ToxChats©

One of the most common misconceptions about the opioid crisis is that it only affects people with a long history of drug abuse. Today, more than ever, a more diverse population is affected, potentially due to illicit fentanyl on the black market. In this ACT ToxChats© podcast, joined by Dr. Richard C. Dart of the Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority, we discu...

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes Coronavirus Disease 2019 (COVID-19), Multisystem Inflammatory Syndrome in Children (MIS-C), Adults (MIS-A), Neonates (MIS-N), and some Vaccinees (MIS-V). These are all considered clinically distinct diseases; however, the MIS-X diseases have overlapping symptoms and treatments with Kawasaki Disease (KD). MIS-C, MIS-A, MIS-N, a...

The severity of COVID-19 varies by individual spanning from asymptomatic, mild, moderate, severe, critical, and chronic disease. Prior to the availability of vaccines, high antibody titers correlated with disease severity. This was also observed for SARS disease. These high antibody titers on initial infections result from memory B cell responses with cross-reactive antibody responses from previou...

Dr. Thomas Hartung is a Professor at Johns Hopkins University and University of Konstanz in Germany, as well as the Director of the Center for Alternatives to Animal Testing. Dr. Sushant Kamath is a Senior Manager of Risk Assessment at Abbott Healthcare. In this podcast, Drs. Hartung and Kamath give a high level overview of the history and evolution of artificial intelligence (AI), different model...

Dr. Cynthia Rohde is a Research Fellow at Pfizer, Pearl River, New York. As a drug safety representative on various project teams, she is responsible for developing and implementing nonclinical safety strategies for oncology products and vaccines. In this podcast, Dr. Rohde gives a high-level overview of the history and benefits of vaccines, and how they work. She then dives into innovative mRNA v...

In this interview, course organizers and experts in the field, Drs. Bill Brock and Mary Beth Genter share an overview of the annual ACT Advanced Comprehensive Toxicology Course. In 2022, a new hybrid format will be offered, as an added benefit to candidates preparing to sit for the ABT Certification Exam. The interview covers test taking tips, and Dr. Brock and Dr. Genter discuss how the DABT cert...

As you advance in your scientific career, you may have the opportunity to transition from the bench to a project or people management role. This transition may be exciting but can also come with its own set of challenges. You may find that the skills that made you a successful bench scientist differ from those required to effectively manage large projects or direct reports. Luckily, this change ca...

The idea behind gene therapy is to introduce, remove, or change a portion of person’s genetic code in order to cure a disease. Several gene therapy products are currently under development and there are two FDA-approved in vivo products, both using adeno-associated virus (AAV) vector gene delivery. Both of these treatments provide a functional copy of a gene that is not functioning properly in ord...

In this episode of ToxChats, Dr. Daniel Rudmann, an ACVP board-certified investigative and toxicologic pathologist and translational medicine scientist with over 20 years of experience in drug discovery and development and current director of digital pathology at Charles River Laboratories, is interviewed. Dr. Rudmann discusses how advances in digital pathology and machine learning are improving t...

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. To expedite the evaluation of new drugs and review of marketing applications for drugs addressing unmet medical needs for p...

The toxicology salary survey began in 1988 to provide the profession with accurate salary information. Since then, the survey has continued to collect information on toxicology salary and employment conditions with results published once every three years. Over its 30-year span the survey has been modified to capture the most relevant data at the time of each iteration. Survey questions query info...

Drug development targeted at pediatric populations has been the subject of a great deal of careful thought and effort by clinical and nonclinical scientists and regulators over the past 25 years. In this podcast, Dr. Judith “Judy” Henck, who is a consulting toxicologist with over 30 years of experience in the pharmaceutical industry, will be interviewed. Dr. Henck's areas of scientific expertise i...

(CAR)T cells, also known as chimeric antigen receptor T cells, have transformed the landscape of cancer treatment. Instead of a standard chemotherapy, CAR-T treatment involves taking a patient's blood cells, engineering them in a lab to specifically attack cancer cells, and then injecting them back in the patient. The advent of in silico and in vitro has propelled our understanding of cancer biolo...

