Evolution of Next Generation Therapeutics: Past, Present, and Future of Precision Medicines

Advances in genomics have offered deeper insights into understanding diseases, understanding of variability in drug exposure and response, and identification of new drug targets. This has led to the development and approval of tailored therapeutic products (some innovative and some old), such as ASOs, CAR‐T cells, and CRISPR/Cas 9. Clinical development and approval of next generation therapies is an intensive process due to the inherent novelty and heterogeneity of these treatment modalities. The product development life cycle for these and any new technologies usually follows a succession of exploratory research, followed by controlled validation and product development, and then adoption in clinic practice. Clinicians, scientists, drug developers, and regulators alike continue to focus on ensuring a proper balance of benefit and risk for new and existing treatments when subgroups that respond well or seem to be more susceptible to adverse events emerge.