ToxChats©

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 good fit for you in your next career and how to get started. Our guests share insights on managing diverse client expectations, balancing unpredictable workloads, and leveraging the tools, soft skills, and business structures that keep practice running smoothly.

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 generation of innovators. Richard DiMarchi shares powerful insights on setting clear expectations in mentor-mentee relationships, delivering constructive criticism with both empathy and precision, and speaking truth to power with integrity and professionalism. The conversation explores how mentorship is a two-way street—where learning flows in both directions and adapting mentorship styles to meet the diverse needs of mentees, as well as building confidence and resilience in emerging scientists, preparing them to lead with both competence and compassion.

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, consultant at Akkeri, Inc., this roundtable-style discussion unpacks the scientific, ethical, and regulatory implications of this paradigm shift. Whether you're deep in the biologics pipeline or navigating the changing CRO landscape, this episode offers valuable perspectives on what the future may hold—and how to prepare for it.

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 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.

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 a nonequine-derived antitoxin as a therapeutic product to a patient.

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 metal oxides, which could potentially pose health risks to users. Of significant concern is the potential harm to children, who may be disproportionately affected due to uncontrolled exposure to ultrafine particles in confined spaces, such as classrooms and libraries. Dr. Kyle Mandler comprehensively addresses the characteristics and human health effects of these FFF 3D printer emissions and propose effective recommendations for mitigating exposure to these emissions.

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 an area of intense interest among drug developers and regulators. A Continuing Education course was held at the 2022 ACT Annual Meeting in Denver, Colorado, where Dr. Delatte presented on identifying seizure liability in nonclinical studies. In this interview with Dr. Delatte, we discuss nonclinical findings that are indicative of seizure liability and appropriate approaches to characterize risks. Many drug classes carry seizure liability which may trigger preliminary studies, such as kindling studies, to understand risks prior to conducting a repeat-dose toxicology study. A description of premonitory signs of seizure in dose-range findings and repeat-dose toxicology studies is also discussed. Finally, this talk briefly discusses when nonclinical EEG studies are warranted and how to leverage the data from general toxicology studies to design an informative EEG study. Learning objectives of this talk are: (1) set up a drug development program for drugs in a class with seizure liability; (2) identify seizure liability in nonclinical studies; and (3) examine the elements from general toxicology studies that inform the pivotal EEG study.

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 this ToxChats© episode, we interview Dr. Lorrene Buckley, Vice President at Eli Lilly & Company. Dr. Buckley is a board-certified toxicologist with over 30 years of experience in the practice of toxicology. In her current position, she is responsible for the design and execution of a nonclinical safety program and global regulatory submissions and interactions of drugs in the development and commercialization phases. Her mentorship of early and late-stage professionals is an important contribution to the success and growth of toxicologists in our field. For this professional development podcast, Dr. Buckley discusses the importance of identifying an appropriate sponsor to support your growth and success in the workplace.

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. Dr. Elise Lewis is currently the Principal Director of Toxicology at Charles River Laboratories and has significant experience in reproductive, developmental, and juvenile toxicology.

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 sponsored by ACT, in which experts in the industry are interviewed about their experiences working with these nontraditional models.

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 process for toxicologists in the biopharmaceutical industry. Dr. Steeves is a Senior Director of Toxicology and hiring manager at Eli Lilly and Mr. Leyden is a Certified Personnel Consultant and President of The Leyden Group, a Colorado-based professional recruiting and search firm. This podcast is of interest for toxicologists at all career stages, with a specific focus on trainees and early career professionals and is presented by the ACT Early Career Professional Subcommittee.