Welcome to ACoP


Saturday, October 29. 2022  
Start End Function/Event Chair/Speakers Room
7:00 AM 8:00 AM Registration & Breakfast -Workshop Attendees   Cottonwood 7
7:00 AM 8:00 AM Breakfast  - ISoP Board   Spruce 3
8:00 AM 5:30 PM ISoP Board Meeting   Spruce 4
8:00 AM 5:00 PM Pre Meeting Workshop -Pumas for non-linear mixed effects modeling Pumas AI, Inc Cottonwood 3
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 Cottonwood 4
8:00 AM 5:00 PM Pre Meeting Workshop - Introductory Course on Pharmacometric Modeling with Monolix  Simulation Plus Cottonwood 5
8:00 AM 5:00 PM Pre Meeting Workshop - Advanced Features of NONMEM 7.5 Workshop for ACoP 2022 ICON Cottonwood 6
12:00 PM 1:00 PM Lunch - Workshop Attendees   Cottonwood 7
12:00 PM 1:00 PM Board Lunch   Spruce 3
Sunday, October 30. 2022 - ACoP13 Conference
Start End Function/Event Chair/Speakers Room
8:00 AM 5:00 PM Speaker Ready Room    Cottonwood 1
7:00 AM 8:00 AM Registration & Breakfast - Workshop Attendees   Cottonwood 7
7:15 AM 8:30 AM Registration & Breakfast - Pre Con Attendees   Cottonwood 8/9
8:00 AM 5:00 PM Pre Meeting Workshop -  Pumas for non-linear mixed effects modeling (Day 2 of 2)  Pumas AI, Inc Cottonwood 3
12:00 PM 5:00 PM Pre Meeting Workshop - A showcase of open-source tools for scalable, reproducible PMx workflows  Metrum Cottonwood 4
8:00 AM 5:00 PM Pre Meeting Workshop - Forest plots in practical use: Implementation and interpretation   Pharmetheus Cottonwood 5
8:00 AM 5:00 PM Pre Meeting Workshop - Advanced course on Pharmacometrics modeling with Monolix   Lixoft, Simulation Plus Cottonwood 6
8:15 AM 4:30 PM Pre Conference Session  - "Challenging the Norm: IV/SC Bridging Strategies for Biologics"   Maple 3 - 5
8:15 AM 8:30 AM Welcome, Introduction & Problem Statement Sihem Bihorel-Merck & Co, Daniele Ouellet-Janssen (Pre-Conference Chairs)  
8:30 AM 9:00 AM Clinical Considerations for mAbs PK Modeling and Simulations Sihem Bihorel-Merck & Co  
9:00 AM 9:30 AM General PK Characteristics for mAbs & Modeling Considerations for mAbs SC Absorption - Preclinical Leonid Kagan-Rutgers University  
9:30 AM 10:15 AM Bridging Strategy for mAbs - Introduction and Considerations for SC Development Jin Y. Jin-Genentech  
10:15 AM 10:30 AM Break     
10:30 AM 11:15 AM Successful Use of MIDD in Posology Bridging  Jun Shen - BMS  
11:15 AM 11:30 AM Selected Poster’s Abstract: Blinatumomab Trimer Formation - Insights from A Mechanistic PKPD Model On The Implications For Switching From Infusion To Subcutaneous Dosing Regimen In Acute Lymphoblastic Leukemia Georgi I. Kapitanov - Applied BioMath  
11:30 AM 11:45 AM Selected Poster’s Abstract: PBPK modelling relates subcutaneous bioavailability of mAbs to the saturation of FcRn-mediated recycling in dosing site draining lymph nodes Felix Stader-Certara UK Ltd  
11:45 AM 12:45 PM Lunch & Posters - Pre-Conference Attendees   Cottonwood 8/9
12:45 PM 1:15 PM Scientific Considerations for Biologics IV/SC Bridging Strategies - An FDA Experience Yow-Ming Wang - FDA  
1:15 PM 2:15 PM Panel Discussion on Regulatory Considerations for Global Development

Shinichi Kijima - PMDA,
Flora Musuamba - EMA,
Yow-Ming Wang - FDA,
Hao Zhu - FDA,
AMit Roy -
Lucia Zhang (Health Canada),
Jin Y. Jin-Genentech,
Daniele Ouellet -

Lucia Zhange - Health Canada

2:15 PM 2:45 PM Coffee Break   Maple Foyer
2:45 PM 3:45 PM How to Design an IV/SC Bridging Study With the Help of MIDD An Interactive Case Study Session Moderations: Marc Gastonguay - Metrum,
Anne-Gaelle Dosne - JanssenParticipants: All Attendees
3:45 PM 4:15 PM General Discussion from Case Study Session (Q&A).  Panelists (Regulatory Agencies & Industry)  
4:15 PM 4:30 PM Concluding Remarks, Wrap Up, and Adjourn Sihem Bihorel - Merck & Co, Daniele Ouellet - Janssen (Pre-Conference Chairs)  
12:00 PM 1:00 PM Lunch - Workshop Attendees   Cottonwood 7
