The addition of Dr. Mizuno and Dr. Mizuno strengthens NDA Partners’ expertise in clinical pharmacology, population PK/PD modeling and simulation, and model-informed clinical study design, and brings exceptional experience within pediatric populations specifically.
WASHINGTON (PRWEB) September 01, 2022
NDA Partners’ General Manager, Eric Fish, announced today that the firm has strengthened its clinical pharmacology expertise with the addition of Expert Consultants, Dr. Tomoyuki Mizuno and Dr. Kana Mizuno.
Dr. Tomoyuki Mizuno is an Assistant Professor of Pediatrics at the Division of Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center, and the University of Cincinnati, College of Medicine. He is an expert in pediatric clinical pharmacology, pharmacometrics, model-informed precision dosing (MIPD), and pediatric clinical trial design and simulation. His academic research focuses on applying pharmacokinetics-pharmacodynamics (PK/PD) and physiologically based pharmacokinetics (PBPK) modeling and simulation, pharmacometrics, and systems pharmacology approach to develop and implement personalized precision dosing strategies in pediatric and adult patients.
Dr. Kana Mizuno is an Assistant Professor of Pediatrics at the University of Cincinnati, College of Medicine, Division of Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center. She is an expert in pediatric clinical pharmacology, population PK/PD modeling and simulation, and model-informed pediatric clinical study design. Her academic research focuses on precision/personalized medicine and the implementation of modeling and simulation approaches to inform precision dosing and clinical trial design for pediatric populations including neonates and infants.
Dr. Mizuno and Dr. Mizuno serve as leading members of the Cincinnati Pharmacometrics Center of Excellence program providing strategic clinical pharmacology consulting and pharmacometric services to help sponsors determine optimal clinical trial design and pharmacometrics analysis as part of Model-Informed Drug Development (MIDD) and initial Pediatric Study Plans (iPSP).
“The addition of Dr. Mizuno and Dr. Mizuno strengthens NDA Partners’ expertise in clinical pharmacology, population PK/PD modeling and simulation, and model-informed clinical study design, and brings exceptional experience within pediatric populations specifically. They are a welcome addition to our Quantitative Drug Development Strategies Practice, whose experts help companies design, analyze, and interpret optimal product development programs that address their most difficult issues, using efficient study designs and regulatory strategies that have a high likelihood of success and that can accelerate timelines,” said Dr. Michael Eldon, who leads the firm’s Quantitative Drug Development Strategies Practice.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Eric Fish, General Manager