About Us
History
Applied PMx & Research LLC was inspired by the loss of the founder’s beloved Golden Retriever “Ginger”. She taught us many things, including that life is precious and one should pursue their true passions. Please find a tribute to Ginger in our company logo.
Kaori Ito, PhD, MBA
Kaori Ito, PhD, MBA strives to provide consultation and analysis for your related needs using mathematical models and statistical science by integrating knowledge across studies and/or programs. Please see her biography below.
Professional Profile
- 20+ years of experience in the pharmaceutical industry including Eisai.Co.Ltd (Japan), and Pfizer (Japan and USA) as a clinical pharmacology lead/pharmacometrician. Served as a Director of Global Pharmacometrics/Point of Contact (PoC) from 2010 to 2017; Sr. Director/POC in 2017 (Pfizer, USA).
- Supported optimal decision making in drug development from exploratory phase to confirmatory phase by integration of scientific knowledge from literature and pre-clinical and clinical studies into mathematical models, implementing quantitative, model-based drug development.
- Mentored industrial post-doc and summer intern students, as well Pfizer colleagues for pharmacometrics skills, e.g. NONMEM, R, PsN.
- Teaching experience with R (basics programming and graphics) at Pfizer across all global sites.
- Working experience with Consortia (not-for-profit organization) in the modeling & simulation group to develop a disease progression modeling and simulation tools.
- Invited speaker, or trainer for R at conferences or regulatory agencies, including PMDA (2010), JCoP (2010), URI (2013), ACoP (2013), ACCP (2016).
Modeling Expertise
- Disease progression model
- Exposure-response model (efficacy, safety)
- Adverse event modeling (binary or ordinal (severity) data with Markov model, Poisson, Cox-PH model)
- Population PK modeling
- Bounded outcome modeling
- Model-based meta-analysis
Education
- MS in Biostatistics Brown University, USA 2020
- MBA in Pharmaceutical University of Rhode Island, USA 2016
- PhD in Pharmaceutical Sciences Kyusyu University, Japan 2003
- MS in Pharmaceutical Sciences University of Tokyo, Japan 1994
- BS in Pharmaceutical Sciences University of Tokyo, Japan 1992
Awards
- AAPS (American Association of Pharmaceutical Scientists) Outstanding manuscript in modeling and simulation award 2008 (published at CPT 84, 127-135 in 2008)
- ACoP (American Conference on Pharmacometrics) Outstanding Modeling and Simulation Abstract Award 2009 (published at Alzheimer’s & Dementia 7: 151-160, 2011)
- Pfizer MDG top publication award (2010) (published at Alzheimer’s and Dementia (6) 39-53, 2010)
- ACoP Outstanding Abstract Award 2011 (published at JAD 39(6): 601-618, 2014)
- CAMD (Coalition Against Major Diseases) Lifetime Achievement Award 2013 for the “fit-for-purpose” Drug-development Tool (DDT) in Alzheimer’s Disease