Welcome to ACoP12 12

Welcome to ACoP


ACoP12 Preliminary Program

“Charting the Course for Our Future”



Pre-Conference: Integrating standardization and innovation in your organization:Find a workflow that works for you!(separate registration required)


Chairs: Jace Nielsen, Chris Penland, Mike K. Smith, Stacey Tannenbaum



Presentation of ISoP Awards & Induction of 2021 Fellows

Lewis B. Sheiner Award Lecture







President’s Address & ACoP12 Welcome

Keynote Lecture

Special Plenary Session

Abstract Awards

Alumni Receptions & Social Event


Brenda Cirincione, Heather Vezina

Andrew Gelman, Columbia University





Quantitative Clinical Pharmacology Modeling and Simulation: A Critical Tool in Addressing the COVID-19 Pandemic


Chairs: Hao Zhu, Jianghong Fan

  • A quantitative systems pharmacology model of the immune response to SARS-CoV-2

Rohit Rao

  • Application of quantitative clinical pharmacology modeling and simulation to support dose selection and clinical development of bamlanivimab for the treatment of COVID-19

Jenny Chien

  • Application of modeling and simulation approach to support the development of biologics for COVID-19 related pneumonia

Jin Yan Jin

  • Clinical pharmacology development of remdesivir for treatment of COVID-19 and pharmacokinetic and pharmacodynamic profile of remdesivir, SARS-CoV-2 replication inhibitor

Rita Humeniuk


Development and Applications of Agent-Based Modeling: Spatial Quantitative Systems Pharmacology/Toxicology


Chairs: Holly Kimko, Aleksander S. Popel

  • Open source multicellular simulations of treatment response in cancer & Covid-19

Paul Macklin

  • QST using data from microphysiological system

Carmen Pin

  • A spatial quantitative systems pharmacology platform spQSP-IO for simulations of tumor-immune interactions and effects of checkpoint inhibitor immunotherapy

Chang Gong


A VUE on the use of QSP models as digital evidence: A Report from the QSP SIG Working Group on Variability, Uncertainty, and Error in QSP Models.


Chairs: Joshua F. Apgar, Michael Weis

  • When the stakes are high: helping key stakeholders understand quantitative predictions by QSP models

Jared Weddell and Pegy Foteinou

  • Taming of the zoo: understanding the menagerie of computational methods in QSP virtual patient population development and calibration, sensitivity analysis, and uncertainty quantification

Jessica Brady

  • Odds are your biggest source of uncertainty is not statistical: transparently dealing with data challenges in QSP models

Cibele V Falkenberg


Towards a standardized assessment framework of mechanistically detailed models including QSP and PBPK: Zooming in on model validation.


Chairs: Anna Sher, Pras Pathmanathan

  • A conversation about current and imminent challenges of simple vs complex models’ validation

Piet Van Der Graaf

  • From current landscape to good practices: proposed framework for assessing credibility of PBPK and QSP models

Hao Zhu

  • Benefits of reduction techniques for validating PBPK and QSP models

Mark Transtrum

  • Lessons from the cardiac modelling field in validating complex QSP models

Prof Gary Mirams


The Terrific Trio, 3-T’s of Mechanistic Modelling for Vaccines: Targets, Translations, and CTS-based Trial Design


Chairs: Bhargava Kandala, Nele Mueller-Plock

  • Found in translation: A translational mechanistic model of immunogenicity to aid prophylactic vaccine development

Jeffrey Perley

  • Modeling the immune response to vaccination during Mycobacterium tuberculosis infection using a host-scale computational model

Denise Kirschner

  • Modeling and simulations for decision making in accelerated vaccine programs

Anna Dari

  • (Lost in) translation: rodent modeling and validation with MBMA

Jos Lommerse

  • Need for speed: Development of a model-based meta-analysis approach to enable rapid decision making for COVID-19 vaccine candidates

Akshita Chawla


Modeling approaches to support the development and approval of engineered cell and cytokine therapies


Chairs: Daniel Kirouac, Anna Kondic

  • Integrating machine learning and mechanistic modelling in the development of pegylated cytokines

Aleksandrs Odinecs/Anna Knodic

  • Mechanism- and data-driven modeling in the discovery, development, and manufacturing of stem cell-based T-cell therapeutics

Daniel Kirouac

  • Advances in mechanism-based cellular kinetic-pharmacodynamic modeling approaches for the development of next generation CAR-T therapies

Andrew Stein

  • Mechanism-based models of immune biology for the development of engineered cytokine-based immunotherapies

Iraj Hoessien/Saroja Ramanujam

  • Agent-based model of the tumor-immune ecosystem for generating virtual patient populations 

Stacey Finley


Application of Pharmacometrics and Clinical Decision Support Tools to Facilitate Precision Dosing in Pediatric Populations


Chairs: Daniel Gonzalez, Eleni Karatza

  • Application of population and physiologically-based pharmacokinetic modeling to characterize drug-drug interactions in pediatric patients

Daniel Gonzalez

  • Pharmacokinetic/pharmacodynamic modeling to facilitate dose individualization in pediatric patients

Michael Neely

  • Use of clinical decision support tools to facilitate pediatric dose individualization at the point of care

Ron Keizer

  • Regulatory considerations for evaluating the need and methodological approach for model-informed precision dosing in pediatric patients