2:15 PM 2:45 PM Coffee Break - Workshop Attendees   Cottonwood Foyer
12:00 PM 7:30 PM ACoP13 Conference Registration   Adams Foyer
5:00 PM 5:30 PM ISoP Awards & Fellows Reception (by invitation only)   Spruce 1
5:30 PM 7:30PM  ACoP13 Opening Session    Adams B-D
    Welcome/Conference Highlights Chris Penland, AstraZeneca (Conference Chair)  
    Presentation of ISoP Awards & Induction of Fellows Navin Goyal, Janssen (Awards Committee Chair)  
    Lewis B. Sheiner Award Lecture - “Lewis Sheiner’s Dream: A Long and Winding Road” Diane Mould - Projections Research Inc  
7:30 PM 10:00 PM Opening Reception   Adams Foyer
Monday, October 31, 2022
Start End Function/Event Chair/Speakers Room
8:00 AM 5:00 PM Speaker Ready Room    Cottonwood 1
7:00 AM 9:00 AM Exhibits/Posters/Coffee Service   Adams A
9:00 AM 11:00 AM General Session - President's Address/President-Elect's Address   Adams B-D
    ISoP: The Year in Review & Ahead CJ Musante - Pfizer (ISoP President)  
    State-of-the-Art Lecture  - Advancing clinical trials in diabetes – opportunities and challenges
Dr. Hiddo J L Heerspink - University Medical Center Groningen  
11:15 AM 1:00 PM Concurrent Session 1A  - Oncology Drug Development - Getting Ready for Project Optimus Tim Nicholas - Pfizer & Wei Gao - EMD Serono Adams B-D
    Project Optimus: Changing the Dosing Paradigm for Oncology Products Mirat Shah - FDA  
    Dose Optimization in Early Clinical Development for Oncology: Regulatory Perspective Jiang Liu - FDA  
    Leveraging Evolutionary Principles to Optimize Doses for Antibody-Targeted Therapy Carter Cao - UNC   
    Is QSP ready for Optimus? Opportunities and challenges with model informed oncology dose optimization. Blerta Shtylla - Pfizer  
    Integration of preclinical and early clinical data to inform rational oncology dose optimization strategy Donghua Yin - 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 Maple 3-5
    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 Cottonwood 8/9
     Determining the Gene Expression Efficiency Factor for Model-based Development of the Viral-mediated in vivo Gene Therapy Chee Ng - NewGround LLC  
    Quantitative Translational and Clinical Pharmacology Approaches towards Effective Dose-selection for CAR-T Cell Therapies: Application towards MIDD Aman Singh - Takeda  
    IS/ID Modeling to Support the First in Human Dose Selection of an mRNA Cancer Vaccine  Stephen Greene - Moderna Tx  
     Determining the FIH dose for an immune booster using a minimal PBPK-PD model  Iraj Hosseini - Genentech  
1:00 PM 2:30 PM Exhibits/Posters    Adams A
1:00 PM 2:30 PM Lunch    Adams Foyer
1:00 PM 2:30 PM Trainee Lunch Mokshada Kumar - SUNY Buffalo Cottonwood 6/7
1:00 PM 2:30 PM JPKPD Meeting (invitation only)   Maple 1
2:30 PM 4:00 PM Concurrent Session 2A - Emerging Opportunities for Real World Evidence and Role of Pharmacometricians Arnab Mukherjee - Pfizer & Christopher  Banfield - Pfizer Adams B-D
    Regulatory perspectives on RWE guidance Hao Zhu - FDA  
    RWE study design and analytical considerations Lauren Becnel - Pfizer  
    Review of Case Studies of Clin Pharm/PMx applications of RWE at
Rui Zhu - Genentech  
    Panel Discussion Brian Corrigan - Pfizer, Vikram Sinha - Takeda, Ellen Wang - Pfizer, Rui Zhu - Genentech, Lauren Becnel - Pfizer  
2:30 PM 4:00 PM Concurrent Session 2B - Modeling and Simulation in Support of New Modalities in Oncology Drug Development   Hongmei Xu - Bicycle Therapeutics,  Diansong Zhou - Astrazeneca  
    The application of PK/PD modelling in the clinical development of BT5528 - a novel toxin delivery platform Hongmei Xu - Bicycle Therapeutics  
    Challenges and opportunities of PKPD modeling of chimeric antigen receptor (CAR) T-cell therapy using ciltacabtagene autoleucel Yaming Su - 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  
2:30 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 Cottonwood 8/9
