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

 

 

Can My Research Continue? Simply, Yes.

In this unprecedented climate of change and uncertainty, we in the research community are faced with all new challenges. Now more than ever, we know our work must continue for the patients who are waiting for new therapies. That’s why our global network is prepared and equipped to help you reach your goals. SOT 2020 may have been cancelled, but scientific progress continues. Keep learning with our rich collection of poster downloads and recordings, and all new webinar content.

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Read more about our response to the COVID-19 pandemic and our business continuity plans.

 

Browse our SOT 2020 Resources

Download the Posters to access all of our SOT 2020 resources.

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28-Day Continuous Intravenous Infusion in Mice: Use of Externalized Magnetic Ports and Tethers to Achieve Study Endpoints and Enhance Animal Welfare

A Model for Evaluating Synergistic Opioid Induced Respiratory Depression

A New Approach Methodology for Assessment of Acute Respiratory Toxicity Using the MucilAir Airway Model In Vitro
Co-authored with The Lubrizol Corporation

Assessing Otic Toxicology: A Comparison of Administration Routes for Middle-Ear Dosing in Rats and Guinea Pigs

Watch the Poster Presentation!
Assessment of Mucociliary Clearance and Cilia Beating Frequency in MucilAir™-Cystic Fibrosis In Vitro

Blood Sampling for Clinical Pathology in Rats: Retro-Orbital Sinus Sampling versus Jugular Vein Sampling

Calculating Estrous Cycle Length versus Number of Estrous Cycles: A Comparison of Results Based on Nearly Thirty Years of Historical Control Data in the Sprague Dawley Rat

Cerebrospinal Administration in the Juvenile CD1 Mouse Using the Intracerebroventricular Route

Clinical Pathology and Histopathology Parameters in Juvenile and Adult Guinea Pigs: A Comparative Study
Co-authored with eXIthera Pharmaceuticals Inc.

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

Comparison of Historical Control Data in CD-1 Mice When Single vs Group-Housed and Considerations for Successful Group-Housing of Male Mice

Comparison of Two Intravenous Infusion Methods in Freely Moving Large Animals*

Demonstrability of an Enzyme-Linked Immunosorbent Assay to Simultaneously Quantify Histamine in Multiple Nonclinical Species and Matrices in a Single Analytical Run

Determination of Blood Pressure Liabilities through Assessment of Vessel Reactivity Using a Tissue Myograph System

Determination of the Normal Reference Levels of Plasma Cytokines in Healthy Large Animals*

Determining Genotoxic Potential and Mode-of-Action in a Mammalian Single Cell Assay

Development and Validation of a qPCR Assay for Human Cell Biodistribution Assessment in Rat Tissues
Co-Authored with KM Pharmaceutical Consulting LLC

Development of Strategies to Determine the In Vitro and Ex Vivo Induction of T4-glucuronidation in Different Species

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

Drug Induced Seizures: Considerations for the Underlying Molecular Mechanisms

Early De-Risking Approaches for Identification of Anti-Fibrotics for Idiopathic Pulmonary Fibrosis (IPF) Treatment

Watch the Poster Presentation!
Effects of Polysorbate 80 as a Vehicle: Large Animal Species Comparison*

Co-Authored with University of Montreal and Genentech

Electrophysiology Testing in Drug Development: Evaluation of Intracardiac Conduction Parameters in Large Animals*

Evaluation of the Carcinogenic Potential of Baclofen after Dose Titration in rasH2 Mice
Co-authored with Ethypharm SA, Saint Cloud, France

Feasibility of the Induction of Skin Blisters Using Negative Pressure Suction in Large Animals*

Historical Immunophenotyping Data in Pre-Clinical Species

Watch the Poster Presentation!
In Vitro Cell-Based Cytotoxicity and T-Cell Activation Assays to Assess Safety and Efficacy of Engineered T-Cell Therapies

Interchangeability of Mainland Southeast Asian Sourced Large Animals Based on Anatomic and Clinical Pathology Parameters*

Is Acidification of Urine a Preanalytical Requirement for the Measurement of Urine Calcium, Phosphorus and Magnesium in Nonclinical Studies?

Is it Hypertension or are You Just Excited to See Me?

LPS Challenge in Large Animals and Cytokine Multiplex Assay*

Neurobehavioral Assessments of Juvenile Male and Female Wistar Han IGS Rats, Hsd:Sprague Dawley SD Rats, and CD-1 IGS Mice

Novel In Vitro Skin Irritation Test Designed for Antimicrobial Cleaning Products Using The Phenion FT Human Skin Model
Co-authored with The Clorox Company; and Physicians Committee for Responsible Medicine

Optimization of UGT Inhibition Assays –Evaluation Of Substrate And Inhibitor Selectivities

Safety Evaluation of High Concentration of Live Bacteria on Models with Compromised Physiological Barriers
Co-Authored with Servatus Biopharmaceuticals

Spontaneous Incidence of Infrequent Neurological Clinical Signs across Species: A Retrospective Analysis

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.

