The American College of Toxicology is a society of professionals from industry, government, and academia. The mission of the College is to educate, lead, and serve scientists by promoting an exchange of information and perspectives on safety assessment and new developments related to applied toxicology. The 40th Annual Meeting will include a wide-ranging scientific program, a welcome reception, the popular traditional poster session reception, an awards ceremony and luncheon, distinguished plenary speakers, and numerous professional networking events.
Charles River is proud to support ACT and our experts are presenting many sessions, CE courses, and posters.
Are you a student or a postdoc presenting a poster this year at ACT?
Submit your poster abstract for a chance to win $500 at this year’s meeting. Click below for the submission details.
Sponsor | Saturday November 16
Co-supported by Charles River
Continuing Education | CE5 | Sunday November 17, 8 – 11:30 am
Optimizing Toxicologic Pathology Data for Toxicologists: 10 Concepts with Recommended Practices
It is well known that successful preclinical safety assessment studies depend on reliable and accurate data, which usually include critical contributions from anatomic and clinical pathology. There are numerous pathology publications that provide insights and recommendations that reliably improve pathology data and overall study outcomes when implemented. This Continuing Education course will present 10 of the most important pathology-related concepts, with practical recommendations that toxicologists can utilize in their preclinical studies. These concepts include using recommended anatomic and clinical pathology study designs, communicating information with the study pathologist before the evaluation, understanding what constitutes a properly trained toxicologic pathologist, following recommended histopathology evaluation practices, appropriately determining the adversity of pathology data, using pathology diagnostic terminology that is globally harmonized and Standard for Exchange of Nonclinical Data (SEND) compliant, knowing when and when not to use pathology historical control data, implementing pathology quality control measures such as pathology peer review, and following recommended pathology reporting practices. This course will be presented by globally recognized toxicologic pathologists who have actively promoted and authored publications on these topics.
Continuing Education | CE7 | Sunday November 17, 1 – 4:30 pm
Safety Testing of Gene and Cell Therapy: Perspective from Industry, CROs, and Regulators
This Continuing Education course is intended to be an overview of the nonclinical testing practices and paradigms for gene and cell therapy products, with perspectives from industry, CROs, and the US FDA. Gene and cell therapies are emerging as important modalities to treat a variety of human diseases. Recent advances have led to important scientific breakthroughs including numerous successful approvals. The time is ripe to review basic concepts in gene and cell therapy, discuss technical approaches and unique analytical testing methods, provide an overview of nonclinical safety testing strategies and share the US FDA/CBER perspective on gene and cell therapies. This Continuing Education course is intended to be an overview of the nonclinical testing practices and paradigms for gene and cell therapy products, with perspectives from industry, CROs, and the US Food and Drug Administration.
Symposia 1 | Monday, November 18, 9 am – 12 pm
New Developments and Trends in Gene & Cell Therapy
Gene and cell therapy products are making strides in drug development, demonstrated by a rapidly growing number of such products in development and the recent approvals of products such as Kymriah®, Yescarta®, and Zolgensma®. Given the advancements and growing enthusiasm for these products, this symposium is focused on discussion of the latest hot topics and developing trends in the nonclinical safety assessment of gene and cell therapies. First, a case study of a genetically-modified cell therapy product will be presented to highlight strategies for the design and execution of a nonclinical program. Next, a framework for evaluating biodistribution and safety pharmacology of CRISPR/Cas9 gene-edited products will be discussed. Third, lessons learned from the development and approval of engineered T-cell therapies will be reviewed to shed light on the safe use and toxicity management of these products. Lastly, unique preclinical studies required to support clinical development of gene and cell therapies will be discussed.
