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Contains 1 Component(s) Includes a Live Web Event on 05/28/2026 at 12:00 PM (EDT)
This talk will cover how to evaluate and optimize clinical trial designs using the Fisher Information Matrix (FIM), as implemented in tools like NONMEM's $DESIGN and PopED. While clinical trial simulation is a powerful approach for assessing design characteristics, such as model identifiability, parameter precision, and even type I error and power, FIM-based evaluation offers a faster alternative that enables exploration of many more designs and makes true design optimization feasible. A number of examples will be presented to show how design evaluation and optimization can be useful in a model-informed drug development context. Robust design techniques that account for uncertainty in models and model parameters will also be discussed.
This talk will cover how to evaluate and optimize clinical trial designs using the Fisher Information Matrix (FIM), as implemented in tools like NONMEM's $DESIGN and PopED. While clinical trial simulation is a powerful approach for assessing design characteristics, such as model identifiability, parameter precision, and even type I error and power, FIM-based evaluation offers a faster alternative that enables exploration of many more designs and makes true design optimization feasible. A number of examples will be presented to show how design evaluation and optimization can be useful in a model-informed drug development context. Robust design techniques that account for uncertainty in models and model parameters will also be discussed.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Andrew Hooker, PhD, ISOP member
Professor of Pharmacometrics
Uppsala University
Andrew C. Hooker, PhD, is a Professor of Pharmacometrics at Uppsala University, Sweden. Andrew received a BS in Physics with a Mathematics Minor at the University of Colorado and received a Masters and then a PhD in Bioengineering from the University of Washington, Seattle. Andrew joined the faculty at Uppsala University in 2006. His research ranges between methodological and applied pharmacometrics, including: optimal (adaptive) experimental design, methodological problems associated with building, evaluating and using pharmacometric models (including using models for bioequivalence evaluation) and the development and use of PKPD models in a range of therapeutic areas and drug classes. Andrew is a co-developer of a number of software programs including Xpose, PsN, Pharmpy and the optimal design program PopED. Andrew has published over 90 papers in peer reviewed journals, supervised 12 students to their PhD degree and mentored 11 post-docs. In 2012, he co-founded the model-informed drug development consultancy company Pharmetheus.
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Contains 1 Component(s) Includes a Live Web Event on 04/24/2026 at 9:00 AM (EDT)
This session provides Working Group updates, two presentations and a panel discussion.
Chair(s): Blerta Shtylla
Federico Reali: Working Group Updates
Alexander Kulesza: The Landscape of QSP Modelling and Virtual Populations in the AI Era: From Current to Best Practice
Conner I. Sandefur: AI-Ready QSP: How Emerging Standards can Support Transparency, Credibility, and Future Regulatory Use
Alexander Kulesza, Conner I. Sandefur, Federico Reali: Panel Discussion: AI, Reporting, and Trust in QSP Modelling$i++ ?>Blerta Shtylla, PhD
Research Fellow Pharmacometrics & Systems Pharmacology
Pfizer Research and Development
$i++ ?>
Federico Reali
$i++ ?>Alexander Kulesza, PhD
Principal Scientist
Systems Pharmacology Lead
Dr. Alexander Kulesza is currently Principal Scientist and Lead of Systems Pharmacology at ESQlabs GmbH, Saterland, Germany operating out of Lyon, France. He is also affiliated with the University of Namur, Belgium. After completing his theoretical and computational chemistry Diplom at the Humboldt-University Berlin, he obtained his PhD from the Free University Berlin studying inorganic - biomolecular hybrid systems by ab-initio quantum chemistry methods and molecular dynamics. He then moved to Lyon, France focusing on integrating advanced molecular dynamics techniques like replica-exchange and Free-Energy methods to integrate gas-phase structural biology experiments data for elucidating structurally disordered proteins. Alexander then moved out of fundamental reasearch into drug development joining Novadiscovery (now Nova In silico) as Scientist, then team leader then executive manager and since then working on quantitative systems pharmacology modeling combined with physiologically based pharmacokinetics in inflammatory, immune, infectious, metabolic disorders and (immuno)oncology with a focus on model credibility assessment for potential regulatory applications.
