From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Vice President, MBMA Capability Lead, Certara Drug Development Solutions

At Certara, Matt advances the integration of external aggregate clinical trial data into development decisions and commercial and regulatory strategy via model-based meta-analysis (MBMA). Matt 与临床开发团队密切合作，确保在做出最关键决策的时候，能利用 MBMA 发挥最佳影响力。

Previously, Matt was at Janssen (J&J) where he led the development of their global MBMA capability and worked together with many clinical development teams to ensure optimal impact of MBMA on critical program decisions. Matt also held positions at Pfizer and Amylin as a pharmacometrician, implementing model-informed drug development strategies across a variety of programs and therapeutic areas. He started his professional career as a business consultant at Applied Predictive Technologies, where he designed and analyzed experimental trials to provide business recommendations for multiple Fortune 500 companies.

Matt received his PhD in Bioengineering from UC Berkeley and UCSF and holds an MBA from UC Berkeley, Haas School of Business.

Director, Clinical Pharmacology Modeling & Simulation at GSK

Nathan Hanan, PharmD, is Director of Clinical Pharmacology Modeling and Simulation at GSK, where he leads clinical pharmacology strategies and applies model-informed approaches to advance programs in neuroscience, infectious diseases, and hepatology. With over a decade of experience in drug development across industry, academia, and non-profit settings, he specializes in the integration of diverse data sources to create robust analysis subsets, enabling models that elucidate disease progression and inform strategic decisions. His recent MBMA contributions describing pegylated IFN-alpha and nucleos(t)ide cessation-induced HBsAg loss in chronic hepatitis B have helped inform Phase 3 trial strategies and regulatory interactions. Collaborating with Certara to utilize the CODEx database, Nathan will share insights from his MBMA work at Certara’s webinar to highlight advancements in therapeutic development at GSK.

Director of Clinical Pharmacology Modeling and Simulation at GSK

As a Director of Clinical Pharmacology Modeling and Simulation at GSK, Richard focuses on oncology, utilizing model-based meta-analysis and tumor size modeling to predict overall survival. Prior to joining GSK, Richard applied myriad modeling and simulation methods to drug development as a consultant at Certara. Before that, Richard taught high school mathematics. He currently delivers guest lectures on pharmacometrics at UNC Chapel Hill and enjoys mentoring colleagues in modeling and simulation.

Richard studied at the University of Oxford; he studied Physics before completing his doctorate in Engineering Science. At Oxford, Richard also conducted research in Computational Biochemistry and in Materials Science.
Richard enjoys running, cooking, and tinkering with cars in his free time; he was a competitive track and cross-country runner for 10 years and he spent several years coaching track and field.

Fellow and Director, Clinical Pharmacology Modelling & Simulation at GSK

Monica Simeoni is a director in the Clinical Pharmacology Modeling and Simulation department and the Model-Based-Meta-Analysis lead for Respiratory and Immuno-Inflammation therapeutic areas at GSK.
After obtaining a Ph.D. in Biomedical Engineering from the Polytechnic of Milan, Italy, she has been an employee of the Department of Computer Science and Systems Engineering, University of Pavia, Italy, assigned to collaborative projects with pharma industry.

She has more than 20 years of experience in the pharmaceutical field across different therapeutic areas such as immuno-inflammation, neurosciences, oncology and glucose-insulin metabolism. Beyond model based meta-analysis, her areas of expertise include non-linear mixed-effect population modelling applied to pharmacokinetics and pharmacodynamics at clinical and preclinical level, efficacy and toxicity evaluation and target mediated drug disposition modelling. Further areas of interest are disease progression modeling, joint modelling, estimation methods, covariate analysis.

She is a member of the Scientific Organizing Committee of the PAGE conference.

She is the current pharmacometrics co-chair in the Stats and Pharmacometrics Special Interest Group (SxP SIG) sponsored by the American Statistical Association and International Society of Pharmacometrics. She has been co-chair of the MBMA Special Interest sub-Group (subSIG) and she recently joined the AI/ML subSIG.