American College of Toxicology (ACT) Annual Meeting

American College of Toxicology Annual Meeting attendee using laptop

Although this year’s American College of Toxicology (ACT) Annual Meeting was virtual, our experts presented several continuing education sessions, symposiums, exhibitor sessions, and posters throughout the week.

In case you missed any of these presentations at ACT and wonder if they’re available on demand, the answer is Simply, Yes. Explore our resources to download presentations, poster recordings, and other content from ACT.

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Fill out the form to the right to download our poster resources from the 2020 ACT annual meeting.

 

Charles River Exhibitor Hosted Session

In Vitro Phenotypic Screening Approaches to Assess Mode of Action and Organ Specific Toxicity | Jeffrey Haskins, Executive Director of Global In Vitro Tox

 

Poster Presentations

Spontaneous Incidence of Infrequent Neurological Clinical Signs Across Species: A Retrospective Analysis | Cristina Ballesteros, Research Scientist
Exploring Immunoconditioning Regimens for Cell Therapies in Murine Models for Toxicology Studies | Christian Li, Director, Toxicology
Building a Seizure Testing Strategy in Toxicology: Considerations for Molecular Mechanisms | Simon Authier, Senior Director, Scientific Operations and Veterinary Services
Optimization of an Indirect Ventricular Contractility Assessments: Heart Rate Correction of the QA Interval | Robert Tavcar, Senior Director of Toxicology
A Comparison of Historical Control Data from Cynomolgus Macaques of Chinese, Cambodian, and Vietnamese Origin | Michael Caruso, Research Scientist
The Göttingen Minipig as a Model for Skin Immunology | Linda Allais, Director, Scientific Operations
Critical Success Factors (CSFs) in the Safety Assessment of COVID-19 Vaccines | Nathalie Truchot-Limonne Principal Research Scientist
Consideration of Species Selection, Ocular Route of Administration and Analytical Support for Ocular Safety Studies | Pramila Singh, Senior Director of Toxicology
Evaluation of Evoked and Non-evoked Pain Endpoints in the Complete Freund's Adjuvant (CFA) Pain Model in Rat | Harunor Rashid, Principal Research Scientist, In Vivo Pharmacology

Our scientists were pleased to present in the following engagements during the ACT Annual meeting. Contact us should you want to explore any of these topics further, and we would be happy to put you in contact with the presenter.

Continuing Education

CE01-1: Practical Considerations in Experimental Design for In Vivo Studies - The Use of In Silico and In Vitro Toxicology Data for the First In Vivo Study | Bennett J. Varsho, Associate Director of Toxicology

When assigned to complete their first in vivo toxicology study or studies, toxicologists sometimes do not know where to start the study design. This course will feature experts who will address this issue by discussing experimental study design for in vivo studies, including case studies (the good, the bad, and the ugly).The course will begin by discussing how to utilize in silico and in vitro data for first-in-use animal studies. What can be gleaned from these data? A pharmacokinetic/toxicokinetic (PK/TK) scientist will present best practices on PK/TK study design and how to utilize the data from a PK/TK study for future in vivo studies. Two further presentations will focus on long-term in vivo studies in multiple species and DART/juvenile toxicology studies.

CE01-4: Practical Considerations in the Design of In Vivo Reproductive, Developmental, and Juvenile Toxicity Studies: Meeting the ICH S5 (R3) and S11 Guidelines | Alan Hoberman, Executive Director, Global Developmental and Reproductive Toxicity

Symposia and Workshops

Workshop 8 - Pharmaceuticals and Lactation: Nonclinical Lactational Study Designs | Pragati Coder, Director, Developmental and Reproductive Toxicology

Evaluating the safety of pharmaceutical products used during lactation is a topic that has garnered substantial interest over the last several years. Although driven primarily by the implementation of the US Food and Drug Administration (US FDA) Pregnancy and Lactation Labeling Rule (PLLR), which provides requirements for the content and format of labeling for human prescription drug and biological products that may be used during lactation, this has also been a topic of recent discussions related to proposed updates to ICH S5(R3). Pharmaceutical labeling communicates important information, allowing for the safe and effective use of approved products in patients, with the PLLR providing specific requirements for the labeling of pharmaceuticals that may be used during lactation (in Section 8.2) in regard to (1) the presence or absence of the drug in milk; (2) the known or predicted effects on the breastfed child from drug exposure through milk; and (3) the effects of the drug on milk production. The extent to which animal data can or cannot inform human risk assessment in these three areas has been a topic for considerable debate. This Workshop will begin by providing an overview of lactational physiology and mechanisms of drug excretion into milk (focusing on similarities and differences between humans and animals used for toxicologic assessment) as well as lactational study designs. The Workshop will also provide perspective and discussion on the usefulness of animal lactation–related data for human risk assessment purposes, as well as considerations for communicating risk in the US prescribing information (USPI).

