| 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 |