Drs. Lisa Plitnick and Alan Stokes recently presented an ACT Signature Webinar titled “History and Risk Assessment of Vaccines: A Practical Perspective from an Immunologist and a Toxicologist.” In this podcast, Drs. Lisa Plitnick and Alan Stokes will continue to answer questions from the webinar audience including questions on vaccine development, nonclinical study design, dose selection and extra...

In this episode, Dr. Nicholas Ponzio, master educator and professor of pathology, immunology, and laboratory medicine at Rutgers University's New Jersey Medical School and School of Graduate Studies and co-founder of the Rutgers Science Communication Initiative was interviewed. Dr. Ponzio discusses how he and his colleagues teach budding scientists how to communicate their cutting-edge research in...

Dr. Thomas Hartung, is a professor at Johns Hopkins University and Director of the Center for Alternatives to Animal Testing. Dr. Hartung discusses some of his innovative contributions to the field of toxicology including developing advanced computer modeling systems using big data analyzed by artificial intelligence used to predict toxicity of novel compounds. Dr. Hartung gives a general overview...

In this episode, Dr. Doug Learn, Director of Toxicology at Charles River Safety Assessment in Horsham, Pennsylvania, was interviewed. Dr. Learn is considered an expert in the field of phototoxicity. In this podcast, Dr. Learn shares his experiences during the evolution of how phototoxicity became a specialty field of its own, what phototoxicity means for toxicologists in the regulatory and pharmac...

In this interview, during the ACT 40th anniversary Annual Meeting in Phoenix, Arizona, plenary speaker Dr. Alessio Fasano highlights the exciting advancements and future outlooks of gastrointestinal (GI) tract health and medicine. Covering a range of topics from diet, microbiome, and personal medicine, this podcast provides detailed perspectives from one of the leading experts in the field.

In this episode, Dr. Armaghan Emami, a toxicologist with the Center for Drug Evaluation and Research at the US FDA and 2019 award winner of Best Paper Published in International Journal of Toxicology for her first-author publication, "Toxicology Evaluation of Drugs Administered via Uncommon Routes: Intranasal, Intraocular, Intrathecal/Intraspinal, and Intra-Articular" was interviewed. Dr. Emami di...

Dr. Jacob Corn, ACT’s 2015 Plenary Lecturer, is a Professor of Genome Biology at the Swiss Federal Institute of Technology in Zurich. The Corn Laboratory develops next-generation genome editing and regulation technologies for fundamental biological discovery and to develop potential therapies for human genetic diseases. In this episode, he will describe how CRISPR may impact the treatment of rare...

In this two-chapter episode, in vitro and alternative models for regulatory submissions were explored from both an industry and government perspective. In the first chapter, Dr. Clive Roper, the head of In Vitro Sciences at Charles River Laboratories, and Dr. Lauren Black, a senior scientific advisor at Charles River Laboratories discuss the current landscape of in vitro and alternative models and...

In this episode, Dr. Arianne Motter, a toxicologist with the Center for Drug Evaluation and Research at the US Food and Drug Administration, discusses the complex regulation of e-cigarettes at the FDA and the issues that toxicologists face when evaluating the potential these products have to reduce harm and the risk of tobacco-related disease. At the time of recording, Dr. Motter was a toxicologis...

In this episode of ToxChats, the opioid epidemic was discussed from a preclinical drug development perspective with Dr. Carrie Blum, Associate Director, Toxicology at Sunovion Pharmaceuticals and Dr. Mary Jeanne Kallman, VP and consultant at her own company Kallman Preclinical Consulting LLC. Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not ne...

The role of biomarkers and their qualification in nonclinical and clinical development is discussed with Dr. William Mattes. Dr. Mattes is Director of the Division of Systems Biology, part of the FDA’s National Center for Toxicological Research in Jefferson, Arkansas. Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not necessarily reflect the off...

Dr. Rodney Dietert has authored a number of books on the immune system and extensively published on the topics of noncommunicable diseases, immune dysfunction, and the microbiome. His latest book is titled “The Human Superorganism: How the Microbiome is Revolutionizing the Pursuit of a Healthy Life.” In this podcast, Dr. Dietert discusses the microbiome in the context of nonclinical development of...