Symposia 13 | Tuesday, November 19, 2 – 5 pm
Safety Pharmacology for Toxicologists: Incorporating Functional Endpoints into Toxicology Studies and Highlighting Proposals for Changes in Guideline Requirements
This session is designed by the board of the Safety Pharmacology Society to update toxicologists on the latest developments within the associated field of safety pharmacology. It focuses on the increased application and acceptance of functional endpoints within investigative and regulatory toxicology studies, but also the ongoing discussions into potential changes to regulatory guidelines in the future. Assessments of acute cardiovascular, neurofunctional, and respiratory systems (the ICH S7A “core battery”) are generally performed as stand-alone studies within the IND-enabling package supporting first-in-human administration. In recent years, safety pharmacologists have increasingly collaborated with toxicologists to incorporate these functional endpoints into toxicology studies, to provide additional information following repeat administration, or often to replace the stand-alone studies altogether. Presentations will provide information highlighting current industry practices for including cardiovascular and CNS (functional observational battery) endpoints into toxicology studies, along with tips for successful collaboration and potential drawbacks to consider. Further presentations will discuss the requirement and predictivity of safety pharmacology data, preparing for proposals to review and update ICH S7A/B Guidelines in the future. These include changes to cardiovascular data following the international CIPA initiative and the value of respiratory data, given the lack of translation to human clinical data. These topics will be presented for audience discussion in conjunction with regulatory feedback.
In Vitro Whole Blood Clotting Evaluation of Hemostasis Altering Compounds in Rat and Human Using the TEG 5000 Thrombelastograph System
A. Pinçon, J.E. McCartney, F.M. Poitout-Belissent; Charles River Laboratories Montreal ULC, Senneville, QC, Canada
Neuromuscular and Cardiac Deficits in Acid a-Glucosidase (GAA) Deficient Mouse Model of Pompe Disease
M. Eggers1, M. Harter2, D. Gauvin2, R. Pussinen3, J. Brassard4, J.J. Cunningham1
1Audentes Therapeutics, San Francisco, CA, USA, 2Charles River Laboratories, Mattawan, MI, USA, 3Charles River Laboratories, Kuopio, Finland, 4Jacqueline Brassard Toxicologic Pathology Consulting, Tustin, CA, USA
Effects of Intravenous or Subcutaneous Polysorbate 80 (Tween 80) in Telemetered Large Animals*
R. Tavcar1, C. Li1, E. Boulay1, S. Maghezzi1, I. Reeves2, M. Demers2, E. Gazaille2, S. Authier1
1Citoxlab, a Charles River Company, Laval, QC, Canada, 2Université de Montréal, St-Hyacinthe, QC, Canada
28-Day Somatic Gene Mutation Study of 1-Bromopropane in Female Big Blue Mice via Whole-Body Inhalation: Support for a Carcinogenic Threshold
J.T. Weinberg1, R.R. Young2, M.E. Stelljes3
1Charles River Laboratories, Ashland, OH, USA, 2MilliporeSigma, BioReliance Testing Services, Rockville, MD, USA, 3SLR International Corporation, Martinez, CA, USA
Model Characterization: Gamma Irradiation for Immunoconditioning Cell Therapy Toxicology and Tumorigenicity Studies in NOD/SCID/IL2Rγnull (NSG) Mice
F-H. Paradis, K. Wong, C. Li, R. Tavcar, S. Authier; Citoxlab, a Charles River Company, Laval, QC, Canada
Refinements to Intravenous Infusion Systems in Sprague Dawley Rats Aid in the Successful Outcome of a Complex Study Design
T.R. Gleason, A.J. Evans, J.L. Shaffer, J.D. Bultman; Charles River Laboratories, Ashland, OH, USA
Optimizing Intracecal Cannulation for Direct Administration in Rats
G. Iacono1, J. Douville1, B. Richard2, F. Emond1, C. Foucault1, M. Halle1, N. Hébert1
1Charles River Laboratories Montreal ULC, Senneville, QC, Canada, 2Progenity, Inc, San Diego, CA, USA
Development of a Large Animal Model for Combined Seizure and Cardiovascular Liability Assessment
N. Sadekova1, K. Norton1, J. Sessenwein1, M. Metea2, F. Emond1, C. Copeman1, E. Wachman1
