ACoP13 13

Welcome to ACoP

 

ACoP13
Aurora, Colorado
October 30- November 2, 2022
Together Moving Moutains
Saturday, October 29. 2022  
  
Start End Function/Event Chair/Speakers
7:00 AM 8:00 AM Registration & Breakfast -Workshop Attendees  
7:00 AM 8:00 AM Breakfast  - ISoP Board  
8:00 AM 5:30 PM ISoP Board Meeting  
8:00 AM 5:00 PM Pre Meeting Workshop -Pumas for non-linear mixed effects modeling Pumas AI, Inc
8:00 AM 5:00 PM Pre Meeting Workshop - Introduction to Finch Studio for NONMEM Analyses with Case Studies in Target-Mediated Drug Disposition  Enhanced  Pharmacodynamics
8:00 AM 5:00 PM Pre Meeting Workshop - Introductory Course on Pharmacometric Modeling with Monolix  Simulation Plus
8:00 AM 5:00 PM Pre Meeting Workshop - Advanced Features of NONMEM 7.5 Workshop for ACoP 2022 ICON
12:00 PM 1:00 PM Lunch - Workshop Attendees  
12:00 PM 1:00 PM Board Lunch  
Sunday, October 30. 2022 - ACoP13 Conference
  
Start End Function/Event Chair/Speakers
8:00 AM 5:00 PM Speaker Ready Room   
7:00 AM 8:00 AM Registration & Breakfast - Workshop Attendees  
7:30 AM 9:00 PM Registration & Breakfast - Pre Con Attendees  
8:00 AM 5:00 PM Pre Meeting Workshop -  Pumas for non-linear mixed effects modeling (Day 2 of 2)  Pumas AI, Inc
8:00 AM 5:00 PM Pre Meeting Workshop - A showcase of open-source tools for scalable, reproducible PMx workflows  Metrum
8:00 AM 5:00 PM Pre Meeting Workshop - Forest plots in practical use: Implementation and interpretation   Pharmetheus
8:00 AM 5:00 PM Pre Meeting Workshop - Advanced course on Pharmacometrics modeling with Monolix   Lixoft, Simulation Plus
9:00 AM 5:00 PM Pre Conference Session  - "Challenging the Norm: IV/SC Bridging Strategies for Biologics" Sihem Bihorel,  Merck; Daniele Ouellet, Janssen
    Regulatory Considerations for IV/SC Bridging Strategies for Biologics Hoa Zhu - FDA, Yow-Ming Wang
12:00 PM 1:30 PM Lunch & Posters - Pre-Conference Attendees Pre-Conference Attendees
12:00 PM 1:00 PM Lunch - Workshop Attendees Lunch - Workshop Attendees
12:00 PM 7:30 PM ACoP13 Conference Registration P13 Conference Registration
5:00 PM 5:30 PM Awards Reception (by invitation only)  
5:30 PM 7:30PM  Opening Session  Opening Session
    Welcome/Conference Highlights Chris Penland, Conference Chair, AstraZeneca
    Presentation of ISoP Awards & Induction of Fellows Navin Goyal, Janssen
    Lewis B. Sheiner Award Lecture TBD
7:30 PM 10:00 PM Opening Reception Opening Reception
Monday, October 31, 2022
  
