Welcome to ACoP12 12

Welcome to ACoP

 

ACoP12 Preliminary Program

“Charting the Course for Our Future”

MONDAY, NOVEMBER 8th

   

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

   
             

TUESDAY, NOVEMBER 9th

   

8:00AM - 9:30AM

 

Poster presentations/coffee/networking

       

9:30AM - 10:00AM

 

Sponsors

 

 

   

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

 

Sponsors

 

 

   

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

1A

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

1B

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

 

 

Coffee/Networking

       

 WEDNESDAY, NOVEMBER 10th

   

8:00AM - 9:30AM

 

Poster presentations/coffee/networking

       

9:30AM - 10:00AM

 

Sponsors

       
 

 

 

 

 

   
 

 

 

 

 

   

10: 00AM- 11:30AM

2A

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

2B

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

2C

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

 

Sponsors

 

 

   

2:00PM - 3:30PM

3A

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

3B

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

3C

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

 

     

THURSDAY, NOVEMBER 11th

   
             

8:00AM - 9:30AM

 

Poster presentations/coffee/networking

       

9:30 AM - 10:00 AM

 

Sponsors

       

10: 00 AM- 11:30 AM

4A

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

4B

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

4C

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

5A

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

5B

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

5C

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

RC1A  

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

RC1B 

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

   

FRIDAY NOVEMBER 12th

8:30 AM - 9:30 AM

 

Coffee/networking

 

 

 

   

9:30 AM - 11:30 AM

 

Trainee Communication Challenge

 

Chair: Mirjam Trame

   
 

11:30 AM - 12:30 PM

 

 

Trainee Mentoring Session

       
             
 

 

TUTORIAL SESSIONS

 

     

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

 

SIG Event: QSP, SPX

 

     
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