Each session includes a presentation and short discussion and lasts about 1 hour

Date Presenter / Topic Register

Sophie Fischer-Holzhausen, PhD, Scientist Systems Pharmacology, ESQlabs GmbH
Sophie Fischer-Holzhausen, PhD, is a Scientist in Systems Pharmacology at ESQlabs. Her work focuses on advancing computational modeling approaches to address questions in women’s health. In 2019, Sophie graduated with a master’s degree in Biophysics from Humboldt University Berlin. During her studies, she began exploring the intersection between computational science and female physiology, working on a systems biology approach to investigate the regulation of the human menstrual cycle. After graduation, Sophie got the opportunity to continue working in this field by joining the Institute of Informatics at the University of Bergen, Norway, as a PhD candidate. Supervised by Prof. Susanna Röblitz, she contributed to the development and extension of mathematical models describing the endocrine regulation of the female reproductive system. In early 2023, Sophie submitted her PhD thesis, "A Matter of Timing – A Modeling-Based Investigation of the Dynamic Behavior of Reproductive Hormones in Girls and Women." - just in time to join AstraZeneca as a Pharmacometrician. Her PhD research included studies demonstrating the potential applications of menstrual cycle models in clinical and pharmaceutical settings, as well as methodological advancements in parameterizing complex models despite limited data availability. In early 2024, she transitioned to ESQlabs, where she now focuses on projects related to female-specific health concerns. Sophie is not only advancing physiologically based kinetic (PBK) modeling strategies but also promotes modeling and simulation to enhance women’s health.

A matter of timing - a modeling investigation of the interplay between reproductive hormones and ovarian follicles
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Robin Haid, PhD, Bayer
Robin Haid is a third-year PhD student at Bayer’s Preclinical Modeling & Simulation subcluster, focusing on the PK/PD modeling of targeted protein degraders (TPDs). His aim is to integrate the experimental data that is routinely generated in drug discovery to arrive at a profound understanding that propels projects forward. Robin studied Pharmaceutical Sciences at ETH Zurich in Switzerland, where he graduated at the top of the 2023 class. His award-winning work on predictive PK/PD modelling of degraders was published in two articles and he has been featured as a speaker at several international conferences, most recently at PAGE in Rome.

Transforming the Discovery of Targeted Protein Degraders: The Translational Power of Predictive PK/PD Modeling
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David Turner, PhD, Distinguished Scientist
David Turner is currently a Distinguished Scientist in the Department of Clinical Pharmacology at Genentech, since September 2021. He has over ten years of experience in Clinical Pharmacology and Modeling and Simulation, contributing to various global regulatory submissions and health authority interactions. At Merck, he was part of the Clinical Pharmacology team working on pembrolizumab approvals in melanoma and metastatic NSCLC, which has since become a standard of care in these settings. Before joining Genentech, David worked at GSK as a clinical pharmacology lead for oncology programs, where he helped develop MBMA methods to compare internal and external oncology treatments. At Genentech, he is involved as a Clin Pharm lead with the mosunetuzumab (bispecific anti-CD20/CD3) program, assisting in its initial regulatory submissions and approvals for relapsed/refractory follicular lymphoma. David has authored over 40 publications, delivered four oral presentations, and presented more than 20 conference posters. His research on exposure-response confounding has been recognized for its influence on the field and dose selection practice for biologic treatments.
Joseph Chen, PharmD, Senior Principal Scientist
Joseph Chen is a Senior Principal Scientist in the Genentech Clinical Pharmacology, Oncology group, supporting large molecule oncology drug development including atezolizumab (anti-PD-L1 mAb). Prior to joining Genentech, he worked as a clinical pharmacologist at Pfizer, supporting small molecule oncology drug development, including Lorbrena, an approved ALK-inhibitor small molecule TKI in NSCLC. He received his PharmD at the UCSD Skaggs School of Pharmacy in 2016.
Russ Wada, Principal Consultant, QuanTx Consulting
QuanTx Consulting is a QCP consulting services company with focus on pharmacometrics, located in Mountain View CA. Russ Wada is the Founder and a Principal Consultant at QuanTx Consulting. Previously Russ worked at Pharsight, Quantitative Solutions, and Certara. He has over 25 years of experience as a modeling and simulation consultant in drug development. He received his PhD in Engineering from UCLA and did a postdoctoral fellowship in Clinical Pharmacology in the Dept of Anesthesiology at Stanford.

