Next Generation Dx Summit

Short Course 10
Regulatory & Reimbursement Issues with NGS and Other Multiplex Assays
Wednesday, August 20 | 6:30pm - 8:30pm | Capital Hilton Hotel | Washington DC

Part 1

Melina CimlerInstructor: Melina Cimler, Ph.D., Vice President, Head, Global Quality Illumina, Inc.

  • Next generation sequencing applications and implications
  • Current regulatory pathways
  • Overview of things to consider in developing NGS applications for clinical use
  • NGS in companion diagnostics – roles of pharma and diagnostic partners

Part 2

Danielle ScelfoInstructor: Danielle Scelfo, Director, Government Affairs, Genomic Health

  • Coverage, Coding and Reimbursement for molecular diagnostics
  • Defining value
  • Payor Concerns
  • Case examples
  • Differences in Clinical Utility definitions
  • Creating a dossier that payor customers can act on

Faculty Biographies:

B. Melina Cimler, Ph.D. is Vice President of Quality at Illumina Inc., leading Illumina's quality, regulatory and government affairs organizations. She has over 24 years of experience in the FDA-regulated diagnostic industry leading regulatory, quality systems, clinical affairs, research, and product development organizations. She has been very actively engaged in global regulatory, government affairs, due diligence and alliance collaborations. Prior to joining Illumina, Dr. Cimler served as president of PandiaDx Consulting, where she provided regulatory and compliance guidance for the development of in vitro diagnostic products and medical devices. Previously, she held leadership positions in quality, regulatory and government affairs at Beckman Coulter Inc. She also served in senior quality and regulatory roles at Abbott Molecular, Gen-Probe Inc., and C.R. Bard. Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.

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