Welcome to ACoP12 12

Welcome to ACoP

 

ACoP12 Preliminary Program

“Charting the Course for Our Future”

MONDAY, NOVEMBER 8

     

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

 

 

   

 

TUESDAY-THURSDAY, NOVEMBER 9-12

     

President’s Address & Keynote Lecture

Special Plenary Session

Abstract Awards

Alumni Receptions & Social Event

 

 

   

 

SYMPOSIUMS:

   

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
 

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
 

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

  • Extreme value theory: Extension to mixed effect models
 

Peter Bonate

  • 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 Kaygedal

  • 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

     

FRIDAY, NOVEMBER 12

 

 

 

Trainee Communication Challenge

 

 

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

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