Model-based meta-analysis (MBMA) of non-small cell lung cancer with PD-(L)1 inhibitors for early development decision making and late phase efficacy benchmarking

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Due to Unexpected Circumstances, Irina Kareva, will be presenting for one of our Summer Webinars instead of January.
Irina Kareva received her PhD in Applied Mathematics for Life and Social Sciences from Arizona State University in 2012. Her research has been focused on mathematical modeling of cancer as an evolving ecological system, with particular focus on applying insights from ecology and evolution to understanding cancer initiation and progression. She did her post-doctoral fellowship at Tufts Medical Center in Boston, prior to joining EMD Serono (US business of Merck KGaA) in 2016, where she is currently an Associate Director in Quantitative Pharmacology Department. Dr. Kareva has co-authored 3 books and over 50 publications, and conducts both applied and basic research. Her current work is focused primarily on fit-for-purpose mechanistic modeling of compounds in immunology and immuno-oncology to enable rational safe and efficacious First-in-Human (FIH) dose projections both for monotherapy and combination therapy.

Due to Unexpected Circumstances, "Guiding model-driven combination dose selection using multi-objective synergy optimization" will be presented this Summer instead of January. Please join us then for this exciting webinar!
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Andrew Goetz - Department of Biomedical Engineering, Yale University, New Haven, CT, US
Andrew is a biomedical engineering graduate student at Yale, studying cellular heterogeneity in signaling and metabolism under Purushottam Dixit. Andrew received his undergraduate degrees in applied mathematics and physics at Georgia Southern University. Andrew completed an industry internship at the biotech company Genentech under the supervision of Luca Gerosa, where he contributed to the development of systems pharmacology methods for targeted therapies of oncogenic signaling.

Computational modeling of in vitro anti-cancer drug combinations to inform dose selection in oncology clinical trials
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Please join us in October for our next Webinar

No Rosa Webinar for September
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Heather Collis, Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden
Heather is a fellow of the AstraZeneca Postdoc Programme. She joined AstraZeneca in January 2023, working from the Cambridge site in the UK before moving to the Gothenburg site in Sweden in June 2023. She obtained a PhD in Mathematics from the University of Nottingham where her work focused on understanding the dynamics of hormone transport in the vasculature of young plants. At AstraZeneca, her focus has shifted towards using machine learning in order to model disease progression of MASLD (metabolic dysfunction-associated steatotic liver disease).

Proteomics data in real-world MASLD cohorts illuminates epidermal growth factor-like 7 as a novel biomarker that is associated with advanced fibrosis and mortality
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Valeriu Damian
Valeriu Damian is a QSP and PBPK consultant with 26 years of experience at GSK, where he led the Systems Modeling and Translational Biology department, overseeing the application of QSP and PBPK from discovery through development. A recognized leader in his field, Valeriu has held influential positions in ISoP and ASCPT, championing the advancement of QSP science. He has made significant contributions to QSP model development and tools, as well as PBPK modeling for inhaled, transdermal, ocular, and long-acting injectable delivery systems.

QSP - A must have for me! Current state of QSP science and applications as a key Quantitative Medicine approach
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We are taking a short break for July. Check back later for our August Webinar details!

No Rosa Webinar for July
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K. Melissa Hallow, PhD
Associate Professor, University of Georgia, School of Chemical, Materials and Biomedical Engineering, Athens, GA USA Melissa Hallow is an Associate Professor at the University of Georgia, with joint appointments in the College of Engineering and College of Public Health. She earned her Ph.D. from the Georgia Institute of Technology and worked for several years at Novartis Pharmaceuticals before making the transition to academia at UGA. Her research group uses mathematical models of renal and cardiac physiology and pharmacology to better understand disease processes and drug mechanisms in hypertension, kidney disease, heart failure, and drug-induced kidney injury.

Multi-scale modeling of multi-organ systems in drug development: a case study on SGLT2 inhibitors
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Dr. Robert Sheehan
Senior Modeler, Rosa & Co. LLC
Dr. Colleen Witt
Principal Scientist, Rosa & Co. LLC

A Mechanistic QSP Model of Alzheimer’s Disease Yields Insights into Pathophysiological and Therapeutic Mechanisms
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Dr. Michael Monine
Scientific Director, Biogen, Cambridge, MA, US

Prediction of PK/PD for Intrathecally-Administered Antisense Oligonucleotides
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Amy Moody, PhD
Senior Principle Scientist, Pfizer, Cambridge, MA

From data driven to theoretical: improving preclinical decision making with modeling

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Brian Topp
Senior Director, Merck, Rahway NJ