    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  
    Daunorubicin PBPK model in Lean and Overweight Children  Sanjana Parikh - Laboratory of Applied Pharmacokinetics and Bioinformatics, Saban Research Institute, CHLA  
4:00 PM 5:30 PM Exhibits/Posters/Coffee Service   Adams A
5:30 PM 7:00 PM Communication Challenge Stacey Tannenbaum - Astellas, Mirjam Trame - Certara, Mokshada Kumar -SUNY Buffalo Adams B-D
7:00 PM 10:00 PM Social Dinner Event   Colorado Ballroom A
Tuesday, November 1, 2022
Start End Function/Event Chair/Speakers Room
8:00 AM 5:00 PM Speaker Ready Room    Cottonwood 1
7:30 AM 9:30 AM Exhibits/Posters/Coffee Service   Adams A
9:30 AM 10:45 AM General Session  - Key Note Speaker - From mass (data) to energy (analytics) to power (decision-making), and how to shape the future of medical product development. Dr. Klaus Romero - Critical Path Institute Adams B-D
11:00 AM 12:30 PM Quality & Trainee Awards  Lian Ma - FDA Adams B-D
    Quality Award Gengbo Liu - Genentech, Logan Brooks - Genentech & John Canty - Genentech  
    Quality Award Rohit Rao - Pfizer  
    Quality Award Tara Yang - Parexel International   
    Trainee Award Aymara Sancho-Araiz - Universidad de Navarra  (Inaki F. Troconiz accepting on behalf of Aymara)  
    Trainee Award Catherine Weathered - Purdue University  
    Trainee Award Thanh Bach - University of Iowa  
12:30 PM 2:00 PM Exhibits/Posters    Adams A
12:30 PM 2:00 PM Lunch    Adams Foyer
12:30 PM 2:00 PM SIG Lunch - QSP (tickets required)   Cottonwood 6
12:30 PM 2:00 PM SIG Lunch - SxP (tickets required)   Cottonwood 7
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 Adams B-D
    Predicting disease activity in Multiple Sclerosis patients - an explainable ML approach in Mavenclad trials Nadia Terranova - Merck 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 -  
2:00 PM 3:30 PM Concurrent Session 3B - Advancing RNA-based therapeutics through model-informed development: current challenges and opportunities Vivaswath Ayyar - Janssen & Sukyung Woo - SUNY Buffalo Maple 3-5
    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  Min Liang - Moderna Tx  
    A translational quantitative systems pharmacology modeling framework for exon skipping oligonucleotide therapies for Duchenne muscular dystrophy  Tomoki Yoneyama - Takeda  
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 & Vincent Lemaire - Genentech Cottonwood 8/9
    Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration Justin Earp - 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   Adams A
4:00 PM 5:00 PM Trainee/Mentor Meeting Mokshada Kumar - SUNY Buffalo Cottonwood 6
5:00 PM 6:00 PM Alumni Reception - U Of Tenn   Maple 2
5:00 PM 6:00 PM Alumni Reception - U of MD   Spruce 1
5:00 PM 6:00 PM Alumni Reception - U of Minn   Spruce 2
5:00 PM 6:00 PM Alumni Reception - U of Buffalo   Spruce 3
5:00 PM 6:00 PM Alumni Reception - U of FL   Spruce 4
5:00 PM 6:30 PM QSP SIG Reception Lourdes Cucurull-Sanchez -  GSK Adams A
6:00 PM 7:30 PM President's Reception (by invitation only)   Juniper B&C
Wednesday,November 2, 2022
Start End Function/Event Chair/Speakers Room
8:00 AM 1:00 PM Speaker Ready Room    Cottonwood 1
7:00 AM 9:00 AM Exhibits/Posters/Coffee Service   Adams A
9:00 AM 11:00 AM Roller Coaster 1 Pavan Vaddady - Daiichi Sankyo, Inc Maple 3-5
    From Casual to Causal: Three Fundamental Concepts to Spiff Up Your Causal Reasoning  James Rogers - Metrum  
    Mathematical Modeling of ventilator-induced lung inflammation Sarah Minucci - Applied BioMath  
    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 Ruihao Huang - FDA  
    PKPDAI: A Pharmacometric Knowledge Repository Structured and Curated with Natural Language Processing Frank Kloprogge - 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 Wei Gao - EMD Serono Adams B-D
    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 - Denali Therapeutics  
