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MONDAY, NOVEMBER 8th
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8:00AM - 4:00PM
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Pre-Conference: Integrating standardization and innovation in your organization: Find a workflow that works for you!
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Chairs: Jace Nielsen, Chris Penland, Mike K. Smith, Stacey Tannenbaum
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4:30PM – 6:00PM
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Presentation of ISoP Awards & Induction of 2021 Fellows
Lewis B. Sheiner Award Lecture
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Chair: Chris Penland
William Gillespie
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TUESDAY, NOVEMBER 9th
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8:00AM - 9:30AM
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Poster presentations/coffee/networking
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9:30AM - 10:00AM
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Sponsors
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10:00AM - 10:30AM
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ACoP12 Welcome/Address by President & President-Elect
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Heather Vezina, Bren da Cirincione, Cynthia J. Musante
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10:30AM - 11:30AM
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Keynote Lecture
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Andrew Gelman, Columbia University
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12:00PM - 1:30PM
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Poster presentations/coffee/networking
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1:30PM - 2:00PM
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Sponsors
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2:00PM - 3:30PM
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Fellows Plenary Session: Charting the future course for pharmacometricians
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Chair: Heather Vezina
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- Training of future pharmacometricians: an academic perspective
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Richard Brundage
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- Statistical methods in pharmacometrics: present and future?
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France Mentre
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- Modeling and simulation in drug development: current state and future vision
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Jin Jin
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- Regulatory opportunities for future pharmacometricians
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Yaning Wang
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Presenters plus Mats Karlsson, Jill Fiedler-Kelly, and Daniele Ouellet
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4:00PM - 5:30PM
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1A
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Towards a standardized assessment framework of mechanistically detailed models including QSP and PBPK: Zooming in on model validation.
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Chairs: Anna Sher, Pras Pathmanathan
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- A conversation about current and imminent challenges of simple vs complex models’ validation: what can QSP learn from pharmacometrics and vice versa?
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Piet Van Der Graaf
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- From Current Landscape to Good Practices: Proposed Framework for PBPK Models and Beyond
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Hao Zhu
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- Benefits of Model reduction for validating QSP Models.
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Mark Transtrum
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- Lessons from the cardiac modelling field in validating complex QSP models
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Prof Gary Mirams
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4:00PM - 5:30PM
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1B
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FDA Town Hall Update: Modeling and Simulation in GDUFA Regulatory Science Program
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Chairs: Lanyan (Lucy) Fang, Robert Lionberger
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Robert Lionberger
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- Overview and Update of GDUFA-funded Modeling and Simulation grants/contracts.
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Liang Zhao
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- The Role of In Silico Modeling and Simulation for Bioavailability/Bioequivalence Evaluation.
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Andrew Hooker
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- Computational fluid dynamics (CFD) modeling of orally inhaled and nasal drug products for facilitating generic drug product development
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Worth Longest
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- Utilization of Text Analysis and Nature Language Processing to Enhance Product-Specific Guidance Development
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Hualou Liang
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5:30PM - 6:30PM
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Coffee/Networking
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WEDNESDAY, NOVEMBER 10th
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8:00AM - 9:30AM
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Poster presentations/coffee/networking
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9:30AM - 10:00AM
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Sponsors
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10: 00AM- 11:30AM
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2A
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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.
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Chairs:Joshua F. Apgar, Michael Weis
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- When the stakes are high: helping key stakeholders understand quantitative predictions by QSP models
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Jared Weddelland Pegy Foteinou
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- Taming of the zoo: understanding the menagerie of computational methods in QSP virtual patient population development and calibration, sensitivity analysis, and uncertainty quantification
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Jessica Brady and Justin Feigelman
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- Odds are your biggest source of uncertainty is not statistical: transparently dealing with data challenges in QSP models
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Cibele V Falkenberg
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10: 00AM- 11:30AM
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2B
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Development and Applications of Agent-Based Modeling: Spatial Quantitative Systems Pharmacology/Toxicology
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Chairs: Holly Kimko, Aleksander S. Popel
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- Brief Introduction to Agent-Based Modeling (ABM)
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Aleksander S. Popel
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- A spatial quantitative systems pharmacology platform spQSP-IO for simulations of tumor-immune interactions and effects of checkpoint inhibitor immunotherapy
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Chang Gong
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- QST using data from microphysiological system
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Carmen Pin
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- Open source multicellular simulations of treatment response in cancer & Covid-19
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Paul Macklin
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10: 00AM- 11:30AM
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2C
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The Terrific Trio, 3-T's of Mechanistic Modelling for Vaccines: Targets, Translations, and CTS-based Trial Design
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Chairs: Bhargava Kandala, Nele Mueller-Plock