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Conner Sandefer
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Contains 1 Component(s) Includes a Live Web Event on 04/23/2026 at 11:00 AM (EDT)
This session provides a Working Group update and two presentations.
Chair(s): Prakash Packrisamy, Vincent Hurez
Prakash Packrisamy, Vincent Hurez: Working Group Update: Addressing Modeling Challenges in QSP: Survey-Based Perspectives on Preclinical Data Handling
Anuraag Saini: Addressing the QSP Knowledge Bottleneck with AI
Xiao Qiu, Lu Huang: From Biology to Scores in Ulcerative Colitis: A QSP Platform Powered by Temporal Machine Learning$i++ ?>Prakash Packrisamy
$i++ ?>Vincent Hurez
$i++ ?>Anuraag Saini
$i++ ?>Xiao Qiu
$i++ ?>Lu Huang
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Contains 1 Component(s) Includes a Live Web Event on 04/22/2026 at 9:00 AM (EDT)
This session contains two presentations and is Chaired by Suruchi Bakshi, Shaina Short, and Jason Sherfey
Session 2. Neuroscience WG. Wednesday, 22nd April (9:00 – 10:00 AM EST):
Chair(s): Suruchi Bakshi, Shaina Short, Jason Sherfey
Stephanie R. Jones: The Human Neocortical Neurosolver Modeling Software for Cell and Circuit Level Interpretation of Pharmacodynamic EEG Biomarkers
Nicholas Tolley: AI Methods to Enhance Parameter Estimation in Large Scale Biophysical Models of EEG$i++ ?>
Suruchi Bakshi
$i++ ?>
Shaina Short
$i++ ?>Jason Sherfey
$i++ ?>Stephanie R. Jones
$i++ ?>Nicholas Tolley
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Contains 1 Component(s) Includes a Live Web Event on 04/21/2026 at 11:00 AM (EDT)
This session provides updates on the Working Group strategy and includes a presentation and panel discussion
Chair(s): Carolyn Cho, Tongli Zhang
Carolyn Cho: Update on Working Group Strategy
Ioannis Androulakis: Question-based Approach to Systems Approaches to Virtual Clinical Trials and Digital Twins
Ioannis Androulakis, Limei Cheng, Tongli Zhang: Panel Discussion: Is QSP an Essential Element of the Digital Twins Concept?$i++ ?>
Carolyn Cho
$i++ ?>Ioannis (Yannis) Androulakis, PhD
Professor
Rutgers University
Dr. Androulakis is a Biomedical Engineering, Chemical & Biochemical Engineering Professor at Rutgers University. He is also a graduate faculty member in the Pharmaceutical Sciences as the Ernest Mario School of Pharmacy at Ritegrs University. He received his BS in Chemical Engineering from NTUA and his MS and Ph.D. from Purdue University. He was a research associate at Princeton University before joining ExxonMobil’s Corporate Strategic Research Laboratories. In 2004 he moved back to academia. He is a fellow of the American Institute of Medical and Biological Engineering and a Fellow of the American Institute of Chemical Engineers. He currently chairs the Quantitative Systems Pharmacology Special Interest Group of the International Society of Pharmacometrics. He has published extensively in quantitative systems biology and quantitative systems pharmacology.
