With the ability to produce vast amounts of data at an extremely low price, next generation sequencing (NGS) technologies are predicted to become one of the most valuable clinical tools in personalized medicine, and diagnostic manufacturers are exploring a variety of NGS strategies and approaches as uncertainty remains around critical areas such as the extent to which clinicians will adopt these novel technologies, as well as identifying ways to effectively demonstrate their clinical value in the current regulatory and reimbursement environment. The following presentation will provide clinical research professionals with a primer on key considerations in the clinical application of genomic sequencing.
- Pre-development considerations and requirements
- Risk-based review of available technical platforms
- Clarification of the clinical questions: the right sample, gold standard, and reimbursement strategy
Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Clinical Operations
Vice President, Clinical Operations
Lyssa Friedman, Vice President, Clinical Operations, Veracyte
As Vice President of Clinical Operations at Veracyte, a molecular diagnostics company in the San Francisco Bay Area, Lyssa Friedman led the clinical strategy which brought the Afirma Gene Expression Classifier to market. She has overseen clinical operations for small oncology companies and large healthcare systems, served as Principal Investigator for a national health economics study, and gained clinical expertise across a variety of indications. She is committed to driving cross-functional, risk-based strategies that get the right diagnostic product to the right patients.
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