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- Found in translation: A translational mechanistic model of immunogenicity to aid prophylactic vaccine development
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Jeffrey Perley
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- Modeling the immune response to vaccination during Mycobacterium tuberculosis infection using a host-scale computational model
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Denise Kirschner
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- Modeling and simulations for decision making in accelerated vaccine programs
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Anna Dari
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- (Lost in) translation: rodent modeling and validation with MBMA
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Jos Lommerse
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- Need for speed: Development of a model-based meta-analysis approach to enable rapid decision making for COVID-19 vaccine candidates
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Akshita Chawla
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12:00PM - 1:30PM
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Poster presentations/coffee/networking
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1:30PM - 2:00PM
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Sponsors
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2:00PM - 3:30PM
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3A
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Modeling approaches to support the development and approval of engineered cell and cytokine therapies
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Chairs: Daniel Kirouac, Anna Kondic
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- Integrating machine learning and mechanistic modelling in the development of pegylated cytokines
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Aleksandrs Odinecs
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- A quantitative systems pharmacology model to characterize the PKPD relationship following treatment with IL-15 agonist
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Louis Joslyn
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- Mechanism- and data-driven modeling in the discovery, development and manufacturing of stem cell-based T-cell therapeutics
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Daniel Kirouac
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- Advances in mechanism-based cellular kinetic-pharmacodynamic modeling approaches for the development of next generation CAR-T therapies
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Andrew Stein
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- Agent-based model of the tumor-immune ecosystem for generating virtual patient populations
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Stacey Finley
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2:00 PM - 3:30PM
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3B
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Application of Pharmacometrics and Clinical Decision Support Tools to Facilitate Precision Dosing in Pediatric Populations
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Chairs: Daniel Gonzalez, Eleni Karatza
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- Application of Population and Physiologically-Based Pharmacokinetic Modeling to Characterize Drug-Drug Interactions in Pediatric Patients
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Daniel Gonzalez
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- Pharmacokinetic/Pharmacodynamic Modeling to Facilitate Dose Individualization in Pediatric Patients
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Michael Neely
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- Use of Clinical Decision Support Tools to Facilitate Pediatric Dose Individualization at the Point of Care
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Ron Keizer
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- Regulatory Considerations for Evaluating the Need and Methodological Approach for Model-Informed Precision Dosing in Pediatric Patients
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Jiang Liu
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2:00 PM - 3:30PM
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3C
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Current Advancements in Pharmacometrics and Systems Pharmacology Approaches towards Development and Regulatory Submissions of Cell Therapies
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Chairs: Aman P. Singh, Fei Hua
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- 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
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Manisha Lamba
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- Evolution of the Multiscale Mechanistic PK-PD Models for Cellular Therapies in Hematological Malignancies and Solid Tumors
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Aman P. Singh
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- A Quantitative Systems Pharmacology (QSP) Model for Autologous Stem Cell Therapy in Sickle Cell Disease (SCD)
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Bo Zheng
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- Regulatory Quantitative Experience on Recent Approved CAR-T Cell Therapy Products
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Yuan Xu
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4:00 PM - 5:30 PM
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SIG Events: Clinical PMx, MCS
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4:00 PM - 5:00 PM
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2021 Cardiac Physiome Quantitative Systems Pharmacology (QSP) & Quantitative Systems Toxicology (QST) Special Session (under joint auspices of Cardiac Physiome and ACoP12)
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- Keynote Talk: The When and Why of Cardiovascular QSP & QST: An Industry Perspective
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Cynthia J. Musante
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- Panel Discussion with Industry QSP & QST representatives including discussions on validation framework, collaboration opportunities, and career opportunities for trainees
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5:30 PM - 6:30 PM
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Alumni Events
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THURSDAY, NOVEMBER 11th
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8:00AM - 9:30AM
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Poster presentations/coffee/networking
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9:30 AM - 10:00 AM
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Sponsors
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10: 00 AM- 11:30 AM
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4A
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Really! Evidence that Pharmacometricians can Leverage Real World Evidence
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Chairs: James Rogers
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- Assessing real-world evidence fitness-for-purpose: A regulatory perspective.
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Mark Levenson
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- Real world evidence to support modeling and simulation-informed clinical trial design
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Zhaoling Meng
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- The Promise of Artificial Intelligence in RWD Exploration for Drug Development
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Fei Wang
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- Developing a PD-PE Simulation Platform with RWD-based parameter estimates
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Dan Polhamus
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10: 00 AM- 11:30 AM
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4B
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Quantitative Clinical Pharmacology Modeling and Simulation: A Critical Tool in Addressing the COVID-19 Pandemic
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Chairs: Hao Zhu, Jianghong Fan
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- A Quantitative Systems Pharmacology Model of the Immune Response to SARS-CoV-2: Application to Current Therapeutic Interventions
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Rohit Rao
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- Application of quantitative clinical pharmacology modeling and simulation to support dose selection and clinical development of bamlanivimab for the treatment of COVID-19.
