Melina Cimler is the CEO and Founder of PandiaDx LLC. She is a senior regulatory, quality in vitro diagnostic device expert with more than 30 years of experience in the life science and FDA-regulated diagnostic industry, leading regulatory, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine.
She currently serves on the Board of Directors of Nanostics, Inc., and is a Scientific Board member of Athira Pharma, Inc., as well as an Expert Consultant of NDA Partners LLC.
Dr. Cimler previously served as Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies until April 2018. 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 regulatory strategy, resulting in the first next-generation sequencing platform to receive FDA marketing authorization (MiSeqDx).
She has held executive leadership positions in quality, regulatory, clinical, and government affairs at Beckman Coulter, Inc., Abbott Molecular, Gen-Probe, Inc. (now Hologic), and C.R. Bard, and was head of Product Development at Epitope, Inc. (now OraSure Technologies).
Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.