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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
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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
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Vincent Hurez
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Anuraag Saini
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Xiao Qiu
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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$i++ ?>
Suruchi Bakshi
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Shaina Short
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Jason Sherfey
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Stephanie R. Jones
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Nicholas Tolley
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Contains 1 Component(s) Includes a Live Web Event on 04/21/2026 at 11:00 AM (EDT)
This session provides updates on the Working Group strategy and includes a presentation and panel discussion
Chair(s): Carolyn Cho, Tongli Zhang
Carolyn Cho: Update on Working Group Strategy
Ioannis Androulakis: Question-based Approach to Systems Approaches to Virtual Clinical Trials and Digital Twins
Ioannis Androulakis, Limei Cheng, Tongli Zhang: Panel Discussion: Is QSP an Essential Element of the Digital Twins Concept?$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) 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
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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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Contains 1 Component(s) Recorded On: 10/14/2025
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++ ?>Eleni Caratzas, MSc, PhD
Principal Scientist II
IM/Janssen R&D
Eleni Caratzas (Karatza), MSc, PhD, is a Principal Scientist II at J&J IM/Janssen R&D. She completed her undergraduate and master’s degrees in pharmacy at the University of Athens, Greece. Following her studies, she started working as a scientist-consultant at a pharmaceutical consulting firm. After earning her PhD, she started her postdoctoral fellowship with the UNC Eshelman School of Pharmacy and GSK. Dr. Karatza has published over 25 peer-reviewed articles and book chapters in the field of clinical pharmacology and pharmacometrics. An active ISoP member since 2018, she has supported various ISoP and ACoP initiatives and she was awarded the ISoP Unsung Hero Award in 2024.
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Contains 1 Component(s) Recorded On: 10/07/2025On-Demand
Building and nurturing your professional network is critical to success, especially in a field as small and collaborative as pharmacometrics. This webinar will help you develop meaningful connections, and schmooze with confidence!
ACoP is less than two weeks after this webinar, and for many, the excitement about the impending conference may be tamped down by the dread of having to NETWORK (!!). But fear not - help is at hand!
Networking is for *everyone*, not just extroverts. In this webinar, what networking is (and isn't) will be defined, and you will be shown some tips and tricks for preparing and executing a networking plan for in-person events. You will also learn to develop conversation prompts to foster meaningful engagements. And while in-person events are great to build relationships, your network needs consistent attention year-round! How to navigate the virtual world and maintain real connections, despite the technological barriers will be discussed, and you will understand how social media can help you to stay connected and visible, and to build your brand … all with authenticity.
Building and nurturing your professional network is critical to success, especially in a field as small and collaborative as pharmacometrics. This webinar will help you develop meaningful connections, and schmooze with confidence!
$i++ ?>Stacey Tannenbaum, PhD, FISoP
Stacey Tannenbaum, PhD, FISoP is a scientist and leader in Model Informed Drug Development, and principal at SJTPharm LLC. She is currently a Consultant and Coach to the MIDD community, supporting the development of leadership, communication, and change management skills.
Her previous roles include VP of Scientific Engagement at Metrum Research Group, and Pharmacometrics science and leadership at Novartis and Astellas. Stacey earned a BSE in Biomedical Engineering (Duke University), a PhD in Pharmaceutical Sciences and Applied Mathematics (University of Arizona), and a post-doctoral fellowship at the Center for Drug Development Science (Georgetown University). During her 25+ years as a PKPD scientist in Pharma and consulting, Stacey contributed to multiple drug development programs and successful submissions. Some of the outcomes of her work were optimization of dosing for future trials and labels, prediction of efficacy and safety with confidence, design of smarter studies and identification of key covariates, and bridging across populations, such as from healthy subjects to patients, and adults to children. As she transitioned from individual contributor into leadership roles, her expertise expanded beyond the science itself to include: championing science communication and soft skills development within technical teams, building infrastructure and implementing best practices for efficient and reproducible MIDD, guiding partners in translating clinical needs into strategic and model-informed solutions, and mentoring and training the next generation of leaders.
Stacey has had a significant impact on the global Pharmacometrics community. She co-founded ISoP, serving as its first President, and is an ISoP Fellow and Leadership Award recipient. Stacey co-founded the ACoP and was conference chair for the first three events; she remains an active volunteer in both ISoP and ACoP. She is the Executive Committee chair for WCoP, and is the chair of the Quantitative Pharmacology Network at ASCPT. She served as a board member of AAPS, chaired the AAPS M&S Focus Group, and was the co-chair for the AAPS Forum for Connecting Predictive Modelers. Stacey also co-founded the networking group Modeling and Simulation Applications in Clinical Pharmacotherapy (MoSAiC), now ISoP-NJ/NY/PA.
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