SC10: Regulatory Compliance in Molecular Diagnostics
Room Location: 152
Sunday, March 10 | 5:30-8:30pm
ABOUT THIS COURSE:
Cancer panels, digital health and use of augmented intelligence (AI) are driving rapid changes in regulatory pathways. This presentation will examine the key issues impacting the changing regulatory framework for diagnostics in complex and key jurisdictions and will provide tips on what is required to obtain successful regulatory approval for these niche products in various markets.
The following topics will be covered:
- Current U.S. regulatory activities and requirements for molecular diagnostics
- Global diagnostics regulation in key markets such as EU, Japan, China and other complex emerging markets
- Biomarker qualification and use of NGS gene panels
- Regulatory and reimbursement convergence – the NGS NCD
- Breakthrough Designation and how it impacts regulatory timeline
Melina Cimler, PhD, CEO & Founder, PandiaDx
Dr. B. Melina Cimler is a senior quality, regulatory, and in vitro diagnostic device expert with over 29 years of experience in the life science and FDA-regulated global diagnostic industry, leading regulatory, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine. She joined NDA Partners as an Expert Consultant in 2018. She currently serves on the Board of Directors of Nanostics, Inc. and is a Scientific Board member of M3 Biotechnology.
Prior to joining NDA Partners, Dr. Cimler served as SVP of Regulatory & Quality at Adaptive Biotechnologies where she worked with FDA and pharma partners to define the regulatory strategy for use of NGS-based immunosequencing in minimal residual disease. She was formerly Head of Global Quality and Vice President of Quality, Regulatory, Clinical, and Government Affairs at Illumina Inc., where she defined and executed on the regulatory strategy for the first next generation sequencing platform (MiSeqDx) to receive FDA marketing authorization.
Dr. Cimler has also previously held executive leadership positions in quality, regulatory, clinical, and government affairs roles at Abbott Molecular, Beckman Coulter Inc., Gen-Probe Inc., and CR Bard, Inc., and was formerly head of Product Development at Epitope, Inc. Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.
Pamela Swatkowski, President, Regulatory Affairs & Compliance, PLS Consulting, LLC
Pamela Swatkowski is Director of Regulatory Affairs at Abbott Molecular responsible for strategic regulatory programs including companion diagnostics, oncology and infectious disease product regulatory and business development support, product life-cycle management, and global product registration for the molecular diagnostics product line. Notable are her twenty plus years and a regulatory and quality professional in the in vitro diagnostics and medical device industry. Pamela is the regulatory affairs lead, responsible for global regulatory strategy development and worldwide approval for the Abbott Vysis ALK FISH test used in identifying those non-small cell lung cancer patients eligible for treatment with the Pfizer drug XALKORI. She has a passion for personalized healthcare and works toward communication and conveying the importance of companion diagnostics products that are beneficial to patients. Pamela received a Bachelor of Science degree from Loyola University of Chicago and has worked in the Abbott Diagnostics group prior to joining Abbott Molecular in 2004.
Morteza Minaee, LPD, RAC, Vice President, Regulatory Affairs, Guardant Health, Inc.
Dr. Morteza Minaee has more than 25 years of experience in the global and FDA-regulated in vitro diagnostics and medical devices industry leading regulatory, quality-systems, and clinical-affairs organizations with focus in molecular diagnostics and precision medicine. He is currently Vice President of Regulatory Affairs at Guardant Health in Red Wood City California where he has been working with FDA and in collaboration with major pharma companies mapping out the regulatory strategy for Guardant Health’s next generation sequencing based non-invasive liquid biopsy technology platform for applications across cancer management continuum including companion diagnostics in targeted therapy, immunotherapy, molecular residual testing, recurrence monitoring and early cancer detection.
Prior to Guardant Health he served as Senior Director, Regulatory Affairs at Roche leading regulatory strategies in NGS, microarrays as well digital pathology technologies and obtaining many FDA clearances including breast cancer biomarkers. Dr. Minaee also held several senior positions in Regulatory, Clinical Affairs, and Quality for companies such as Abbott Molecular and Siemens Healthcare. He holds a doctorate in law and policy from Northeastern University, and MS in administration from Boston University.
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