Learning Center

Catalog Advanced Search

Search by Category
Search by Type
Sort By
Search by Keyword
Search by Category
Search by Format
Search by Type
Search by Speakers
Search in Packages
Search by Date Range
Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
Start
End
Search by Keyword
Sort By
  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 12/15/2026 at 11:00 AM (EST)

    This session will introduce pharmacometricians to the fundamentals of Large Language Models and the practical skills needed to use them effectively for pharmacometrics communication, particularly prompt and context engineering. We will cover how LLMs generate responses, techniques for crafting stronger prompts and providing useful context, and common pitfalls including hallucinations, bias, and overreliance on AI-generated content.

    ISoP Education Committee & AI/ML SIG Joint Webinar

    Why does an LLM sometimes produce brilliant insights and other times confidently generate nonsense? The difference often lies not in the model, but in how we work with it. This session will introduce pharmacometricians to the fundamentals of Large Language Models and the practical skills needed to use them effectively for pharmacometrics communication, particularly prompt and context engineering. We will cover how LLMs generate responses, techniques for crafting stronger prompts and providing useful context, and common pitfalls including hallucinations, bias, and overreliance on AI-generated content. 

    Through two simple, hands-on examples selected based on ISoP member input, participants will learn how to refine prompts and context when using common AI tools for tasks. Topics may include creating strong presentations efficiently, using AI to plan your narrative, creating beautiful and finely-controlled figures, or using LLMs as a constructive critic to mimic different target audiences. Whether you are new to AI tools or already experimenting with them, this webinar will provide practical methods to help you work more effectively, critically, and confidently with LLMs.

    Ana Solaguren-Beascoa

    Ana Solaguren-Beascoa

    Dr. Ana Solaguren-Beascoa is an Associate Director of AI with 10 years of experience in the field of AI. She holds a PhD in Theoretical Particle Physics. 

     
    During her eight years in London, she built her career across multiple companies as an ML scientist, starting her journey in the biotech industry at BenevolentAI and later on at CoSyne therapeutics. Since, she has been working on projects such as LLM-graph enhanced models for target identification, protein druggability assessment, single cell RNA-seq foundation models or AI agents for rare diseases drug identification. Alongside the industry she was also a visiting lecturer at City University of London teaching machine learning and data science. 
     
    Outside of work, she enjoys cooking and travelling whenever she gets the chance.

    Bovornpat Suriyapakorn

    Bovornpat Suriyapakorn

    Bovornpat Suriyapakorn is a Quantitative Pharmacologist at Sanofi with a background in clinical pharmacy and biostatistics. Originally from Thailand, he previously worked as a lecturer and clinical pharmacist at Chulalongkorn University before completing his PhD in Experimental and Clinical Pharmacology at the University of Minnesota. His scientific interests include population PK, PK/PD, mechanistic and translational modeling, clinical trial simulation, and model-informed drug development, with particular interests in CNS drug development and biologics. Beyond his scientific work, Bovornpat is actively involved in the International Society of Pharmacometrics (ISoP), with a strong interest in education, mentoring, and scientific communication.

    Jane Knöchel

    Jane Knöchel

    Assistant Professor

    University of Copenhagen

    Jane Knöchel is a Tenure-track Assistant Professor at the University of Copenhagen, where she is building a research group at the intersection of mechanistic and data-driven modelling. Her work focuses on methodological advances in pharmacometrics, including synthetic data generation, systems pharmacology modelling, and AI-enhanced analysis. Trained as an applied mathematician, she recently transitioned back to academia after seven years in industry, where she worked in applied pharmacometrics across both large pharmaceutical companies and CROs.

    Stacey Tannenbaum, PhD, FISoP

    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.

