Biologics Nonclinical Drug Development Course

The American College of Toxicology (ACT) offers the comprehensive Biologics Nonclinical Drug Development Course. The course offers an in-depth exploration of regulatory considerations and the toxicologic evaluation and development of protein biologics, modified protein biologics, and specialized biologics, including cell and gene therapies, and oncolytic viruses.

Participants will gain a thorough understanding of the key principles and methodologies employed in the nonclinical safety assessment of these advanced therapeutic modalities. The curriculum covers a wide range of studies essential for advancing biotherapeutic drug candidates through all stages of drug development from candidate selection to marketing authorization. These include general toxicity studies and a variety of specialized studies, including off-target assessment, safety pharmacology, carcinogenicity, and reproductive and developmental toxicity studies. Additionally, the course provides insight into pharmacokinetic and biodistribution assessments and the potential impact of immunogenicity for various of different therapeutic modalities. Several case studies will be used to highlight how specific strategies and issues are approached on a case-by-case basis.

The Biologics Nonclinical Drug Development Course will be held in person in Gaithersburg, Maryland, from June 14–16, 2027. More information about the schedule and registration will be available soon.

The ACT course is only being offered as an in-person format. Virtual or hybrid participation is not an option.