Start End Function/Event Chair/Speakers
8:00 AM 5:00 PM Speaker Ready Room  Speaker Ready Room
7:00 AM 9:00 AM Exhibits/Posters/Coffee Service Posters/Coffee Service
9:00 AM 11:00 AM General Session - President's Address/President-Elect's Address President-Elect's Address
    ISoP: The Year in Review CJ Musante
    ISoP:The Year Ahead President Elect
    State-of-the-Art Lecture  - Title Dr. Hiddo J L Heerspink
11:15 AM 1:00 PM Concurrent Session 1A  - Oncology Drug Development - Getting Ready for Project Optimus Tim Nicholas - Pfizer, Wei Gao - EMD Serono
    Project Optimus: Changing the Dosing Paradigm for Oncology Products Mirat Shah - FDA
    Integration of preclinical and early clinical data to inform rational oncology dose optimization strategy Donghua Yin - Pfizer
    Leveraging Evolutionary Principles to Optimize Doses for Antibody-Targeted Therapy Carter Cao - UNC 
    Dose Optimization in Early Clinical Development for Oncology: Regulatory Perspective Jiang Liu - FDA
    Is QSP ready for Optimus? Opportunities and challenges with model informed oncology dose optimization. Blerta Shtylla - Pfizer
    Dose Optimization in Oncology Drug Development: Opportunities and Enablers in the Context of Project Optimus Karthik Venkatakrishnan - EMD Serono
11:15 AM 1:00 PM Concurrent Session 1B - Opportunities and Challenges in Special Population Drug Development Applications of PBPK Modeling and Simulation for Small Molecules and Therapeutic Proteins Annie Lumen - Amgen; Blessy George - FDA; Xinwen Zhang - Amgen
    Applications of MIDD for Pediatric Drug Development Gilbert Burckart - FDA
    Model Informed Drug Development Application for Organ Impairment (Renal/Hepatic) Special Populations using PBPK Modeling & Simulation  Vijay Upreti - Amgen
    Use of Physiologically-Based Pharmacokinetic Modeling to Support Dosing in Pregnancy Considering Fetal Exposure  Blessy George - FDA
    PBPK Modeling and Simulation to Guide Pediatric Dosing for Therapeutic Proteins Through Various Routes of Administration Xinwen Zhang - Amgen
    Mechanistic Predictive Modeling of Ocular Toxicity in Oncology Patients for Therapeutic Proteins using PBPK M&S Annie Lumen - Amgen
11:15 AM 1:00 PM Concurrent Session 1C - Modeling approaches to determine FIH dose for cell and gene therapeutics and novel modes of drug delivery in low data environments. Maithreye Rengaswamy - Vantage; Iraj Hosseini - Genentech
    IS/ID Modeling to Support the First in Human Dose Selection of an mRNA Cancer Vaccine Stephen Green - Moderna Tx
    Determining the FIH dose for an immune booster using a minimal PBPK-PD model Iraj Hosseini - Genentech
    Determining the Gene Expression Efficiency Factor for Model-based Development of the Viral-mediated in vivo Gene Therapy Chee Ng
    Quantitative Translational and Clinical Pharmacology Approaches towards Effective Dose-selection for CAR-T Cell Therapies: Application towards MIDD Aman Singh - Takeda
1:00 PM 2:30 PM Lunch  Lunch
1:00 PM 2:30 PM Exhibits/Posters  Exhibits/Posters
1:00 PM 2:30 PM Trainee Lunch Mokshada Kumar
2:30 PM 4:00 PM Concurrent Session 2A - Emerging Opportunities for Real World Evidence and Role of Pharmacometricians Arnab   Mukher - Pfizer; Christopher Banfield - Pfizer
    Regulatory perspectives on RWE guidance Hao Zhu - FDA
    RWE study design and analytical considerations Lauren Becnel - Pfizer
    End to End Application of RWE in drug development at Pfizer Brian Corrigan - Pfizer
    Examples of RWD Data Applications in Drug Development and Approval Vikram Sinha - Takeda
    Review of Case Studies of Clin Pharm/PMx applications of RWE at
Genentech
Rui Zhu - Genentech
    Future opportunities for Clinical Pharmacology/PMx Ellen Wang - Pfizer
2:30 PM 4:00 PM Concurrent Session 2B - Advancing RNA-based therapeutics through model-informed development: current challenges and opportunities Vivaswath Ayyar - Janssen; Sukyung Woo - SUNY Buffalo
    Mechanistic PK-PD modeling for siRNA Therapeutics Sukyung Woo - SUNY Buffalo
    Translational Considerations for GalNAc-siRNA Development: Insights from a Minimal PBPK-PD Model  Vivaswath Ayyar - Janssen
    Pharmacometrics for Translational and Clinical Development of mRNA Vaccines and Therapeutics  Husain Attarwala - Moderna Tx
    Poster Presenter TBD
2:30 PM 4:00 PM Concurrent Session 2C - The MPRINT Hub and BPCA:  Moving Mountains in Maternal and Pediatric Precision Therapeutics Sara Quinney - Indiana University School of Medicine; Robert Bies - SUNY Buffalo
    The BPCA Framework Initiative and Enhancing Pediatric Drug Development and Therapeutics Gilbert Burckart - FDA
    Utilizing pharmacometrics to support personalized therapy in pregnant and lactating women Sara Quinney - Indiana University School of Medicine
    Towards Development of PBPK Models to Characterize the PK of Protein Therapeutics in Children Dhaval Shah - SUNY Buffalo
    Abstract presenter TBD
4:00 PM 5:30 PM Exhibits/Posters/Coffee Service Posters/Coffee Service
4:30 PM  5:00 PM Coffee Chat - TBD - Social Chat - TBD - Social
5:30 PM 6:30 PM Communication Challenge Stacey Tannenbaum, Astellas; Mirjam Trame, Certara; Mokshada Kumar, Univ. of Buffalo
7:00 PM 10:00 PM Social Dinner Event Social Dinner Event
Tuesday, November 1, 2022
  