  • UPCOMING LIVE!
    Contains 2 Component(s) Includes a Live Web Event on 12/09/2026 at 12:00 PM (EST)

    Etentamig is a BCMA x CD3 bispecific antibody in development for RRMM and AL amyloidosis. The webinar will showcase the MIDD strategies that guided key decisions and advancements: (1) optimal dosing regimen selection for RRMM, including step-up dosing via exposure-response and PK/IL6/CRS analyses; (2) demonstration of no DDIs via an IL-6 PBPK model; (3) repriming/restart therapy guidance after dosing delays using PK simulations; and (4) interplay between sBCMA, free, and total PK using a semi-mechanistic PK/PD model to recommend free PK assay only in future studies. Overall, MIDD successfully guided optimal dosing regimen selection and key regulatory decisions for etentamig. 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.

    Etentamig is a BCMA x CD3 bispecific antibody in development for RRMM and AL amyloidosis. The webinar will showcase the MIDD strategies that guided key decisions and advancements: (1) optimal dosing regimen selection for RRMM, including step-up dosing via exposure-response and PK/IL6/CRS analyses; (2) demonstration of no DDIs via an IL-6 PBPK model; (3) repriming/restart therapy guidance after dosing delays using PK simulations; and (4) interplay between sBCMA, free, and total PK using a semi-mechanistic PK/PD model to recommend free PK assay only in future studies. Overall, MIDD successfully guided optimal dosing regimen selection and key regulatory decisions for etentamig.

    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.

    Akshanth Polepally

    Akshanth Polepally

    Research Fellow, Director

    Abbvie

    Dr. Akshanth Polepally is a Research Fellow and Director at AbbVie with over 15 years of experience in drug discovery, clinical pharmacology, and model-informed drug development (MIDD). At AbbVie, he leads efforts in optimal dose selection and the design and execution of clinical pharmacokinetic and pharmacology studies. He has contributed to multiple successful drug approvals and plays a key role in advancing dose optimization strategies across clinical development programs.

    Benjamin Englehardt

    Benjamin Englehardt

    Associate Director, Pharmacometrics

    Abbvie

    Dr. Benjamin Engelhardt is an Associate Director in Pharmacometrics at AbbVie. Over his nine years at AbbVie, he has led the oncology pharmacometrics team and contributed to multiple successful regulatory submissions, applying methods ranging from exposure-response analyses to advanced model-informed drug development. Beyond industry, he is a lecturer at multiple universities, a reviewer for journals including CPT and Nature, and a regular contributor to major scientific conferences and consortia.

  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 12/03/2026 at 11:00 AM (EST)

    Transcription factors are important molecules which control the levels of mRNA and proteins within cells by modulating the process of transcription and hence translation. Transcription factors are part of a wider family of molecular interaction networks known as gene regulatory networks (GRNs) which play an important role in key cellular processes such as cell division and apoptosis (e.g. the p53-Mdm2, NFκB pathways). Transcription factors exert control over molecular levels through feedback mechanisms, with proteins binding to gene sites in the nucleus and either up-regulating or down-regulating production of mRNA. In many GRNs, there is a negative feedback in the network and the transcription rate is reduced. Typically, this leads to the mRNA and protein levels oscillating over time and also spatially between the nucleus and cytoplasm. When experimental data for such systems is analyzed, it is observed to be noisy and in many cases the actual numbers of molecules involved are quite low. In order to model such systems accurately and connect with the data in a quantitative way, it is therefore necessary to adopt a stochastic approach as well as take into account the spatial aspect of the problem. In this talk, we present both deterministic and stochastic spatio-temporal models of both observed GRNs and synthetic GRNs e.g. repressilators and activator-repressor systems.

