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The American College of Toxicology podcast program, ToxChats ©, reports on cutting-edge news in toxicological research from around the globe.


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Overview of mRNA Vaccines

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.
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Tips for Taking the ABT Exam

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.
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Moving from Minion to Manager

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.
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Off the Beaten Path: The Nonclinical Development of Gene Therapy Products to Cure Monogenic Diseases

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.
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Digital Pathology

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

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.
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Expedited FDA Programs

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.
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Toxicology Salary Survey

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.
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Pediatric Drug Development

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.
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CAR/T: New Modalities Paving the Way for Cancer

(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.
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History and Risk Assessment of Vaccines?Q&A

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.
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Scientific Communication: Distilling and Rehearsing to Reach Your Audience

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.
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AI and Big Data for Safety Testing

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.
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Shining a Light on the Science and Strategy of Phototoxicity Assessments

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.
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The Twists and Turns of GI Health and Medicine: An Interview with Dr. Alessio Fasano

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.
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The Scientific Approach to Address Uncommon Routes and Best Practices for Forming a Working Group

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.
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CRISPR Then and Now: An Interview with Dr. Jacob Corn, ACT 2015 Plenary Speaker

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.
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In Vitro and Alternative Models for Regulatory Submission

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
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Regulation of E-Cigarettes

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.
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The Opioid Epidemic

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
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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.
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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.
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Oligonucleotide Therapeutics

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
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