Upcoming Events

Special Topics Module 4: Routes of Exposure–Inhalation

Abstract: Routes of Exposure–Inhalation
This presentation will begin with an overview of the anatomy, physiology, and function of the respiratory tract, including key species differences which should be considered when interpreting the results of animal inhalation toxicology studies for human risk assessment. Inhalation toxicology studies are technically very challenging; unlike other routes of exposure where the exact dose administered is known, for inhaled studies the given dose needs to be calculated based on a series of
measurements, calculations and assumptions. The design and conduct of these studies will be described including inhalation exposure systems for different species, inhalation devices and methods of aerosol generation for different physical forms of test substance (nebulizers, metered-dose inhalers and other dry powder generators), understanding and measuring inhaled dose and common toxicity findings (including irritation, inflammation and hyper/metaplasia). Finally, the use of inhaled toxicity study data for risk assessment will be discussed.

Modules are available for purchase individually or as a discounted set of six modules. Once the live module presentation concludes, registrants will have on-demand access to the modules for 30 days from the time each archive is first accessed. Each module is 90 minutes or fewer in duration.

Webinar registration is intended for single-person use only.

Signature Webinar: An Overview of Nonclin Considerations in Translating AAV Gene Therapies to Clinic

In this webinar speaker, Dr. Laura Dill Morton, DVM, PhD, DABT, DACVP, will present this free webinar titled "An Overview of Nonclinical Considerations in Translating AAV Gene Therapies to the Clinic."

Abstract: Adeno-associated viral vectors are currently the most commonly used vectors for gene editing and gene replacement approaches in both CNS and ocular indications. The first part of the presentation will cover case by case considerations for making decisions about nonclinical program design to enable clinical trials of AAV-mediated gene therapies. These will include communication with clinical team members; interactions with regulatory authorities; planning for formulation and delivery of test articles; planning for analytical methods to support toxicology studies; decisions about model selection and justification; dose selection; and study design. 

In the second part of the presentation, general regulatory expectations for nonclinical testing of a CRISPR-based gene editing therapeutic will be discussed, including expectations for evaluation of genotoxicity including off-target editing, characterization of gross chromosomal changes, and evaluation of tumorigenicity.

Special Topics Module 5: Routes of Exposure–Dermal

Abstract: Routes of Exposure–Dermal
The skin is the largest organ in the body by area, if not by weight, and is of great interest to toxicologists. In this presentation, we will consider the anatomy of the skin and topics such as metabolism, penetration of drugs, and toxicology and pharmacology, including the relationship between dermal drug application and systemic toxicity. The presentation will have a particular focus on drug delivery and aspects of purpose (not all dermally applied drugs are intended to have an effect
in the skin), formulation/dosage forms, penetration and kinetics. From a toxicological testing viewpoint, we will consider species selection (including selection of both non-rodent and rodent species in programme design strategies), and relevance to humans; study design and study performance will be discussed.

Modules are available for purchase individually or as a discounted set of six modules. Once the live module presentation concludes, registrants will have on-demand access to the modules for 30 days from the time each archive is first accessed. Each module is 90 minutes or fewer in duration.

Webinar registration is intended for single-person use only.

Toxicology for Pharmaceutical and Regulatory Scientists

This annual ACT course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. New this year, the course will include Cell and Gene Therapy. By popular demand, the course will include discussion of regulatory case studies and hands-on analyses of nonclinical data. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology.

Special Topics Module 6: Thresholds and Their Definition

Abstract: Thresholds and Their Definition
Characterizing and interpreting the dose response relationship is perhaps the most challenging task in health risk assessment. Toxicologists understand that “the dose makes the poison”, but the types of effects under consideration and the magnitude of their deviation from the “normal” range pose separate and appreciable challenges. In the context of EPA’s Reference Dose paradigm, some effects may not represent adverse changes; for other effects, some deviations, even if statistically significant,
have been interpreted to not represent biologically meaningful changes. Application of benchmark dose modeling allows risk assessors to estimate doses associated with predetermined levels of response, often 10% for non-cancer effects, 5% for developmentally toxic effects and 1% for cancer. These values and traditional NOAEL or LOAEL values may be used as point of departure (POD) values for determining risk. Whether defined in animals or humans in vivo, the POD is the “jumping off point” from which we depart from the realm of empirical dose response data and begin to
extrapolate the identified “point” to human exposure conditions that may differ relative to species, human population subgroup, exposure duration, and/or magnitude of effect. While the POD identified in vivo may (might, can) represent a threshold, the further that POD is extrapolated from the conditions under which it is identified, the less certain it becomes as a threshold (in fact, its name changes and its definition often acknowledges a potential range of uncertainty). The decisions surrounding what effect is selected as the critical effect, the acceptability of the study design employed to develop dose response data, the selection of the point of departure and the methods used to extrapolate the POD to the risk value each embody multiple considerations and decisions, carrying with them different levels of bias toward health conservatism – a condition which may not be fully acknowledged or appreciated. This presentation will explore aspects of risk value development focused on identifying and extrapolating the biological threshold for adversity.

Modules are available for purchase individually or as a discounted set of six modules. Once the live module presentation concludes, registrants will have on-demand access to the modules for 30 days from the time each archive is first accessed. Each module is 90 minutes or fewer in duration.

Webinar registration is intended for single-person use only.

Practical Reproductive and Developmental Toxicology

Co-Hosted with the Society for Birth Defects Research and Prevention

This joint ACT/BDRP course is designed to provide a basic understanding in reproductive and developmental biology and principles of various testing approaches for reproductive and developmental toxicology, with strong emphasis on the practical application of these principles and interpretation of nonclinical safety data as well as risk assessment. The intended audience for this course includes industrial and regulatory scientists, graduate students, and postdoctoral fellows.

Advanced Comprehensive Toxicology

This advanced course is a complement to the Toxicology for Pharmaceutical and Regulatory Scientists course. In this five-day intensive course, attendees will be provided detailed descriptions of principles of toxicology, effects of xenobiotics on organ systems, discussions of specific classes of toxicants, mechanisms of toxicity, risk assessment, and other contemporary toxicological concepts. The content of this course will provide information that may be helpful to those seeking certification in toxicology or to those seeking advanced training in toxicology.

More information will be provided on the ACT website once available.

ACT 42nd Annual Meeting

We invite you to attend the 42nd Annual Meeting, November 14–17, 2021, at the Gaylord National Harbor located along the Potomac River with views of the nation’s capital.

The 42nd Annual Meeting will include a wide-ranging scientific program with distinguished plenary speakers, the popular poster session reception, a welcome reception, an awards ceremony and luncheon, and numerous professional networking events. 

Registration and housing will open in March 2021. 

Join us and discover why the ACT Annual Meeting has become the preferred venue for practicing toxicologists.