CE course in Fluid-based biomarkers of the nervous system
The Society of Toxicologic Pathology (STP) (toxpath.org)
Fluid-Based Biomarkers of the Nervous System and Neurotoxicity
Friday, September 15, 2023, 12:00 Noon–3:45 PM EDT
Co-Chairs: Ingrid D. Pardo, DVM, MS, DACVP, FIATP, Biogen Inc., Cambridge, MA; and Madhu P. Sirivelu, BVSc, PhD, DACVP, Pfizer, Inc. Cambridge, MA
There is a critical need to develop non-invasive biomarkers to detect and/or predict nervous system alterations in preclinical species and humans. These can also be used to evaluate efficacy of novel drugs, and to monitor neurologic diseases. In preclinical studies, fluid-based biomarkers for neurotoxicity can be measured in standard samples collected (serum/plasma) or by collecting additional samples such as, urine, ocular fluid, saliva, and CSF (invasive). In 2019, the US FDA authorized marketing of the first blood-based test to aid in the evaluation of traumatic brain injury (TBI) in adults to assess GFAP [glial fibrillar acidic protein] and UCH-L1 [ubiquitin C-terminal hydrolase L1] (Takala et al., 2015) In addition, the US FDA has authorized the use of NF-L (Neurofilament light chain) to monitor patients with multiple sclerosis (www.fda.gov). The objectives of this course are to update the attendees of the use of fluid-based biomarkers of nervous system toxicity in preclinical species, their correlation with histopathology and neurofunctional testing; the role pathologists and toxicologists play in validating and interpreting biomarker data and regulatory aspects of biomarker implementation.
Introduction and the Role of Pathologists in Biomarkers for the Nervous System and Neurotoxicity
Ingrid D. Pardo, DVM, MS, DACVP, FIATP, Biogen Inc, Cambridge MA
Validation of Fluid-Based Neurobiomarkers in Nonclinical Toxicology Species and Their Utility in Gene Therapy Studies
Madhu P. Sirivelu, DVM, PhD, DACVP, Pfizer Inc., Cambridge, MA
Fluid-Based Biomarkers of Neurotoxicity with Gene Therapy Toxicity Studies in Nonhuman Primates
Kelley Penraat, DVM, PhD, DACVP, Novartis, Newmarket, NH
Identification of Translational Biomarkers of Neurotoxicity: HESI’s NeuTox Committee
Syed Imam, PhD, US FDA HESI, Little Rock, AR
European NeuroDeRisk Innovative Medicines Initiative Strategy: Peripheral Neuropathy in Rats: Neurobehavioral Testing, Histopathology, and Correlation with Biomarkers
Diethilde Theil, DVM, PhD, Hoffmann-La Roche AG, Basel, Switzerland
Fluid-Based Biomarkers for Neurologic Diseases in Clinical Trials
Denitza Raitcheva, PhD, Biogen Inc, Cambridge, MA
Drug-Induced Peripheral Neuropathy in Dogs: Nonclinical Safety Assessment and Follow-up Strategies
Diethilde Theil, DVM, PhD, Hoffmann-La Roche AG, Basel, Switzerland
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Date/Time
Date(s) - 15/09/2023
12:00 pm - 3:45 pm
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