    Transcription factors are important molecules which control the levels of mRNA and proteins within cells by modulating the process of transcription and hence translation. Transcription factors are part of a wider family of molecular interaction networks known as gene regulatory networks (GRNs) which play an important role in key cellular processes such as cell division and apoptosis (e.g. the p53-Mdm2, NFκB pathways). Transcription factors exert control over molecular levels through feedback mechanisms, with proteins binding to gene sites in the nucleus and either up-regulating or down-regulating production of mRNA. In many GRNs, there is a negative feedback in the network and the transcription rate is reduced. Typically, this leads to the mRNA and protein levels oscillating over time and also spatially between the nucleus and cytoplasm. When experimental data for such systems is analyzed, it is observed to be noisy and in many cases the actual numbers of molecules involved are quite low. In order to model such systems accurately and connect with the data in a quantitative way, it is therefore necessary to adopt a stochastic approach as well as take into account the spatial aspect of the problem. In this talk, we present both deterministic and stochastic spatio-temporal models of both observed GRNs and synthetic GRNs e.g. repressilators and activator-repressor systems.


    Mark Chaplain

    Mark Chaplain

    Gregory Chair, Applied Mathematics

    University of St. Andrews

    Mark Chaplain is the Gregory Chair of Applied Mathematics at the University of St. Andrews. He received his Ph.D. in mathematics from the University of Dundee in 1990 and has been actively working mathematical biology with an emphasis on oncology since then. During this time he has published over 300 research articles and books. 

    Additional details can be found at:
    https://research-portal.st-and...

  • UPCOMING LIVE!
    Contains 1 Component(s) Includes a Live Web Event on 12/02/2026 at 12:00 PM (EST)

    Recently, NeuralODE-based approaches have emerged as promising tools to learn dynamical systems governing drug exposure and effects directly from data. However, these models are often difficult to train, prone to overfitting, and empirically show unreliable extrapolation beyond training data.

    Recently, NeuralODE-based approaches have emerged as promising tools to learn dynamical systems governing drug exposure and effects directly from data. However, these models are often difficult to train, prone to overfitting, and empirically show unreliable extrapolation beyond training data. To address these limitations, we propose Gaussian Process Flows (GPFlows), a method to perform Bayesian Inference over the space of mechanistic models. The result is a flexible full random effect model that naturally limits model complexity while learning subject-specific dynamics. Similarly to NeuralODEs, model components can be visualised to interpret learned effects. Adopting a Bayesian framework unlocks several additional benefits: principled uncertainty estimates, more faithful and robust model comparison, and continuous learning as new data becomes available. A unique benefit of GPFlows is that it compresses data into a set of inducing points, which can be safely shared without risks of patient re-identification.

    Alexander Janssen

    Alexander Janssen

    Alexander is a postdoctoral researcher and university lecturer working at the intersection of AI and Health at the AmsterdamUMC and ErasmusMC. He is also a use-case leader in the PHEMS consortium, an EU Horizon project that is developing the "Paediatric Health Data Space". This platform utilizes federated learning to enable partners to train ML methods using health record data obtained from all participating centres; all while maintaining strict patient privacy.

    His past research has focussed on causal inference, generative AI, and bringing reliable AI methods to pharmacometrics. His current research focus is on de novo drug design, where he is working on fast-tracking in silico design candidates for experimental validation. He is the author of the Deep Compartment Models Julia package, which is an open-source project that provides a flexible environment to define and train novel ML-based models such as NeuralODEs within pharmacometrics.

  • UPCOMING LIVE!
    Contains 2 Component(s) Includes a Live Web Event on 11/04/2026 at 12:00 PM (EST)

    The ICH M15 Guideline “General Principles for MIDD” stresses the importance of performing model evaluation targeting the Question of Interest (QoI) that model is intended to help to answer. In this presentation we elaborate on how reference corrected visual predictive check (rcVPC) methodology can be used for this purpose. The rcVPC can provide an efficient and more easily communicable tool to validate models, increasing confidence in model-informed decision-making among broader, non-modeling stakeholders. 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 ICH M15 Guideline “General Principles for MIDD” stresses the importance of performing model evaluation targeting the Question of Interest (QoI) that model is intended to help to answer. In this presentation we elaborate on how reference corrected visual predictive check (rcVPC) methodology can be used for this purpose.  The rcVPC can provide an efficient and more easily communicable tool to validate models, increasing confidence in model-informed decision-making among broader, non-modeling stakeholders.

