BIO
Naomi Suminski
Senior Advisor and COA Expert
Prior to joining Parexel, Naomi has accumulated extensive experience in clinical research, focusing on the development of patient-centered outcome measures with pharmaceutical and biotechnology organizations. She provides strategic and scientific guidance on robust study design, COA development, validation, and implementation throughout the product lifecycle. Naomi has led numerous qualitative interview studies, conducted systematic literature reviews, and supported regulatory interactions with agencies such as the FDA and EMA, including meeting preparation and briefing book development.
Naomi specializes in the development and delivery of 'in-trial' interview studies, such as exit interviews. Her expertise spans multiple therapeutic areas, with a particular focus on rare diseases, oncology, neuroscience, and pediatric indications.
Naomi holds an MS in Drug Development and Product Management from the University of California, San Diego, CA, and a BS in Biochemistry and Public Health from Simmons University, Boston, MA.