Society of Toxicology (SOT) 59th Annual Meeting and ToxExpo

DATE

Sunday, March 15, 2020 - Thursday, March 19, 2020

LOCATION

Anaheim, CA

Request a Meeting at SOT

Scientist looking at a vial.

Charles River is pleased to participate in the scientific program of the Society of Toxicology (SOT) 59th Annual Meeting and ToxExpo. Joining scientists from more than 45 countries for the largest toxicology conference and expo in the world, we are proud to present our latest research and industry news through four scientific sessions, two continuing education courses and over 40 scientific posters.

Whether you need stand-alone studies or support for your entire program, our team can solve your toughest development challenges. Visit us at booth 839 to discover our affirmative approach to meeting all your outsourcing needs.

Sunday, March 15

Continuing Education Course | 1:30-2:15 p.m.
The Male Reproductive Tract: Development, Toxicology, and Pathology | An Overview of the Male Reproductive System: Applied Anatomy and Physiology from a Pathologist’s Perspective

Continuing Education Course | 3:30-4:15 p.m.
The Male Reproductive Tract: Development, Toxicology, and Pathology | Postnatal Development of the Juvenile Male Reproductive Tract in Rats: Microscopic Evaluation, Interpretation, and Time Points of Toxicologic Significance

Monday, March 16

Exhibitor Session |10:30-11:30 a.m. | Room 206B
Tools and Strategies to Predict Unwanted Immunotoxicities Throughout the Drug Development Phases
Christina M. Satterwhite, PhD, Senior Director, Global Laboratory Sciences

The complexity of today’s biologic and immune-targeting drugs demands new approaches and tools to predict the immunotoxic potential of these therapies prior to first-in-human studies. Scientifically sound in vitro and ex vivo testing strategies are critical to understand and predict potential adverse clinical outcomes.

Exhibitor Session | 1:45-2:45 p.m. | Room 206B
Dietary Exposure in Rabbits is a Relevant Route of Exposure for Chemicals and Pesticides
Pragati S. Coder, PhD, DABT, Director DART
Presented with: Bethany Hannas, PhD, DABT, Senior Toxicologist, DART at Corteva Agriscience

Rodent safety studies often utilize the most relevant route of human exposure; but rabbits are dosed via gavage as they can be sensitive to palatability, consume pelleted feed, and display variable feed consumption. Charles River and Corteva have optimized dietary studies using feed rationing and flavor additives to improve palatability.

Symposia | 3:00-4:30 p.m. | Room 304A
Evolving Technologies for Determination of Biotherapeutic Specificity

Tuesday, March 17

Platform Presentation | 8:30-8:45 a.m. | Room 204A
Optimization of UGT Inhibition Assays: Evaluation of Substrate and Inhibitor Selectivities

Exhibitor Session | 10:30-11:30 a.m. | Room 206B
An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?
Annie Jarabek1, Matt Reed2, James Randazzo, PhD, DABT3, Clive Roper, PhD3, Mark Freke, BSc, MSc3
1US EPA; 2Coelus Consultancy; 3Charles River

Industry experts will explore the in vitro models and applications that are gaining acceptance from regulatory authorities for the assessment of human risk, as well as the challenges of these new methodologies and the animal models we’ll need in the interim as we move to adopt in vitro alternatives.

Wednesday, March 18

Exhibitor Session | 10:30-11:30 a.m. | Room 206B
Cell and Vector Based Gene Therapies: Practical Considerations and Evolving Toxicology Study Designs
Simon Authier, Senior Director, Scientific Operations and Veterinary Science 

Regulatory toxicology for cell and gene therapies often involves customized study designs adapted to product characteristics and considerations for immunogenicity . During this session case studies showcasing approaches to safety testing will be discussed along with the selection of supporting laboratory assays in the context of de-risking these therapies.