Jiang Liu


Current Advancements in Pharmacometrics and Systems Pharmacology Approaches towards Development and Regulatory Submissions of Cell Therapies


Chairs: Aman P. Singh, Fei Hua

  • Exposure-Response Considerations for CAR-T Cell Products

Manisha Lamba

  • Mechanistic PK-PD Considerations for Development of CAR-NK Cell Therapies

Aman P. Singh

  • A Quantitative Systems Pharmacology Model for Autologous Stem Cell Therapy in Sickle Cell Disease (SCD)

Bo Zheng

  • Regulatory Quantitative Experience on Recent Approved CAR-T Cell Therapy Products

Yuan Xu


Really! Evidence that Pharmacometricians can Leverage Real World Evidence


Chair: James Rogers

  • Assessing real-world evidence fitness-for-purpose: A regulatory perspective

Mark Levenson

  • Real world evidence to support modeling and simulation-informed clinical trial design

Zhaoling Meng

  • The promise of artificial intelligence in RWD exploration for drug development

Fei Wang

  • Developing a PD-PE simulation platform with RWD-based parameter estimates

Dan Polhamus


FDA Town Hall Update: Modeling and Simulation in GDUFA Regulatory Science Program


Chairs: Lanyan (Lucy) Fang, Robert Lionberger

  • Overview and update of GDUFA-funded modeling and simulation grants/contracts

Liang Zhao

  • The role of in silico modeling and simulation for bioavailability/bioequivalence evaluation

Mats Karlsson

  • Computational fluid dynamics (CFD) modeling of orally inhaled and nasal drug products for facilitating generic drug product development

Worth Longest

  • Utilization of text analysis and nature language processing to enhance product-specific guidance development

Hualou Liang


Pediatric Drug Development with Long Acting Injectables - Addressing the Confluence of Dual Challenges


Chairs: Navin Goyal, Roberto Gomeni

  • Modeling complex pharmacokinetics of long-acting injectable products

Roberto Gomeni

  • Achieving efficiency in study designs with LAI administration of drugs in pediatric subjects

Navin Goyal

  • Tailored approaches to address opportunities and challenges with LAI dose selection

Rajendra Singh


Specialized PBPK Models for Target Tissue Dynamics of Protein Therapeutics


Chairs: Seshasai Pallikonda Chakravarthy, Kapil Gadkar

  • Development of a translational PBPK model to characterize brain disposition of protein therapeutics

Dhaval K Shah

  • An avidity-based binding model for a biparatopic anti-HER2 antibody for brain metastasis within a minimal PBPK framework

Isha Taneja

  • A physiologically based ocular model to support preclinical and clinical drug development

Gregory Z Ferl

  • An integrated framework leveraging mechanistic and AI approaches to gain deeper insights into target engagement

Joga Gobburu


MCS+:  Bringing More Mathematical and Computational Sciences (MCS) into Pharmacometrics


Chairs: Peiying Zuo, Tongli Zhang

  • Understanding virtual patients both efficiently and rigorously with integrated machine learning dynamical analysis

Tongli Zhang

  • Agent-based modeling in drug treatment of tuberculosis

Maral Budak

  • Comparison of machine learning models and traditional pharmacometrics models in regulatory applications

Yaning Wang


Real world pharmacometrics


Chairs: Athena Zuppa, Darlene Santiago Quinones

  • Association between side effects occurrence and concentrations of ibrutinib and idelalisib (PK-E3I)

Prof Etienne Chatelut

  • Predictors of work disability in multiple sclerosis

Sebastian Ueckert

  • How to leverage the wealth of biomarker data to optimize antimicrobial treatment?

Coen van Hasselt

  • Real world phamacodynamics in haematopoietic stem cell transplant

Jeannine S McCune


Roller Coaster Session 1A



  • A case-study of model-informed drug development of a novel PCSK9 anti-sense oligonucleotide

Dinko Rekic

  • Quantitative knowledge-based platform for oncolytic Immunotherapy of cancer treatment

Malidi Ahamadi

  • Exploring link between ctDNA and tumor growth for improved predication of outcomes

Matts Kagedal

  • The potential for digital health technologies to transform clinical trials in neuroscience

Marissa Dockendort


Roller Coaster Session 1B



  • Parsing safety-related drug attrition and failure with systems pharmacological modalities: exemplar of drugs-induced mitochondria Injury

Sihem Ait-Oudhia

  • Insight for the future, how far our quantitative approach can take us to protect our next generation

Jeff Barrett

  • Application of trial simulation in the design of a prospective study for concentration QTc analysis in support of TQT waiver

Penny Zhu

  • Automated calibration of cellular models to infer cell-to-cell variability in molecular alterations from myocardial infarction (MI)

Eric Sobie






Trainee Communication Challenge


 Chair: Mirjam Trame

Trainee Mentoring Session




TUTORIALS (free, separate registration required)


Know a Good Model When You See It, See a Good Model When you Find It: Effective Visualizations for Developing and Qualifying popPK/PKPD, MBMA, and other Pharmacometric Models


Chairs: Jos Lommerse, Jeffrey Sachs


Efficient and reproducible non-compartmental analysis in R


Chairs: Anne Kummel, Henning Schmidt


Trainee Tutorial: Application of Machine Learning in Drug Development with Regulatory Considerations (students/trainees only)


Chairs: Patrick Hanafin, Jagdeep Podichetty