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PAGE 2022

PAGE 2022
Speakers & Posters
We are excited to be presenting at this conference
MBMA SubSIG: a collaborative example for promoting model-based meta-analysis and its application in drug development
Monica Simeoni, Clinical Pharmacology Modelling & Simulation, Glaxo SmithKline, UK; Phyllis Chan, Clinical Pharmacology, Genentech; Yaming Hang, Quantitative Solutions, Takeda; Rana Jreich, Data & Data Sciences, Sanofi; Junshan Qiu, Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA; Clemence Rigaux, Data & Data Sciences, Sanofi; Chandni R. Valiathan, Clinical Pharmacology and Pharmacometrics, Janssen R&D; Jian Zhou, Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb; Hao Zhu, Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA; Matthew L. Zierhut, Integrated Drug Development, Certara USA, Inc., Co-Senior; Marion Bouillon-Pichault, Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb |
Pre-clinical and clinical applications of PBPK models for monoclonal antibodies and other large molecule modalities.
Iain Gardner | Translational DMPK Science, Certara UK LTD –Simcyp Division, Sheffield, UK
Combining aggregate data and individual patient/subject data in model-based meta-analysis: An illustrative case study of tofacitinib in rheumatoid arthritis patients
Thao-Nguyen Pham, Certara, Integrated Drug Development, Princeton, NJ, USA, Normandie Univ, UNICAEN, CNRS, ISTCT, GIP CYCERON, 14000 Caen, France; John Maringwa, Certara, Integrated Drug Development, Princeton, NJ, USA; Maria Luisa Sardu, Certara, Integrated Drug Development, Princeton, NJ, USA; Richard C Franzese, Certara, Integrated Drug Development, Princeton, NJ, USA; Anna Largajolli, Certara, Integrated Drug Development, Princeton, NJ, USA; S Y Amy Cheung, Certara, Integrated Drug Development, Princeton, NJ, USA |
Repository of model parameters for physiologically based pharmacokinetic modelling in obese validated against triazolam and caffeine observed data
Mattia Berton, University Hospital Basel, Switzerland, University of Basel, Switzerland; Sara Bettonte, University Hospital Basel, Switzerland, University of Basel, Switzerland; Felix Stader, Certara UK Limited, United Kingdom; Manuel Battegay, , University Hospital Basel, Switzerland, University of Basel, Switzerland; Catia Marzolini, , University Hospital Basel, Switzerland, University of Basel, Switzerland, University of Liverpool, United Kingdom |
Learn-and-Confirm in Quantitative Systems Pharmacology: Evaluation of an Immunogenicity Platform
Hans Peter Grimm, Roche Pharma Research & Early Development, Switzerland; Linnea C. Franssen, Roche Pharma Research & Early Development, Switzerland; Maciej Swat, Certara, United Kingdom; Andrzej M. Kierzek, Certara, United Kingdom; Rachel Rose, Certara, United Kingdom; Piet H. van der Graaf, Certara, United Kingdom |
Utilizing model informed drug development to support study design for Tovorafenib (DAY101), a novel, type II, pan RAF kinase inhibitor: a focus on longitudinal safety markers
Katrina Hui, Certara, Integrated Drug Development, Princeton, NJ, USA; YuWei-Lin, Certara, Integrated Drug Development, Princeton, NJ, USA; Anna Largajolli, Certara, Integrated Drug Development, Princeton, NJ, USA; John Maringwa, Certara, Integrated Drug Development, Princeton, NJ, USA; A. Yin Edwards, Certara, Integrated Drug Development, Princeton, NJ, USA; Antonio Goncalves, Certara, Integrated Drug Development, Princeton, NJ, USA; James Smith, Certara, Integrated Drug Development, Princeton, NJ, USA; Elly Barry, Day One Biopharmaceuticals, Inc, USA; Eleni Venetsanakos, Day One Biopharmaceuticals, Inc, USA; Samuel C Blackman, Day One Biopharmaceuticals, Inc, USA; S. Y. Amy Cheung, Certara, Integrated Drug Development, Princeton, NJ, USA |
Use of Quantitative System Pharmacology (QSP) Modeling to Optimize Dosing Frequency and Interval for Nemvaleukin Alfa (Nemvaleukin), an Investigational Cancer Immunotherapy