Tools and Strategies to Predict Unwanted Immunotoxicities Throughout the Drug Development Phases

Christina M. Satterwhite, PhD
Senior Director, Global Laboratory Sciences, Reno, NV

Headshot of Christina M. Satterwhite, PhD, Senior Director, Global Laboratory Sciences, Charles River, Reno, NV.Dr. Christina Satterwhite received her PhD in cellular and molecular pharmacology and physiology from the University of Nevada, Reno, School of Medicine. Over the course of her career, she has worked on an extensive breadth and number of compounds in the areas of pathology, toxicology (with an emphasis on immunotoxicology studies), large molecule bioanalytical chemistry and immunobiology. Prior to taking on her role as Senior Director of Global Laboratory Sciences and head of our Immunology Center of Excellence, she led the laboratory sciences group in Nevada overseeing interactions with regulatory authorities and Sponsors, interpretation and reporting of study data, and the conduct, management and regulatory compliance of assigned nonclinical and clinical studies.


Dietary Exposure in Rabbits is a Relevant Route of Exposure for Chemicals and Pesticides

Pragati S. Coder, PhD, DABT
Director DART, Ashland, OH

Headshot of Pragati S. Coder, PhD, DABT Director DART, Ashland, OHDr. Pragati Coder is the Director at Charles River laboratories Ashland, where she is responsible for scientific direction at the Ashland OH and Mattawan MI sites. She serves as a Subject Matter Expert for DART, neurotoxicity and juvenile toxicity studies supporting product development programs for pharmaceutical, agrochemical, and veterinary medical products. Dr. Coder received her PhD in Molecular Biology from Indian Institute of Technology-Bombay, India (2000) and was a postdoctoral fellow at the College of Pharmacy, University of Texas at Austin (2000-2005). Dr. Coder joined Charles River (formerly WIL Research) in Ashland, OH in 2005. Dr. Coder is board-certified as a Diplomate of the American Board of Toxicology, and a member of several professional organizations, including the Society of Toxicology, Society for Birth Defects Research and Prevention (BDR-P, formerly Teratology Society), American College of Toxicology, European Teratology Society and the Middle Atlantic Reproduction and Teratology Association (MARTA). She has served in various capacities in these organizations, is the current Treasurer for BDR-P and the outgoing Senior Councillor for the Reproductive and Developmental Toxicity Specialty Section.


Dietary Exposure in Rabbits is a Relevant Route of Exposure for Chemicals and Pesticides

Bethany Hannas, PhD, DABT
Senior Toxicologist, DART, Corteva Agriscience, Newark, DE

Headshot of Bethany Hannas, PhD, DABT, Senior Toxicologist, DART, Corteva Agriscience, Newark, DEDr. Bethany Hannas is a Senior Toxicologist at Corteva Agriscience, where she serves as a DART Subject Matter Expert and Lead Scientist on guideline and mode of action studies in support of crop protection compounds and heads investigational research in the area of endocrine disruption. Dr. Hannas received PhD in Toxicology from North Carolina State University (2009) and was a postdoctoral fellow at the U.S. EPA (2009-2013). Dr. Hannas joined the Dow Chemical Company in Midland, MI in 2013 and recently transitioned to the toxicology laboratory of the agriculture spinoff, Corteva Agriscience, in Newark, DE.(2018). Dr. Hannas is board-certified as a Diplomate of the American Board of Toxicology, and a member of several professional organizations, including the Society of Toxicology, Society for Birth Defects Research and Prevention (BDR-P, formerly Teratology Society), ToxForum, and the Middle Atlantic Reproduction and Teratology Association (MARTA). She has served in various capacities in these organizations, is a Councillor for the Middle Atlantic Reproduction and Teratology Association (MARTA) and is the incoming Vice President for the Reproductive and Developmental Toxicity Specialty Section.


An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?

