Into the weeds of CDX COMMERCIALIZATION: AN ONCOLOGY REFERENCE LABORATORY PERSPECTIVE

JUNE 29, 2021 | 12:00-12:45pm EST

Considerations for successfully commercializing oncology CDx

hubXchange is delighted to host this webinar on June 29th in partnership with NeoGenomics.

As the largest oncology-focused contract research organization (CRO) in the USA, with comprehensive and global one-stop testing and nearly two decades of cancer-testing experience, NeoGenomics has one of the most robust, analytically validated oncology diagnostic menus in the world. NeoGenomics Pharma Services is committed to delivering an unparalleled level of expertise, flexibility and scalability in our offering. We can and we will work with you to identify the best approach for your biomarker testing strategy, because we remain platform-agnostic.

NeoGenomics consists of three divisions which unify under a common purpose of saving lives by improving patient care:

Pharma Services – biomarker testing CRO specializing in assay development, validation and clinical trial testing
Clinical – largest oncology focused clinical reference laboratory in the US
Informatics – leveraging real-world data generated from NeoGenomics’ clinical division to accelerate clinical trial site and patient recruitment, diagnostics alerts or real world insights

Emphasis on personalized and precision medicines is driving partnerships between pharmaceutical and diagnostic organizations to develop companion diagnostics, with the goal of accelerating clinical trials and regulatory approval. Because companion diagnostics are regulated devices, there are additional development requirements beyond those for biomarkers or clinical assays used in clinical trials. Careful consideration must be given to the regulatory strategy, design of the assay, and supporting technology platform to ensure the device can be successfully commercialized.

As of March 2021, NeoGenomics has participated in more than 90 companion diagnostic track projects, developing and deploying diagnostic tests intended to select and enroll patients in a clinical trial. These cover a broad range of technologies and platforms, ranging from early-stage to pivotal clinical trials. We have extensive experience assay development, transfer, and analytical validation across a broad range of technologies.Oncology

Topics to be covered

NeoGenomics has a unique position in the market whereby we provide support to CDx development in clinical trials and provide testing services to US-based hospitals and physicians as the largest oncology reference laboratory
In this talk, NeoGenomics provides their perspective on technology and platform choice to optimize performance in clinical trials and additionally facilitate commercial launch
Includes a focus on the use of Laboratory Developed Tests (LDTs) to support early-phase development before commitment to full CDx development

Key Learnings

Considerations for early phase CDx development and validation such that the assay can be successfully commercialized
The use of Laboratory Developed Tests and single-site FDA-approved tests to reduce costs and accelerate CDx development times
Learn about the differences between a clinical reference lab and CRO laboratory in the context of running a R&D assay
Misconceptions about CDx commercialization
Options for early phase clinical trial assay development
Best practices for pre-launch
How NeoGenomics can assist/support new and planned biomarker programs from nascent stages through to commercialization with use cases of NeoGenomics’ experience, e.g. PIK3CA, Day-One readiness

Meet the Expert Presenter

Scott Reid heads up companion diagnostic services and strategic alliances at NeoGenomics. He has been with NeoGenomics since 2016 and previously covered Business Development for the New England territory. He has been working in oncology since graduate school with a focus on diagnostics and IVD commercialization that has included previous positions at LabCorp and Covance. Scott completed his PhD in Biochemistry and MBA at Duke University.

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hubXchange-NeoGenomics' Oncology Companion Diagnostics webinAR – june 29 2021