    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.

    Moustafa Ibrahim

    Moustafa Ibrahim

    Global Clinical Pharmacology Lead

    Astrazeneca

    Moustafa M. A. Ibrahim obtained his Ph.D. in Pharmacometrics from Uppsala University, Sweden. Following his Ph.D., Moustafa joined Pharmetheus AB as MIDD Consultant, where he provided pharmacometrics expertise across the spectrum of drug development, from non-clinical studies through late-stage clinical development and regulatory submissions. In 2024, Moustafa joined the Clinical Pharmacology and Safety Sciences Department at AstraZeneca, within the Rare Disease Unit, as a Global Clinical Pharmacology Lead. In this role, he provides scientific and strategic leadership for multiple global development programs to inform dose selection, optimize study design, support regulatory interactions, and enable data-driven decision-making throughout clinical development.

    Martin Bergstrand

    Martin Bergstrand

    Principal Consultant and MIDD Platform Science Lead

    Pharmetheus

    Martin obtained his PhD in Pharmacometrics from Uppsala University. He has 20+ years of drug development experience in areas such as metabolic disorders, autoimmune disease, infectious disease, hematological disorders etc. In 2012 Martin co-founded the consulting company Pharmetheus AB. In the consultant role he has been engaged as strategic advisor on behalf of multiple clients and acted as the main responsible consultant for 50+ pharmacometric data analysis projects on behalf of more than 20 different clients. The projects have ranged from pre-clinical translational projects to submission ready large-scale phase III PKPD analysis. These analyses have among other things contributed to 5+ successful NDA filings. 

  • On-Demand
    Contains 1 Component(s) Recorded On: 09/18/2026

    This webinar will introduce an AI-enabled approach to preparing analysis-ready Non-Compartmental Analysis (NCA) datasets for pharmacokinetic parameter generation.

    This webinar will introduce an AI-enabled approach to preparing analysis-ready Non-Compartmental Analysis (NCA) datasets for pharmacokinetic parameter generation.

    NCA estimates pharmacokinetic exposure parameters from observed concentration–time data without assuming a specific compartmental model.

    The NCA input dataset is the analysis-ready deliverable that integrates PK concentrations, sample collection and dosing information, demographics, metadata, and study-specific rules.

    It serves as the foundation for PK parameter generation, CDISC dataset creation, and subsequent TFL generation to support the clinical study report.

    To accelerate and standardize NCA dataset preparation, the team has implemented AI-driven automation that addresses repetitive, study-specific programming activities.

    The business need stems from the consistent interpretation of source data, specifications, and data standardization workflows across studies.

    By combining data science capabilities with PK subject matter expertise, the team is developing a scalable application that automates routine dataset generation while improving speed, consistency, and transparency.

    A key design principle is that AI generates a transparent, study-specific configuration rather than executable code.

    The dataset-building pipeline remains fixed and validated, while AI derives the settings that drive the pipeline from each study’s specifications and source data.

    Each AI-derived decision is auditable and surfaced to the PK SME for review, preserving human oversight for interpretation while reducing repetitive programming burden.

    Weidong Chen

    Weidong Chen

    Bristol Myers Squibb

    Weidong Chen is an Associate Director in Data Science within Translational Medicine & Clinical Pharmacology at Bristol Myers Squibb. Since joining BMS in 2015, he has provided data science and programming leadership for pharmacometric analyses supporting early drug development, late-stage submissions, regulatory filings, and internal decision-making across Immuno-Oncology, Immunology, and Cardiovascular studies. Weidong brings deep expertise in SAS programming and clinical trial data standardization. Earlier in his career, he held statistical and SAS programming roles at Frontage Labs and Allergan, supporting Phase I/II, Phase IV, and bioequivalence clinical trials across multiple therapeutic areas. He holds a PhD in Biochemistry and Molecular Biology from Stony Brook University.