Clive Roper, PhD
Head of In Vitro Sciences

Headshot of Clive Roper, PhD Head of In Vitro Sciences, Charles River.Clive graduated with a PhD in in vitro dermal metabolism and toxicology from Newcastle University. He joined Inveresk Research (acquired by Charles River in 2004) as a Research Officer to develop the in vitro skin penetration service. After serving in study director and scientific manager roles, he became Head of In Vitro Sciences, growing the organization from a team of 1 to 25, exclusive of QA, bioanalysis, and pathology support staff. His department currently performs in vitro safety pharmacology, investigational and mechanistic toxicology, and in vitro respiratory toxicology with 10 additional staff. He has presented at many meetings and organized small meetings (Skin Metabolism) and large conferences (WC9). Dr. Roper has authored and co-authored many posters and abstracts as well as peer review papers. He is a peer reviewer for journals including TIV, Regulatory Pharmacology & Toxicology, Annals of Work Exposures, and Health and Skin Pharmacology and Physiology. He has been actively involved in advising regulatory agencies including NIH, SCCS and EPA, as well as industry bodies and has presented a webinar on in vitro toxicology with the FDA. A member of several working groups for Charles River’s Centers of Excellence, Dr. Roper is a founding member of the North American 3Rs Collaborative.


An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?

Mark Freke
Principal Scientist, Montreal, Canada

Headshot of Mark Freke, Principal Scientist, Montreal, Canada.Mark Freke is the Principal Scientist of Charles River’s Montreal-based inhalation toxicology department. He graduated with a BSc (Hons) in biology from Bath University and a Grad Dip Tox and MSc in toxicology from the Royal Melbourne Institute of Technology. With more than two decades of experience in the pharmaceutical industry across positions at Charles River and Covance, he has directed more than 50 GLP studies. Programs included inhalation, general, and reproductive toxicology ranging in duration from acute to chronic, with numerous 2-year carcinogenicity studies. In his current role, Mark also validates new technology and procedures and is an active member of the Institute for Animal Care and Use Committee.


An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?

James Randazzo
Associate Director of Inhalation Toxicology, Ashland, Ohio

Headshot of James Randazzo, Associate Director of Inhalation Toxicology, Ashland, Ohio.James Randazzo is the Associate Director of Inhalation Toxicology at the Charles River site in Ashland, Ohio (formerly WIL Research). In 8.5 years at Ashland, he directed nearly 200 nonclinical studies, from range-finding toxicity to genetic to reproductive toxicology. He has experience with nearly every routes of administration, and acute to 2-year duration. He specializes in evaluation of the toxicity of agrochemicals and industrial chemicals in rodents by nose-only and whole-body routes of administration.


An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?

Annie Jarabeik
Senior Science Advisor, US EPA

Annie is a senior science advisor in the immediate office of the Center for Public Health and Environmental Assessment (CPHEA) at its Health and Environmental Effects Assessment Division (HEEAD) in the Research Triangle Park, within the U.S. Environmental Protection Agency’s Office of Research and Development (ORD), following recent service as the Deputy Director of the Human Health Risk Assessment (HHRA) national research program in ORD. With expertise in inhalation toxicology in both laboratory and clinical environments, dosimetry modeling, risk assessment, and decision analysis, she was principal author of the Agency’s Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry. She has worked on risk assessments, dosimetry models, or analysis methods across all media and routes of exposure. In addition to leading the Agency’s risk assessment of ingested perchlorate, she has addressed several priority interdisciplinary Agency assessments including: inhaled particulate matter, vinyl acetate, manganese, and Libby amphibole asbestos. Her current research efforts focus on multi-scale dosimetry modeling, including approaches for in vitro to in vivo extrapolation (IVIVE) of inhalation exposures to advance the application of emerging methods for translation and evidence integration across various experimental platforms. Annie received three awards for best manuscript in risk assessment application from the Risk Assessment Specialty Section (RASS) of the Society of Toxicology, along with several best abstract presentation awards. A manuscript on her collaborative IVIVE work received an honorable mention as the best 2018 paper from the Biological Modeling Specialty Section (BMSS) at the 2019 annual SOT meeting in Baltimore. She has also received a Lifetime Achievement Award from the University of Massachusetts, the Risk Practitioner of the Year award from the Society of Risk Analysis (SRA), the Superfund National Notable Achievement Award, and several award medals (gold, silver and bronze) and technical or special service awards from the Agency.


An Integrated Respiratory Toxicology Testing Strategy Amidst Regulatory Changes: Are We Ready for Full Replacement?

