The pace of biomedical progress is accelerating . . .
We are in a therapeutic development transformation enabled by expanding understanding of pathophysiology and the advent of tools to study and modulate disease biology in precise ways. These advances bring hope that the resulting therapies will provide clinicians and patients new and individualized treatments for unmet medical needs. After decades of research this promise is becoming reality, and these new therapeutic modalities are achieving clinical approval and significant impact on patients’ lives.
. . . but advances are outpacing the progress of preclinical model systems.
While there is reason for optimism, research and development efficiency - as measured by successful approval and launch of new therapeutic products - has been declining. A significant contributor has been the limited capacity of applied preclinical models to accurately predict human response. As commitments and investments in biologics, gene and cell therapies, and precision medicine approaches continue to expand, it is critical that the most clinically relevant test systems are employed to ensure programs are de-risked prior to undertaking the significant investment in human trials.