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Regulatory Challenges with Next Generation Sequencing
Session Chair(s)
Kim Tyrrell-Knott, JD
Partner
Epstein Becker & Green, P.C., United States
The high interest and rapid uptake of next-generation sequencing in the clinic speaks to the promise of this technology as a valuable adjunct for optimizing therapeutic treatment, yet much of this promise remains untapped. The challenge associated with establishing a regulatory framework stems from the lack of available standards to help establish the safety and effectiveness of this technology, and from the lack of high quality, public databases with data curated from validated methods for use in clinical decision making
Learning Objective : Explain recent efforts by regulatory bodies, academia, and regulated industry to curate data from this technology and use it for regulatory decision making.
Speaker(s)
What's Next for Next Gen Sequencing
Kim Tyrrell-Knott, JD
Epstein Becker & Green, P.C., United States
Partner
FDA Perspective
Laura Koontz, PHD
Flatiron Health, United States
Director of Regulatory Policy
Panelist
Ingo Chakravarty
NAVICAN, An Intermountain Healthcare Company, United States
President and Chief Executive Officer
Panelist
Kelli Lynn Tanzella, PHD, MS
Thermo Fisher Scientific, United States
Senior Director, Regulatory Affair, Clinical and Compliance Life Sciences Soluti