$i++ ?>Limei Cheng, PhD
Sr Director, QSP Lead
Incyte Corporation
Dr. Limei Cheng is an accomplished scientist with 20 years of experience in developing novel algorithms, modeling and simulations for healthcare applications such as quantitative systems pharmacology (QSP). She is currently the QSP Lead of Clinical Pharmacology and Pharmacometrics at (CP&P) at Incyte Corporation in Delaware. In her position, Dr Cheng uses model-based QSP approaches to integrate clinical and non-clinical data in a quantitative and mechanistic way to generate actionable predictions. Prior to joining Incyte, she led QSP-CV group in the department of CP&P at Bristol Myers Squibb (BMS) for almost 8 years. Prior to working at BMS, she spent 3+ years working at Philips Research North America in the Department of Clinical Decision Support Solutions. She began her career as a research associate at the Biomedical Simulation Resource (BMSR) in the Department of Biomedical Engineering at the University of Southern California (USC). Dr. Cheng has numerous recent presentations and publications demonstrating the utility of Systems Pharmacology in Pharmaceutical R&D. Dr. Cheng earned a B.E. in Biomedical Electronic Engineering from Xi’an Jiao Tong University, an M.S. in Electrical Engineering from the University of California, Los Angeles (UCLA), and a Ph.D. in Biomedical Engineering from USC. Her key areas of interest include QSP modeling, pharmacometrics, virtual population simulation, machine learning and AI, and personalized precision medicine.
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Tongli Zhang
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Contains 1 Component(s)
This webinar will focus on the PKPD models developed and used end-to-end to design and execute a Phase 1 study for a first brain-penetrant PROTAC ARV-102. Core PKPD models were developed using nonclinical data and included allometrically scaled PK parameters and animal-derived PD parameters for target engagement. Model simulations were used to select a dose range for the first in human study and the PKPD models were updated to refine the dose response. The iterative modeling-experimentation resulted in a successful Phase 1 study and illuminated important translational relationship of PROTAC PKPD between animals and humans.
This webinar will focus on the PKPD models developed and used end-to-end to design and execute a Phase 1 study for a first brain-penetrant PROTAC ARV-102. Core PKPD models were developed using nonclinical data and included allometrically scaled PK parameters and animal-derived PD parameters for target engagement. Model simulations were used to select a dose range for the first in human study and the PKPD models were updated to refine the dose response. The iterative modeling-experimentation resulted in a successful Phase 1 study and illuminated important translational relationship of PROTAC PKPD between animals and humans.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Sergey Aksenov, PhD
Arnivas
Sergey Aksenov, a PhD in Physics from Moscow State University, is currently Head of Modeling and Simulation at Arvinas. He spearheads PKPD and pharmacometrics modeling for all PROTAC projects from discovery through confirmatory studies in neurology and oncology. His extensive experience includes translational and early-phase modeling for small molecules, biologics, and gene therapies at Novartis, and serving as Pharmacometrics Science Lead at AstraZeneca. Previously, he was a modeling and simulation scientist at Novartis, focusing on developing drug for neurology and ophthalmology diseases.
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Contains 1 Component(s) Recorded On: 03/18/2026
Quantitative Systems Pharmacology (QSP) is increasingly applied in MIDD frameworks and regulatory interactions, though challenges remain in ensuring transparency and credibility. This webinar will share insights from the group’s work, including considerations on virtual populations, regulatory submission examples, proposed minimum evaluation criteria, and ongoing challenges highlighting areas in need of further regulatory guidance.
Quantitative Systems Pharmacology (QSP) is increasingly applied in MIDD frameworks and regulatory interactions, though challenges remain in ensuring transparency and credibility. This webinar will share insights from the group’s work, including considerations on virtual populations, regulatory submission examples, proposed minimum evaluation criteria, and ongoing challenges highlighting areas in need of further regulatory guidance.
The presentation will be given by ISoP QSP SIG WG on Credibility Assessment of QSP for regulatory use. The ISoP QSP SIG Working Group on Credibility Assessment of QSP for regulatory use was launched in fall of 2024 with multiple members from the QSP community. The Working Group has a charter focused on: i)identification and systematic evaluation of typical regulatory context of use scenarios for QSP based on community experiences and published examples, ii) evaluation and formulation of best practices for credibility assessment and reporting of QSP in regulatory settings, iii) engagement of the community via outreach to develop a shared vision for QSP credibility assessment standards based on existing case studies and future areas of growth for QSP.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Blerta Shtylla, PhD
Research Fellow Pharmacometrics & Systems Pharmacology
Pfizer Research and Development
$i++ ?>
Susana Zaph
Head of QSP US
Sanofi
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Contains 1 Component(s) Recorded On: 02/18/2026
Clinical Utility Indexes (CUIs) provide a quantitative, integrated measure of efficacy and safety within a scalable platform. Traditionally, benefit and risk are assessed through exposure-response (ER) analyses and compared qualitatively to choose a dose. CUIs transform this by combining multiple ER geometries into a single, reproducible, and flexible dose/PK exposure-dependent metric, often represented as a bell-shaped curve, with the peak CUI mapped to a nominal dose or regimen.
