STP News Blog

Microbiome and Drug Development
(Sponsored by the American College of Toxicology)

Friday, August 25, 2023 |12:00 Noon–3:45 PM EDT

Co-Chairs: Rana Samadfam, PhD, DABT, MSc, Charles River Laboratories, Montreal, QC, Canada; and Alan Hoberman, PhD, DABT, ATS, Charles River Laboratories, Horsham, PA

The human body is an ecosystem consisting of different communities including human cells with all the complexity of human cell biology, bacteriome, virome, and other microorganisims with both harmless and pathogenic members. There are interactions and competition for resources between members of each community. In this ecosystem, complex interfaces consolidate signals from hosts (bacteria and human) and microbiota (bacterial, phage, virus, etc.) and activate appropriate effector programs to maintain a delicate balance. Failure to maintain this balance contributes to inflammatory disorders, including arthritis, allergies, and colitis. This course will discuss new findings on cross talk between the immune system and the microbiome and how efficacious in treating inflammatory disorders the new therapeutic approaches with microbiome origin are compared with standard of care.

Human Ecosystem
Rana Samadfam, PhD, DABT, MSc, Charles River Laboratories, Montreal, QC, Canada

Preclinical Studies in the Era of the Microbiome
Rodney R. Dietert, PhD, Cornell University, Ithaca, NY

The Influence of Gut Virome (Phages) and the Immune System on Intestinal Health
Corinne Maurice, BSc, MSc, PhD, McGill University, Montreal, QC, Canada

Efficacy of Live Therapeutics in Inflammatory and Autoimmune Conditions
Samantha Coulson, PhD, Coolum Beach, Australia

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 U.S. 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 U.S 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, Fellow IATP, 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