Not every drug that has reached human clinical trials has needed preliminary nonclinical studies to demonstrate safety. This podcast episode is a case study for replacing the use of animals during the safety testing that occurs prior to human clinical trials, in which our guest speaker reviews conversations with regulatory authorities regarding a m…

This ToxChats© episode is part of a series on the different career paths in the field of toxicology. In this episode, we interview Dr. Marcus Delatte on his career path to his current position as the Vice President of Regulatory Strategy at the consulting company, Allucent. Dr. Delatte also shares his experiences as a pharmaceutical consultant in t…

In this podcast, recent findings from toxicological studies on the emissions produced during fused filament fabrication (FFF) 3D printing are discussed. The use of low-cost FFF 3D printers is on the rise in households, businesses, and educational settings, enabling the creation of 3D objects from digital models. However, this process releases volat…

This podcast is part of a series on different career paths in the field of toxicology. In this episode, Dr. Chuck Schwartz, PhD, DABT, shares the career path that led to his current position as the principal consulting toxicologist and managing member of a consulting practice that specializes in the fields of occupational and quality toxicology. Dr…

Drug-induced seizures are a major concern for central nervous system active pharmaceuticals during development. Currently, there are no guidelines for interrogating and mitigating seizure liability associated with new pharmaceuticals. Because of the risks to patient safety during clinical trials, the understanding of nonclinical characterization th…

In this ToxChats© podcast, we spoke with Dr. René Meisner, Head of Safety Assessment at Denali Therapeutics, on using both transgenic and disease mouse models in a drug development program. Topics include considerations for program design, regulatory interactions, and the role of these mice moving forward. s for program design, regulatory interacti…

Mentors meet with you, listen to you, and provide advice. Sponsors have influence, connections, and can speak to your talents, abilities, and potential in new opportunities. Learning how to distinguish between the two and identify a sponsor that can help support your key growth and access to future opportunities is a critical skill needed to suppor…

In this podcast, Dr. Tetyana Cheairs gives a detailed overview of the fertilized egg model and how it is currently being used in safety assessment studies. She then describes important ways in which toxicologists and drug development programs could benefit from utilizing the fertilized egg model. This podcast is incredibly informative and is tailor…

In this ToxChats© podcast, Dr. Elise Lewis provides a thorough background on the use of rabbits in DART and the future direction of their use as alternative species for other types of nonclinical safety studies. Topics include advantages and challenges, sourcing, behavior, physiology, and the practicality of rabbits, and the translatability of rabb…

In this ToxChats© episode, we interview Dr. Chris Christou, Director of Preclinical Imaging and Research Laboratories at the South Australian Health and Medical Research Institute. Dr. Christou discusses the history of sheep as a preclinical species for medical device testing, novel groundbreaking neurological disease models, and the use of sheep a…

During the COVID-19 pandemic, there was a reduction in the availability of nonhuman primates available for conducting nonclinical toxicity assessments, and as a result, the FDA released a guidance in 2022. This sparked interest in evaluating the feasibility of performing safety studies with alternative nonrodent species or other models. This podcas…

In this ACT ToxChats© episode, Dr. Shayne Gad and Samantha Gad of Gad Consulting Services host a question and answer follow-up discussion to the ACT Signature Webinar, The Role of Chemical Characterization in Biological Risk Evaluation of Medical Devices. During the first part of the podcast, they discuss diverse medical device categories for safet…

In this ACT ToxChats© episode, Dr. Meredith Steeves and Mr. Terry Leyden share their perspectives on the current hiring landscape for toxicologist roles in industry, how to find the right fit, tips for transitioning from a bench-based position, and how to prepare for and successfully navigate the interview and negotiation process. Dr. Steeves and M…

In this new ACT ToxChats© episode, Dr. Jeffrey Foy, Vice President of Toxicology at Pepgen and Dr. Scott Henry, Vice President of Nonclinical Development at Ionis Pharmaceuticals are interviewed. Drs. Foy and Henry discuss the past, present, and future of oligonucleotides. Their focus is discussing the development and challenges that oligonucleotid…

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 Safe…

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 …

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 w…

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 evolutio…

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 ho…

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 …

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 p…

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…

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 digi…

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 applicati…

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 t…

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 interv…

(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 vit…

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, …

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…

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 nov…

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 mea…

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 fr…

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, …

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 des…

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 curren…

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 t…

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 pod…

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 gue…

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 micro…

Oligonucleotide therapeutics are all medications that utilize RNA- or DNA-based techniques as the effective entity. The nonclinical development of these therapeutics presents unique challenges and these are discussed here with Drs. Sven Korte from Covance, Brian Vuillemenot from Genentech and Scott Henry from Ionis Pharmaceuticals, all experts in o…