Lei Sun, Alkermes, Inc., Waltham, MA, USA; Tomomi Matsuura, Certara UK Ltd, Simcyp Division, Canterbury, UK; Cesar Pichardo-Almarza, Certara UK Ltd, Simcyp Division, Canterbury, UK (at time of study); Rita Dalal, Alkermes, Inc., Waltham, MA, USA; Bhaskar Rege, Alkermes, Inc., Waltham, MA, USA, Corresponding author: Bhaskar.Rege@alkermes.com |
Population pharmacokinetics of selpercatinib in patients with an advanced solid tumor, including RET fusion-positive NSCLC, RET-mutant MTC, and other tumors with increased RET activity
Dan Liu, Global PKPD and Pharmacometrics; Johan Wallin, Global PKPD and Pharmacometrics, Eli Lilly and Company, United Kingdom; Ayman Akil, iDD, Certara USA Inc, USA.; Craig Comisar, iDD, Certara USA Inc, USA; Nathan Teuscher, iDD, Certara USA Inc, USA; Jan-Stefan van der Walt, Global PKPD and Pharmacometrics |
Value of literature review to inform development and use of biologics in juvenile idiopathic arthritis
Klervi Golhen, Pediatric Pharmacology and Pharmacometrics, University Children’s Hospital Basel (UKBB), University of Basel, Basel, Switzerland; Carolyn Winskill, Integrated Drug Development, Certara LP, Princeton, New Jersey, USA; Cynthia Yeh, Integrated Drug Development, Certara LP, Princeton, New Jersey, USA Nancy Zhang; Tatjana Welzel, Pediatric Pharmacology and Pharmacometrics, University Children’s Hospital Basel (UKBB), University of Basel, Basel, Switzerland, Pediatric Rheumatology, University Children’s Hospital Basel (UKBB), University of Basel, Basel, Switzerland; Marc Pfister, Pediatric Pharmacology and Pharmacometrics, University Children’s Hospital Basel (UKBB), University of Basel, Basel, Switzerland, Integrated Drug Development, Certara LP, Princeton, New Jersey, USA *Klervi Golhen and Carolyn Winskill have contributed equally to this work and share first authorship. Tatjana Welzel and Marc Pfister have contributed equally to this work and share last authorship. |
Exposure-Response Analysis of Tovorafenib (DAY101) Relating Objective Response to Exposure, Patient- and Disease Characteristics
John Maringwa, Certara, Integrated Drug Development, Princeton, NJ, USA; Anna Largajolli, Certara, Integrated Drug Development, Princeton, NJ, USA; YuWei-Lin, Certara, Integrated Drug Development, Princeton, NJ, Usual; Katrina Hui, Certara, Integrated Drug Development, Princeton, NJ, USA; Yin Edwards, Certara, Integrated Drug Development, Princeton, NJ, USA; James Smith, Certara, Integrated Drug Development, Princeton, NJ, USA; Eleni Venetsanakos, Day One Biopharmaceuticals, Inc, USA; Elly Barry, Day One Biopharmaceuticals, Inc, USA; Samuel C Blackman, Day One Biopharmaceuticals, Inc, USA; S. Y. Amy Cheung, Certara, Integrated Drug Development, Princeton, NJ, USA |
Exposure-safety analysis of Tovorafenib (DAY101), an investigational oral pan-RAF kinase inhibitor, in oncology patients with solid tumors
A. Yin Edwards, Certara, Integrated Drug Development, Princeton, NJ, USA; Anna Largajolli, Certara, Integrated Drug Development, Princeton, NJ, USA; YuWei-Lin, Certara, Integrated Drug Development, Princeton, NJ, USA; Katrina Hui, Certara, Integrated Drug Development, Princeton, NJ, USA; John Maringwa, Certara, Integrated Drug Development, Princeton, NJ, USA; James Smith, Certara, Integrated Drug Development, Princeton, NJ, USA; Elly Barry, Day One Biopharmaceuticals, Inc, USA; Eleni Venetsanakos, Day One Biopharmaceuticals, Inc, USA; Samuel C Blackman, Day One Biopharmaceuticals, Inc, USA; S.Y. Amy Cheung, Certara, Integrated Drug Development, Princeton, NJ, USA |
Comparison of two-stage and joint TGI-OS modelling using data from six clinical studies in metastatic non-small cell lung cancer patients
