ACCP Clinical Practice Webinars | Cytokine Release Syndrome: Implications in Drug Development - Live
Includes a Live Web Event on 05/29/2025 at 12:00 PM (EDT)
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ACCP Clinical Practice Webinars: Cytokine Release Syndrome: Implications in Drug Development - LIVE
Live Session: Thursday, May 29th, 2025, from 12:00 to 1:00 PM ET
On Demand: May 29th, 2025 to May 29th, 2025
Why is this webinar important to your practice?
Cytokine release syndrome (CRS) is a life-threatening systemic inflammatory syndrome involving elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions and monogenic disorders. Many therapeutics such as cancer immunotherapy (CAR-T, CD3 bispecifics, etc.) can lead to CRS. To mitigate the CRS risk, various approaches were investigated in clinical trials, including priming dosing (step-up dosing, split dosing, dose fractionation, etc.) and premedications. Translational modeling approaches such as mechanistic quantitative systems pharmacology models were also developed to optimize the dose in the clinic to minimize the CRS. In addition, CRS could also result in drug-drug interaction (DDI) risks due to the suppression of CYP enzymes and transporters by the proinflammatory cytokines. Physiologically-based pharmacokinetic approaches have been utilized to assess CRS mediated DDI risks. This activity will focus on the current scientific aspects for CRS and its implications in drug development as well as future perspectives. Learners who complete this activity will have enhanced knowledge utilizing case examples and discussions.
Target Audience:
Interprofessional team of graduate students, postdoctoral fellows/trainees and professionals in the field of pharmacy, pharmacometrics, clinical pharmacology and clinical pharmacy practice. This activity is applicable to participants across academia, pharmaceutical industry and regulatory agencies interested in expanding their knowledge in cytokine release syndrome.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the cytokine release syndrome (CRS);
- Discuss the implication of CRS in drug development;
- Explain the utility of modeling approaches for prediction of CRS;
- Describe the utility of modeling approaches for estimating CRS mediated DDI.
Yanke Yu
Distinguished Scientist
Genentech Inc/Roche
Dr. Yanke Yu, is a distinguished scientist of clinical pharmacology in Genentech Inc. Prior to Genentech, Dr. Yu held positions in Pfizer Inc. and Eisai Inc. Dr. Yu has a wealth of experience in clinical pharmacology, and modeling and simulation. Following a 13+ year industry career, Dr. Yu contributed to multiple products regulatory approvals in both oncology and immunology. Prior to his industry career, Dr. Yu completed his Ph.D. in Pharmaceutical Sciences at the University of Michigan. Dr. Yu is a prolific publisher, with 39 peer-reviewed articles and 50+ abstracts/posters/oral presentations.
Benjamin Colton (Moderator)
Section Chief, Clinical Pharmacy Specialists
National Institutes of Health
Dr. Colton received his Doctor of Pharmacy from Drake University before completing a postdoctoral fellowship in Infectious Diseases Pharmacotherapy at the University of Illinois at Chicago. In 2015, Dr. Colton joined the NIH Clinical Center's Pharmacy Department. As the Infectious Diseases and Immunology Clinical Pharmacy Specialist, Dr. Colton collaborates with NIAID Intramural Research Program Clinical Investigators on the design, implementation, conduct, and interpretation of early phase clinical trials. His contributions to this translational research include proctocol study design, dose selection, dose modification, risk management strategies, and pharmacometric approaches and analysis. Current collaborations include research evaluating immunomodulating therapies for patients with primary immunodeficiencies and autoinflammatory disorders and optimizing antimicrobial therapy for fungal and mycobacterial disease. Further, Dr. Colton maintains a clinical practice at the NIH Clinical Center, leveraging his expertise to support the pharmacotherapy needs of these unique patient populations. Collectively, these collaborations and patient care advance the knowledge and understanding of the complexity of the immune system, the interface between host immunity and pathogen, and pioneering interventions to modulate these complex interactions to improve the health of patients with primary immunodeficiencies, autoinflammatory conditions, disseminated fungal and mycobacterial infections, and their accompanying complications.
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