The Long Road from Discovery to Design
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Tom Yankeelov, Ph.D.
W.A. "Tex" Moncrief Chair of Computational Oncology; Director, Center for Computational Oncology, Oden Institute for Computational Engineering and Sciences; Director, Cancer Imaging Research, Livestrong Cancer Institutes; Co-leader, Quantitative Oncology Research Program, Livestrong Cancer Institutes; Adjunct Professor of Imaging Physics, MD Anderson Cancer Center; Professor of Biomedical Engineering, Diagnostic Medicine, Oncology; The University of Texas at Austin, Austin, Texas

Clinical Trials For Patients Who Are Not Average
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Norman A. Mazer, M.D., Ph.D.
Founder and Disease Modeling Consultant, NAM Consulting, Basel, Switzerland

The Q-ATN Model of Alzheimer’s Disease: A Work in Progress
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Jiawei Zhou, PhD
Pharmacometrician, Pfizer Inc., New York, United States

Understand Tumor Response Heterogeneity in Colorectal Cancer: Share the similarities, celebrate the differences.
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Mikael Boberg, PhD
Senior Scientist, AstraZeneca R&D, Gothenburg, Sweden

PK/PD modelling of eflornithine: Assessment of an oral treatment for the fatal parasitic disease human African trypanosomiasis
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Sheena Sharma, PhD
Research Investigator, PBPK, Clinical Pharmacology and Pharmacometrics, Bristol Myers Squibb, Lawrenceville, NJ

Proteomics-Informed PBPK Modeling to Predict Systemic and Tissue Drug Concentrations in Rats
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Robin T.U. Haid, MSc
PhD Student, Bayer AG, Preclinical Development, Drug Metabolism and Pharmacokinetics, Preclinical Modeling and Simulation / ETH Zurich, Institute of Pharmaceutical Sciences, Biopharmacy

A Pharmacodynamic Model for the Assessment and Optimization of PROTACs
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Dr. Marcus Rosenblatt, PhD
Physicist, Institute of Physics, University of Freiburg, Freiburg, Germany

Mechanistic insights into sensitization/desensitization of IFNα signaling and its effect on patient treatment strategies.
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Jared Weddell, Ph.D.
Senior Manager, Clinical Pharmacology and Exploratory Development, Astellas Pharma US, Northbrook, IL

A QSP model to understand clinical cytokine dynamics following bispecific dosing in solid tumors
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Robert R. Bies, Pharm.D. Ph.D. FISoP
Professor of Pharmaceutical Sciences, Member Institute for Artificial Intelligence and Data Science, University at Buffalo, Buffalo NY

Leveraging machine learning strategies for nonlinear mixed effects model selection (using pyDarwin)
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Rebecca Baillie, PhD, Christina Friedrich, PhD, Jake Nichols, PharmD, MBA
Principal Scientist; Chief Engineer, Rosa & Co., San Carlos, CA; Director of Medical Affairs, US WorldMeds, Louisville, KY

Demonstrating Efficacy When Clinical Trials Are Impossible: QSP Modeling to Support a New Dose Application
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Natalie Morris, BSc
University of Bristol, Bristol, UK

Defining design rules for next-generation snakebite antivenoms
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Vincent Lemaire, Ph.D.; Fei Hua, Ph.D.
Distinguished Scientist Modeling and Simulation, Genentech, South San Francisco, CA; VP, Head of Modeling and Simulation Services, Applied BioMath Concord, MA

From Cold to Hot: Perceptions of the Use and Impact of QSP in Immuno-oncology – A Survey of the Community and Stakeholders
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Dr Dinko Rekic, PhD and Dr Jane Knöchel, PhD
Global Product Leader – ticagrelor; Clinical Pharmacometrician, AstraZeneca, Gothenburg, Sweden

A case‐study of model‐informed drug development of a novel PCSK9 antisense oligonucleotide
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The team is taking some time to spend with their families.

No Webinar for December
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Chuanpu Hu, PhD
Senior Scientific Director and Fellow, Janssen R&D, LLC

Variability and uncertainty: interpretation and usage of pharmacometric simulations and intervals
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Wojciech Krzyzanski PhD, MA
Associate Professor, University at Buffalo

Pharmacodynamic age structured population model for cell trafficking
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Philippe Moingeon PhD, MBA
Head of Immuno-inflammation portfolio, Servier

AI-powered modeling approaches to support the development of new therapies for autoimmune diseases
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Bill Brastow, Ph.D.
Chief Technology Officer for Rosa Market Modeling

