scientific advisor

Kenjie Amemiya, PhD, DABT

Dr. Kenjie Amemiya has over 35 years of toxicology experience, along with extensive expertise in regulatory strategy development and hands-on GLP compliance as both a study director and head of GLP and nonclinical operations. Over the span of his career, he has worked in both large and startup pharmaceutical companies, holding various positions related to nonclinical drug safety. During his tenure at his last pharmaceutical company, Genentech, part of his career was also focused on clinical safety. In addition, Kenjie has served as both a Discovery and Development project leader, successfully leading a team through a Phase 2 proof-of-concept (POC) study.

With regard to nonclinical safety, Kenjie has led the nonclinical safety evaluation of numerous small molecules and biologics across a variety of therapeutic areas, including oncology, neurology, antipsychotics, anti-infectives, cardiovascular, respiratory, inflammation, and metabolic disorders. He has also participated in several FDA and global health authority interactions and submissions. Additionally, as part of Genentech’s early clinical safety team, Kenjie carried out pharmacovigilance and risk management activities, providing clinical drug safety input as a component of clinical development strategies.

Previously a consultant for Aclairo Pharmaceutical Development Group, Inc., and now at Akkeri, Kenjie has successfully advised companies on nonclinical safety evaluations, early clinical drug safety, regulatory strategy, regulatory agency interactions, and occupational exposure limits. His approach to working with sponsors is to view himself as a team member, taking complete ownership of the safety aspects of projects while contributing to the overall success of the entire program.