Short Course 10
Regulatory & Reimbursement Issues with NGS and Other Multiplex Assays
Wednesday, August 20 | 6:30pm - 8:30pm | Capital Hilton Hotel | Washington DC
Instructor: 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
Instructor: 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
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.
Danielle Scelfo is Senior Director, Government Affairs and Public Policy for Genomic Health Incorporated and is based out of Genomic Health's company headquarters in Redwood City and her San Diego office. Ms. Scelfo is the current co-chair of the Diagnostics Workgroup for the California Healthcare Institute, former founder and co-chair of the Coalition for 21s Century Medicine's Reimbursement and Policy Workgroup and contributes to molecular diagnostic workgroups with American Clinical Lab Association (ACLA), Personalized Medicine Coalition (PMC), California Healthcare Institute (CHI), California Clinical Lab Association (CCLA) and BayBio. She has also been an active participant in the AMA's Molecular Diagnostic Workgroup, Tier 1 and the Multiple Analyte Assay with Algorithms sub teams and serves on the editorial faculty for the journal Personalized Medicine in Oncology. Ms. Scelfo has a comprehensive understanding of the pharmaceutical, biotech and diagnostic industries, Medicare and Medicaid programs, and managed care delivery systems. Her extensive knowledge of government and commercial reimbursement policies and procedures lends valuable insight to the financial impact of legislation and the regulatory rule making process in the healthcare arena. Ms. Scelfo's background in reimbursement policy has led to many successful coverage policies for oncology therapeutics and advanced personalized diagnostics. She is considered by many in industry as a valuable resource in the areas of coverage, coding and reimbursement. Ms. Scelfo's current responsibilities include representing Genomic Health in government affairs, public health policy, corporate reimbursement strategy, coding and payment of new technologies by public payors and supporting regulatory compliance efforts for the organization.
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