Pathway Considerations to CDx Development and Commercialization

In the era of personalized medicine, drug developers face increasing pressure to create targeted therapies. Companion diagnostics (CDx) can enable new opportunities to be realized by identifying safety and/or efficacy biomarkers that stratify patient populations. There are several paths to consider in the development towards the commercialization of these Companion Diagnostic assays.

Whether developing an In-Vitro Diagnostic (IVD) or a regulated Laboratory Developed Test (LDT), many efficiencies can be realized with novel approaches that unify parallel co-development and approval of the therapy and accompanying diagnostic. As many of these opportunities are being considered earlier in the drug development process and, a co-development strategy requires a carefully coordinated oversight to accelerate the process and extract the most value out of the clinical trials.

With the recent merger of Covance and LabCorp, you can now access an unprecedented level of scientific and operational synergies, from development and validation to commercialization. Spanning solutions across novel biomarker discovery to rapid deployment strategies, our subject matter experts will discuss how these combined, end-to-end strengths can transform your CDx development.

You’ll learn about key considerations to initiate an efficient process that best meets your program’s unique needs. Together, we’ll:

• Explore models for accelerating your CDx development to commercialization
• Compare approaches between In-Vitro Diagnostics (IVD) and Regulated Laboratory Developed Tests (LDT)
• Learn how to leverage resources and expertise between specialty and central lab partners
• Discover strategies to reduce CDx development timelines, costs and potential risks
• Review recent case studies with FDA submissions that demonstrate successful outcomes for both models

Speakers

Mark Roberts, Ph.D., Director of Diagnostics Development, Covance

Mark J. Roberts received his PhD in Pharmaceutical Sciences from the University of Nottingham (UK) and has worked in the clinical diagnostics arena for over 20 years, holding senior positions in both the in vitro diagnostic and reference laboratory industries. He joined Covance in 2012 to spearhead their Companion Diagnostics initiative, designed to assist Pharmaceutical and diagnostic companies in drug/ companion diagnostic co-development.

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Alan Wookey, Associate Vice President and Executive Director of Companion Diagnostics, Covance

Alan Wookey works across the industry to develop biomarker programs with pharma and biotech, from analytical and clinical validation through to regulatory approval and commercialization. Prior to joining Covance, Alan held leadership positions in oncology clinical development at AstraZeneca. He earned his degrees in Microbiology from the University of Liverpool, and has been focused in pharmacogenetics and personalized medicine for more than 10 years.

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