ToxChats©

This episode of ToxChats is designed to offer listeners a practical and insightful overview of the waiver process for carcinogenicity studies in pharmaceutical development, with a focus on the ICH S1B and S1B(R1) guidance documents. In this episode, host Zac Iloyd engages with two recognized experts to explore critical considerations for obtaining waivers, discuss the characteristics of strong versus weak waiver requests, and share real-world strategies for leveraging the weight of evidence framework. Through an accessible conversation, we discuss key data requirements, regulatory expectations, and common pitfalls in preparing a successful waiver application.

To learn more about the speakers and connect with them professionally, please visit their LinkedIn: Todd Bourcier and Tim McGovern

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 modeling. Together, they discuss how Organ Chips outperform traditional in vitro and animal models, the promise of personalized “human avatars,” and the technical, regulatory, and cultural challenges that remain. Future-focused and packed with insight, this episode spotlights the breakthroughs changing toxicology as we know it.

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 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 Generation Risk Assessment strategies to more accurately predict disease risk and guide public health strategies. From innovative technologies to ethical implications, this conversation offers a compelling look at the future of health science in a complex and rapidly changing world.

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. 

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 candidates, and then get practical about moving forward.

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, 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 in occupational toxicology as well as emerging tools and challenges. She also explores current strategies in managing impurities in therapeutics as well as the evolving regulatory requirements for pharmaceutical drug products. Dr. Graham conveys leading trends in alternative methods for hazard identification and risk assessment, shedding light on how these innovations are transforming human health hazard assessments in the areas of worker safety and impurity assessment. Whether you're a safety professional or just curious about the field, this episode offers essential insights into protecting workers, patients, and maintaining high industry standards.

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 positively impact people's lives. In this episode, we also explore an overview of the responsibilities and the education requirements needed to pursue a career in toxicology in the food industry.

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.

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 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.

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 and then consultant in the field of toxicology will be discussed.

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.

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 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 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.

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.

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.

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. 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.

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.

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.

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 discuss the history of opioid abuse, the factors that might have contributed to the current crisis, and other drugs that have played a role. We also discuss ways pharmaceutical and regulatory toxicologists may intervene.

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, and KD occur with increased frequencies several weeks following increased numbers of COVID-19 and for KD other pathogens. The incidence rate for MIS-C, MIS-A, MIS-N, and KD are typically a factor of roughly 5,000 lower than COVID-19 and for KD other pathogens. In this podcast, Dr. Darrell Ricke advances the hypothesis that MIS-C, MIS-A, MIS-N, MIS-V, and KD all represent a novel type of antibody-dependent enhanced (ADE) diseases associated with hyperactivation of granulocytes or mast cells. Symptoms for these diseases overlap those of histamine intolerance (HIT) coupled with pathogen associated symptoms. This ADE model proposes that antibody titer levels higher than primary immune response levels can hyperactivate granulocytes or mast cells to release inflammatory molecules including histamine; MIS-X and KD disease symptoms onset when histamine levels exceed the individual’s tolerance level. The proposed ADE model purports that patient treatment with intravenous immunoglobulin (IVIG) is successful in treating the MIS-X disease because IVIG compete with pathogen antibodies for binding to Fc receptors on immune cells, thereby reducing the immune responses to the pathogen or vaccine protein. This model is further supported with the vaccine spike protein activating immune cells via envisioned Fc receptor binding. This ADE model proposes additional antihistamine and diamine oxidase (DAO) adjunctive treatments combined with current standard of care treatments for investigation.

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 previous infection of likely other betacoronavirus family members. In general, family members of the betacoronavirus family leverage Fc receptor antibody uptake of viruses by phagocytic cells to infect these innate immune cells. This extended cellular tropism of phagocytic immune cells is dependent upon Fc receptors and antibodies. It is hypothesized that SARS-CoV-2 with higher antibody titers can infect phagocytic immune cells; SARS-CoV-2 infection of these cells has been observed in some patients with severe COVID-19. This proposed antibody-dependent enhancement (ADE) of disease has been proposed to a key transition of infection from respiratory infection to multi-organ disease in some severe COVID-19 patients. While the main medical community believes that there is no ADE associated with SARS-CoV-2 infections, multiple clinical studies are consistent with SARS-CoV-2 infection of monocytes and macrophages in some severe COVID-19 patients. The podcast discusses data available in the summer of 2022.

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 models used in AI, and also case examples of the use of AI in toxicology. We also discussed updates on the regulation of AI use in healthcare and toxicology and its ethical aspects. Last, we discussed challenges faced with AI and strategies to improve AI use. This podcast is incredibly informative, with general and high-level information about AI in toxicology—the future of AI is bright!