    Amir Molavi

    Amir Molavi

    Bristol Myers Squibb

    Amir Molavi is a Senior Software Engineer and Computational Scientist on the Data Science team at Bristol Myers Squibb in Cambridge, MA, where he supports AI, generative AI, and machine learning efforts within TMCP. His work focuses on bringing modern AI capabilities into scientific and data-driven workflows. Amir has a strong foundation in computer programming, physics, and mathematics, with deep expertise in Python, numerical modeling, and machine learning. Before joining BMS, he spent four years at Applied BioMath, where he redesigned the backend and Python client API powering model-informed drug discovery simulations. He previously conducted computational research as a postdoctoral associate at Northeastern University. Amir holds a PhD in Structural Engineering and an MSc in Applied Mathematics from the University of Akron, along with certifications in Machine Learning and Deep Learning from the University of Texas at Austin.

  • On-Demand
    Contains 2 Component(s) Recorded On: 08/26/2026

    Pediatric dose optimization is constrained by small cohorts and sampling limits. We applied Bayesian Forecasting to select the RP2D for pediatric patients with ALK-fusion tumors. An established PopPK model using adult data as prior in combination with real-time PK monitoring during Cycle 1 guided dose confirmation and/or adjustments. Doses were selected to match the adult steady-state therapeutic exposures. Model‑predicted doses achieved target exposure without adjustment in all 14 patients ≥20kg; 4/5 patients

    Pediatric dose optimization is constrained by small cohorts and sampling limits. We applied Bayesian Forecasting to select the RP2D for pediatric patients with ALK-fusion tumors.  An established PopPK model using adult data as prior in combination with real-time PK monitoring during Cycle 1 guided dose confirmation and/or adjustments. Doses were selected to match the adult steady-state therapeutic exposures. Model‑predicted doses achieved target exposure without adjustment in all 14 patients ≥20kg; 4/5 patients <20kg required up-titration. Bayesian borrowing of adult knowledge enabled efficient pediatric dose optimization and rapid confirmation by improving the accuracy of exposure predictions across weight bands.

    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.

    Tu Mai

    Tu Mai

    Senior Principal Scientist, Clinical Pharmacology, Modeling & Simulation

    Genentech

    Tu Mai is a Senior Principal Scientist in Clinical Pharmacology, Modeling & Simulation at Genentech, where she leads clinical pharmacology and modeling and simulation strategies across multiple early and late-stage development programs. She has extensive experience in model-informed drug development (MIDD), including population PK/PD modeling, Bayesian forecasting, exposure-response analysis, and MIDD strategies to support regulatory submissions and dose optimization. Her work spans ophthalmology, oncology, immunology in small molecules and biologics. Tu received her Ph.D. in Pharmacology from Vanderbilt University.

  • On-Demand
    Contains 2 Component(s) Recorded On: 07/23/2026

    A model-based dose selection and pharmacokinetic (PK) bridging approach was applied to support development of pembrolizumab SC (pembrolizumab with berahyaluronidase alfa for subcutaneous administration) from intravenous (IV) administration. Methodology, results and conclusions will be discussed in this presentation. 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.

    A model-based dose selection and pharmacokinetic (PK) bridging approach was applied to support development of pembrolizumab SC (pembrolizumab with berahyaluronidase alfa for subcutaneous administration) from intravenous (IV) administration. Methodology, results and conclusions will be discussed in this presentation.

    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.


    Gina Song

    Gina Song

    Gina Song is a Director in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics (QP2) function at Merck. She has over 10 years of experiences in the Pharmaceutical industry across therapeutic areas including preclinical and clinical oncology, infectious disease and pediatric development for different modalities with time spent at Hamner Institute, Labcorp and currently Merck.  She is currently leading SC pembrolizumab program for clinical pharmacology and modeling &simulation efforts across indications as well as supporting regulatory submissions in global markets.

