ACoP13 Will Be Live!

Welcome to ACoP


ACoP12 Preliminary Program

“Charting the Course for Our Future”



8:00AM - 4:00PM


Pre-Conference: Integrating standardization and innovation in your organization:  Find a workflow that works for you!


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


4:30PM – 6:00PM


Presentation of ISoP Awards & Induction of 2021 Fellows

Lewis B. Sheiner Award Lecture


Chair: Chris Penland

William Gillespie




8:00AM - 9:30AM


Poster presentations/coffee/networking


9:30AM - 10:00AM






10:00AM - 10:30AM


ACoP12 Welcome/Address by President & President-Elect


Heather Vezina, Bren da Cirincione, Cynthia J. Musante


10:30AM - 11:30AM


Keynote Lecture


Andrew Gelman, Columbia University


12:00PM - 1:30PM


Poster presentations/coffee/networking




1:30PM - 2:00PM






2:00PM - 3:30PM


Fellows Plenary Session: Charting the future course for pharmacometricians


Chair: Heather Vezina

  • Training of future pharmacometricians: an academic perspective

Richard Brundage

  • Statistical methods in pharmacometrics: present and future?

France Mentre

  • Modeling and simulation in drug development: current state and future vision

Jin Jin

  • Regulatory opportunities for future pharmacometricians

Yaning Wang

  • Panel discussion/Q&A

Presenters plus Mats Karlsson, Jill Fiedler-Kelly, and Daniele Ouellet


4:00PM - 5:30PM


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: what can QSP learn from pharmacometrics and vice versa?

Piet Van Der Graaf

  • From Current Landscape to Good Practices: Proposed Framework for PBPK Models and Beyond

Hao Zhu

  • Benefits of Model reduction for validating QSP Models.

Mark Transtrum

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

Prof Gary Mirams


4:00PM - 5:30PM


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


Chairs: Lanyan (Lucy) Fang, Robert Lionberger

  • Opening Remarks

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.

Andrew Hooker

  • 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


5:30PM - 6:30PM







8:00AM - 9:30AM


Poster presentations/coffee/networking


9:30AM - 10:00AM














10: 00AM- 11:30AM


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 Weddelland 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 and Justin Feigelman

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

Cibele V Falkenberg


10: 00AM- 11:30AM


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


Chairs: Holly Kimko, Aleksander S. Popel

  • Brief Introduction to Agent-Based Modeling (ABM)

Aleksander S. Popel

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

Chang Gong

  • QST using data from microphysiological system

Carmen Pin

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

Paul Macklin


10: 00AM- 11:30AM


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


12:00PM - 1:30PM


Poster presentations/coffee/networking




1:30PM - 2:00PM






2:00PM - 3:30PM


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

  • A quantitative systems pharmacology model to characterize the PKPD relationship following treatment with IL-15 agonist

Louis Joslyn

  • 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

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

Stacey Finley


2:00 PM - 3:30PM


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


2:00 PM - 3:30PM


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 Idecabtagene vicleucel, first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy for relapsed and refractory multiple myeloma

Manisha Lamba

  • Evolution of the Multiscale Mechanistic PK-PD Models for Cellular Therapies in Hematological Malignancies and Solid Tumors

Aman P. Singh

  • A Quantitative Systems Pharmacology (QSP) 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


4:00 PM - 5:30 PM


SIG Events: Clinical PMx, MCS



4:00 PM - 5:00 PM


2021 Cardiac Physiome Quantitative Systems Pharmacology (QSP) & Quantitative Systems Toxicology (QST) Special Session (under joint auspices of Cardiac Physiome and ACoP12)



  • Keynote Talk: The When and Why of Cardiovascular QSP & QST: An Industry Perspective

Cynthia J. Musante

  • Panel Discussion with Industry QSP & QST representatives including discussions on validation framework, collaboration opportunities, and career opportunities for trainees

5:30 PM - 6:30 PM


Alumni Events





8:00AM - 9:30AM


Poster presentations/coffee/networking


9:30 AM - 10:00 AM




10: 00 AM- 11:30 AM


Really! Evidence that Pharmacometricians can Leverage Real World Evidence


Chairs: 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


10: 00 AM- 11:30 AM


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: Application to Current Therapeutic Interventions

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.

Emmanuel Chigutsa

  • MIDD Application in COVID-19 Drug Development, Case example: Whole Body PBPK Modeling of Remdesivir and its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients with Organ Dysfunction

Jianghong Fan

  • Model-Informed Approaches in Development of Remdesivir for Treatment of COVID-19

Rita Humeniuk


10: 00 AM- 11:30 AM


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


12:00 PM - 1:00 PM


Poster presentations/coffee/networking


1:00 PM- 2:30 PM


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


1:00 PM- 2:30 PM


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


Chairs: Peiying Zuo, Tongli Zhang

  • Comparison of Machine Learning Models and Traditional Pharmacometrics Models in Regulatory Applications

Yaning Wang

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

Tongli Zhang

  • Therapeutic implications of distinct mechanisms of oncolytic virus spread within the tumor microenvironment: investigations with a computational model

Jess Wu (Abstract)

  • Agent-based Modeling in Drug Treatment of Tuberculosis.

Maral Budak


1:00 PM- 2:30 PM


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

  • Real world phamacodynamics in haematopoietic stem cell transplant

Jeannine S McCune


3:00 PM- 4:30 PM


Roller Coaster 1A


Chair: Wei Gao

  • A Case-Study of Model-Informed Drug Development of a Novel PCSK9 Anti Sense Oligonucleotide. First time in Man up to Phase 2

Dinko Rekic

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

Malidi Ahamadi

  • Minimal Residual Disease growth model for Chronic Lymphocytic Leukemia

Tong Lu

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

Marissa Dockendorf


3:00 PM- 4:30 PM


Roller Coaster 1B


Chair: Rajendra Singh

  • 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 sim in the design of a prospective study for conc QTc analysis in support of TQT waiver

Penny Zhu

  • Automated calib of cellular models to infer cell-to-cell variability in molecular alterations from MI

Eric Sobie


4:30 PM - 5:30 PM


Abstract Awards


Chairs: Molly Zhao, Lian Ma


5:30 PM - 6:30 PM


Social Event


Chairs: Stacey Tannenbaum, Eric Jordie



8:30 AM - 9:30 AM







9:30 AM - 11:30 AM


Trainee Communication Challenge


Chair: Mirjam Trame


11:30 AM - 12:30 PM



Trainee Mentoring Session






11:30 AM - 3:00 PM


Tutorial 1: 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 R. Sachs


11:30 AM - 3:00 PM


Tutorial 2: Efficient and reproducible non-compartmental analysis in R


Chairs: Anne Kummel, Henning Schmidt


12:30 PM - 3:30 PM


Tutorial 3: Trainee Tutorial: Application of Machine Learning in Drug Development with Regulatory Considerations


Chairs: Jagdeep Podichetty, Patrick Hanafin


3:30 PM - 5:00 PM