The successful and well-attended “Nonclinical to Clinical Translation of Antibody-Drug Conjugates” Workshop Session at the 2018 Annual Meeting and ToxExpo highlighted the challenges in nonclinical to clinical translatability of ADCs and regulatory considerations based on ICH S9.
Recent years have seen an increasing surge in the development of novel biotherapeutics. Preclinical safety evaluation plays a crucial role in drug development and the highly diverse modalities and complexity of biotherapeutics poses several development challenges.
Attend these webinars in February.
The Biotechnology Specialty Section (BTSS) Executive Committee is excited to announce an upcoming webinar entitled, “Predictivity/Translatability of Toxicities Observed in Nonclinical Toxicology Studies to Clinical Safety Outcomes” with talks from four experts in the field to be held on February 9.
During the November SOT Council meeting, two new SOT Issue Statements were approved and adopted: “The Complexities in Assessing the Risk to Public Health of Low-Level Arsenic Exposure” and “Food and Feed Safety of Genetically Engineered Food Crops.”