Start End Function/Event Chair/Speakers
8:00 AM 5:00 PM Speaker Ready Room  Speaker Ready Room
7:30 AM 9:30 AM  Exhibits/Posters/Coffee Service Posters/Coffee Service
9:30 AM 10:45 AM General Session  - Key Note Speaker - Topic Dr. Klaus Romero
11:00 AM 12:30 PM Quality & Trainee Awards  Lian Ma
    (6) speakers - TBD 6
12:30 PM 2:00 PM Exhibits/Posters  Exhibits/Posters
12:30 PM 2:00 PM Lunch  Lunch
12:30 PM 2:00 PM SIG Lunch - QSP QSP SIG
12:30 PM 2:00 PM SIG Lunch - SxP SxP SIG
2:00 PM 3:30 PM Concurrent Session 3A - Explainable Machine Learning for Disease Progression Modeling & Digital Twins   James Lu - Genentech; Nicholas Ellinwood - Eli Lilly
    Predicting disease activity in Multiple Sclerosis patients - an explainable ML approach in Mavenclad trials Nadia Terranova - KGaA
    An Explainable Deep Learning Framework for Tumor Dynamic Modeling and Overall Survival Prediction using Neural-ODE James Lu (Genentech)
    Neural ODEs for Multi-State Modeling and Cause-Specific Time-to-Event Analysis Stefan Groha (Dana-Farber Cancer Institute)
    Machine Learning Enables Smaller Clinical Trials Daniele Bertolini (Unlearn.ai)
2:00 PM 3:30 PM Concurrent Session 3B - Modeling and Simulation in Support of New Modalities in Oncology Drug Development   Hongmei Xu - Bicycle Therapeutics; Diansong Zhou - Astrazeneca
    Bicycle-Toxin Conjugates: is it another type of ADC? Hongmei Xu - Bicycle Therapeutics
    Challenges and opportunities of PKPD modeling of chimeric antigen receptor (CAR) T-cell therapy using ciltacabtagene autoleucel Liviawati Wu - Janssen
    Mechanistic PK/PD Modeling in Support of Targeted Protein Degrader Vaishali Dixit - Kymeratx
    MIDD on clinical development of T cell redirecting bispecific antibodies Xiling Jiang - FDA
2:00 PM 3:30 PM Concurrent Session 3C - QSP modelers and conventional pharmacometricians meet at the nexus of late-stage clinical development: expanding the scope of MID3   Weirong Wang - Janssen; Yaning Wang - Createrna
    Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration Hao Zhu - FDA
    What can pharmacometrics learn from QSP? Piet van der Graaf - Certara
    What can QSP learn from pharmacometrics? Chuanpu Hu - Janssen
    What can clinical development learn from QSP? Steven Chang - Immunetrics
3:30 PM 4:30 PM Exhibits/Posters/Coffee Service Posters/Coffee Service
4:00 PM 5:00 PM Trainee/Mentor Mtg Moksgada Kumar
5:00 PM 6:30 PM Alumni Reception - U Of Tenn U Of Tenn
5:00 PM 6:30 PM Alumni Reception - U of MD Reception - U of MD
5:00 PM 6:30 PM Alumni Reception - U of Minn Reception - U of Minn
5:00 PM 6:30 PM Alumni Reception - U of Buffalo Reception - U of Buffalo
5:00 PM 6:30 PM Alumni Reception - U of FL Reception - U of FL
6:00 PM 7:30 PM President's Reception (by invitation only)  
5:00 PM 6:30 PM QSP SIG Reception Lourdes Cucurull-Sanchez 
Wednesday, November 2, 2022
  
