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The American College of Toxicology podcast program, ToxChats ©, reports on cutting-edge news in toxicological research from around the globe.
Discussions on Identifying Seizures Liability in Nonclinical Studies
1 JUL 2024 · 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.
Alternative and Nontraditional Species Series: The Use of Transgenic and Disease Mouse Animal Models for Toxicology Studies
6 MAY 2024 · 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.
Identifying an Appropriate Sponsor to Support Your Growth and Success in the Workplace
4 MAR 2024 · 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.
Alternative and Nontraditional Species Series: Fertilized Egg Model as an Alternative Species for Safety Assessment Studies
29 JAN 2024 · 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 scientific audience. Dr. Cheairs is an Assistant Professor of Pathology, Microbiology, and Immunology at New York Medical College, where she leads an innovative research program focused on using nonanimal models to study the hazardous effects of chemicals. As a result of her active involvement in teaching activities, she was appointed as Assistant Dean for PhD Programs at the Graduate School of Biomedical Sciences in 2019.
Alternative and Nontraditional Species Series: Advantages and Challenges of Using Rabbits
22 JAN 2024 · 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.
Alternative and Nontraditional Species Series: Sheep as an Alternative Model for the Safety Evaluation of Medical Devices
15 JAN 2024 · 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 studies. Critical regulatory standards and international guidelines are discussed to ensure successful submissions with the US Food and Drug Administration, the Australia Therapeutic Goods Administration, and the Australia New Zealand Therapeutic Products Agency.
Alternative and Nontraditional Species Series: Mini Pig–Alternatives to Traditional Nonrodent Models in Nonclinical Safety Testing
8 JAN 2024 · 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.
Medical Devices: Safety Evaluation and Becoming a Medical Device Toxicologist
28 NOV 2023 · 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 biocompatibility evaluations accepted by the FDA, and address differences in safety assessments for regulatory bodies in the US and other countries. During the second part of the podcast, they provide career advice for ACT colleagues interested in transitioning from the pharmaceutical industry or academia to medical devices in toxicology.
Interviewing and Negotiation 101 for Toxicologist Roles in the Biopharmaceutical Industry
5 SEP 2023 · 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.
The History and Future of Oligonucleotide Drug Development
5 JUL 2023 · 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.
The American College of Toxicology podcast program, ToxChats ©, reports on cutting-edge news in toxicological research from around the globe.
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| Organization | ACT ToxChats |
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