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 vaccines and discusses the important Emergency Use Authorization process that was utilized for mRNA vaccines against COVID-19. This podcast is incredibly informative, with general and high-level information about vaccines and regulatory processes, tailored to be understandable and enjoyed by a wide audience.

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 certification is of value personally, and of value in terms of position and salary.

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 can be made easier by learning how other scientists made the transition, including how they developed the skills and networks to be successful in their new roles. In this podcast, Dr. Daniella Pizzurro, Senior Director, Regulatory Toxicology and Preclinical Development at AVROBIO, shares her experience and lessons learned from her career transition. Presented by the ACT Early Career Professional Subcommittee.

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 order to provide the body with the instructions for making the appropriate gene product or protein. One is for inherited retinal dystrophy and was approved in 2017, the other is for spinal muscular atrophy and was approved in 2019. In this podcast Dr. Nicholas Buss from REGENXBIO will discuss the science behind the nonclinical development of gene therapy products using AAVs.

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 toxicology pathology workflows.

For further information on digital pathology in drug discovery, we encourage you to check out the following links:
1. Society of Toxicologic Pathology Digital Pathology and Image Analysis Special Interest Group Article*: Opinion on the Application of Artificial Intelligence and Machine Learning to Digital Toxicologic Pathology
https://journals.sagepub.com/doi/10.1177/0192623319881401?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

2. BIGPICTURE is a public-private partnership funded by the EU Innovative Medicines Initiative (IMI) bringing together academic institutions, small- and medium-sized enterprises, public organizations, pharmaceutical companies, and a large network of partners.
https://bigpicture.eu/

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 patients with serious or life-threatening conditions, the FDA has established four expedited programs: Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval. This episode examines FDA Expedited Programs with CDER’s Senior Regulatory Expedited Programs Manager, Miranda Raggio.

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 information including gender, age, degree, years of experience, certifications, areas of specialization, society membership, employment, benefits, and income. This podcast examines the salary survey process and highlights some of the key findings. Lastly, we will discuss what type of information future versions of the survey may collect.

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 include developmental, reproductive, and juvenile toxicology, as well as developmental neurotoxicology. Some of the unique features of pediatric drug development and in particular focusing on nonclinical safety assessment of pharmaceuticals intended to be used in pediatric populations will be discussed.

(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 biology and allowed us to make such leaps in cancer care. In this episode, Dr. Brian McIntosh of Covance describes these cells, how their safety or efficacy are evaluated, explains how these nontraditional precision medicines contribute to the patient’s journey and he shares his thoughts on the future of this type of cancer immunotherapy during this ACT ToxChats.

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 extrapolation, and DART requirements.

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 involving complex topics including vaccine development for the COVID-19 virus, clearly, accurately, and understandably to both general and scientific audiences.

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 of these concepts, and his perspective on the future of predictive modeling to supplement current toxicology research strategies. Dr. Hartung also discusses the potential for predictive modeling to expedite drug development decisions and challenges faced with introducing these technologies to regulated industries.

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 pharmaceutical world, and how this translates to the consumer.

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 discusses her inspiration for the collaborative paper, key considerations for the design and interpretation of studies utilizing an uncommon route, and provides advice to fellow scientists looking to form a working group or collaborative publication.

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 diseases, while providing context for drug safety evaluation. Potential applications and ethical considerations for livestock and human organ development will be covered, in addition to primary concerns about the future of CRISPR. Dr. Corn will share what he considers to be the key milestones, greatest advancements, and unforeseen surprises in the evolution of CRISPR technologies.

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 share their thoughts about future directions of the field. In the second chapter, Dr. Paul Brown, the associate director of pharmacology and toxicology in the Office of New Drugs in the Center for Drug Evaluation and Research at the US Food and Drug Administration, discusses the acceptance of in vitro models for safety evaluations and the value of integrative toxicology.

Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not necessarily reflect the official policy or position of the American College of Toxicology. For the College’s policy on the ethical treatment of animals in research, please see our comprehensive policy statement at www.actox.org.

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 toxicologist with the Center for Tobacco Products at the FDA.

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 necessarily reflect the official policy or position of the American College of Toxicology. For the College’s policy on the ethical treatment of animals in research, please see our comprehensive policy statement at www.actox.org.

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 official policy or position of the American College of Toxicology.

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 therapeutic drugs.

Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not necessarily reflect the official policy or position of the American College of Toxicology.

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 oligo therapeutic development.

Disclaimer: The views and opinions expressed in this podcast are those of the guest speakers and do not necessarily reflect the official policy or position of the American College of Toxicology. For the College’s policy on the ethical treatment of animals in research, please see our comprehensive policy statement at www.actox.org.