Symposium 13 - New Era of Drug Development: Will Physiologically Based Pharmocokinetic (PBPK) Modeling Software and Applications Replace the Scientist and the Model?

Session Chairs: Laura Lotfi, Research Scientist, and Julie Douville, Director, IPN

Computational and artificial intelligence (AI) tools for predicting toxicity have been envisaged for their considerably high impact on the rate of compound discovery and lead candidate selection in drug research and development. The pharmaceutical and biotech industry as well as Contract Research Organizations (CROs) supporting these programs are in constant search of novel approaches to accelerate transition of drug molecules from laboratory benches to patients. It has been shown that robust tools and sophisticated system algorithms can be exhaustively applied to optimize detection of early safety endpoints to aid in determination of first-in-human dose. One of the various AI approaches that can be used to assist with regulatory communications, impacting clinical decisions and reducing the number of animal models used at these stages, is physiologically based pharmacokinetic (PBPK) modeling. Related publications and regulatory submissions have risen dramatically in recent years. This Symposium will provide attendees with an update on the cutting-edge applications in PBPK and related predicting software and present strategies for implementing PBPK and intelligent modeling in the program design of a drug candidate. It will also highlight considerations and challenges in regulatory submissions and risk assessments. Topics will include an introduction to use of PBPK in drug research, the perspective of regulatory authorities on the validation of such a technology, and successes and challenges in Investigational New Drug (IND) application submissions using this technology, focusing on case-based examples.

Symposium 14 - Juvenile Bone Toxicity: Study Considerations, Regulations, and Techniques for Assessment | Aurore Varela, Director, Musculoskeletal Research and Imaging

This Symposium will focus on juvenile bone toxicity, i.e., the design of juvenile animal studies to adequately assess bone toxicity, the usefulness of biomarkers, the imaging modalities to assess bone structure, the interpretation of the significance of bone effects, and relevant regulatory issues. The first speaker will cover study design and interpretation of the data in the context of ICH Guidelines. The second speaker will address in depth how micro-CT applications can be used to evaluate skeletal elements and bone growth in embryo-fetal development (EFD) and pre- and postnatal development (PPND) studies as well as juvenile toxicology studies, while the third speaker will describe the various tools that can be used to monitor bone toxicity, healing, and remodeling, and how they relate to or drive study design. A regulatory perspective on the assessment of juvenile bone toxicity and the potential concerns about adverse skeletal effects in the pediatric population will be presented by the fourth speaker.

Charles River Exhibitor Hosted Session

In Vitro Phenotypic Screening Approaches to Assess Mode of Action and Organ Specific Toxicity | Jeffrey Haskins, Executive Director of Global In Vitro Tox

Phenotypic screening approaches have proven to be extremely valuable tools for small-molecule drug discovery. Recent technology advances are enabling development of a new range of phenotypic models for in vitro toxicity assessment, including evaluations of mode of action (MoA) and supporting the development of highly predictive organ specific toxicity platforms.

Current Trends in Toxicology video thumbnail.

Current Trends in Toxicology

Eureka gathered three of Charles River's tox experts, Shawna Jackman, PhD, Senior Principal Scientist and an expert in cellular therapies, Mike Templin, PhD, a Director of Scientific Advisory Services and Jeff Haskins, PhD, Executive Director of Global In Vitro Toxicology to chat about cell and gene therapy, predictive toxicology and IND-enabling studies and how their work has been colored by the pandemic.
Watch the Interview

Linda Allais head shot
Linda Allais
Director, Scientific Operations

Simon Authier head shot
Simon Authier, DVM, MSc, MBA, PhD, DSP
Senior Director of Scientific Operations and Veterinary Science

 

Cristina Ballesteros head shot
Cristina Ballesteros
Study Director

 

Michael Caruso, PhD
Study Director, General Toxicology

 

Pragati Coder head shot
Pragati Coder, PhD, DABT
Director DART

Alan Hoberman head shot
Alan Hoberman, PhD
Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology

 

Christian Li head shot
Christian Li
Director, Study Management

Pramila Singh head shot
Pramila Singh, PhD, DABT
Senior Director of Toxicology

 

Robert Tavcar head shot
Robert Tavcar, BSc, DABT
Senior Director of Toxicology

Aurore Varela head shot
Aurore Varela, DVM, MSc, DABT
Director, Musculoskeletal Research & Imaging

 

 

Bennett Varsho head shot
Bennett Varsho, BS, MPH, DABT
Associate Director of Toxicology

 
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Safety Pharmacology Society (SPS) Annual Meeting 2020
Charles River was proud to support the 2020 SPS Virtual Meeting and SPS Virtual Networking Event. In case you missed us at our virtual booth or want to view our posters, online copies and on-demand recordings are now available for download.
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