Injecting Reality into Commercial Due Diligence for In-Licensing, Partnering or Purchasing Pharmaceutical Assets in Development
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• Christina Friedrich, PhD, Chief Engineer, Rosa & Co, San Carlos, CA• Stephen Duffull, PhD, Professor, (1) Senior Scientific Advisor, Certara, (2) Otago Pharmacometrics Group, School of Pharmacy, University of Otago, Dunedin, New Zealand• Theodor

VPs... You got to know when to hold them, know when to remove them, know when to resample, know when to run.
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Stefano Morotti, PhD.
Assistant Professor at University of California Davis

Cross-species translation of drug-induced electrophysiological response in cardiac myocytes
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Chuanpu Hu, PhD.
Senior Scientific Director and Fellow at Janssen R&D, LLC

Analyzing Outcome Score Data
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Joga Gobburu
Professor, University of Maryland

Predictive Healthcare Analytics
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Nick Holford, Emeritus Professor
Emeritus Professor, University of Auckland, New Zealand

Concentration Guided Dosing
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Christina Friedrich, PhD; Jérémy Huard
Chief Engineer, PhysioPD, Rosa & Co, LLC; Senior Application Engineer, MathWorks

Using Machine Learning Surrogate Modeling for Faster QSP VP-Cohort Generation
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Check back soon for more webinars.

We are taking January off and will resume the webinars in February
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Dr. Dipak Barua
Research Principal Scientist, Takeda Pharmaceutical Company Limited

A mechanistic model-based analysis of Fn14 - NF-Kappa B dysregulation in glioblastoma multiforme
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James Lu, PhD
Principal AI Scientist, Genentech

Using Machine Intelligence in building PK/PD and Disease Progression Models
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Dr Adam Palmer
Assistant Professor of Pharmacology, UNC Chapel Hill

Models to understand and predict the clinical efficacy of combination cancer therapy
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Yanguang (Carter) Cao, PhD.
Assistant Professor | University of North Carolina at Chapel Hill

Probing antibody-target interactions in living systems
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Tongli Zhang, PhD
Assistant Professor, University of Cincinnati

Integrating Quantitative Systems Pharmacology and Machine learning, why bother?
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Anastasios Siokis, PhD
Postdoc in Translational Disease Modeling, Sanofi, Germany

An agent-based simulation platform studying the immunological synapse dynamics
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Vincent Hurez, DVM, PhD
Senior Scientist at Rosa & Co LLC

Predicting subjective or complex clinical outcomes in QSP models: challenges and approaches
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Thorsten Lehr, PhD
Professor of Clinical Pharmacy, Saarland University

Cancelled
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Amber Smith, PhD.
Assistant Professor at The University of Tennessee Health Science Center

The Ravaging Respiratory Infection: Fighting Influenza Using Mechanistic Models
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Bill Brastow, PhD
Principal and CTO Rosa Market Modeling

tbd
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Bill Brastow, PhD
Principal and CTO Rosa Market Modeling

Out of the Lab - Into the Market: Modeling Physician Decision-Making Behavior Using Discrete Choice
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Paul B. Watkins, M.D. FAASLD.
Director, Institute for Drug Safety Sciences at the University of North Carolina in Chapel Hill

QST and the Transformation in Drug Safety Assessment
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Luca Gerosa, PhD
Postdoctoral Fellow, Laboratory of Systems Pharmacology, at Harvard Medical School

Building Kinetic Models with Complex Drug-Protein Interactions: application to the targeted inhibition of MAPK signaling in cancer
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Katherine Kudrycki, PhD
Principal Scientist at Rosa & Co. LLC

Do you need a life scientist for QSP modeling?
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Eric Sobie, PhD
Professor, Pharmacological Sciences at Icahn School of Medicine at Mount Sinai

Using QSP to predict cardiotoxicity caused by cancer drugs
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Dr. Jonathan E. Allen
Informatics Thrust Leader, Biosecurity Center at ATOM Consortium and Lawrence Livermore National Laboratory

An Integrated Machine Learning Framework for Novel Small Molecule Drug Design
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Dr. Bill Brastow
Principal and Chief Technology Officer at Rosa Market Modeling

Driving Market Share for Healthcare Products by Integrating Market Modeling
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Stacey Tannenbaum, PhD, FISoP
Senior Director, Pharmacometrics US Clinical Pharmacology and Exploratory Development, Astellas Pharma, Northbrook, IL

Making the 'Moster' of Your Poster
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Iraj Hosseini, PhD and Justin Feigelman, PhD
Scientists at Genentech, Inc in South San Francisco

gQSPSim: a SimBiology®-based GUI app for standardized QSP model development and application
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Paolo Denti, PhD
Associate Professor at the University of Cape Town

