Toxicology Workshop Snapshot
Nonclinical Safety Assessments of Biologics and Other Novel Modalities for IND/NDA/BLA Filings. Pharmaceutical and BioScience Society (PBSS) San Francisco Bay
Sonia Appel
9/25/2024
Last week I attended a PBSS workshop on Pharmacology and Toxicology of Biologics. In my early drug development work in the Chemistry Manufacturing and Controls (CMC) department, I interact closely with my toxicology and pharmacology colleagues. For example, my team provides them with the drug in several development stages, we share analytical methods and stability data, and their results help determine the clinical trial protocol, which affects the downstream stages of manufacturing when the volume or strength of the drug product must be decided. So, I wanted to learn more about this field.
The panel of speakers was amazing and included reputable scientists, subject matter experts, from key pharmaceutical companies all over North America and the FDA. They were knowledgeable as well as friendly, and I met most of them during the conference breaks, lunch, and happy hour. The atmosphere of camaraderie and scientific sharing was inspiring.
Just a few of the many take-home messages from the talks that stayed with me:
In a conventional space like Oncology, sets of ADCs (antibody drug conjugates) that share the same cytotoxic payload open potential options for leveraging a platform approach, where one set of studies may be acceptable as representative of the platform, thereby reducing timelines and cost.
Peptides, Protein Degraders and Molecular Glues have specific safety considerations and require additional studies and creative approaches to safety packages, including careful and early selection of relevant species.
Immunogenicity of human biologics is common in non-clinical species - it should be managed and understood; it may not be predictive of clinical studies.
Speakers stressed that we should always look for ways to replace, reduce and refine (3Rs) studies and methods for in-vivo studies - considering in-vitro and in-silico methods, leveraging WoE (weigth-of-evidence), and using platform approaches when possible.
Thank you to PBSS, the speakers and the volunteers for an incredibly enriching day!