1Charles River Laboratories Montreal ULC, Senneville, QC, Canada, 2Preclinical Electrophysiology Consulting, LLC, Boston, MA, USA
Refinement of Techniques for Cardiovascular Assessments on Repeat-Dose Toxicology Studies
K. Norton, N. Sadekova; Charles River Laboratories Montreal ULC, Senneville, QC, Canada
Microsampling Blood Collection Technique in Juvenile Rodent Studies
M. Felx, B. Heroux, K. Robinson; Charles River Laboratories Montreal ULC, Senneville, QC, Canada
Intra-articular Injection: Compartmental Dosing and Species Selection
T. McKinnon1, J. Douville1, J. Sweet2, M.M. Laffins3, A. Varela1, N. Doyle1
1Charles River Laboratories Montreal ULC, Senneville, QC, Canada, 2Charles River Laboratories, Mattawan, MI, USA, 3Charles River Laboratories, Reno, NV, USA
Using Pathology Findings to Improve Animal Welfare and Toxicology Study Quality
R.R. Hukkanen1, K.G. Nelson2, N. Dybdal3, P.V. Turner4
1Eisai, Inc., Cambridge, MA, USA, 2Charles River Laboratories, Mattawan, MI, USA, 3Genentech, South San Francisco, CA, USA, 4Charles River Laboratories, Wilmington, MA, USA
Characterization of a Proinflammatory Response in Large Animals Using a 17 Cytokine Multiplex Assay*
A-M. Downey, R. Genard, R. Riffon, C. Li, R. Tavcar, I. Boulay, S. Authier; Citoxlab, a Charles River Company, Laval, QC, Canada
Optimized Monitoring of Peripheral Neuropathy on Preclinical Studies
N. Sadekova, J. Douville, K. Norton, P-A. Robillard, G. Muhire, F. Goulet, L. Chouinard; Charles River Laboratories Montreal ULC, Senneville, QC, Canada
Development of a Challenge Model to Study the CD8-Specific Response in Large Animal*
C. Dumont1, R. Graveline1, M. Haida1, D. Poulin1, R. Samadfam1, S. Kronenberg2, F. Regenass2, M-S. Piche1
1Charles River Laboratories, Senneville, QC, Canada, 2F. Hoffmann-La Roche Ltd., Basel, Switzerland
Comparison of Single, Paired, and Group Housing on Cardiovascular Parameters and Body Temperature in Telemetered Large Animals*
P. Singh, S. Loriot, F. El Amrani-Callens, M-E. Duclos, R. Forster, A-I. El Amrani; Charles River Laboratories, Evreux, France
Interspecies Comparison of Embryo-Fetal Data among Control Groups of Sprague Dawley Rats, New Zealand White Rabbits, and Göttingen Minipigs
A. Parenteau1, F-H. Paradis1, A-M. Downey1, S. Ellemann-Laursen2, K. Hill3, P. Singh4, J. Hargitai5, R. Forster4, R. Tavcar1, S. Authier1
1Citoxlab, a Charles River Company, Laval, QC, Canada, 2Citoxlab, a Charles River Company, Ejby, Koge, Denmark, 3Citoxlab, a Charles River Company, Kansas City, KS, USA, 4Citoxlab, a Charles River Company, Evreux, Normandy, France, 5Citoxlab, a Charles River Company, Veszprem, Hungary
*Titles have been altered due to their sensitive nature.
Are you a student or postdoc who has submitted a poster at ACT?
Here’s your chance to win $500:
Charles River's Fast Facts Competition
Sunday, November 17 | 12:00 - 12:45 pm
Summarize your poster content on just one PowerPoint slide and present it to our panel of judges and fellow ACT attendees. You’ll have 2 minutes to share your work and win everyone over. Judging criteria:
• Presentation skills
• Subject matter knowledge
• Clarity of your results
• Impact of the research
• Enthusiasm and charisma
We’re limiting the field to just 25 contestants, giving you a great chance to win one of three top prizes. Charles River will award three talented students, postdocs, or new investigators with $500, $300, and $200 for 1st, 2nd, and 3rd place, respectively.
Up for the challenge? Send the title, authors, and abstract for your ACT poster to [email protected]. The deadline to submit is Friday, November 8.
Charles River is ready to help you with your toxicology testing needs. Our exceptional team of scientists regularly designs and performs safety programs ranging from acute through chronic toxicity and carcinogenicity studies. We also offer a broad range of animal models and numerous routes of administration. Stop by booth 312 to learn more or schedule a meeting with our specialists.