Of “clever” models and “dumb” spreadsheets”: what is more effective to drive policy change?
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Sergio Iadevaia, PhD
Scientific Director QSP, Pharmacometrics and Data Analysis at Takeda

Development of a QSP Platform to Quantify Benefits of DAAO Inhibition in Schizophrenia
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Rajanikanth (Raj) Madabushi, PhD
Team Lead, Guidance and Policy & CDER Point-of-Contact for the MIDD paired Meeting Pilot Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, USFDA

Mainstreaming MIDD: A Holistic and Integrative Approach
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Jeffrey R. Sachs, Ph.D.
Senior Principal Scientist, Merck & Co., Inc. based in Kenilworth, NJ, USA, known as MSD outside Canada and USA

MIDD: Vaccine R&D Gets a Shot in the Arm from Pharmacometrics
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Sietse Braakman, PhD
SimBiology Application Engineer at MathWorks

A general workflow for parameter estimation to help establish confidence in model predictions
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Dr. Britta Goebel
Head of Translational Disease Modeling (Diabetes-CV & I&I) at Sanofi, Frankfurt

Quantitative Systems Pharmacology Modeling Support in Development of Novel Diabetes Treatments
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Robert Bies, Pharm.D. Ph.D
Associate Professor of Pharmaceutical Sciences, Member Computational and Data Enabled Sciences Program at the University at Buffalo, NY

Hybrid Genetic Algorithm Approaches to Model Selection
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James Yates, MMath, PhD
Principal Scientist, AstraZeneca, Cambridge UK

Attack of the Clones: Understanding the kinetics of resistance to cancer treatment
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Maria Trujillo PhD
Principal Scientist, Merck and Co Inc, Kenilworth, NJ

Leveraging a Diabetes QSP Model to Drive Decisions in Target Identification and Validation for Proinsulin to Insulin Conversion Therapy
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Loveleena Bansal, PhD
Scientific Leader, GSK Associate Fellow, at GSK, Collegeville PA

Modular development and application of platform QSP models to support a broad R&D portfolio: Examples from immuno-oncology and respiratory therapeutic areas
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Vivaswath S. Ayyar, Ph.D.
Adjunct Assistant Professor of Pharmaceutical Sciences, University at Buffalo, NY and PK/PD Scientist, Janssen BioTherapeutics, Spring House, PA

Expanding from Basic Towards Systems Pharmacodynamic Models for Methylprednisolone
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Dr.-Ing. Markus Rehberg
Scientist QSP at Sanofi-Aventis Deutschland GmbH

Systems Immunology Modeling: From Mechanistic Details to Clinical Outcomes in Rheumatoid Arthritis
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Stephan Schmidt, B.Pharm, Ph.D., F.C.P.
Associate Professor & Associate Director, Center for Pharmacometrics & Systems Pharmacology, University of Florida

Pharmacometrics, PBPK, QSP – What’s Next?
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Professor Ioannis (Yannis) P. Androulakis
Rutgers University - Biomedical Engineering

Dynamic Models for Personalized QSP: How models can help us explore big data
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Chi-Chung Li, Ph.D., Senior Scientist, Clinical Pharmacology, and Iraj Hosseini, PhD. Scientist
Genentech, Roche, South San Francisco.

Enhancing Phase I Clinical Decision Making Through the Use of Quantitative Systems Pharmacology Modeling: A Case Study of Mosunetuzumab in Relapsed/Refractory Non-Hodgkin’s Lymphoma
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Eric Sobie, PhD, Professor, Pharmacological Sciences, Icahn School of Medicine at Mount Sinai, New York, NY

Combining mechanistic modeling with machine learning to predict cardiotoxicity and streamline drug development
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Theresa Yuraszeck, Associate Director, Quantitative Pharmacology, CSL Behring

Quantitative Approaches to Informing Clinical Decisions – Where does Systems Pharmacology Fit In?
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Richard Gliklich, MD, Founder and CEO, OM1

Advancing Drug Development and Outcomes Research with Artificial Intelligence, Machine Learning, and Predictive Models
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Iraj Hosseini, PhD. Scientist at Genentech

The gPKPDsim Simbiology app
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Prasad Dhurjati, PhD, Professor of Chemical & Bio-molecular Engineering, Joint appointment as Professor Biological Sciences and Professor of Mathematical Sciences, University of Delaware

System Level Modeling of the Human Gut Microbiome
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1) Lealem Mulugeta, Executive Committee Member of CPMS, Founder/Executive of InSilico Labs and Medalist Fitness.2) Andrew Drach, Senior Research Fellow at University of Texas at Austin, Executive Committee Member of CPMS

