Overcoming regulatory obstacles in omics-driven IVD approval: Panel discussion
May 13, 2025, at 15:00 BST / 16:00 CEST / 10:00 EDT / 9:00 CDT / 7:00 PDT
The development, approval, and delivery of advanced molecular in vitro diagnostics (IVD) is a complex and lengthy process, often hindered by numerous barriers. These challenges range from access to high-quality orthogonal datasets and properly consented specimens with associated longitudinal health records, to navigating a vast array of tools, solutions, and platforms for biomarker discovery, result generation, regulatory submission, and regulatory approval acceleration using component registered and cleared devices.
This unique panel discussion with two experts in the field, will explore the key data, informatics, and regulatory obstacles, along with innovative solutions - both established and emerging - that can significantly streamline IVD development and delivery.
Key learning objectives
- Navigating development challenge: Understand the key barriers in developing advanced ‘omics-based diagnostics, from ideation and hypothesis testing to market access, verification, validation, and regulatory approval.
- Optimizing data access and quality: Learn how to overcome challenges in acquiring high-quality datasets, consented specimens, and longitudinal health records to support robust diagnostic development.
- Harnessing advanced analytics and technologies: Explore cutting-edge data analytics, insights generation solutions, and emerging technologies that can address development and regulatory hurdles.
- Accelerating market readiness: Discover how integrated informatics and regulated software solutions can streamline regulatory approval and speed up the delivery of high-quality molecular diagnostics.
Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
If you view the on-demand webinar, you can request a certificate of attendance by emailing editor@selectscience.net.
Speakers
Dr. Jack DiGiovanna is Chief Science Officer at Seven Bridges (a Velsera company) as well as an executive leader at Velsera where he oversees the Scientific Program Management and Researcher Education & Adoption teams. At Seven Bridges, he has led the development of many discovery and analysis ecosystems, where he is committed to building systems that accelerate the pace of scientific discovery.
Rakesh Nagarajan M.D., Ph.D., has been a pioneer in genomics and informatics for 20+ years. He started at Washington University, the first CAPCLIA laboratory for clinical NGS, where he facilitated clinical and translational research by integrating EHR, clinical trials, patient registry, biospecimen, and genomics data and supported complex multimodal analyses across these data types. As the Founder and President of Pierian, he built the Clinical Genomics Workspace (CGW), an end-to-end disease, assay and instrument agnostic informatics solution used to process clinical NGS cases. At Velsera, Dr. Nagarajan leads the Knowledgebase team, which is responsible for curated clinical content that supports tertiary analysis in the CGW, and is responsible for regulatory submissions and for incubating and developing technology solutions to extend Velsera's reach.
Moderator