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Emmanuel Chigutsa
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- 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
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Jianghong Fan
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- Model-Informed Approaches in Development of Remdesivir for Treatment of COVID-19
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Rita Humeniuk
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10: 00 AM- 11:30 AM
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4C
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Pediatric Drug Development with Long Acting Injectables - Addressing the Confluence of Dual Challenges
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Chairs: Navin Goyal, Roberto Gomeni
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- Modeling Complex Pharmacokinetics of Long-Acting Injectable Products
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Roberto Gomeni
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- Achieving efficiency in study designs with LAI administration of drugs in Pediatric subjects
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Navin Goyal
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- Tailored approaches to address opportunities and challenges with LAI dose selection
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Rajendra Singh
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12:00 PM - 1:00 PM
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Poster presentations/coffee/networking
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1:00 PM- 2:30 PM
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5A
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Specialized PBPK Models for Target Tissue Dynamics of Protein Therapeutics
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Chairs: Seshasai Pallikonda Chakravarthy, Kapil Gadkar
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- Development of a translational PBPK model to characterize brain disposition of protein therapeutics
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Dhaval K Shah
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- An avidity-based binding model for a biparatopic anti-HER2 antibody for brain metastasis within a minimal PBPK framework
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Isha Taneja
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- A physiologically based ocular model to support preclinical and clinical drug development
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Gregory Z Ferl
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- An Integrated Framework Leveraging Mechanistic and AI Approaches to Gain Deeper Insights into Target Engagement
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Joga Gobburu
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1:00 PM- 2:30 PM
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5B
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MCS+: Bringing More Mathematical and Computational Sciences (MCS) into Pharmacometrics
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Chairs: Peiying Zuo, Tongli Zhang
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- Comparison of Machine Learning Models and Traditional Pharmacometrics Models in Regulatory Applications
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Yaning Wang
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- Understanding virtual patients both efficiently and rigorously with integrated machine learning and dynamical analysis
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Tongli Zhang
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- Therapeutic implications of distinct mechanisms of oncolytic virus spread within the tumor microenvironment: investigations with a computational model
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Jess Wu (Abstract)
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- Agent-based Modeling in Drug Treatment of Tuberculosis.
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Maral Budak
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1:00 PM- 2:30 PM
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5C
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Real world pharmacometrics
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Chairs: Athena Zuppa, Darlene Santiago Quinones
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- Association Between Side Effects Occurrence and Concentrations of Ibrutinib and Idelalisib (PK-E3I)
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Prof Etienne Chatelut
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- Predictors of work disability in multiple sclerosis
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Sebastian Ueckert
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- Real world phamacodynamics in haematopoietic stem cell transplant
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Jeannine S McCune
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3:00 PM- 4:30 PM
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RC1A
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Roller Coaster 1A
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Chair: Wei Gao
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- A Case-Study of Model-Informed Drug Development of a Novel PCSK9 Anti Sense Oligonucleotide. First time in Man up to Phase 2
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Dinko Rekic
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- Quantitative knowledge-based platform for oncolytic Immunotherapy of cancer treatment
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Malidi Ahamadi
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- Minimal Residual Disease growth model for Chronic Lymphocytic Leukemia
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Tong Lu
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- The potential for digital health technologies to transform clinical trials in NS
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Marissa Dockendorf
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3:00 PM- 4:30 PM
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RC1B
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Roller Coaster 1B
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Chair: Rajendra Singh
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- Parsing Safety-related Drug Attrition and Failure with Systems Pharmacological Modalities: Exemplar of Drugs-induced Mitochondria Injury
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Sihem Ait-Oudhia
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- Insight for the future, how far our quantitative approach can take us to protect our next generation
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Jeff Barrett
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- Application of trial sim in the design of a prospective study for conc QTc analysis in support of TQT waiver
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Penny Zhu
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- Automated calib of cellular models to infer cell-to-cell variability in molecular alterations from MI
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Eric Sobie
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4:30 PM - 5:30 PM
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Abstract Awards
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Chairs: Molly Zhao, Lian Ma
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5:30 PM - 6:30 PM
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Social Event
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Chairs: Stacey Tannenbaum, Eric Jordie
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FRIDAY NOVEMBER 12th
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8:30 AM - 9:30 AM
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Coffee/networking
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9:30 AM - 11:30 AM
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Trainee Communication Challenge
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Chair: Mirjam Trame
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11:30 AM - 12:30 PM
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Trainee Mentoring Session
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TUTORIAL SESSIONS
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11:30 AM - 3:00 PM
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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.
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Chairs: Jos Lommerse, Jeffrey R. Sachs
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11:30 AM - 3:00 PM
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Tutorial 2: Efficient and reproducible non-compartmental analysis in R
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Chairs: Anne Kummel, Henning Schmidt
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12:30 PM - 3:30 PM
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Tutorial 3: Trainee Tutorial: Application of Machine Learning in Drug Development with Regulatory Considerations
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Chairs: Jagdeep Podichetty, Patrick Hanafin
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3:30 PM - 5:00 PM
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SIG Event: QSP, SPX
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