Translating advances from the basic biology of aging into clinical application

Abstract

Recently, lifespan and healthspan have been extended in experimental animals using interventions that are potentially translatable into humans. A great deal of thought and work is needed beyond the usual steps in drug development to advance these findings into clinical application. Realistic pre-clinical and clinical trial paradigms need to be devised. Focusing on subjects with symptoms of age-related diseases or frailty or who are at imminent risk of developing these problems, measuring effects on short-term, clinically relevant outcomes, as opposed to long-term outcomes such as healthspan or lifespan, and developing biomarkers and outcome measures acceptable to regulatory agencies will be important. Research funding is a major roadblock, as is lack of investigators with combined expertise in the basic biology of aging, clinical geriatrics, and conducting investigational new drug clinical trials. Options are reviewed for developing a path from the bench to the bedside for interventions that target fundamental aging processes.

Figure 1

The path from an idea about an intervention to clinical application. ADME refers to pharmacokinetic studies of absorption, distribution, metabolism, and excretion. GMP refers to “good manufacturing practices”. FDA refers to Food and Drug Administration. IND refers to investigational new drug.