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What Does That Term Actually Mean? Demystifying Concepts in Quantitative Drug Development

Workshop Schedule

10:00 AM - 10:10 AM Opening

Jackson Burton and Stacey Tannenbaum

10:10 AM - 10:55 AM Neural Ordinary Differential Equations

Workshop Speaker: Nazanin Ahmadi
Nazanin Ahmadi
PhD candidate, Brown University
I am a PhD candidate in Biomedical Engineering at Brown University, specializing in systems biology and systems pharmacology modeling via Physics-Informed Networks. I am passionate about integrating advanced modeling techniques into drug development and precision medicine to optimize treatment outcomes. Currently, I enjoy conducting research while also pursuing my passion for event organization, including coordinating the CRUNCH Seminar, scientific symposia at ACoP, ASCPT, and the BMES Conference, and serving as Chair of the Finance Committee for the Graduate Student Council (GSC) at Brown University. I find fulfillment in mentoring students from undergraduate to PhD levels and am enthusiastic about connecting with and learning from new scientists in the field.
 
Workshop Speaker Victor Poon
Victor Poon
Senior Scientist, Genentech
Victor Poon, MS, is a Senior Scientist at Genentech. He is an accomplished, results-oriented scientist with six years of biopharmaceutical industry experience in modeling and simulation. He is motivated to apply his advanced computational and leadership skills to advance high-impact research and development.
 

10:55 AM - 11:40 AM QSP Workflow

Workshop Speaker: Lourdes Cucurull-Sanchez Lourdes Cucurull-Sanchez, PhD
Principal Director & QSP Business Line Lead | Pharmetheus
Lourdes Cucurull-Sanchez, PhD MPhil, is a Principal Director, MIDD consultant, and QSP Business Line Lead at Pharmetheus AB. She has over 20 years of experience in the pharmaceutical industry, with 15+ years in Quantitative Systems Pharmacology (QSP) and 8 years in Machine Learning (ML).

Previously, she held leadership positions at GSK and Pfizer, and a postdoctoral position at the University of Cambridge. She is also an elected member of the ISoP Board of Trustees, Chair of ACoP 2026, former Chair of the ISoP QSP SIG, former IQ Consortium member, a founder of the UK QSP Network, and a member of ASCPT since 2019.

Lourdes has a PhD in Chemistry (Quantum Chemistry, 2000) from the Universitat Autonoma de Barcelona, and an MPhil in Chemistry (X-ray Crystallography, 1995) from the University of Newcastle upon Tyne. She is a proud champion of equity principles and an active scientific conference speaker (+30 invited oral communications) and author (), with contributions to QSP best practices (UK QSP Network), QSP model assessment (IQ Consortium), and an industrial perspective on QSP. She serves as a reviewer for several scientific journals, including ASCPT, and is a member of the editorial board for the Quantitative Medicine journal.
 
Workshop Speaker: Kathleen Morgan-Kehr
Kathleen Morgan Kehr, PhD
Director/Sr. Principal Scientist | Simulations Plus
Dr. Morgan-Kehr’s work focuses on understanding the therapeutic modulation of the innate and adaptive immune responses in a variety of therapeutic areas. These processes are challenging to understand due to the complexity of positive and negative feedback loops and other immuno-modulatory mechanisms. This complex in silico work leverages known disease networks, including both immune and tissue cells, along with known cell-specific responses that are used to simulate clinical trials.

Prior to joining Simulations Plus, Dr Morgan-Kehr worked at Immunetrics, Inc for 14 years where she was involved with the development of several autoimmune QSP models for rheumatoid arthritis, psoriasis, psoriatic arthritis, ulcerative colitis, Crohn’s disease, systemic lupus erythematosus as well as early development of immune-oncology models. Dr Morgan-Kehr received her Ph.D. in Biochemistry and Molecular Genetics from the University of Pittsburgh School of Medicine Pittsburgh and a bachelor of science degree from Westminster College in New Wilmington, PA.
 

11:40 AM - 12:25 AM Digital Twins

Workshop Speaker: David Clifford

David Clifford
Head of Data Science and Applied Machine Learning | Biogen
Dave Clifford is Head of Data Science and Applied Machine Learning at Biogen, where he leads a team of scientists and engineers advancing the use of machine learning in the life sciences. Prior to working at Biogen, Mr. Clifford worked in enterprise machine learning for civil engineering, transportation engineering, and automotive applications in the private sector and served as a consultant and advisor to the Defense Advanced Research Projects Agency’s Defense Sciences Office and Biological Technology Office.

 
Workshop Speaker: Monica Susilo
Monica E. Susilo, PhD
Senior Principal Scientist | Genentech
Monica E. Susilo is a senior principal scientist specializing in systems pharmacology modeling in the Clinical Pharmacology department at Genentech, where she supports the modeling and simulation efforts for T-cell dependent bispecific antibodies in clinical development. She received her MS and PhD in Mechanical Engineering from Purdue University, transitioned to enter the pharmaceutical industry as a postdoctoral fellow in the quantitative systems pharmacology lab at Pfizer.
 