Mathilde Marchand, Certara Strategic Consulting, Paris, France; Antonio Gonçalves, Certara Strategic Consulting, Paris, France; Phyllis Chan, Certara Strategic Consulting, Paris, France; Jin Y Jin, Clinical Pharmacology, Genentech, South San Francisco, California, USA; Jérémie Guedj, Université de Paris, INSERM, IAME, Paris, France; René Bruno, Clinical Pharmacology, Genentech-Roche, Marseille, France |
A translational cardiovascular systems model to quantify drug effects on contractility and other hemodynamic variables
Yu Fu, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Tingjie Guo, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Hadi Taghvafard, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Medhat M. Said, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Cleo Demeester, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Victor Dudal, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands; Piet H. van der Graaf, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands, Certara QSP, Canterbury, United Kingdom; Nelleke Snelder, LAP&P Consultants BV, Leiden, the Netherland; J. G. Coen van Hasselt, Leiden Academic Centre for Drug Research, Leiden University, the Netherlands |
Mathematically Modelling CD19+ B Cell Reconstitution After Insult to the Immune System: Paediatric Allogeneic Haematopoietic Stem Cell Transplantation, Rituximab Therapy and Epstein-Barr Viral Reactivation
Soumya Perinparajah, Infection, Immunity and Inflammation Research & Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom; Juliana M.F. Silva, Department of Bone Marrow Transplantation, Great Ormond Street Hospital for Children, London, United Kingdom; Reem Elfeky, Department of Bone Marrow Transplantation, Great Ormond Street Hospital for Children, London, United Kingdom; Natalia Builes Restrepo, Department of Bone Marrow Transplantation, Great Ormond Street Hospital for Children, London, United Kingdom; Oscar J. Charles, Infection, Immunity and Inflammation Research & Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom; John Booth, Digital Research, Informatics and Virtual Environment Unit, NIHR Great Ormond Street Hospital Biomedical Research Centre, London, United Kingdom; S.Y. Amy Cheung, Integrated Drug Development, Certara, Princeton, New Jersey, United States; James W.T. Yates, DMPK Modelling, In-Vitro In-Vivo Translation, GlaxoSmithKline, Stevenage, United Kingdom; Nigel Klein, Infection, Immunity and Inflammation Research & Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom; Persis J. Amrolia, Infection, Immunity and Inflammation Research & Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom, Department of Bone Marrow Transplantation, Great Ormond Street Hospital for Children, London, United Kingdom; Joseph F. Standing, Infection, Immunity and Inflammation Research & Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom, Department of Pharmacy, Great Ormond Street Hospital for Children, London, United Kingdom |
Establishing correlates of protection for herpes zoster infection via MBMA analysis
Maria Luisa Sardu, Certara; Princeton, NJ, USA; Anna Largajolli, Certara; Princeton, NJ, USA; Nele Plock, Certara; Princeton, NJ, USA; Emilie Schindler, Certara; Princeton, NJ, USA; Carolyn Cho, Merck & Co., Inc.; Kenilworth, NJ, USA; Seth Robey, Merck & Co., Inc.; Kenilworth, NJ, USA; Jos Lommerse, Certara; Princeton, NJ, USA; Li Qin, Certara; Princeton, NJ, USA; S. Y. Amy Cheung, Certara; Princeton, NJ, USA; Jeffrey R. Sachs, Merck & Co., Inc.; Kenilworth, NJ, USA |
Characterisation of time course of response using model based meta-analysis of public domain data to support trial design in axial spondyloarthritis
Anubha Gupta, Clinical pharmacology modelling and simulation, GSK UK; Olivier Collignon, Clinical Stats, GSK, UK; Sofia Fernandes, Clinical Science GSK, UK; Monica Simeoni, Clinical pharmacology modelling and simulation, GSK UK; Jaap Mandema, Certara USA, Inc., Princeton NJ |
