Translational Medicine：Optimizing Preclinical Safety Evaluation of Biopharmaceuticals

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified-proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody-drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient and predictive preclinical development program to ensure clinical efficacy and safety.

Key Features:Defines best practices for leveraging of discovery research to facilitate a development programIncludes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applicationsDiscusses rare diseasesEach topic area discusses "What-Why-When-How" highlighting different considerations based upon product attributes.