Introduction to Biologics

This course is a brief introduction to and summary of the topic of biologics as drug therapy and centers on the things that biologics can do, and 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.

Who Should Attend?

• Biologists involved in drug discovery
• Medicinal chemists
• Students of pharmacology
• Academic pharmacologists

Course Benefits

• 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)
• Vaccines
• Ab Therapy for Cancer
• Nucleotide-based Therapies (DNA [Gene therapy], RNA)
• RNAi-based Drug Therapy
• Biologic Pharmacokinetics: Delivery, Distribution, Duration, Elimination
• Biologic Safety; Immunogenicity

Instructor

Terry Kenakin, Ph.D.
UNC School of Medicine, Chapel Hill, NC

After obtaining a B.S. in chemistry and Ph.D. in Pharmacology at the University of Alberta, Dr. Kenakin worked for three years at University College London UK with Sir James Black. From there he spent 32 years in industry (Sever at Burroughs-Wellcome, 25 at GlaxoSmithKline). He is currently a Professor at the University of North Carolina School of Medicine. His interests have always been in quantitative pharmacodynamics and the discovery of new drugs and he has worked on projects for AIDS, heart failure and metabolic diseases. He is editor and chief of Journal of Receptors and Signal Transduction, and Co-Editor in Chief of Current Opinion in Pharmacology. He has written 12 books on pharmacology.