Adam Berger | Senior Staff Fellow of Personalized Medicine
Food and Drug Administration

Adam Berger, Senior Staff Fellow of Personalized Medicine, Food and Drug Administration


BioData West- NASA Ames Satellite Conference & Workshops @ 14:40

Precision FDA- Taking Genomic Testing to the Next Level

  • How the FDA is creating a modern, flexible and dynamic regulatory system for NGS
  • Ways to develop these standards, which can be used by test developers to ensure their tests produce accurate and reliable results
  • How the aggregation of clinical information in curated databases will create a “data commons” that will serve as a reliable source of scientific evidence that test developers could use to demonstrate that NGS test results are relevant to a person’s disease or outcome

BioData West: Day 1 @ 09:20

Where does emerging technology such as AI, precision medicine and next generation diagnostics fit into a health system- What is the value? Where is the evidence? How do you persuade us to implement?

  • Is the clinic ready for the influx of new precision medicines?
  • What are CIOs at large healthcare systems looking for to drive precision medicine into the clinic? 
  • What value has been generated to health systems through precision medicine? Are we focusing on the right priorities?

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