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The ACT podcast program, ToxChats©, reports on cutting-edge news in toxicological research from around the globe. The program features interviews with experts and a review of the current advances. Tune into the podcast using a internet connection to learn about breakthroughs and regulatory developments in toxicological research and more.
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.
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.
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.
Considerations in 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.
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.
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.
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.
Dr. Thomas Hartung—Artificial Intelligence 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.
Panel Discussion with ACT International Travel Award Recipients
In this podcast, the 2019 ACT International Travel Grant Award recipients were interviewed. The recipients were asked how receiving this award has impacted them and how they enjoyed the meeting; for some of them this is the first time they are attending an international meeting.
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.
State of the College and 2019 Annual Meeting Highlights: An Interview with 2019 ACT President Dr. David Compton
In this interview, recorded on-site during the 40th anniversary Annual Meeting in Phoenix, Arizona, Dr. David Compton speaks to the current strengths and promising future for ACT, and highlights key takeaways from the 2019 meeting.
Successes for the Annual Meeting included the 40th-anniversary celebration activities, strong scientific content across various formats (CE, symposia, and exhibit hall/posters), and record attendance. We thank Dr. Compton for his many years of dedicated service to ACT and for taking the time to provide us with an inspiring message moving forward.
The ABCs of IJT: An Interview with Editor-in-Chief, Dr. Mary Beth Genter
International Journal of Toxicology (IJT), the official journal of the American College of Toxicology (ACT), provides a great forum to share your scientific research. The peer-reviewed journal is seeking to publish articles in various emerging areas such as advances in drug development, new therapeutic targets, regulatory issues, and biomarkers/mechanisms of toxicology.
Specialty Tox Series: Shining a Light on the Science and Strategy of Phototoxicity Assessments
In the first episode of Specialty Tox, a new podcast series produced by ToxChats© and hosted by the Early Career Professional Subcommittee of ACT. In this episode we interviewed, Dr. Doug Learn, Director of Toxicology at Charles River Safety Assessment in Horsham, Pennsylvania. He is considered an expert in the field of phototoxicity. In this podcast, Dr. Learn provides 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.
Scientist in the Spotlight Series: with Dr. Doug Learn: How to Become an Expert across Toxicology Fields
In the second episode of Scientist in the Spotlight, a podcast series produced by ToxChats© and hosted by the Early Career Professional Subcommittee of ACT. In this episode we interviewed, Dr. Doug Learn, Director of Toxicology at Charles River Safety Assessment in Horsham, Pennsylvania. His creative and diverse career path has made him an excellent mentor and resource to early career professionals. Dr. Learn now oversees projects in several cutting-edge fields of toxicology, including gene therapy, cell therapy, and viral vector vaccine safety. Hear his valuable insight into what it means to be an applied toxicologist who can work in several disciplines of toxicology.
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.
40th Annual Meeting Anniversary Special Program
In this podcast, Dave Serota chairman of the CHARGE40 Working Group is interviewed. Dave provides background on the plans for the upcoming Anniversary Special Program, “Reliving the History of ACT” scheduled on Sunday evening being held from 5:30 pm–7:00 pm at the ACT Annual Meeting, November 17, 2019 in Phoenix, Arizona.
Highlights and Preview of ACT 40th Annual Meeting
In this podcast, incoming ACT President, Lorrene Buckley and ACT Education Chair Grace Furman, provide a preview of the program at the upcoming 2019 Annual Meeting in Phoenix, Arizona.
CRISPR Then and Now: An Interview with Dr. Jacob Corn
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 describes 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 is covered, in addition to primary concerns about the future of CRISPR. Dr. Corn shares what he considers to be the key milestones, greatest advancements, and unforeseen surprises in the evolution of CRISPR technologies.
Where Are They Now Series: the Rising Stars of ACT
Part 3: 2013 Early Career Professional Award Recipient, Lisa D. Beilke, MSPH, PhD, DABT, ERT
Lisa D. Beilke, MSPH, PhD, DABT, ERT received the Early Career Professional Award in 2013. Since receiving her award, Lisa transitioned from Principal Scientist in Aragon Pharmaceuticals to Sr. Director of Drug Safety at Tricida, Inc. and is now currently the President/CEO of Toxicology Solutions, Inc. Lisa also currently serves on the Editorial Board for International Journal of Toxicology.
