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Date Presenter / Topic Register

Nelleke Snelder Senior Consultant LAP&P Consultants BV Leiden, The Netherlands

QSP modelling - at the heart of the action.

Sietse Braakman, PhD MathWorks

Enabling QSP and PK/PD workflows using SimBiology and MATLAB: What’s New?

Dr. Ryan Tasseff Scientist Procter and Gamble

Development of a multiscale skin barrier model for de novo, in silico prediction

Valeriu Damian, Director Systems Modeling and Translational Biology GlaxoSmithKline, King of Prussia, PA

QSP - What’s in it for me? Case study examples

Dr. Herbert Sauro, Associate Professor, Bioengineering, University of Washington

Approaches to Reproducibility in Systems and Physiological Modeling

Aman P. Singh, PhD Candidate Department 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

Dr. Michael Weis, Senior Engineer, PhysioPD™, Rosa & Co.

Considerations for adopting models for PhysioPD-style Research

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?

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

Ben-Fillippo Krippendorff, Ph.D. Quantitative Systems Pharmacology, Pharmaceutical Sciences Roche Pharma Research & Early Development Roche Innovation Center Basel

Predicting Tissue Distribution and Clearance of Large Molecules to Improve Selectivity of Targeted Therapies

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

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

Helen Moore, PhD, Associate Director, Quantitative Clinical Pharmacology, Bristol-Myers Squibb, Princeton, NJ

Mathematical Optimization of Combination Therapy Regimens

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

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

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

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

Dr. Lourdes Cucurull-Sanchez, Senior Scientific Investigator; GlaxoSmithKline

Modelling Cytokine Receptors as Drug Targets – A Case Study

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

Ananth Kadambi, Ph.D., Senior Vice President, PhysioPD™, Rosa & Co.

Differential applications of Quantitative Systems Pharmacology and traditional modeling approaches in pharmaceutical R&D

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

Peter L. Bonate, PhD, Senior Director, Astellas; Global Head - Pharmacokinetics, Modeling, and Simulation; Global Clinical Pharmacology & Exploratory Development

Modeler Tailor Listener Buy

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

Loveleena Bansal, PhD, Post-Doctoral Researcher, GlaxoSmithKline

A Quantitative Systems Pharmacology (QSP) Approach to Understand the Pathogenesis of Acne and Evaluate New Acne Therapies

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

Samik Ghosh, PhD, The Systems Biology Institute, Tokyo, Japan

Garuda: Fly to the future of biology

Sandra Visser, Principal Scientist, Early Stage Quantitative Pharmacology & Pharmacometrics, Merck

Bringing Quantitative and Systems Pharmacology to Drug Discovery: Implementation, Impact, and Challenges

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?

Mike Reed, Chief Scientist, PhysioPD, Rosa & Co

Building and Using a Quantitative Systems Pharmacology Model: Overview and Case Study

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

Dhaval Shah Assistant Professor at SUNY Buffalo

Evolution of the Platform PBPK Model for Monoclonal Antibodies Towards Pediatric Population

Marc Birtwistle, PhD; Asst Professor, Pharmacology and Systems Therapeutics, Icahn School of Medicine, Mount Sinai, NY

Noise and Signaling in Cancer Systems Pharmacology

Yu-Nien (Tom) Sun, Director, Quantitative Pharmacology Group; Pharmacokinetics & Drug Metabolism Department, Amgen, Inc.

Model-Based Drug Development for Oncology Therapeutics

Kapil Gadkar, Scientist at Genentech

A mechanistic systems pharmacology model for prediction of LDL cholesterol lowering by anti-PCSK9 in human dyslipidemia

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

Thierry Lave, Head DMPK and TOX Project Leader and Modeling and Simulation, F. Hoffmann-La Roche

Translational modeling in support of nonclinical safety assessments

Ron Beaver, PhD, Founder, Chairman, and CEO, Rosa & Co LLC

Systems Pharmacology: Science or Non-science? And so what?

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

Kosmas Kretsos, Associate Director, Global Exploratory Development, UCB New Medicines

Differentiate or die: Preclinical and early clinical assessment of differentiation potential via modeling

Dr. Frank Bergmann, University of Heidelberg

Applying the Scientific Method to Simulation Experiments

Tarek Leil, Director, Bristol-Myers Squibb

A Bayesian Perspective on Estimation of Variability and Uncertainty in Mechanism-Based Models

Robert Leipold, Research Scientist, Evidera

Modeling in Healthcare Economic Evaluations

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

Michael A. Eldon, Principal Scientific Fellow, VP, Clinical Pharmacology, Nektar Therapeutics

PK/PD Modeling and simulation: Applications in discovery through development

Christina Friedrich, Chief Engineer, Rosa and Co.

Learnings from the Field: The Rosa Physiological Model Qualification Method

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

Dr. Chee Ng, Assistant Professor at Children's Hospital of Philadelphia

Model-based Discovery/Development of Therapeutic Monoclonal Antibodies

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

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

Pratap Singh, Ph.D, Senior Principal Scientist, Pfizer

Role of Myostatin in Muscle Growth: Key Learnings From PK/PD Modeling Analysis

Malcolm Rowland, PhD, Professor Emeritus, University of Manchester

Addressing drug development questions with physiologically based pharmacokinetics

Dr. Valeriu Damian-Iordache, Director Pharmacokinetics and Translational Biology, GlaxoSmithKline

Physiological based modeling for ocular drug delivery

Dr. Scott Q Siler, Lead DILI-sim Consultant

The DILIsym™ model and its application to hepatotoxicity testing in drug development

Dr. Toufigh Gordi, Rosa and Co.; President, PK/PD and Clinical Pharmacology Services

Mechanistic PK/PD Modeling in Pediatrics

Dr. Birgit Schoeberl; Vice President of Discovery; Merrimack Pharmaceuticals

Using mathematical models to set design criteria for antibody-based therapies

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

Hartmut Derendorf, PhD; University of Florida, Gainesville

PK/PD-based Development of Anti-infective Agents

Tristan Maurer, PharmD, PhD; Research Fellow at Pfizer Pharmaceuticals

Translational Modeling & Simulation in Support of Rational Drug Discovery: Principles, Challenges and Examples

William J. Jusko, PhD, SUNY (Buffalo)

Moving PK/PD From Basic Towards Systems Pharmacology

Christina Friedrich, PhD, Rosa & Co

Developing Models that are Fit for Purpose — A Model Qualification Method

Nick Holford, MBChB, University of Auckland, New Zealand

Clinical Pharmacology = Disease Progression + Drug Action

Herbert Sauro, PhD, University of Washington, Seattle

Standards and Software in Biomedical Systems Modeling

Rebecca Baillie, PhD, Rosa & Co

How to build a PhysioPD model

Rada Savic, PhD, Uppsala University

Overview of modeling tools in drug development

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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