Press Release (ePRNews.com) - Toronto, Canada - Mar 06, 2018 - Join esteemed speakers from Covance including Steven Anderson, PhD, Senior Vice President and Chief Scientific Officer, and Tom Turi, PhD, Vice President of Companion Diagnostics for a live session on Wednesday, March 21, 2018 at 11 a.m. EDT (3 p.m. GMT),
The Laboratory Developed Test (LDT) approach, incorporating the single-site pre-market approval, for Companion Diagnostic development has seen a recent increase in interest because of the evolving regulatory and business environment. In a precision medicine approach to drug development there is great uncertainty at the beginning of a program as to whether it will produce a viable companion diagnostic; the benefits of flexibility, faster results, reduced upfront investment and effective risk management make the single-site pre-market approval path an increasingly appealing option. If a successful CDx candidate does emerge, the development can bridge to an in vitro diagnostic (IVD) approach, enabling global distribution.
Specifically, you will learn:
- How to assess the appropriateness of a single-site pre-market approval approach
- Regulatory considerations for design and validation of the CDx assay
- Speed to commercialization benefits through a single-site pre-market approval approach
- How and when to most effectively engage a CRO / lab partner in the process
Please join us for an insightful discussion – and answers to your questions – on these clinically and commercially relevant topics.
The webinar will benefit senior professionals involved in research and development, personalized medicine, biomarker development, targeted therapeutics, molecular oncology, clinical pharmacology, medical/regulatory affairs, translational medicine, companion diagnostics and preclinical or clinical outsourcing.
For more information about this complimentary event, visit: Flexible, Fast, Efficient: The Expanding Role of Single-Site Pre-Market Approval in Companion Diagnostics Development.
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