Matt Reed
Principal, Coelus Consultancy

Matt is Principal at Coelus where he facilitates early to late phase development of pharmaceutical IP and provides consulting services in integrated drug development strategies, toxicology, pharmacology, and hazard assessment. Dr. Reed is a pharmacologist, board certified toxicologist, ABT Board Member, and Fellow of the Academy of Toxicology Sciences (ATS). He has developed large scale hazard assessment programs (e.g., chemical mixtures, air pollutants, etc.), integrated drug development plans and timelines, and has developed hundreds of safety and pharmacology programs for R&D initiatives. Specifically, he has overseen and consulted on initiatives to include toxicant/drug delivery, applied toxicology studies, formulation/device feasibility and development, pharmacokinetics, pharmacology, safety pharmacology, pivotal IND and NDA GLP compliant studies, etc. He has been a part of multiple successful R&D programs that that have transitioned to IND, NDA, and other regulatory registration milestones for small molecules, biologics, oligonucleotides, and alternative fuel additives. He has been an awardee, PI/co-PI, or subcontract PI of more than $51M in federal R&D grants and contracts for drugs and vaccines working with government-funded commercial firms, NIH, BARDA, and DOD to develop pharmaceutics for clinical indications as well as combat, homeland, and defense security threats.


Cell and Vector Based Gene Therapies: Practical Considerations and Evolving Toxicology Study Designs

Simon Authier, DVM, MBA, PhD, DSP
Senior Director Scientific Operations and Veterinary Science

Headshot of Simon Authier, DVM, MBA, PhD, DSP, Senior Director Scientific Operations and Veterinary Science at Charles River.
Simon Authier, DVM, MBA, PhD, DSP, is Senior Director Scientific Operations and Veterinary Science at Charles River. He coauthored 90+ peer reviewed scientific publications, overviewed 800+ preclinical studies and is associate professor in immunology at the Faculty of Veterinary Medicine, University of Montreal.

Monday, March 16 | 9:00 – 10:45 a.m.

Session: Safety Evaluation of Nonpharmaceutical Products | Poster Board: P822
A 13-Week Rat Inhalation Study of Aerosols Generated from Two Flavor Mixtures
Co-Authored with Altria Client Services LLC

Session: Safety Evaluation of Nonpharmaceutical Products | Poster Board: P828
Neurobehavioral Assessments of Juvenile Male and Female Wistar Han IGS Rats, Hsd:Sprague Dawley SD Rats, and CD-1 IGS Mice

Monday, March 16 | 10:45 a.m. – 12:30 p.m.

Session: Respiratory Toxicology | Poster Board: P221
Effect of Tyloxapol Treatment on % Active Cilia, Cilia Beating Frequency, and Mucociliary Clarance in MucilAir™-Cystic Fibrosis Tissues

Session: Respiratory Toxicology | Poster Board: P232
A Model for Evaluating Synergistic Opioid Induced Respiratory Depression

Session: Respiratory Toxicology | Poster Board: P235
Early De-Risking Approaches for Identification of Anti-Fibrotics for Idiopathic Pulmonary Fibrosis (IPF) Treatment

Session: Respiratory Toxicology | Poster Board: P244
Next Generation Risk Assessment Approach for Inhalation Exposures: Polymer Case Studies
Co-Authored with Unilever; Institute for In Vitro Sciences Inc; and Epithelix

Session: Biomarkers | Poster Board: P331
Demonstrability of an Enzyme-Linked Immunosorbent Assay to Simultaneously Quantify Histamine in Multiple Nonclinical Species and Matrices in a Single Analytical Run

Session: Reproductive Toxicology II | Poster Board: P698
Surgical Implantation of Vascular Access Buttons Has No Impact on Male or Female Reproduction in Crl:CD1(ICR) Mice
Co-Authored with Atox Bio, Ltd.

