Description
Speakers:
Jan Hendrik Beumer, PharmD, Ph.D., DABT
- Pharm.D. (Utrecht University)
- Ph.D. (Utrecht University)
- Diplomate of the American Board of Toxicology
- Professor (PAR) of Oncology, Johns Hopkins University School of Medicine
- Director, Analytical Pharmacology Core / Shared Resource, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland
Salvatore J. Salamone, Ph.D.
- Ph.D. in Chemistry, Rutgers University
- SERC Fellow, University of Oxford
- Founder, President & Chief Executive Officer of Saladax Biomedical, Inc., Bethlehem, Pennsylvania
Learning objectives
After the webinar, participants should be able to:
- Understand the role of Project Optimus in drug development and clinical rationale for implementing therapeutic drug monitoring (TDM) in oncology, including its role in personalizing chemotherapy dosing to improve efficacy and minimize toxicity.
- Review the current topics supporting TDM use in cancer care, and real-world case applications.
- Explore practical strategies for integrating TDM into oncology workflows, including laboratory considerations and clinician adoption.
- Develop a better understanding of DPYD and the role that 5-FU TDM plays in patient management.
Description
This educational session aims to review recent developments in the field of precision dosing in oncology. It will discuss the strenghts and weaknesses of Project Optimus and how it has effected drug development. It will also address how therapeutic drug monitoring (TDM) can be used to improve overall exposure levels can be used to individualize exposure levels on an individual basis. The session will also address issues concerning 5-fluorouracil (5-FU) dosing in context of screening for DPYD variants and the need to follow up testing with 5-FU TDM.
Dr. Jan H. Beumer is an internationally recognized clinical pharmacologist specializing in pharmacokinetics and pharmacology of anti cancer agents. He earned both his Doctor of Pharmacy (PharmD) and Ph.D. from Utrecht University in the Netherlands, and is a board certified toxicologist (DABT). Currently, Dr. Beumer serves as Professor (PAR) of Oncology at the Johns Hopkins School of Medicine and directs the Analytical Pharmacology Core within the Sidney Kimmel Comprehensive Cancer Center. In this role, he leads pharmacological studies across the drug development spectrum—from preclinical evaluations to Phase III clinical trials. Previously, he held a tenured professorship in Pharmaceutical Sciences at the University of Pittsburgh, with a secondary appointment in medicine. He also co directed the Cancer Therapeutics Program at UPMC Hillman Cancer Center and led its Cancer Pharmacokinetics & Pharmacodynamics Facility. He has held key roles in NCI-funded consortia, including serving as PI for UM1 and U24 pharmacology grants, liaising between PK resources and clinical trial networks (e.g., ALLIANCE and NRG), and co chairing NCI/CTEP’s Investigational Drug Steering Committee and Pharmacology Task Force. Dr. Beumer has authored over 200 peer-reviewed publications and serves as U.S. Editor-in-Chief of Cancer Chemotherapy and Pharmacology. His research critically advances the optimization of anticancer drug dosing via rigorous PK analysis and personalized trial design. Among his recognitions are leadership awards from the UPMC Hillman Cancer Center and the National Cancer Institute
Dr. Salvatore J. Salamone is an internationally recognized expert in Therapeutic Drug Monitoring (TDM). Prior to founding Saladax Biomedical in 2004, Dr. Salamone spent 17 years at Roche Diagnostics, rising to Vice President of R&D for North America and then served as Senior VP of R&D at OraSure Technologies. During his time in industry, Dr. Salamone’s group has developed nine technology platforms that led to over 70 FDA approvals. Saladax Biomedical develops rapid assays to measure therapeutic drug levels for oncology and psychiatry care. Dr. Salamone holds 41 US patents, has authored over 90 of publications, contributed to textbook chapters, and is recognized for advancing TDM in oncology. His honours include induction into the New Jersey Inventors Hall of Fame (2016), the Ben Franklin Award for Innovation and the prestigious C.E. Pippenger Award from IATDMCT (2021), recognizing exceptional achievement in the field of therapeutic drug monitoring. Dr. Salamone dual bachelor’s degrees at Villanova University, a Ph.D. in Chemistry from Rutgers University, and was a Science Engineering Research Council (SERC) Post‑Doctoral Fellow at Oxford University