2023 Annual Symposium - The Society of Toxicologic Pathology (STP)
Contact Information
  •   11190 Sunrise Valley Dr., Suite 300, Reston, VA, 20191
  •   stp@toxpath.org
  •   703-438-7508
2023 STP Annual Symposium

Continuing Education Courses

Continuing Education Courses

STP will offer two continuing education courses in-person at the 2023 Annual Symposium and two virtually later in the summer. More information about the virtual courses is below.

Sunday, June 25

CE1 (Sunday AM) 8:00 AM–12:00 Noon
  • Development of Gene Therapies for Ocular Indications: From Concepts to Risk Assessment

    Co-Chairs: Helen S. Booler, BSc (Hons), BVetMed, DECVP, PhD, MRCVS, Novartis; Jacqueline Brassard, DVM, PhD, DACVP, Brassard Toxicologic Pathology Consultancy; and Meg Ferrell Ramos, DVM, PhD, DACVP, AbbVie

    Gene therapy in general has emerged as a research topic of choice in recent years. There has been a resurgence of interest and investment in the field of ocular gene therapy, driven by improved understanding of the genetic basis of ocular disease, advances in viral vector technology and unique anatomic and immunologic properties of the eye. The approval in 2017 of the first ocular gene therapy, indicated for patients with RPE65-associated retinal dystrophies, has provided hope for patients with many previously untreatable inherited retinal dystrophies, and has shifted the way we think about the treatment of ocular diseases more widely. With more ocular gene therapeutics in the pipeline, it is a good time to review the design and development of gene therapy products, with an emphasis on the non-clinical development, common in-life and histopathologic findings, risk assessment and a discussion of the translatability of non-clinical findings and the relevance to patients.

    An Overview of Gene Therapies both General and Specific to Ocular Indications
    Jacqueline Brassard, DVM, PhD, DACVP, Brassard Toxicologic Pathology Consultancy

    Toxicology, Study Design, Emerging Safety Trends, and Regulatory Considerations in the Development of Ocular Gene Therapies
    Brian Short, DVM, PhD, DACVP, Brian Short Consulting, LLC

    Immunological Considerations and Immune-Mediated Pathology in the Development of Ocular Gene Therapies
    Meg Ferrell Ramos, DVM, PhD, DACVP, AbbVie

    In-Life Observations and Pathology of AAV-Based Gene Therapies
    Helen S. Booler, BSc (Hons), BVetMed, DECVP, PhD, MRCVS, Novartis

    An Introduction to Ocular Oligonucleotide Therapies, In-Life Observations, and Associated Pathology
    Krishna Yekkala, BVSc, PhD, DACVP, Janssen Research and Development of Johnson & Johnson

    This program (20-1008492) has been approved for 2.25 hours of continuing education credits in jurisdictions that recognize RACE approval.


CE2 (Sunday PM) 1:30 PM–5:30 PM
  • Toxicologic Neuropathology of Novel Therapeutics

    Co-Chairs: Dinesh Bangari, BVSc, MVSc, MS, PhD, DACVP, Sanofi; and Lisa Lanigan, DVM, PhD, DACVP, Charles River Laboratories

    In this half day session, we will present an overview of the mechanisms of action, toxicologic liabilities, and safety risk assessment approaches for novel biotherapeutics for use in treating nervous system disorders and neuromuscular diseases. These modalities include vector-based therapies such as lentiviral and adeno-associated viral vectors (AAVs), cell-based therapies such as stem cells and CAR-T cells, nucleic acid-based therapies such as antisense oligonucleotides (ASOs) and mRNAs, and novel antibody-based therapeutics. The session will begin with an overview of the mechanisms of action for each of these therapeutics, how they can specifically target the nervous system and the unique aspects of safety risk assessment for these novel biotherapeutics. Additionally, there will be a presentation on the methods for investigating biodistribution, pharmacokinetics and pharmacodynamics to enable clinical/human dose prediction of these novel therapeutics. Finally, there will be 2–4 short case studies to demonstrate the importance of an informed safety assessment for novel biotherapeutics that target the nervous system. The goal of this session is to provide a well-rounded overview of the rapidly emerging biopharmaceutical research that is focused on developing novel therapeutics for the treatment of nervous system disorders and neuromuscular diseases.

    Vector-Based and Cell-Based Therapies
    Sarah Cramer, DVM, PhD, DACVP, StageBio

    Case Presentation: Routed by ROA: Effect of Route of Administration on AAV Neuropathology
    Elizabeth Galbreath, DVM, PhD, Takeda Development Center Americas, Inc.

    RNA-Based Therapies
    Jessica Grieves, DVM, PhD, DACVP, Ionis Pharmaceuticals

    Transport Vehicles to Deliver Biologics to the CNS
    Rene Meisner, DVM, DACVP, DABT, Denali Therapeutics

    RNAi Pharmacokinetics and Activity Assessment
    Arlin Rogers, DVM, PhD, Alnylam Pharmaceuticals

    Concept Presentation: Grappling with Gliosis in Assessing Adversity
    Brad Bolon, DVM, MS, PhD, DACVP, DABT, ATS, FIATP, FRCPath, GEMpath, Inc.

    This program (20-1008516) has been approved for 2.50 hours of continuing education credits in jurisdictions that recognize RACE approval.


Virtual Continuing Education Courses

Friday, August 25, 2023, 12:00 Noon–3:45 PM EDT
  • Microbiome and Drug Development
    (Sponsored by the American College of Toxicology)

    Session Chairs: Rana Samadfam, Charles River Laboratories, Montreal, QC, Canada; and Alan Hoberman, 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, Charles River Laboratories, Montreal, QC, Canada

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

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

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

Friday, September 15, 2023, 12:00 Noon–3:45 PM EDT
  • Fluid-Based Biomarkers of the Nervous System and Neurotoxicity

    Co-Chairs: Ingrid D. Pardo, DVM, MS, DACVP, 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]) to help health care professionals determine the need for a CT scan in patients suspected of having mild TBI with the purpose of preventing unnecessary neuroimaging and associated radiation exposure to patients (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 in preclinical species, the role pathologists and scientists play in validating and interpreting biomarker data and regulatory aspects of biomarker applications.

    Introduction and the Role of Pathologists in Biomarkers for the Nervous System and Neurotoxicity
    Ingrid D. Pardo, DVM, MS, DACVP, 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, MS, DVM, MVetSc, DACVP, Novartis, Newmarket, NH

    Identification of Translational Biomarkers of Neurotoxicity: HESI’s NeuTox Committee
    Syed Imam, PhD, US FDA HESI, Little Rock, AR

    European Innovative Medicines Initiative (IMI) NeuroDeRisk Strategy: Peripheral Neuropathy in Rats: Biomarkers, Histopathology and IHC Correlation
    Diethilde Theil, DVM, Dr med vet, Hoffmann-La Roche AG, Basel, Switzerland

    Utilizing Fluid-Based Biomarkers for Clinical Trial Decision Making in Neuromuscular Diseases
    Denitza Raitcheva, BS, Biogen Inc, Cambridge, MA

    Development of Biomarkers of Neurotoxicity: Regulatory Perspective

Continuing Education Chair:
Maria L. Dagli, DVM, MS, PhD, Universidade de São Paulo, São Paulo, Brazil

Continuing Education Co-Chair:
Melanie Greeley, DVM, PhD, DACVP, Charles River Laboratories, Ashland, OH