Rapid identification of potential therapeutic targets for medical product development has been facilitated by widely accessible biological information, sophisticated bioinformatics tools to map pathways and build systems biology models, and high throughput screening methods.
We've made significant progress in understanding how genomic variations alter an individual's response to activation or inhibition of these therapeutic targets, enabling potential improvements in the clinical use of existing therapeutics and opening up the possibility of co-developing therapies and tests that can be used to tailor treatment to individual patients (personalized medicine).
Genomic information has already been added to drug labels to identified patients who will most benefit from a drug, patients who will be at most risk of an adverse drug reaction, and select the optimal dose for a given patient.
However, the process of translating new scientific findings into safe and effective use of medical products and optimizing the use of existing products for all populations remains a major challenge. Clinical development programs are lengthy and expensive with uncertain outcomes. There is an imperative to speed efficacious medical products to patients by increasing efforts to reduce the uncertainties in this process.
FDA is collaborating with partners to help develop the new tools and approaches needed to catalyze the development of personalized medicine and to modernize and advance the science and conduct of clinical trials.