Date: Tuesday, January 13, 2026
Time: 12:30 pm to 1:30 pm EST
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VP, EU/APAC Regional Lead of Quantitative Science, Global Lead of Certara’s Pediatric and Maternal Innovation Engine
Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modelling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and different therapeutic areas across early, late-phase and post marketing drug development. She is an honorary professor at the School of Engineering at the University of Warwick, UK. She is leading the EU funding project, ERAMET (grant agreement number 101137141), in work package 5, championing the enhancement and utilization of extrapolation in pediatric populations and for rare diseases.
Before joining Certara, Amy was a Senior Pharmacometrician and Scientific and Project Leader at the AstraZeneca Pediatric Working Group, which included 22+ cross-functional pediatric experts. During this time, she also served as the company representative on the IMI DDMoRe initiative and co-led work packages (e.g., PMX-workflow, cardiovascular training) and IQ consortium CPLG Pediatric Working Group. Dr Cheung has been a member of the EFPIA MID3 workgroup since the 2011 EMA M&S workshop, which resulted in several white papers. Currently, she is contributing her expertise to various professional societies, such as the IQ Consortium, EFGCP, ASCPT, and EU Horizon-funded projects. She has published over 50 papers on MIDD methodology/applications, reviews, and white papers in peer-reviewed journals.
Senior Director, Clinical Pharmacology Consulting, Co-Lead of Certara’s Rare and Neglected Innovation Engine
Dr. Hay joined Certara in 2022 with 25+ years of clinical pharmacology experience having started his career as Senior Clinical Scientist at the Centre for Human Drug Research (CHDR), Leiden. More recently he worked as Senior Pharmacokinetics Assessor and Deputy Unit Manager at the Medicine and Healthcare Products Regulatory Agency (MHRA), UK where he also had a leading role with the Access Consortium (Regulatory agencies of Australia, Canada, Singapore, Switzerland and UK).
Justin has also been a member of the EMA’s former Modelling and Simulation Working Party (MSWP). He has a special interest in biologics, CNS research, pain management and pediatric pharmacology. Justin has a PhD from the University of Adelaide, Australia.
Cincinnati Children’s Hospital Medical Center
Dr. Mizuno is an Associate Professor of Pediatrics in the Division of Translational and Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati College of Medicine. Dr. Mizuno also serves as director of the Pharmacometrics Center of Excellence Program and the Clinical Pharmacokinetics Consultation Service. Additionally, he holds a visiting professorship at Kyoto University, Japan.
His research focuses on pharmacometrics, systems pharmacology, and AI/machine learning–driven precision dosing for pediatric patients. Dr. Mizuno also provides strategic clinical pharmacology and model-informed drug development (MIDD) consulting to pharmaceutical companies, supporting optimized clinical trial design and pediatric dose selection for FDA submissions.
Tomoyuki has authored over 120 peer-reviewed publications and has been invited to speak at various national and international conferences. His work has been recognized with several prestigious awards, including the Victor Armstrong Young Investigator Award from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT), the Young Scientist Award from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT), and the Tanabe Young Investigator Award from the American College of Clinical Pharmacology (ACCP). He currently serves as the Secretary of IATDMCT.
