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Digital Webinar Sponsor - NeoGenomics Laboratories
Launching a Companion Diagnostic: Research and Development Through Commercialization
Wednesday 2nd September 2020 | 16:00 BST | 11:00 EDT
Presented by Scott Reid, PhD, MBA; Executive Director Strategic Alliances and CDx, NeoGenomics
New approaches to personalized medicine have made drug development more efficient by identifying patient populations most likely to benefit from immune or targeted therapy. These advances have simultaneously made drug development more complicated, by requiring the co-development, regulatory approval, and marketing launch of a companion diagnostic (CDx). Drug developers now find themselves responsible for not only developing a therapeutic, but also a CDx that is compatible with standard laboratory practices, easy to order, produces quick results, and is easily interpreted by the ordering physician. A well-functioning clinical trial assay may not necessarily meet these criteria. In this presentation, NeoGenomics shares our experience developing and deploying diagnostics for use in clinical trials (through our Pharma Services Division) and marketing CDx to hospitals, oncologists, and pathologists (through our Clinical Division). In this discussion we highlight our experience developing CDx through different regulatory pathways and the pros and cons associated with the different technology and platform choices available. Additionally covered is the challenge of transitioning a CDx from clinical trials to commercial practice post-approval, where the incentives and reimbursement are starkly different than those in the CRO industry. Finally, given the large number of CDx available, we provide an overview into NeoGenomics’ decision process whether or not to offer a diagnostic on our commercial menu, or whether development of an equivalent laboratory developed test (LDT) may be warranted. Our goal is to provide guidance and best practice to ensure that CDx are not only successful in clinical trial applications, but also market launch.
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