ToxChats©

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.