Clinical Utility Indexes (CUIs) provide a quantitative, integrated measure of efficacy and safety within a scalable platform. Traditionally, benefit and risk are assessed through exposure-response (ER) analyses and compared qualitatively to choose a dose. CUIs transform this by combining multiple ER geometries into a single, reproducible, and flexible dose/PK exposure-dependent metric, often represented as a bell-shaped curve, with the peak CUI mapped to a nominal dose or regimen.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Venkatesh Pilla Reddy
Senior Director
Global PKPD and Pharmacometrics group at Eli Lilly and Company
Dr. Venkatesh Pilla Reddy is a Senior Director in the Global PKPD and Pharmacometrics group at Eli Lilly and Company in the UK. At Lilly, Venkatesh provides MIDD/PKPD Lead support for projects in oncology ADC and RLT projects and immunology. He earned his PhD in Pharmacometrics through a collaborative program involving Pfizer, Janssen Pharmaceuticals, and Merck via TI Pharma in the Netherlands. He was a Deputy Topic Leader at ICH, shaping the ICH M12 DDI guideline. He plays a leading role in influential cross-industry working groups, such as IQ TALG, ISOP, ASCPT, and ISSX M&S.
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Contains 1 Component(s) Recorded On: 12/02/2025
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Piet van der Graaf
Senior Vice President and Head of Applied BioSimulation
Certara
Piet van der Graaf is Senior Vice President and Head of Applied BioSimulation at Certara, Professor of Systems Pharmacology at Leiden University, and Professor of Pediatrics, Cincinnati Children’s Hospital Medical Center. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various research leadership positions at Pfizer in Discovery Biology, Pharmacokinetics and Drug Metabolism and Clinical Pharmacology. He was the founding Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology from 2012-2018 before becoming Editor-in-Chief of Clinical Pharmacology & Therapeutics. Piet received his doctorate training in clinical medicine with Nobel laureate Sir James Black at King's College London and is a Fellow of the British Pharmacological Society. He was the recipient of the 2021 Leadership Award from the International Society of Pharmacometrics (ISoP) and the 2024 Gary Neil Prize for Innovation in Drug Development from the American Society for Clinical Pharmacology & Therapeutics (ASCPT).
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Contains 1 Component(s) Recorded On: 11/11/2025
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
The MIDD Webinar Series, coordinated by Yash Kapoor and Fulya Akpinar Singh, is a series of webinars focused on shaping the future of drug development and regulatory decision-making sponsored by the ISoP Education Committee. Topics range from MIDD approaches in regulatory submission to pharmacometrics topics that are at the core of model development.
$i++ ?>Prashant Dogra
Assistant Research Professor
Houston Methodist Research Institute
Prashant Dogra is an Assistant Professor in the Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences at the University of Southern California, where he also serves as Associate Director of the Center for Quantitative Drug and Disease Modeling. He leads interdisciplinary research integrating multiscale mechanistic modeling, quantitative systems pharmacology, and data science to predict in vivo disease dynamics, optimize drug delivery, and support therapeutic development. His work advances the fields of cancer therapeutics, infectious disease vaccines, and nanomedicine by providing innovative modeling tools to accelerate clinical translation. He is particularly enthusiastic about integrating artificial intelligence with mechanistic modeling approaches and currently serves as Principal Investigator on an NIH R01 grant focused on developing AI-integrated mechanistic models to advance nanoparticle-based drug delivery systems.
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