Session: Developmental and Juvenile Toxicology | Poster Board: P713
Pre- and Postnatal Subchronic Toxicity Studies of Boric Acid in the Harlan Sprague Dawley Rat
Co-Authored with NIEHS/NTP; ILS; Southern Research; and MRIGlobal

Session: Developmental and Juvenile Toxicology | Poster Board: P716
Dietary Route of Exposure for Rabbit Provides a Reliable, Relevant, and Conservative Characterization of Developmental Toxicity
Co-Authored with Corteva Agriscience

Session: Developmental and Juvenile Toxicology | Poster Board: P718
Developmental Toxicity Studies of an AcetylCoA Carboxylase Inhibitor in Sprague Dawley Rats and New Zealand White Rabbits
Co-Authored with Pfizer Inc.

Session: Developmental and Juvenile Toxicology | Poster Board: P741
Use of Extended One-Generation Reproductive Toxicology Studies in Safety Assessments under REACH Regulations

Session: Safety Assessment: Pharmaceutical—Drug Discovery | Poster Board: P845
Safety Evaluation of High Concentration of Live Bacteria on Models with Compromised Physiological Barriers
Co-Authored with Servatus Biopharmaceuticals

Tuesday, March 17 | 9:00 – 10:45 a.m.

Session: Stem Cell Biology and Toxicology | Poster Board: P431
Validation of a qPCR Assay for Human Cell Biodistribution Assessment in Rat Tissues
Co-Authored with KM Pharmaceutical Consulting LLC

Tuesday, March 17 | 10:45 a.m. – 12:30 p.m.

Session: Immunotoxicity I | Poster Board: P110
The Kinetic Direct Peptide Reactivity Assay (kDPRA): An In Chemico Method to Characterize the Skin Sensitization Potency of Chemicals
Co-Authored with BASF SE; Givaudan Schweiz AG; L´Oréal Research and Innovation; IIVS; Procter & Gamble; National Institute of Public Health

Session: Endocrine Toxicology | Poster Board: P205
Development of Strategies to Determine the In Vitro and Ex Vivo Induction of T4-glucuronidation in Different Species

Tuesday, March 17 | 2:15 – 4:30 p.m.

Session: Animal Models | Poster Board: P535
Comparison of Two Intravenous Infusion Methods in Freely Moving Large Animals*

Session: Animal Models | Poster Board: P536
Clinical Pathology and Histopathology Parameters in Juvenile and Adult Guinea Pigs: A Comparative Study
Co-authored with eXIthera Pharmaceuticals Inc.

Session: Animal Models | Poster Board: P538
Differences in Survival, Incidence of Spontaneous Neoplasms, and Neoplastic Onset in 2-Year Carcinogenicity Studies Conducted in Crl:CD(SD) Rats and Crl:WI(Han) Rats

Session: Animal Models | Poster Board: P540
Blood Sampling for Clinical Pathology in Rats: Retro-Orbital Sinus Sampling versus Jugular Vein Sampling

Session: Animal Models | Poster Board: P541
28-Day Continuous Intravenous Infusion in Mice: Use of Externalized Magnetic Ports and Tethers to Achieve Study Endpoints and Enhance Animal Welfare

Session: Animal Models | Poster Board: P544
Combination of Lacto-Bacillus Formulation with Cyclosporine A Completely Prevents Disease Progression in a Murine Model of Inflammatory Bowel Disease
Co-authored with Servatus Biopharmaceuticals

Session: Animal Models | Poster Board: P545
Cerebrospinal Administration in the Juvenile CD1 Mouse Using the Intracerebroventricular Route

Session: Risk Assessment Applications II | Poster Board: P608
Evaluation of the Carcinogenic Potential of Baclofen after Dose Titration in rasH2 Mice
Co-authored with Ethypharm SA, Saint Cloud, France

Wednesday, March 18 | 9:00 – 10:45 a.m.

Session: Education, Ethical, Legal, and Social Issues | Poster Board: P447
Expanding the Reach of Undergraduate Education Programs at Regional Meetings: Model Programs at Four Regional SOT Chapters
Co-authored with U.S. Coast Guard Academy; Bates College; Rutgers University; St. John's University; Drake University; and Northern Kentucky University.

