Precision Medicine allows researchers, regulators and clinicians to have more precise and individualized approach for diagnosis, prognosis, treatment protocols and disease prevention methodologies. The United States Food and Drug Administration has developed significant research and regulatory capacity for dealing with precision medicine submissions where evidence is based on large scale data, complex analytics, and sophisticated protocols of interpretation (Next Generation Sequencing - NGS, Real World Data - RWD, large scale clinical data with -omics evidence).
Goal of the Lecture
This session will educate medical product manufacturers on FDAs perspective, capacity, standards and arsenal of tools for evaluation of precision medicine submission datasets in order to facilitate future submissions, minimize regulatory loops and avoid mistakes, thus de-risking the submission.
- Overview of FDA structure and product areas for PM submissions
- FDA big-data processes: from submission to archival
- FDA PM platforms authorized to operate in regulatory environment
- FDA analytical processes
- FDA considerations for analytical pipelines
- BioCompute harmonization standard
- FDA sampler of regulatory reviews in NGS space
- Additional resources
February 19th, 2020 at 10 AM EST, details will be provided to you once you register.