Inside the Intrathecal Space and ICV Dosing: Practical Principles and Real-World Lessons in Nonclinical Study Design

Recorded On: 02/25/2026

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Intrathecal (IT) and intracerebroventricular (ICV) administration enable direct access to the central nervous system but introduce route-specific complexities in nonclinical study design, execution, and interpretation. This webinar translates those complexities into practical principles for toxicologists aiming to deliver sound risk assessment and regulatory-ready packages. The speakers will examine how administration parameters, surgical technique, catheter/device considerations, dosing paradigms, and species selection (rodent vs. nonrodent) shape data quality and translational relevance. Direct IT delivery can produce procedure-related microscopic findings from localized injury or irritation of CNS tissues; however, microscopic changes of similar character and/or severity may also arise from the test article (TA), complicating interpretation. Approaches that can be used to help differentiate procedure-related from TA-related microscopic changes will also be discussed.

(1)   Technical Considerations for Intrathecal and Intracerebroventricular Routes: Essential Insights for Toxicologists – Stefania Cinquino, BSc

(2)   Intrathecal Administration in Non-Human Primates: Technique, Study Designs, Challenges   – Florian Timo Ludwig, PhD

(3)   Procedure-Related Microscopic Findings Secondary to Intrathecal Dosing of Test-Articles – Lisa Berman-Booty, VMD, PhD, DACVP

Lisa Berman-Booty, VMD, PhD, DACVP

Lisa Berman-Booty, VMD, PhD, DACVP

Director of Pathology

Ionis Pharmaceuticals, Inc.

Lisa Berman-Booty attended the University of Pennsylvania for both her undergraduate and veterinary degrees. After receiving her VMD, she pursued an anatomic pathology residency at the Ohio State University, where she also earned her PhD in comparative and veterinary medicine. She obtained board certification in anatomic pathology in 2012 and has had a variety of roles as a toxicologic pathologist since then. Lisa has been working for Ionis since 2022, where she is currently the director of pathology. In this role, she frequently performs primary pathology reads and/or peer reviews for studies of IT delivered oligonucleotides.

 

Stefania Cinquino, BSc

Stefania Cinquino, BSc

Director of Infusion, Parenteral Administration, and Neurotoxicology

Charles River Laboratories

Stefania Cinquino received her education from Concordia University in Cellular and Molecular biology and has more than 15 years of experience as a research scientist and toxicologist. She is currently the director of infusion, parenteral administration, and neurotoxicology at Charles River Senneville, where she oversees numerous IND-enabling programs supporting various CNS indications.

Florian Timo Ludwig, PhD

Florian Timo Ludwig, PhD

Senior Study Director of Safety Assessment

Labcorp Early Development Services, GmbH

Florian Timo Ludwig holds a PhD of Biology from the University of Muenster Germany. After receiving his PhD, he stayed at the University Hospital of Muenster where pursued his postdoc at the Institute of Physiology. Since 2014, Florian has been working as a study director at Labcorp Early Development Services in Germany

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Inside the Intrathecal Space and ICV Dosing: Practical Principles and Real-World Lessons in Nonclinical Study Design
Recorded 02/25/2026  |  90 minutes
Recorded 02/25/2026  |  90 minutes Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and co-host societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.
You must register to access.
PDF of Presentations
Technical Considerations for Intrathecal and Intracerebroventricular Routes: Essential Insights for Toxicologists– Stefania Cinquino
Open to download resource.
Open to download resource. Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and co-host societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.
You must register to access.
Intrathecal Administration in Non-Human Primates: Technique, Study Designs, Challenges. – Florian Timo Ludwig
Open to download resource.
Open to download resource. Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and co-host societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.
You must register to access.
Procedure-Related Microscopic Findings Secondary to Intrathecal Dosing of Test-Articles – Lisa Berman-Booty
Open to download resource.
Open to download resource. Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and co-host societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.
You must register to access.