SOURCE: Xtalks

Xtalks Webinars

June 12, 2015 07:00 ET

Pathways Considerations to CDx Development and Commercialization, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - June 12, 2015) - Join industry experts Mark Roberts, Director of Diagnostics Development at Covance, and Alan Wookey, Associate Vice President and Executive Director of Companion Diagnostics at Covance, as they discuss key considerations to initiate an efficient process. The live webinar takes place on Tuesday, June 30, 2015 at 10am EDT / 3pm BST (UK GMT +1).

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. Yet there are several paths to consider in the development towards the commercialization of these CDx 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, clinical trial professionals 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 CDx development.

Participants will learn key considerations to initiate an efficient process to meet their program's unique needs. The presenters will:

  • 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

To learn more about this complimentary event visit: Pathways Considerations to CDx Development and Commercialization

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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