Ten Simple Rules of Credible Practice of Modeling and Simulation in Healthcare: Application to Bone Remodeling and Heart Valve Modeling
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Aman Singh, PK-PD Scientist, Biologics Development Sciences, Janssen R&D

Towards Development of a Systems PK-PD Model to Characterize Bystander Effect of Antibody-Drug Conjugates (ADCs)
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Christina Friedrich, PhD, Chief Engineer, and Mike Reed, PhD, Chief Scientist, Rosa & Co, CA

How to Ensure Your QSP Model is Useful – Illustrative Examples and Lessons Learned
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Richard A. Gray, PhD, Senior Research Biomedical Engineer, Food and Drug Administration, Silver Spring, MD

The Potential Impact of Physiological Computer Models in Medicine: Regulation and Considerations for Ensuring Patient Safety
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Chihiro Hasegawa, PhD, PK/PD Scientist, Ono Pharma, Japan, Otago Pharmacometrics Group, School of Pharmacy, University of Otago, New Zealand

Automated scale reduction of nonlinear QSP models with an example of a bone biology system
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Frank Gibbons, PhDPrincipal Scientist, DMPK, IMED Oncology Biotech UnitAstraZeneca

Pulling your model up by its bootstraps: evolving your way to QSP
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Sietse Braakman, PhDMathWorks

Enabling QSP and PK/PD workflows using SimBiology and MATLAB: What’s New?
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Dr. Ryan TasseffScientistProcter and Gamble

Development of a multiscale skin barrier model for de novo, in silico prediction
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Konstantinos (Kostas) Biliouris, PhD Principal Pharmacometrics Scientist Novartis Cambridge, MA, USA

Quantitative Modeling in Support of the Development of a Systemic Lupus Erythematosus Drug
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Nelleke Snelder Senior Consultant LAP&P Consultants BV Leiden, The Netherlands

QSP modelling - at the heart of the action.

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Joga Gobburu, PhD, Division of Parmacometrics, OCP/FDA

Learn & Apply Paradigm in Drug Development: How disease-drug-trial models can aid decisions
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Dr. Valeriu Damian-Iordache, Director Pharmacokinetics and Translational Biology, GlaxoSmithKline

Physiological based modeling for ocular drug delivery
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Dr. Scott Q Siler, Lead DILI-sim Consultant

The DILIsym™ model and its application to hepatotoxicity testing in drug development
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Dr. Toufigh Gordi, Rosa and Co.; President, PK/PD and Clinical Pharmacology Services

Mechanistic PK/PD Modeling in Pediatrics
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Dr. Birgit Schoeberl; Vice President of Discovery; Merrimack Pharmaceuticals

Using mathematical models to set design criteria for antibody-based therapies
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Joga Gobburu, PhD FCP MBA; School of Pharmacy|School of Medicine, Univ. of Maryland, Baltimore

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions
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Hartmut Derendorf, PhD; University of Florida, Gainesville

PK/PD-based Development of Anti-infective Agents
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Tristan Maurer, PharmD, PhD; Research Fellow at Pfizer Pharmaceuticals

Translational Modeling & Simulation in Support of Rational Drug Discovery: Principles, Challenges and Examples
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William J. Jusko, PhD, SUNY (Buffalo)

Moving PK/PD From Basic Towards Systems Pharmacology
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Christina Friedrich, PhD, Rosa & Co

Developing Models that are Fit for Purpose — A Model Qualification Method
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Nick Holford, MBChB, University of Auckland, New Zealand

Clinical Pharmacology = Disease Progression + Drug Action
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Herbert Sauro, PhD, University of Washington, Seattle

Standards and Software in Biomedical Systems Modeling
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Rebecca Baillie, PhD, Rosa & Co

How to build a PhysioPD model
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Rada Savic, PhD, Uppsala University

Overview of modeling tools in drug development
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Dr. Frank Bergmann, University of Heidelberg

Applying the Scientific Method to Simulation Experiments
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Tarek Leil, Director, Bristol-Myers Squibb

A Bayesian Perspective on Estimation of Variability and Uncertainty in Mechanism-Based Models
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Robert Leipold, Research Scientist, Evidera

Modeling in Healthcare Economic Evaluations
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Dean Bottino, Head Modeling & Simulation Oncology at Roche Pharmaceuticals

Multi-scale modeling to optimize the antitumor effect of antibody-dependent cell-mediated cytotoxicity (ADCC) enhanced therapies
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Michael A. Eldon, Principal Scientific Fellow, VP, Clinical Pharmacology, Nektar Therapeutics

PK/PD Modeling and simulation: Applications in discovery through development
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Christina Friedrich, Chief Engineer, Rosa and Co.

