SOURCE: Xtalks

Xtalks Webinars

October 08, 2015 07:00 ET

Developing an Effective Global CDx Regulatory Strategy, Upcoming Webinar Presented by Precision for Medicine, Hosted by Xtalks

TORONTO, ON--(Marketwired - October 08, 2015) - In an upcoming webinar on October 19, 2015, Precision for Medicine experts will present strategies to develop and manage an effective Global Companion Diagnostic (CDx) Program, designed to maximize the chance of a successful, coordinated launch of a therapeutic and companion assay world-wide.

Precision for Medicine experts Austin Speier, Director of Emerging Technologies and Markets, and Judi Smith, Vice President of In Vitro Diagnostics Regulatory and Quality, will present the four key building blocks to an effective global CDx launch: in-country expertise, global data plan, timeline management, and effective communication. In addition, aspects unique to therapeutics and diagnostics as well as how to manage multi-company partnerships will be addressed. Lastly, recent updates relevant to global CDx regulatory programs and potential changes to anticipate will be reviewed.

The live broadcast takes place on Monday, October 19, 2015 at 11am EDT / 4pm BST (UK/GMT+1). For more information or to register for this complimentary event, visit: Developing an Effective Global CDx Regulatory Strategy.

Launching a CDx globally requires a multifaceted approach and an understanding of an ever increasingly demanding global landscape. While each component is a fundamental building block to an effective Global CDx Program, it is the overall context of how they are implemented within the CDx program team that is key. Participants will learn how to navigate the unique and often shifting challenges of launching a Global CDx - anticipating new regulations, coordinating with the therapeutic approval strategy, generating locally required data, managing on-the-ground meetings and submissions, aligning efforts with partners and stakeholders, and optimizing timelines while mitigating risk.

About Precision for Medicine

Formed in 2012, Precision for Medicine is a specialized services company supporting next generation approaches to drug development and commercialization. It provides integrated services and infrastructure to support pharmaceutical and life sciences companies as they develop new products in the age of precision medicine. Precision for Medicine brings expertise, technology, and project execution to support innovative, patient-centric solutions from discovery through commercialization. The company is headquartered in Bethesda, MD, with offices in Cambridge, MA, Chicago, IL, Frederick, MD, Gladstone, NJ, Indianapolis, IN, New York, NY, and Stamford, CT. For more information, visit

About Xtalks

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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