Dr. Hasegawa has over 15 years of drug development experience focused on the areas of clinical pharmacology, pharmacometrics and specializes in development for Asia Pacific regions (APAC; Japan-Korea-Taiwan).
Dr. Hasegawa has experience in both early and late development programs across therapeutic areas of Oncology/Immunology, Rheumatoid Arthritis and Cardiovascular. She has extensive regulatory interaction experience with health authorities including FDA, EMA and PMDA and has supported multiple filings and accountability for Clin Pharm related scientific issues with global health authorities. She has special expertise in development strategy, Model Informed Drug Development, immunogenicity and biomarkers. Mayumi leverages implementation of innovative strategies and pharmacometric analyses in order to maximize the value of the compound with a focus on prioritizing broad access to patients. Mayumi also has experience in assay method development and validation for a broad spectrum of biopharmaceuticals (large and small molecules).
Prior to Certara, Dr. Hasegawa’s held roles at Bristol-Meyers Squibb (BMS) as Senior Investigator for Pharmacometrics and Clinical Pharmacology and a leadership role in the Japan Medical and Development team. While at BMS, Mayumi was topic leader representing Japan PhRMA for the ICH E11A Pediatric Extrapolation Experts Working Group. Dr. Hasegawa has also worked for Takeda Pharmaceuticals (Japan) in the Analytical Development Laboratory in the CMC department. Mayumi is a pharmacist by training and received her BS and MS from the University of Tokyo in bioanalytical chemistry and her Ph.D. from Musashino University in Pharmaceutical Science. Her research activity focused on dosing optimization with pharmacometric analyses in biologics.
At Certara Mayumi is responsible for APAC consulting activities to support clients who are working on Asian-related development programs or submissions to APAC region health authorities to deliver a wide range of Certara’s MIDD capabilities to Asian customers. Mayumi is based out of Tokyo, Japan.