Session: Neurotoxicity: General | Poster Board: P704
Spontaneous Incidence of Infrequent Neurological Clinical Signs across Species: A Retrospective Analysis

Wednesday, March 18 | 10:45 a.m. – 12:30 p.m.

Session: Immunotoxicity II | Poster Board: P107
Historical Immunophenotyping Data in Pre-Clinical Species

Session: Immunotoxicity II | Poster Board: P119
Validation of a 14-Color Flow Cytometry Panel for GLP-Compliant Blood Cell Subpopulation Analyses in the Large Animal*

Session: Immunotoxicity II | Poster Board: P122
In Vitro Differentiation and Characterization of Plasmablasts and Plasma Cells from Large Animal CD20+ B Cells*
Co-authored with Celgene Corporation

Session: DNA Damage and Repair | Poster Board: P309
Determining Genotoxic Potential and Mode-of-Action in a Mammalian Single Cell Assay

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P367
Is Acidification of Urine a Preanalytical Requirement for the Measurement of Urine Calcium, Phosphorus and Magnesium in Nonclinical Studies?

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P371
Is it Hypertension or are You Just Excited to See Me?

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P374
Chronic Subcutaneous Administration of 30% (w/v) Aqueous Sulfobutyl Ether 7-β-cyclodextrin (Captisol™) in Wistar Han Rats Causes Malignant Sarcomas at the Injection Site
Co-authored with Research Pathology Associates, LLC; and Aclairo Pharmaceutical and Development Group, Inc.

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P382
Threshold for Anaphylactoid Reaction to Polysorbate-80 in Large Animals*
Co-Authored with Amgen

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P385
Interchangeability of Mainland Southeast Asian Sourced Large Animals Based on Anatomic and Clinical Pathology Parameters*

Session: Safety Assessment: Pharmaceutical—Drug Development | Poster Board: P395
Comparison of Historical Control Data in CD-1 Mice When Single vs Group-Housed and Considerations for Successful Group-Housing of Male Mice

Wednesday, March 18 | 2:15 – 4:30 p.m.

Session: Emerging In Vitro Systems | Poster Board: P406
In Vitro Cell-Based Cytotoxicity and T-Cell Activation Assays to Assess Safety and Efficacy of Engineered T-Cell Therapies

Session: Cardiovascular Toxicology/Hemodynamics | Poster Board: P735
Effects of Polysorbate 80 as a Vehicle: Large Animal Species Comparison*
Co-Authored with University of Montreal and Genentech

Session: Cardiovascular Toxicology/Hemodynamics | Poster Board: P741
QA Interval Heart Rate Correction: Multispecies Comparison of an Indirect Ventricular Contractility Biomarker

Session: Cardiovascular Toxicology/Hemodynamics | Poster Board: P756
Electrophysiology Testing in Drug Development: Evaluation of Intracardiac Conduction Parameters in Large Animals*

Session: Cardiovascular Toxicology/Hemodynamics | Poster Board: P759
Determination of Blood Pressure Liabilities through Assessment of Vessel Reactivity Using a Tissue Myograph System

*Titles may have been modified due to their sensitive nature.

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Mila’s Story

Mila was diagnosed in January 2017 with Batten disease; a rare disease caused by genetic mutations that leads fat to accumulate in nerves and brain cells. Her type of Batten's is particularly rare and fatal with no therapy available at the time of her diagnosis.

Supporting the clinical team at Boston Children's Hospital with regulatory consulting, toxicology and behavioral testing, bioanalysis, and drug product safety testing, we achieved for Mila what had never been done before: a novel drug treatment within a year of her diagnosis, and approved treatment for her just six weeks after the first trial.

Her family is on a mission to turn her incredible story into a new treatment path for children across hundreds of devastating diseases, and you can help. Check in at the Charles River booth (#839) at SOT to hear Mila’s story, and we’ll make a $5 donation on your behalf to Mila’s Miracle Foundation to Stop Batten. Let’s make a difference together.

Check out everystep.criver.com to learn more about Mila’s story or to make your own donation, please visit please visit Mila's Miracle Foundation.