AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Vice President, Certara Drug Development Solutions

S.Y. Amy Cheung, PhD, is a Vice President at Certara, regional lead (EU and APAC) for Quantitative Science Services within Certara Drug Development Services, and Global Lead of the Pediatric and Maternal Health Center of Excellence/Innovation Engines. 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 to late-phase drug development. She is currently an honorary professor in the School of Engineering at the University of Warwick, UK. She is leading an EU funding project, ERAMET (grant agreement number 101137141), in work package 5, championing the enhancement and utilisation of extrapolation in the pediatric population and for rare diseases.

Before joining Certara, she was a Senior Pharmacometrician and Scientific and Project Leader at the AZ 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). 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, EFPIA, 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, Regulatory Strategy and Clinical Pharmacology, Certara Drug Development Solutions

Justin joined Certara in 2022 with 20+ 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).

He has also been a member of the EMA’s Modelling and Simulation Working Party (MSWP). He has a special interest in biologics, CNS research, pain management and paediatric pharmacology. Justin has a PhD from the University of Adelaide, Australia.

Faculty member in the Division of Translational and Clinical Pharmacology at Cincinnati Children’s Hospital Medical Center

Tomoyuki, 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.

Dr. Mizuno 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.