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. Mizuno and Dr.
Mizuno serve as Assistant Professors of Pediatrics at the Division
of Clinical Pharmacology at Cincinnati Children's Hospital Medical
Center, and the University of
Cincinnati, College of Medicine.
WASHINGTON, September 1,
2022 /PRNewswire-PRWeb/ -- 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.
Contact
Eric Fish, General Manager
Office: 540-738-2550
FishEric@ndapartners.com
Media Contact
Eric Fish, NDA Partners,
540-738-2550, FishEric@ndapartners.com
SOURCE NDA Partners