Topics

Symposium and Workshop Sessions are three hours each and Mini Symposia are scheduled for 75 minutes each.

Symposia and Workshops are scheduled for Monday, November 17, from 9:00 am to 12:00 noon and in the afternoon from 2:00 pm to 5:00 pm; Tuesday, November 18, from 9:00 am to 12:00 noon and in the afternoon from 2:00 pm to 5:00 pm; and Wednesday, November 19, from 9:00 am to 12:00 noon and in the afternoon from 2:00 pm to 5:00 pm. Mini Symposia are scheduled for Wednesday, November 19, in the afternoon from 2:00 pm to 5:00 pm. Times listed are in Mountain Standard Time.

The following learning levels have been identified for ACT educational offerings.

Foundational (Basic)
Focuses on core skills or fundamental understanding of a topic

Advanced
The converse of basic, if not basic then advanced

Practical
How to do it—procedures, design, reporting, use of tools, tips, tricks, experiences, and/or advice

Emerging
New, unusual, or uncommon techniques, modalities, ROA, guidance, tools/equipment (hardware and software), and/or changes to standard practice


Below are the titles of the Symposia/Workshop sessions to be presented at this year’s Annual Meeting. Detailed information about each session will be shared in April.

  • Advancing Nitrosamine Risk Assessment for Human Health Risk Assessment.
  • Antibody-Drug Conjugate (ADC) Nonclinical Safety: Background, Challenges, and Mitigation Strategies
  • Balancing Innovation and Caution: Artificial Intelligence (AI) and Machine Learning (ML) in Toxicology
  • Consulting Is a Viable Career Path: How to Start and Build a Career as a Toxicology Consultant
  • Developing Predictive Models to Facilitate Interpretation of Toxicology Study Results
  • From Bench to Birth: Navigating DART Challenges in Next Generation Therapeutics
  • Harnessing Complex New Approach Methodologies (NAMs) to Tackle Discovery Toxicology Challenges
  • Hot Topics
  • Impurity Limits and Approaches for Endogenous Substances Commonly Identified in Biologic Therapeutics
  • Navigating the Frontier of Science and Regulation: Exploring the Latest Breakthroughs in New Approach Methodologies
  • Nonclinical Considerations for the Development of Radiopharmaceuticals
  • Nose to the Grindstone: Intranasal Therapies
  • Oligonucleotide-Based Therapeutics, Hybridization-Dependent Off-Target Effects, and Impacts on Nonclinical Safety Packages
  • Optimize Your FDA Interactions: An Industry and FDA Perspective
  • Predicting Adversities in New Modalities: Lessons Learned from Clinical and Preclinical in Cell and Gene Therapies
  • Strategic Use of Transgenic Mice or Surrogate Molecules in DART Studies to Support Biologic Drug Development: Recent Success/Failure
  • Toxicologic Assessment of Psychoactive/Psychedelic Drugs: Disentangling CNS Pharmacology and Toxicity
  • Transitioning to the New ICH M12 Guideline on Drug-Drug Interactions: Concepts and Implications
  • What to Do When Things Go Wrong: Perspectives from Early Career Experts on Navigating Unexpected Situations
  • When to Waive: Balancing Risk and Flexibility in Nonclinical Safety Studies