Part 2: 2017 Early Career Professional Award Recipient, Heidi Hsieh, PhD
Heidi Hsieh, PhD is currently a Study Director at Covance. She is one of only two past ACT members to have been awarded both the Early Career Professional Award in 2017 and the Furst Award in 2015. Since receiving her award, Heidi has continued her role as Study Director at Covance and currently serves on the Editorial Board for International Journal of Toxicology.
Part 1: 2011 Early Career Professional Award Recipient, Melissa Rhodes, PhD, DABT and 2014 Early Career Professional Award Recipient, Ilona Bebenek, PhD, DABT
Celebrating the 40 year anniversary of the ACT Annual Meeting, past Early Career Professional Award
recipients are interviewed.
An Interview with Distinguished Scientist and Early Career Professional Award Recipients
In this podcast, Cheryl Lyn Walker, who received the 2018 Distinguished Scientist Award in Toxicology, and Kristina DeSmet, who received the 2018 Early Career Professional Award, react to being honored by the American College of Toxicology. Dr. Walker and Dr. DeSmet also share personal stories about how they became involved in toxicology and discuss their visions about the future of the field.
ACT’s Impact via Outreach and Sister Societies
In this podcast, the former ACT President, Tracey Zoetis, discusses recent and ongoing outreach initiatives by the ACT. American College of Toxicology engages in a variety of outreach initiatives, ranging from partnering with sister societies to service in the field of toxicology on an international level.
Scientist in the Spotlight Series: Inaugural Mildred Christian Women’s Leadership in Toxicology Award Recipient
In the first episode of Scientist in the Spotlight, a new podcast series produced by ToxChats© and hosted by the Early Career Professional Subcommittee of ACT. In this episode, we interviewed Dr. Hanan Ghantous, the award recipient of the Inaugural Mildred Christian Women’s Leadership in Toxicology Award. She is a supervisor in the Division of Anti-Viral Products in the Office of New Drugs, at the US FDA. Dr. Ghantous discussed her career transition from industry to regulatory toxicology and provided advice for early career professionals. Additionally, she provided a brief history of how Mildred Christian helped shape ACT, and why the award was created in her honor.
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.
Scientific Liaison Coalition
In this podcast the 2018–19 chairperson of the Scientific Liaison Coalition (SLC), Ken Hastings, highlights how the SLC provides the opportunity for societies to expand their outreach by partnering on a global basis with other societies to advance science to improve human and environmental health and well-being. The SLC is a nimble coalition of scientific, biomedical, and health-based societies working collaboratively on cutting-edge webinars, conferences, and sessions/continuing education courses at scientific meetings. More information about upcoming events can be found on the SLC website.
ACT Annual Meeting in West Palm Beach: Highlights and Preview
In this podcast, 2017–18 ACT President, Andy Kiorpes, provides insight into the upcoming ACT meeting in West Palm Beach, Florida and discusses some new initiatives ACT is implementing to reorganize and restructure the College to best serve the membership.
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.
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.
Unique Identity Podcast
The goal of this podcast was to get an understanding of how ACT is different from other organizations and what makes ACT unique. In this episode, several meeting attendees were interviewed (aka ACT ToxChats stars!) at the 2017 ACT Annual Meeting in Palm Springs California. The individuals were asked about their involvement in ACT, what they think makes ACT unique, and what they love about the organization and the Annual Meeting. Members who have been part of ACT for over two decades, as well as those who have just recently discovered ACT, were among those interviewed.
2017 ACT Annual Meeting in Palm Springs: Highlights and Preview
Tracey Zoetis, current president of ACT, we will be talking about the upcoming Annual Meeting of ACT in Palm Springs, California, in November.
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.
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.
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.
Introduction to the American College of Toxicology
The American College of Toxicology organizes a variety of educational opportunities throughout the year. This year is no different, however in addition to webinars and courses, ACT is launching podcasts. In addition, strategic planning meetings are held every three years to help keep the College stay on track with activities and objectives for the coming years. Current ACT President, Tracey Zoetis, discusses planned activities for this coming year and provides an update on the strategic meeting, which was held in February 2017.