Events

An Overview of the Safety Evaluation of Veterinary Pharmaceuticals

Hosted by: The Regulatory and Safety Evaluation (RSESS) and Comparative Toxicology, Pathology, and Veterinary Toxicology (CTPVSS) Specialty Sections

Drug Regulatory Authorities, which are members of ICH and have mutually confidential agreements, have independently reviewed the submitted documents and evaluated the degree of concordance with Sponsors. Data are collected solely for real world experience. Submitted CADs were finely compared to the real outcome of the two-yr carcinogenicity studies. The main objective has been the assessment of accuracy of the predictions. Eventually 48 CADs have been collected, with 24 agreed cases with the outcome of “no added value.” The presentation will discuss the strengths and weaknesses of the CADs, and the reasons why the DRA’s decided to deviate from the initial categorization by the sponsor. The Expert Working Group has developed a document as an addendum to ICH-Guideline S1B, which is now finalized.

Registration is required for this free webinar.

Speaker(s):
Samuel Fletcher, Head of the Human and Environmental Safety Team at Veterinary Medicines Directorate (VMD), UK

Regulatory and Safety Evaluation 2025 Award Winners Recognition Webinar

Speaker(s):
Emma Hailwood, UK Health Security Agency
Gabrielle Griffin, University of Louisville School of Medicine
Li Xia, US FDA NCTR
Shaun McCullough, RTI International

Hosted by: SOT Regulatory and Safety Evaluation Specialty Section

RSESS is pleased to announce the 2025 award winners and recognize their great accomplishments. This webinar will offer an opportunity for the award winners to present their work and for the RSESS members and SOT community to appreciate the great advancements made in 2024. The winners span several awards including Best Paper, Graduate Student Award, Postdoc Award, and three-minute thesis presentation.

Three-Minute Thesis Winners:
Emma Hailwood—“Understanding how blending renewable fuels with diesel changes the in vitro toxic potential effects within the lungs and influences lung cancer mechanisms.”
Druthi Mutyala—“Lipid Raft Disruption by E-Cigarette Exposure: Insights into Proteasomal Dysfunction and Inflammatory Pathways.”

Graduate Student Winner:
Gabrielle Griffin—“Unraveling the Sex-Dependent Mechanisms of Hexavalent Chromium-Altered, Diet-Induce Metabolic-dysfunction Associated Steatotic Liver Disease”

Postdoctoral Winner:
Li Xia—“Mechanistic exploration of mutagenicity of N-nitrosodiethylamine via the ceII transgenic mutation assay, Duplex Sequencing and gene expression analysis of the liver and bone marrow samples in Big Blue rats.”

Best Paper Winner:
Shaun McCullough—“Liquid application dosing alters the physiology of air-liquid interface (ALI) primary human bronchial epithelial.”

Materials:
Webinar Recording and Materials

Opportunities to Harness AI and Machine Learning in Drug Discovery Toxicology

Speaker(s):
Yodi Melnikov, PhD, Principal Data Scientist, Computational Toxicology, Genentech

Hosted by: The SOT Regulatory and Safety Evaluation and Computational Toxicology Specialty Sections

Yodi Melnikov, PhD, is a principal data scientist in the safety assessment group at Genentech where he has focused on developing artificial intelligence and machine learning (AI/ML) models for early hazard identification in small molecule development. More recently, Yodi has been responsible for developing and optimizing bioinformatics pipelines for cross-species and cross-platform data inference in safety assessment, as well as data related data integrity and robust data inference work.

In this webinar, Dr. Melnikov will describe the various opportunities to leverage AI/ML in the drug discovery and development process to ultimately support decision making, improve efficiencies, and potentially reduce animal use. Case studies on modeling and practical application of toxicological endpoints ranging from simple single endpoint prioritization models like hERG, to more complex models combining data from multiple sources such as secondary pharmacology and drug induced liver injury, will be presented.

Nitrosamine Potency Prediction: Reviewing the Carcinogenic Potency Categorization Approach

Speaker(s):
Kevin Cross, PhD, Vice President, Regulatory Science, and PI, USA FDA Collaborations, Instem

Materials:
Webinar Recording
Kevin Cross Presentation

The Modernization of Cosmetics Regulation Act and Confirming Cosmetic Safety

Speaker(s):
Kim Norman, PhD, DABT, ERT, Senior Director of Toxicology, Personal Care Products Council
Lauren Brown, DABT, MS, Senior Scientist, ToxStrategies, LLC

Materials:
Webinar Recording
Kim Norman Presentation
Lauren Brown Presentation

Update: The UK’s Medicines and Healthcare Products Regulatory Agency

Speaker(s):
David R. Jones, Retired, Expert PharmacoToxicologist, Medicines and Healthcare products Regulatory Agency

Materials:
Webinar Recording
David R. Jones Presentation

Risk Evaluation of Nongenotoxic Carcinogenic Pharmaceuticals: Impact of The ICH S1B Addendum, A European Viewpoint

Speaker(s):
Jan Willem van der Laan, PhD, Medicines Evaluation Board, European Medicines Agency Representative, ICH S1 Carcinogenicity Regulatory Chair

Materials:
Webinar Recording
van der Laan Presentation

Considerations Regarding Nonhuman Primate Use in Pharmaceutical Development

Speaker(s):
Ronald Wange, PhD, Associate Director for Pharmacology and Toxicology, OND, CDER

Materials:
Webinar Recording
Wange Presentation

Safety of COVID-19 Therapies and Vaccines

Speaker(s):
Kenneth L. Hastings, DrPH, DABT, ATS, Hastings Toxicology Consulting LLC

Materials:
Webinar Recording
Hastings Presentation

Membership Meet & Greet 2022

Cannabis: A Review of the Current State of Safety and Regulatory Considerations

Speaker(s):
Tom Jonaitis, DABT
Garrett Graff, Esq.