Learnings from the Field: The Rosa Physiological Model Qualification Method
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David J. Klinke II, Ph.D, Associate Professor, Chemical Engineering; West Virginia University

In silico model-based inference: A contemporary approach for hypothesis testing in systems
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Dr. Chee Ng, Assistant Professor at Children's Hospital of Philadelphia

Model-based Discovery/Development of Therapeutic Monoclonal Antibodies
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Dhavalkumar Shah, Senior Scientist; Modeling & Simulation, Pharmacokinetics, Dynamics, and Metabolism; Pfizer

Bench to Bedside Translation of Antibody Drug Conjugates Using a Multiscale Mechanistic PK/PD Model: A Case Study with SGN-35
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Arthur Lo, Senior Scientist; Theravance

Integration of in vitro data into a viral kinetics model to investigate rapid development of Hepatitis C resistance to therapy
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Pratap Singh, Ph.D, Senior Principal Scientist, Pfizer

Role of Myostatin in Muscle Growth: Key Learnings From PK/PD Modeling Analysis
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Malcolm Rowland, PhD, Professor Emeritus, University of Manchester

Addressing drug development questions with physiologically based pharmacokinetics
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Dr. Richard Peck, Global Head Clinical Pharmacology, Pharmaceutical Research and Development (pRED), Roche Products Ltd

How can We Use Mechanism-based Receptor Models for Designing First in Human Studies?
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Mike Reed, Chief Scientist, PhysioPD, Rosa & Co

Building and Using a Quantitative Systems Pharmacology Model: Overview and Case Study
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Hugo Geerts Scientific Liaison Officer at In Silico Biosciences

Quantitative Systems Pharmacology in CNS Disorders Providing value for Pharmaceutical R&D in Neurology and Psychiatry
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Dhaval Shah Assistant Professor at SUNY Buffalo

Evolution of the Platform PBPK Model for Monoclonal Antibodies Towards Pediatric Population
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Marc Birtwistle, PhD; Asst Professor, Pharmacology and Systems Therapeutics, Icahn School of Medicine, Mount Sinai, NY

Noise and Signaling in Cancer Systems Pharmacology
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Yu-Nien (Tom) Sun, Director, Quantitative Pharmacology Group; Pharmacokinetics & Drug Metabolism Department, Amgen, Inc.

Model-Based Drug Development for Oncology Therapeutics
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Kapil Gadkar, Scientist at Genentech

A mechanistic systems pharmacology model for prediction of LDL cholesterol lowering by anti-PCSK9 in human dyslipidemia
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C.J. Musante, Associate Research Fellow, Cardiovascular and Metabolic Diseases; Gianluca Nucci, Senior Director, Clinical Pharmacology, and Mark Peterson Director, Pharmacometrics, Pfizer Inc.

Quantitative Systems Pharmacology at Pfizer: A Paradigm Shift to Improve the Probability of Successful Proof of Concept Studies
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Thierry Lave, Head DMPK and TOX Project Leader and Modeling and Simulation, F. Hoffmann-La Roche

Translational modeling in support of nonclinical safety assessments
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Ron Beaver, PhD, Founder, Chairman, and CEO, Rosa & Co LLC

Systems Pharmacology: Science or Non-science? And so what?
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Dr. Yanguang Cao, Research Assistant Professor, Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY

Applications of minimal PBPK models to small and large molecules
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Kosmas Kretsos, Associate Director, Global Exploratory Development, UCB New Medicines

Differentiate or die: Preclinical and early clinical assessment of differentiation potential via modeling
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Stephen Duffull, PhD, Chair of Clinical Pharmacy, Otago Pharmacometrics Group, School of Pharmacy, University of Otago, Dunedin, New Zealand

Systems models–their use and simplification
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Ananth Kadambi, Ph.D., Senior Vice President, PhysioPD™, Rosa & Co.