    Quantitative modeling to support Gene Therapy in Rare Diseases Satyaprakash Nayak - Pfizer  
9:00 AM 11:00 AM Roller Coaster 3 Eric Sobie - Mount Sinai Cottonwood 8/9
    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 - Takeda  
    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 DE & I Session - Pharmacometric strategies to drive meaningful change in health equity  Leticia Arrington - AMgen & Nadia Noormohamed - GSK Adams B-D
    Introduction and ISoP DEI committee objectives Leticia Arrington - AMgen  
    Case Study: Attaining equity of access to research and evidence based medication use Catriona Waitt  - University of Liverpool  
    Case Study: Expansion of the Cabotegravir Pre-exposure Prophylaxis (PreP) label to include transgender women by leveraging M&S approaches. Yash Gandhi - GSK  
12:00 PM 1:30 PM Exhibits/Posters    Adams A
12:00 PM 1:30 PM Lunch   Adams Foyer
12:00 PM 1:30 PM SIG Lunch - CPmx (tickets required)   Cottonwood 6
12:00 PM 1:30 PM SIG Lunch - MCS (tickets required)   Cottonwood 7
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 Adams B-D
    Regulatory landscape of PBPK, the progress of PBPK qualification and gaps for pediatric Ine Rusten - Systems Resource Lab (SRLAB), Flora Musuamba - EMA, FAMHP Belgium  
    Where are we with pediatric PBPK? Kunal Taskar - GSK  
    Model-based extrapolation to support new pediatric formulation approval without a single pediatric study? A case study with tofacitinib Cheng Chang - Pfizer new
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 - Amador Bio & Nidal Huniti - Amador Bio Maple 3-5
    An overview of joint modeling of longitudinal data and time to event data Luke Fostvedt - Pfizer  
    Use of joint modeling in oncology drug development: Challenges and
Marion Kerioui - Memorial Sloan Kettering Cancer Center  
    Nasopharyngeal viral load reduction with early administration of anti–SARS-CoV-2 monoclonal antibodies was associated with decreased risk of disease progression in non-hospitalized patients with SARS-CoV-2 Daniela J Conrado - Regeneron & Yuhuan Wang - Regeneron  
1:30 PM 5:00 PM Trainee Tutorial - Pharmacometric Analysis of Categorical data by Dr. Lena Friberg and Dr Andrew Hooker Mokshada Kumar - SUNY Buffalo, Lena Friberg - Uppsala University,  Andrew Hooker - Uppsala University Cottonwood 8/9
3:15 PM 3:45 PM Closing General Session   Adams B-D
4:30 PM 6:00 PM ACoP 13 Meets ACoP 14 (by invitation only)   Maple 1
Thursday, November 3, 2022
Start End Function/Event Speakers Room
7:00 AM 8:00 AM Tutorial Coffee Service   Cottonwood Foyer
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 - Gilead & Pavan Vaddady - Daiichi Sankyo [Instructors: Casey Davis - Gilead, Pavan Vaddady - Daiichi Sankyo, Arya Pourzanjani - AMgen, Yasong Lu - Daiichi Sankyo] Maple 3 - 5
8:00 AM 12:00 PM Tutorial #2 - Using nlmixr2 for automatically selecting PK models with PKNCA Matthew Fidler - Novartis & William Denney - Human Predictions Cottonwood 8/9
12:00 PM 1:00 PM Workshop Registration & Lunch (workshop attendee only)   Spruce 3/4
1:00 PM 5:00 PM Post Workshop - Bayesian Analysis in Pumas -  (Almost) everything a Bayesian needs   Pumas AI, Inc Spruce 1
1:00 PM 5:00 PM Post Workshop - Exposure-response modeling for binary and time-to-event data using R and Stan   Metrum Spruce 2
1:00 PM 5:00 PM Post Workshop - Development of AI-based surrogates from Quantitative Systems Pharmacology models Mathworks  
Friday, November 4, 2022
Start End Function/Event Speakers Room
7:00 AM 8:00 AM Workshop Breakfast   Spruce 3-4
8:00 AM 5:00 PM Post Workshop - Bayesian Analysis in Pumas -  (Almost) everything a Bayesian needs   Pumas AI, Inc Spruce 1
8:00 AM 5:00 PM Post Workshop - Exposure-response modeling for binary and time-to-event data using R and Stan   Metrum Spruce 2
12:00 PM 1:00 PM Workshop Lunch   Spruce 3-4