Start End Function/Event Chair/Speakers
8:00 AM 1:00 PM Speaker Ready Room  Speaker Ready Room
7:00 AM 9:00 AM  Exhibits/Posters/Coffee Service Posters/Coffee Service
9:00 AM 11:00 AM Roller Coaster 1 Roller Coaster 1
    From Casual to Causal: Three Fundamental Concepts to Spiff Up Your Causal Reasoning  James Rogers - Metrum
    Comparing the Applications of Machine Learning and PBPK/Pop-PK Models in Pharmacokinetic Drug-Drug Interaction Modelling Venkatesh Reddy - Astrazeneca
    Regulatory Perspective on Artificial Intelligence Integrated Drug Development Qi Liu - FDA
    PKPDAI: A Pharmacometric Knowledge Repository Structured and Curated with Natural Language Processing Joseph  Standing, University College London
    Disease Progression Modeling benefitting from emergence of novel approaches such as RWD & AI/ML Pascal Chanu - Genentech
9:00 AM 11:00 AM Roller Coaster 2 Roller Coaster 2
    Quantitative clinical pharmacology considerations for cevostamab, an anti-FcRH5/CD3 TDB in relapsed or refractory multiple myeloma Monica Susilo - Genentech
    Dose Justification Strategies for Teclistamab, an anti-BCMA/CD3 TDB in Relapsed or Refractory Multiple Myeloma Suzette Girgis - Janssen
    Modeling Immunological Synapse Dynamics Induced by Bispecific T-cell Engagers  Carter Cao - UNC
    Evaluation of potential for subasumstat to overcome rituximab resistance via PK/PD and QSP modeling of antibody dependent cell mediated cytotoxicity Dean Bottino - Takeda
    Quantitative Systems Pharmacology Modeling of Enzyme Replacement Therapies for Mucopolysaccharidosis Type II Reveals Key Brain & CSF PK/PD Relationships Mohammad Jafarnejad
    Quantitative modeling to support Gene Therapy in Rare Diseases Satyaprakash Nayak - Pfizer
9:00 AM 11:00 AM Roller Coaster 3 Roller Coaster 3
    Generating Model-integrated Evidence for Developing and Approving Complex Generic LAI Products Liang Zhao - FDA
    Rapid Decision Making: Utility of Automation and Pro-active modeling Jessica Wojciechowski - Pfizer
    Association between Immune -mediated adverse events and treatment efficacy in patients treated with immune checkpoint inhibitors Agnish Dey
    Regulatory experience on the application of MIDD  for COVID-19 EUA. Su-Young Choi - FDA
    Establishing correlates of protection for herpes zoster infection via MBMA analysis. Maria-Luisa Sardu - Certara
    Moving beyond boundaries: utilization of continuous bounded outcome score model in drug development decision making Yeamin Huh - Pfizer
11:00 AM 12:00 PM General Session DE & I Session Leticia Arrington - Amgen; Nadia Noormohamed - GSK
12:00 PM 1:30 PM Exhibits/Posters  Exhibits/Posters
12:00 PM 1:30 PM Lunch Lunch
12:00 PM 1:30 PM SIG Lunch - CPmx SIG Lunch - CPmx
12:00 PM 1:30 PM SIG Lunch - MCS SIG Lunch - MCS
1:30 PM 3:00 PM Concurrent Session 4A - PBPK and other extrapolation approaches in pediatrics: past, present and future Amy Cheung - Certara; James Yates - GSK
    Regulatory landscape of PBPK, the progress of PBPK qualification and gaps for pediatric Ine Rusten - EMA, The Norwegian Medicines Agency
Flora Musuamba - EMA, FAMHP Belgium
    Where are we with pediatric PBPK? Kunal Taskar - GSK
    The Next step toward Evidence Based Pharmacotherapy  Elizabeth de Lange - Leiden University
    Applications of pharmacokinetic-pharmacodynamic (PK/PD) modeling and simulation and physiologically based pharmacokinetics (PBPK) and pharmacogenetics/genomics in pediatrics Sander Vinks - CCHMC
1:30 PM 3:00 PM Concurrent Session 4B - Use of Bayesian joint modeling of longitudinal data and time to event data in drug development   Wonkyung Byon - A2PG; Sunny Chapel - A2PG
    An overview of joint modeling of longitudinal data and time to event data Luyuan Qi - Certara
    Use of joint modeling in oncology drug development: Challenges and
opportunities.
Nidal Huniti - A2PG; Daniel Lee - Bayesian Ops
     Multivariate joint modeling for COVID clinical outcomes Daniela J Conrado - Regeneron; Yuhuan Wang - Regeneron
1:30 PM 3:00 PM Trainee Tutorial - Pharmacometric Analysis of Categorical data by Dr. Lena Friberg and Dr Andrew Hooker Moksgada Kumar - Univ. Buffalo; Lena Friberg; Andrew Hooker 
3:30 PM 4:00 PM Closing General Session Closing General Session
4:30 PM 6:00 PM ACoP 13 Meets ACoP 14 (by invitation only) by invitation only
Thursday, November 3, 2022
  
