Professor UNC School of Medicine, North Carolina, United States
Additional Fees Apply -- visit the Short Course Program section for more information.
This course is a brief introduction to and summary of the topic of biologics as drug therapy. It centers on the things that biologics can do (that small drug molecules also do) but more importantly what some biologics can do that small molecule drugs cannot do. In addition, safety issues with biologics can be different from those of small molecules and most certainly the pharmacokinetics of biologics is a unique challenge as compared to small molecules. The specific topics covered in this course include recombinant replacement protein biologics (assessment of biological activity, production, quality control, heterogeneity, removal of undruggable proteins through PROTACs), peptides (measurement of response, biased peptide signaling, methods to demonstrate target engagement), immunotherapy (vaccines, antibody approaches to modifying the immune system), antibodies (features, agonism, antagonism, antibody-drug complexes, antibody scavenging of endogenous species), and Nucleotide-based therapies (DNA- Gene therapy, CRISPR, RNA; exploiting the siRNA system). In addition, development issues with biologics will be addressed such as specific safety topics (immunogenicity) and importantly pharmacokinetics. Specifically, the delivery of biologics can be challenging and distribution and duration also a concern. Finally, mention of determining in vivo effectiveness will be discussed. [Insert brief description here]
Who Should Attend:
Biologists involved in drug discovery
Medicinal chemists
Students of pharmacology
Academic pharmacologists
How You Will Benefit From This Course?
Gain new insights into state of the art ideas on the utilization of biologics as therapy
Learn new tools to quantitatively assess molecular effects of biologics
Learn what biologics can do that small drug molecules cannot do
Learn the unique challenges around biologics in terms of pharmacokinetics and safety
Course Topics:
General introduction to biologics
Replacement proteins / production / quality control/ assessment of activity and purity
Replacement peptides as drugs, biased signaling
Methods to demonstrate target engagement
Antibodies: general principles, Ab agonism, antagonism, scavenging ligands
Immunotherapy (Abs, CAR T Cell therapy, immune checkpoint inhibitors)
