ToxChats©

In this episode of ToxChats, hosts Lauren Walker and Sarah Benjamin sit down with the groundbreaking Donald Ingber—visionary scientist, engineer, and Founding Director of the Wyss Institute. Dr. Ingber shares how his unique path through medicine, biology, and design converged to spark breakthroughs such as human Organ Chips—systems that are redefining toxicology, drug development, and disease mode...

In this episode, Tanya McDonnell and Hemraj Dodiya sit down with two highly regarded toxicologists, Ric Stanulis and Mary Ellen Cosenza, who transitioned from industry and currently work as consultants, either independently or within a consulting firm. During our time together we will explore what it really takes to build and sustain a consulting career to help you consider if consulting may be a...

In this episode, Aimee Altemus and Adelaide Frimpong speak with Dr. Gary Miller of Columbia University, a widely recognized leader in exposome research. Dr. Miller discusses how the exposome—the full spectrum of environmental exposures throughout a lifetime—is transforming our approach to human and environmental health. He highlights how exposomics, data science, and toxicology contribute to Next...

In this compelling ToxChats podcast episode, hosts Kristin DeSouza and Michael Dorato speak with renowned drug development scientist Richard DiMarchi as he shares his deep understanding into the art and science of mentorship within the biomedical research community. Drawing from decades of experience, Dr. DiMarchi explores the evolving nature of mentorship and its critical role in shaping the next...

Laid off—or worried you might be—and wondering what's next? In this episode, hosts Sunjay Sethi and Sarah Benjamin partner with the Early Career Professionals to demystify the post-layoff job search for early- to mid-career toxicologists. Kristin DeSouza and Terry Leyden are interviewed to talk about the hard stuff: quiet firing, the market that favors 10+ years’ experience or entry-level candidat...

This podcast episode is designed to offer listeners a discussion about the FDA’s evolving stance on animal testing and exploring thoughts on its potential phase-out for monoclonal antibody (mAb) therapies. Hosted by Zac Lloyd and featuring expert insights from Dr. Whitney Helms, Executive Director of Nonclinical Development, Large Molecule Discovery at Eli Lilly and Company, and Dr. Diann Blanset,...

In this episode, host Zac Lloyd engages with expert in the field Colleen Johnson to discuss critical considerations in designing in vivo nonclinical programs for dermal and topical products. Through this conversation we aim to enhance understanding of key aspects in this specialized area of toxicology.  This podcast is designed to offer listeners an introduction to dermal product drug development.

In this episode, we speak with Jean-Philippe Therrien, a senior director of R&D, to discuss critical considerations in designing nonclinical programs for dermal and topical products. Through this conversation, we aim to enhance understanding of key aspects in this specialized area of toxicology. This podcast offers listeners an introduction to dermal product drug development.

In this episode, Dr. Katie Sokolowski and Dr. Tanya McDonnell sit down with Dr. Jessica Graham, a leader in the fields of occupational toxicology and product quality. During our time together, we discuss the current science of safety assessment, focusing on worker safety (occupational toxicology) and patient safety as it relates to pharmaceutical product quality. Dr. Graham explains key concepts i...

In this podcast, Dr. Derek Leishman discusses the development of regulatory guidance (ICH and GLP) for safety pharmacology studies. He follows this discussion with a conversation about nonclinical data predicting clinical outcomes, as well as potential changes to future regulatory updates to ICH guidance.

This podcast is part of a series on the different career paths in the field of toxicology. In this episode, we interview Dr. Alex Eapen on his career path to his current position as the Director of R&D Scientific & Regulatory Affairs – North America at Cargill. Dr. Eapen shares his experiences as a toxicologist in the food industry and the exciting opportunities this job brings to positive...

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 modern nonanimal testing strategy utilized to bring...

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 toxicology.

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 volatile organic compounds, ultrafine particles, and me...

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. Schwartz's experiences as a corporate director a...

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 that informs the translation of risks to humans is a...

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 interactions, and the role of these mice moving forward. 

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 support one's professional and personal development. In...

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 tailored to be understood and enjoyed by a broad scienti...

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 rabbit data to other nonclinical species and humans. D...

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 as an alternative model in general toxicology studi...

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 podcast is the first in a series of several podcasts spo...

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 safety evaluation, explore novel aspects of biocompatib...

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 Mr. Leyden have complementary roles in the hiring p...

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 oligonucleotides face as a class of drugs.