Start End Function/Event Chair/Speakers
7:00 AM 8:00 AM Tutorial Coffee Service Tutorial Coffee Service
8:00 AM 12:00 PM Tutorial #1 - Stan and R for Stan-da-R-d Pharmacometric Analyses “ A Bayesian Approach for Population Pharmacokinetics and Exposure Response Modeling" Casey Davis - Amgen; Pavan Vaddady - Daiichi Sankyo [Instructors: Casey Davis - Amgen; Pavan Vaddady - Daiichi Sankyo; Arya Pourzanjani - Amgen; Yasong Lu - Daiichi Sankyo]
8:00 AM 12:00 PM Tutorial #2 - Using nlmixr2 for automatically selecting PK models with PKNCA Matthew Fidler - Novartis; William Denney - Human Predictions
12:00 PM 1:00 PM Workshop Registration & Lunch (workshop attendee only) workshop attendee only
1:00 PM 5:00 PM Post Workshop - Bayesian Analysis in Pumas -  (Almost) everything a Bayesian needs   Pumas AI, Inc
1:00 PM 5:00 PM Post Workshop - Exposure-response modeling for binary and time-to-event data using R and Stan   Metrum
1:00 PM 5:00 PM Post Workshop Mathworks
Friday, November 4, 2022
  
Start End Function/Event Chair/Speakers
7:00 AM 8:00 AM Workshop Breakfast Workshop Breakfast
8:00 AM 5:00 PM Post Workshop - Bayesian Analysis in Pumas -  (Almost) everything a Bayesian needs   Pumas AI, Inc
8:00 AM 5:00 PM Post Workshop - Exposure-response modeling for binary and time-to-event data using R and Stan   Metrum
12:00 PM 1:00 PM Workshop Lunch Workshop Lunch
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