12:25 PM - 1:10 PM Large Language Models

Workshop Speaker: Wes Anderson
Wes Anderson, PhD
Scientist | Critical Path Institute
Wes Anderson, PhD, is a Quantitative Medicine Scientist at the Critical Path Institute, where he develops data-driven solutions to support drug development using machine learning, artificial intelligence, natural language processing, and healthcare informatics. He has also contributed to the development of data standards and tools for critical care research, including efforts adopted by global health organizations. Dr. Anderson earned his PhD in Biomedical Engineering from Colorado State University and completed a postdoctoral fellowship in AI and quantitative medicine at the Critical Path Institute.
 
Workshop Speaker: Richard Franzese
Richard Charles Franzese, DPhil, MPhys
Director | GlaxoSmithKline
Richard C. Franzese, DPhil, is a Director of Clinical Pharmacology Modeling and Simulation at GSK. Richard has a current focus in oncology drug development.

After spending time as a high school mathematics teacher, Richard began his pharmacometrics career at Certara. Richard maintains an interest in teaching and mentoring; he delivers guest lectures on population PK modeling at UNC Chapel Hill and mentors within GSK. Richard was trained as a physicist at the University of Oxford, where he focused on biological and condensed matter physics. He completed his DPhil in Engineering Science; his doctoral research utilized mixed-effects modeling and dynamics systems theory in Biomechanics.

Richard enjoys running, cycling, and cooking in his free time; he was a competitive track and cross-country runner for 10 years, winning the Oxford-Cambridge Varsity Cross Country and Mile races, and spent 6 years coaching track and field.
 
Workshop Speaker: Sam Callisto
Samuel P. Callisto, PhD
Senior Scientist | Metrum Research Group
Samuel Callisto, PhD, is a Senior Scientist at Metrum Research Group and an Adjunct Assistant Professor in the College of Pharmacy at the University of Minnesota. He is a pharmacometrician with extensive experience supporting drug development across several therapeutic areas, including CNS, inflammation, and oncology, with a focus on population PK and PK/PD modeling for regulatory decision-making.

Dr. Callisto has contributed to asset-level pharmacometric strategies, authored regulatory reports for submission to the FDA and international agencies, and collaborates on the development of open-source pharmacometric software to enable modern, reproducible modeling workflows. He has also played a key role in training scientists on contemporary R-based workflows used in both industry and academic settings.

His recent work has focused on the application of artificial intelligence and machine learning methods to pharmacometrics and quantitative drug development. This includes contributing to methodological research at the intersection of AI and pharmacometrics, as well as exploring how large language models can support scalable analysis workflows, model development, and scientific communication. His research and teaching emphasize the practical, responsible use of AI to augment—not replace—scientific judgment.
 

1:10 PM - 1:55 PM Causal inference

Workshop Speaker: James Rogers
James A. Rogers, PhD
VP Statistics, Quantitative Sciences | Metrum Research Group
Jim Rogers is the Vice President of Statistics in the Quantitative Sciences Business Unit at Metrum Research Group. After receiving his doctorate in statistics from The Ohio State University in 2001, Jim worked for two years on genomic and metabonomic analyses for biotechnology companies, followed by five years at Pfizer Global Research and Development, where he worked initially and as a nonclinical statistician and later as a clinical biostatistician. In 2008, Jim joined Metrum Research Group in order to work in closer collaboration with quantitative biologists and pharmacometricians. Over the course of his 17 years at MetrumRG, Jim has worked on decision informatics across a wide range of therapeutic areas and therapeutic modalities. Recurring areas of focus have included problems related to dose selection and dose optimization, as well as platform development based on disease progression models and clinical trial simulation. From a methodological perspective, Jim’s focus in recent years has centered on the role of causal inference concepts in evidence integration. Jim believes that scientists trained in statistics can revolutionize the discipline of pharmacometrics and that scientists trained in pharmacometrics can revolutionize the discipline of statistics.
 
Workshop Speaker: Manuela Zimmerman
Manuela Zimmermann, PhD
Senior Principal Pharmacometrician | Novartis
Manuela Zimmermann, Ph.D., is a Senior Principal Pharmacometrician at Novartis in Switzerland, supporting the oncology portfolio across all phases of clinical development. Her current work focuses on integrating causal inference and pharmacometrics modelling & simulation to strengthen evidence generation in drug development. She is an active member of the PMX Estimands and Causality initiative at Novartis, the INVENTS EU-project consortium focusing on drug development in rare diseases and pediatric populations, and a cross-industry working group on Causal Inference and Pharmacometrics, among others.

Manuela holds a Ph.D. in Biophysics and Biophysical Chemistry from the University of Cambridge, UK. Prior to her current role, she advanced statistical methodology for type-I error-controlled variable selection as a postdoctoral researcher in Novartis’ Advanced Methodology and Data Science group.
 

1:55 PM - 2:00 PM Closing

Stacey Tannenbaum and Jackson Burton
 
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