Early and frequent communication with regulators ensures faster time to market. Quality systems should be effective, efficient, scalable, and sustainable. Building the right team ensures operational excellence.
Melina Cimler is the CEO and Founder of PandiaDx LLC, and an expert consultant with NDA Partners, a ProPharma Group company.
Dr. Cimler was SVP of Regulatory & Quality at Adaptive Biotechnologies where she developed the regulatory strategy for their NGS-based immunosequencing products and led regulatory interactions with pharma partners during oncology drug trials and submissions. She was previously Head of Global Quality & Regulatory at Illumina where she led the regulatory strategy resulting in the first ever NGS platform to receive FDA marketing authorization. She has held leadership positions in quality, regulatory, clinical, and government affairs at Beckman Coulter, Abbott Molecular, Gen-Probe (now Hologic), and C. R. Bard.
She serves on the Board of Directors of Monod Bio, Nanostics, and as a member of the Scientific Advisory Board of GRAIL. Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.
1791 Hilton Head Ln., Frisco, Texas 75034, United States