medicine

Deb Phippard, PhD, is the Chief Scientific Officer at Precision for Medicine. With over 25 years of experience in biotechnology and clinical translational research, she is a veteran in the pharma industry and an expert in biomarker-driven clinical trial design and execution. Dr. Phippard leads biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. She spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.

Maham Ansari

Senior Director, IVD Regulatory Affairs, Gene Therapy CDx, Precision for Medicine

Maham Ansari, MS, RAC, is a seasoned regulatory affairs professional with global leadership experience in IVDs and medical devices. She excels in developing global regulatory strategies and ensuring rapid market entry for innovative technologies, including gene therapy products. Maham is skilled in managing high-performing teams and aligning regulatory vision with corporate strategy throughout the product lifecycle. She has hands-on experience with a variety of high-risk devices and is an expert in US FDA, European CE marking, and global regulatory submissions.

moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.