Differential applications of Quantitative Systems Pharmacology and traditional modeling approaches in pharmaceutical R&D
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Satyaprakash Nayak (Satya), Pharmacometrician - Systems Biologist at Pfizer

Development of a Quantitative Systems Pharmacology Model of the Blood Coagulation Network & its Application to Clinical Programs
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Peter L. Bonate, PhD, Senior Director, Astellas; Global Head - Pharmacokinetics, Modeling, and Simulation; Global Clinical Pharmacology & Exploratory Development

Modeler Tailor Listener Buy
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Eric A. Sobie Ph.D., Associate Professor, Dept. of Pharmacology and Systems Therapeutics; Icahn School of Medicine at Mount Sinai, NYC, NY

Quantitative Cardiovascular Systems Pharmacology: Exploiting mathematical models to generate novel insight
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Loveleena Bansal, PhD, Post-Doctoral Researcher, GlaxoSmithKline

A Quantitative Systems Pharmacology (QSP) Approach to Understand the Pathogenesis of Acne and Evaluate New Acne Therapies
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Dr. Ioannis (Yannis) P. Androulakis, Professor, Rutgers University, Piscataway, NJ

Systems engineering meets Quantitative Systems Pharmacology: From low-level targets to engaging the host defenses
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Samik Ghosh, PhD, The Systems Biology Institute, Tokyo, Japan

Garuda: Fly to the future of biology
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Sandra Visser, Principal Scientist, Early Stage Quantitative Pharmacology & Pharmacometrics, Merck

Bringing Quantitative and Systems Pharmacology to Drug Discovery: Implementation, Impact, and Challenges
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Michael Bolger, Ph.D., Chief Scientist and Ted Grasela, Ph.D., President, Simulations Plus; Lancaster, CA

Applying QSAR and PBPK Modeling to Bridge Discovery and Assessment of Clinical Potential
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Helen Moore, PhD, Associate Director, Quantitative Clinical Pharmacology, Bristol-Myers Squibb, Princeton, NJ

Mathematical Optimization of Combination Therapy Regimens
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Christina Friedrich, PhD, Chief Engineer, Rosa & Co., San Carlos, CA and Fulden Buyukozturk, PhD, Technical Evangelist, MathWorks; Natick, MA

MATLAB and SimBiology facilitate QSP modeling and analysis to support drug development
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Melissa Hallow, Ph.D., Assistant Professor, College Of Engineering And Department Of Epidemiology And Biostatistics, University of Georgia, Athens, GA

Application of Physiology - Disease-Drug Model of Kidney Disease
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Jonathan Wagg, MD, PhD, Disease Therapeutic Area Modeling Leader – Oncology, Roche Pharmaceutical Research and Early Development

Optimizing Delivery of Cancer Vaccines: Short Peptides Insights from Disease Modelling
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Oliver Ghobrial, Sr. Scientist III, Systems Pharmacology/DMPK/PKPD, AbbVie, Inc.

AbbVie Dermatology QSP Platform: Build Strategy and Applications in Psoriasis Drug Discovery and Clinical Development
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Dr. Lourdes Cucurull-Sanchez, Senior Scientific Investigator; GlaxoSmithKline

Modelling Cytokine Receptors as Drug Targets – A Case Study
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Valeriu Damian, DirectorSystems Modeling and Translational Biology GlaxoSmithKline, King of Prussia, PA

QSP - What’s in it for me? Case study examples
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Dr. Herbert Sauro, Associate Professor, Bioengineering, University of Washington

Approaches to Reproducibility in Systems and Physiological Modeling
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Aman P. Singh, PhD CandidateDepartment of Pharmaceutical Sciences, University at Buffalo, Buffalo, NY

A PK-PD Modeling and Simulation Based Strategy for Clinical Translation of Antibody-Drug Conjugates: A case study with T-DM1
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Dr. Michael Weis, Senior Engineer, PhysioPD™, Rosa & Co.

Considerations for adopting models for PhysioPD-style Research
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Stacey Tannenbaum, PhD, FISoP Director: Pharmacokinetics, Modeling, and Simulation Clinical Pharmacology & Exploratory Development Astellas Pharma Global Development; Northbrook, IL

Pharmacometricians and Statisticians in Drug Development: Can’t We All Just Get Along?

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Natal van Riel, MSc, PhD Professor Computational Modelling Associate Professor Systems Biology and Metabolic Disease Eindhoven University of Technology, and Amsterdam Medical Center Eindhoven, The Netherlands

Quantification of Variability and Uncertainty in Multi-Level Systems Pharmacology Models

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Ben-Fillippo Krippendorff, Ph.D.Quantitative Systems Pharmacology, Pharmaceutical SciencesRoche Pharma Research & Early DevelopmentRoche Innovation Center Basel

Predicting Tissue Distribution and Clearance of Large Molecules to Improve Selectivity of Targeted Therapies
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Craig Thalhauser, Ph.D., Associate Director/Quantitative Clinical Pharmacology, Bristol-Myers Squibb, Princeton, NJ

Calibration, Validation, and Responder Analysis in a Virtual Population of Rheumatoid Arthritis Patients
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