Crowne Plaza Hotel – Foster City

With the recent FDA memo on phasing out preclinical animal testing requirements for certain drugs and promoting the use of New Approach Methodologies (NAMs), the shift in broader strategy has brought new technologies to the forefront. This symposium covers a broad spectrum of NAMs, including organ-on-a-chip and AI/ML computation modeling, to reduce traditional animal studies..

Pharmacokinetic (PK) studies are essential in drug development to understand how a drug is absorbed, distributed, metabolized, and excreted in the body. This information guides dose selection, optimizes efficacy, minimizes toxicity, and supports regulatory approval. Join this full day workshop led by industry experts, the panel will cover the latest advances and practical strategies on..

This workshop provides a comprehensive overview of AAV gene therapy, from foundational principles and the discovery of novel therapeutics using NanoCas and Zinc Finger Proteins, to critical nonclinical and clinical development considerations. Strategies for Bioanalytical method and companion diagnostic development, as well as genotoxicity and carcinogenicity concerns will be explored. In addition, the speakers will..

This PBSS workshop will cover strategies, best practices, and regulatory guidance for toxicological assessments to assess workplace safety, product quality / patient safety, and environmental toxicology. These assessments are critical for manufacturing, and essential for successful drug development. Included will be a discussion on occupational safety, toxicological risk assessment, impurities, cleaning validation, and will cover..