Threshold for Anaphylactoid Reaction to Polysorbate-80 in Large Animals*
Co-Authored with Amgen

Thymic Lymphomas in a Six-Month CByB6F1/Tg rasH2 Carcinogenicity Study with a RORãt Inverse Agonist, BMS-986251
Co-authored with Bristol-Myers Squibb Company

Use of Extended One-Generation Reproductive Toxicology Studies in Safety Assessments under REACH Regulations

Watch the Poster Presentation!
Using Deep Learning Artificial Intelligence (AI) Algorithms to Verify N-nitroso-N-methylurea (NMU) and Urethane Positive Control Proliferative Changes in Tg-rasH2 Mouse Carcinogenicity Studies
Co-authored with Deciphex

Validation of a 14-Color Flow Cytometry Panel for GLP-Compliant Blood Cell Subpopulation Analyses in the Large Animal*

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

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Live Webinar | May 5, 2020
Navigating SEND Requirements and Understanding the Role of the Technical Rejection Criteria

Live Webinar | May 21, 2020 - Registration coming soon!
Dietary Exposure in Rabbits is a Relevant Route of Exposure for Chemicals and Pesticides

On Demand Webinar
Interchangeability of Southeast Asian Sourced Large Animals and Managing Supply

On Demand Webinar
Unpacking the ERA Guideline Revisions

On Demand Webinar | Coming this November
Tools and Strategies to Predict Unwanted Immunotoxicities Throughout the Drug Development Phases

Interchangeability of Southeast Asian Sourced Large Animals and Managing Supply

Elaine Debien, DVM, MSc, DACVP
Senior Veterinary Pathologist

Headshot of Elaine Debien, DVM, MSc, DACVP.Elaine Debien received her DVM from the University of Montreal, Canada. After a short period in practice (small animals and meat hygiene/animal health), Dr. Debien pursued her interest in anatomic pathology with a residency and a master’s degree, both completed at the University of Montreal. Board-certified by the American College of Veterinary Pathologists (ACVP) in anatomic pathology, Dr. Debien is now one of the lead pathologists at our Sherbrooke site, with interest and expertise in intrathecal toxicity studies in large animals and carcinogenicity studies in transgenic mice.


Interchangeability of Southeast Asian Sourced Large Animals and Managing Supply

Angela L. Wilcox, BVSc, MS, DACVP, DABT
Scientific Director, Clinical Pathology

Headshot of Angela L. Wilcox, BVSc, MS, DACVP, DABT.Based in our Nevada facility, Dr. Wilcox primarily interprets complex data sets for GLP and investigative nonclinical toxicology studies in large animals, minipig, rat, and mouse. Overseeing the clinical pathology laboratory and biomarker and instrument validations, she is keenly interested in biomarkers of inflammation and microscopic evaluation of bone marrow. Angela received her veterinary degree (BVSc, First Class Honors) from the University of Queensland in Brisbane, Australia and later completed a clinical pathology residency and master’s degree in veterinary pathology at Texas A & M University. She is board-certified in clinical pathology (DACVP) and toxicology (DABT). She has been a reviewer for Veterinary Clinical Pathology and Toxicologic Pathology and is published in multiple peer-reviewed journals. Dr. Wilcox served as President of the Toxicologic and Exploratory Pathology Specialty Section of SOT, as a member of the Education Committee of STP, and has presented at multiple national meetings.


Interchangeability of Southeast Asian Sourced Large Animals and Managing Supply

Candace Heining
Senior Director Global Large Animal Supply, Demand and Logistics

Headshot of Candace Heining.Candace has been working in the preclinical research industry and large animal supply for over 20 years. As director of client services and supply chain for rabbits, canines and large animals at Covance, she pursued her passion for developing solutions to help clients meet their large animal demands, managing up to 39 client-owned large animal breeding, maturation and overseas colonies. During this time, she led the establishment of a formal behavior and enrichment program, created the “Colony Connection” web portal, allowing clients to track their colony data on a real-time basis, and built a team of large animal experts to support managing over 15,000 animals across multiple sites. Candace spent extensive time furthering her knowledge of successful large animal breeding in positions at Noveprim Group Ltd., an organization that consistently sets the industry bar for breeding efficiency by implementing improvements that support the natural behaviors of large animals. She continues to work closely with the Noveprim team to share best practices. Joining Charles River in 2018, she currently manages our large animal supply, including our two quarantine and holding locations in Houston and Frederick, and oversight of the partnered quarantine location in Camarney, Spain. Candace also manages our joint venture breeding farm in Mauritius and Haikou, Hainan, China and oversees our network of contract farms through robust physical audits conducted at regular intervals. Working closely with a team of large animal experts, she ensures that our supply chain is the most reliable in the industry.


Mastering qPCR for Biodistribution and Shedding Studies of Cell & Gene Therapies

Philippe Ancian, PhD
Director, Biomarkers

Headshot of Philippe Ancian, PhD.Dr. Ancian has spent the last 20 years in the pharma, biotech and CRO industries where he has implemented and monitored biomarker analyses at the discovery, preclinical and clinical stages with expertise in specialized genomics and proteomics platforms. He holds a PhD in molecular and cellular biology from Nice University as well as an engineering degree in chemistry from the National School of Chemistry of Montpellier, France. Philippe is passionate about advanced therapies, in particular cell and gene therapies.


Mastering qPCR for Biodistribution and Shedding Studies of Cell & Gene Therapies

Milena Blaga, MSc
Study Director, Immunobiology

Headshot of Milena Blaga, MSc.Milena specializes in applications of quantitative polymerase chain reaction (qPCR) such as biodistribution, shedding, and biomarker and gene expression (PD) investigations for the development of advanced therapies. Milena plays a crucial role in guiding clients’ analytical assay design and validation from a scientific and regulatory perspective.


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.

Mila’s Story

Mila was diagnosed in January 2017 with Batten disease, a rare genetic disorder caused by mutations that lead fat to accumulation in nerves and brain cells. Her strain was found to be 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 personalized medicine within a year of her diagnosis, and regulatory approval 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. Our plans to raise awareness of their cause will not be deterred. In addition to our $1500 donation to MIla's Miracle Foundation on behalf of all SOT attendees, we urge you to visit everystep.criver.com to learn more about this remarkable young girl and what her treatment means for the future of drug development.

To make your own donation, please visit please visit Mila's Miracle Foundation.

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