Materials:
Webinar Recording
Tom Jonaitis, DABT Presentation
Garrett Graff, Esq. Presentation

Assessment of Adversity and NOAEL in Toxicology Studies to Support Regulatory Decision

Speaker(s):
John L. Vahle, DVM, PhD, DACVP
Vincent Meador, DVM, PhD, DACVP

Materials:
Webinar Recording (Unavailable)
Dr. Vahle Presentation
Dr. Meador Presentation

Finding Your Dream Job in Regulatory Toxicology

Speaker(s):
Edward V. Ohanian, PhD
Amy L. Roe, PhD, DABT
Anne E. Loccisano, PhD, DABT

Materials:
Webinar Recording (Unavailable)
Dr. Ohanian Presentation
Dr. Roe Presentation
Dr. Loccisano Presentation

Updates for FDA’s GLP Regulations

Speaker(s):
Mark Seaton, PhD, DABT, US FDA

Materials:
Webinar Recording (Unavailable)
Dr. Seaton Presentation

First-in-human studies: Recent experiences in Europe

Speaker(s):
Jan Willem van der Laan, Medicines Evaluation Board, Utrecht, The Netherlands
David Jones, MHRA, London, United Kingdom

Materials:
Jan Willem van der Laan Presentation
Lutz Müller Presentation

EPA’s Guidelines and Other Related Activities for Cyanotoxins

Speaker(s):
Lesley V. D’Anglada, DrPH, MEH, US Environmental Protection Agency, Washington, DC

Precautionary Principle = Risk Assessment (or Not)?

Speaker(s):
Professor Christopher Portier, PhD, FASA, FISI, FWIF, Thun, Switzerland
Professor Alan R. Boobis, OBE, PhD, FRSB, FBTS, Imperial College, London, UK

CTA/NDA Regulatory Landscape in China

Speaker(s):
Dr. Jianxun (Jack) Xie, PhD, DABT, Director, Head of Toxicology, Roche Innovation Center Shanghai (China)

Materials:
Presentation

The Integration of LNT and Hormesis for Cancer Risk Assessment Optimizes Public Health Protection

Speaker(s):
Edward J. Calabrese, Ph.D.

Materials:
Webinar Recording (Unavailable)
Presentation

Global Regulatory Toxicology: First Stop EU

Speaker(s):
Beatriz Silva Lima, Universidade de Lisboa, PT, IMI Scientific Committee, BE, NDA Advisory Board, UK

Materials:
Presentation

Can/Should Peer-Reviewed Publications Be Used to Formulate Regulatory Policy?

HA Mutagen Is a Carcinogen Because It Is a Mutagen

Hazard Information Provides an Adequate Basis for Restricting Chemical Use

Speaker(s):
RSESS Past President James C. Lamb, IV, of Exponent
George Gray, George Washington University
Lorenz Rhomberg, Gradient Corporation

Materials:
Debate Flyer

Are the Blind Leading the Blind or Are Pathologists Biased? A Debate on the Pros and Cons of Blinded Histopathology Evaluation for the Qualification of New Biomarkers of Toxicity

Speaker(s):
B. Short
K. Pandher
B. Maronpot

Materials:
B. Short Presentation
K. Pandher Presentation
B. Maronpot Presentation

Limit the Use of the Non-Rodent in Toxicity Testing: Scientific Considerations

Speaker(s):
Monticello
Olson

Materials:
Monticello Presentation
Olson Presentation

MTD: Is Testing to the MTD Unnecessary Animal Use or Always Necessary to Assure Human Safety?

Speaker(s):
Reynolds
Osterberg
Sistare

Materials:
Reynolds Presentation
Osterberg Presentation
Sistare Presentation

Ten Years after the Food Quality Protection Act: Healthier Children or Unnecessary Burden?

Speaker(s):
Fenner-Crisp
Faustman
Bus

Materials:
Fenner-Crisp Presentation
Faustman Presentation
Bus Presentation

Animal and Human Testing: What’s Appropriate?

Speaker(s):
Doull
Sandusky
Rodricks

Materials:
Doull Presentation
Sandusky Presentation
Rodricks Presentation

Rodent Carcinogenicity Assay: Relevant or Relic?

Speaker(s):
Dr. Cohen
Dr. Jacob

Materials:
The Great Debate
Dr. Cohen’s Presentation
Dr. Jacob’s Carcinogenicity Prediction Article

Positive Genetic Toxicity Findings: Now What?

Speaker(s):
David Kram
Galloway
Gary Williams

Materials:
David Kram Presentation
Galloway Presentation
Gary Williams Presentation