Predicting RSV Efficacy for MK-1654 During Post-COVID-19 Pandemic RSV Seasons with Protracted Transmission Pattern using MBMA and Clinical Trial Simulation Approaches that Account for RSV Force-of-Infection
Nele Plock, Certara, Princeton, NJ, USA; Jos Lommerse, Certara, Princeton, NJ, USA; Brian M. Maas, Merck & Co., Inc., Kenilworth, NJ, USA; Jingxian Chen, Merck & Co., Inc., Kenilworth, NJ, USA; Francesco Bellanti, Certara, Princeton, NJ, USA; Li Qin, Certara, Princeton, NJ, USA; Han Witjes, Certara, Princeton, NJ, USA; Philippe Pierrillas, Certara, Princeton, NJ, USA; Radha A. Railkar, Merck & Co., Inc., Kenilworth, NJ, USA; Antonios O. Aliprantis, Merck & Co., Inc., Kenilworth, NJ, USA; Kalpit Vora, Merck & Co., Inc., Kenilworth, NJ, USA; Wei Gao, Merck & Co., Inc., Kenilworth, NJ, USA; Luzelena Caro, Merck & Co., Inc., Kenilworth, NJ, USA; S. Y. Amy Cheung, Certara, Princeton, NJ, USA; Jeffrey R. Sachs, Merck & Co., Inc., Kenilworth, NJ, USA |
Physiologically-based pharmacokinetic modelling of basmisanil to evaluate CYP3A mediated victim and perpetrator drug-drug interaction propensity
Yumi Cleary, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland, Centre for Applied Pharmacokinetic Research, University of Manchester, Manchester, UK; Michael Gertz, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland; Felix Jaminion, Roche Pharma Research and Early Development, Roche Innovation Center Basel, Basel, Switzerland; Sian Lennon-Chrimes, Roche Pharma Research and Early Development, Roche Innovation Center Welwyn, UK; Darren Bentley, Certara UK Ltd, Sheffield, UK and Michael Derks, Roche Pharma Research and Early Development, Roche Innovation Center Welwyn, UK |
Cabotegravir pharmacokinetics after oral and intramuscular administration using physiologically based pharmacokinetic modelling
Sara Bettonte, University Hospital Basel, Switzerland; Mattia Berton, University Hospital Basel, Switzerland, University of Basel, Switzerland; Felix Stader, Certara UK Limited, United Kingdom; Manuel Battegay, University Hospital Basel, Switzerland, University of Basel, Switzerland; Catia Marzolini, University Hospital Basel, Switzerland, University of Basel, Switzerland, University of Liverpool, United Kingdom |
Comparison of Robustness and Efficiency of Four Machine Learning Algorithms for Identification of Optimal Population Pharmacokinetic Models
Mark Sale M.D., Certara; Mohamed Ismail Pharm. D., M.S., Enhanced Pharmacodynamics LLC, 4), Fenggong Wang Ph.D., FDA; Kairui Feng Ph.D., FDA; Meng Hu Ph.D., FDA ; Liang Zhao Ph.D., MBA, FDA; Robert Bies Ph.D., State University of New York at Buffalo |
Can mAb dose selection in IBD be supported by public domain data from other immune-mediated inflammatory diseases?
Li Qin, Certara USA, Inc., Princeton NJ; Núria Buil-Bruna, Clinical Pharmacology Modelling and Simulation, GSK UK; Maria Luisa Sardu, Certara USA, Inc., Princeton NJ; Alienor Berges, Clinical Pharmacology Modelling and Simulation, GSK UK; Paul Matthias Diderichsen, Certara USA, Inc., Princeton NJ; Monica Simeoni, Clinical Pharmacology Modelling and Simulation, GSK UK |
Characterising the onset of response using public domain data and MBMA: application cases in Atopic Dermatitis and Psoriatic Arthritis
Maria Luisa Sardu, Alienor Berges, Carly Barnett, Tony Ning, Jaap Mandema, Li Qin, Paul Matthias Diderichsen, Monica Simeoni | Certara USA, Inc., Princeton NJ; Clinical pharmacology modelling and simulation, GSK UK; Biostatistics, GSK UK; Clinical Development, GSK USA
Covariate Modelling and Bayesian Inference for Physiologically Based Pharmacokinetic Models
Vo Hong Thanh, Certara, Simcyp Division, Sheffield, UK; Janak Wedagedera, Certara, Simcyp Division, Sheffield, UK; Hiroshi Momiji, Certara, Simcyp Division, Sheffield, UK; Richard Matthews, Certara, Simcyp Division, Sheffield, UK; Masoud Jamei, Certara, Simcyp Division, Sheffield, UK; and Frederic Y. Bois, Certara, Simcyp Division, Sheffield, UK |