    Mallika Lala

    Mallika Lala

    Mallika Lala is Senior Director, Group Leader at Merck in the Oncology Global Clinical Development organization, Quantitative Pharmacology and Pharmacometrics function. She has 15 years of drug development experience across therapeutic modalities, including early and late clinical oncology, infectious diseases and CV-met. She has been involved with the clinical development of pembrolizumab across indications and regulatory submissions in several global markets, most recently MIDD for dosing regimen and SC formulation additions, as well as multiple oncology assets including ADCs and targeted therapies. Before joining Merck, in industry in India to advancing pharmacometrics and was an ORISE fellow at FDA with focus on application of innovative quantitative approaches to enhance pediatric drug development.

  • On-Demand
    Contains 1 Component(s) Recorded On: 07/14/2026

    This presentation explores the complementary strengths of statistical and pharmacometric (PMx) approaches in clinical drug development. We will gain insight into how integrating these two quantitative disciplines – from exposure-response modeling and model-based meta-analysis to optimal designs and PK bridging studies – can yield more robust, efficient, and scientifically rigorous development programs. Through three worked examples, the presentation demonstrates that collaboration between statisticians and pharmacometricians produces outcomes neither discipline could achieve alone.

    Presented by ISoP's SxP SIG.

    Pharmacometrics Meets Statistics: Building Bridges for Modern Drug Development - This presentation explores the complementary strengths of statistical and pharmacometric (PMx) approaches in clinical drug development. We will gain insight into how integrating these two quantitative disciplines – from exposure-response modeling and model-based meta-analysis to optimal designs and PK bridging studies – can yield more robust, efficient, and scientifically rigorous development programs. Through three worked examples, the presentation demonstrates that collaboration between statisticians and pharmacometricians produces outcomes neither discipline could achieve alone.

    Alex Sverdlov

    Alex Sverdlov

    Senior Director

    Novartis

    • PhD biostatistics leader with over 18 years of research and development experience in biopharmaceutical industry, in various roles with increasing responsibilities.

    • Passionate for complex problem solving and integration of different fields and functions across the biopharmaceutical development continuum.

    • Strategic and managerial experience of teams of statisticians and programmers to support multiple programs/indications of various complexity.

    • Out-of-the-box thinker and reliable team player with excellent stakeholder management, communication, analytical, computational and technical writing skills.

    • Lifelong learner and entrepreneur with original research and publications on adaptive designs for clinical research. 

    • Hands on statistical modeling, complex data analysis and simulations; proficiency in SAS and R; very good knowledge of the regulatory landscape.

  • On-Demand
    Contains 2 Component(s)

    This talk explores how model-informed drug development (MIDD) can evolve from a supportive tool into a central pillar of clinical strategy. Using the development of AZD8233—a novel PCSK9 antisense oligonucleotide—as a case study, the presentation will walk through how modeling guided key decisions from Phase 2b to Phase 3, including trial design, dose optimization, and cardiovascular risk prediction. 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.

    This talk explores how model-informed drug development (MIDD) can evolve from a supportive tool into a central pillar of clinical strategy. Using the development of AZD8233—a novel PCSK9 antisense oligonucleotide—as a case study, the presentation will walk through how modeling guided key decisions from Phase 2b to Phase 3, including trial design, dose optimization, and cardiovascular risk prediction.

    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.


    Jane Knöchel

    Jane Knöchel

    Assistant Professor

    University of Copenhagen

    Jane Knöchel is a Tenure-track Assistant Professor at the University of Copenhagen, where she is building a research group at the intersection of mechanistic and data-driven modelling. Her work focuses on methodological advances in pharmacometrics, including synthetic data generation, systems pharmacology modelling, and AI-enhanced analysis. Trained as an applied mathematician, she recently transitioned back to academia after seven years in industry, where she worked in applied pharmacometrics across both large pharmaceutical companies and CROs.