General Pharmacometrics
Francois Combes, PhD PharmD
Director pharmacometrics
Novartis Pharmaceuticals Corporation
east hanover, New Jersey, United States
Hunter Stephens, PhD
Scientist
Certara
Rolesville, North Carolina, United States
Mirwais Wardak, Ph.D.
Principal Scientist
Genentech, Inc.
South San Francisco, California, United States
Moses Wilks, PhD (he/him/his)
Assistant Professor of Radiology & Biomedical Imaging
Yale University
New Haven, Connecticut, United States
Karthik Lingineni, PhD
Sr. Principal Pharmacometrician
Novartis Pharmaceutical Corporation
Northborough, Massachusetts, United States
Kuangyu Shi, PhD (he/him/his)
Associate Professor, Chief Medical Physicist & Head of Lab for AI and Translational Theranostics
University of Bern, Bern, Switzerland
Fariba Khanshan, PhD (she/her/hers)
PK/PD/PMX
AstraZeneca/Novartis
BROOKLINE, Massachusetts, United States
Description of session (include background & scientific importance): Radiopharmaceutical therapy (RPT) utilizes targeted molecules conjugated with alpha or beta emitters (e.g., 177Lu, 225Ac) to treat various cancers. Exposure of cancer cells to radioactivity leads to DNA damage that can overwhelm the cancer cell’s repair capabilities. In RPT, radiation is delivered systemically or locally via molecules that selectively bind to cancer cells or accumulate by physiological mechanisms. This targeted approach enables the destruction of cancer cells while sparing healthy tissue. These molecules can also be tagged with radioisotopes (e.g., 18F, 68Ga) that can be imaged using techniques like a PET scan to visualize the location and distribution of the cancer cells. Major pharmaceutical companies have expanded their portfolios by acquiring radiopharmaceutical firms.
Current RPT guidelines, however, typically follow a “one-size-fits-all” approach, where patients receive the same amount of radioactivity per cycle. This overlooks individual variations in radiopharmacokinetics, radiation biology, and immune factors that can affect treatment outcomes. To optimize RPT, more personalized strategies are needed.
Modeling techniques have emerged as key tools in this effort, helping to predict the behavior of radiopharmaceuticals in patients. By integrating pharmacokinetics, dosimetry, and biological response models, these modeling approaches can provide insights into dose distribution, efficacy, and potential toxicity. Techniques like physiologically-based radiopharmacokinetic modeling or digital twin technology are being used to analyze RPTs. These efforts are crucial for optimizing therapies and ensuring safe, effective clinical trials. To advance this field, we are hosting a session with experts from academia and industry to explore how computational modeling approaches can optimize RPTs.
SPONSORED BY: NOVARTIS
Speaker: Moses Wilks, PhD (he/him/his) – Yale University
Speaker: Karthik Lingineni, PhD – Novartis Pharmaceutical Corporation
Speaker: Kuangyu Shi, PhD (he/him/his) – University of Bern
Speaker: Fariba Khanshan, PhD (she/her/hers) – AstraZeneca/Novartis