The White House just released a National Bioeconomy Blueprint which outlines initiatives and policies for Federal government agencies to advance and promote development of a broad range of biology-related industries from biofuels through environmental sciences. Of course, a large portion of the report the report focuses on the largest segment of the bioeconomy, biomedical research. Two of the six outlined objectives target the major challenges with developing and launching new drugs, diagnostic tests, and medical devices.
In an effort to speed up the discovery of new drugs and disease markers, the blueprint talks about increasing support for translational research. Activities supporting this objective includes the National Center for Advancing Translational Sciences (NCATS) started the end of last year. NCATS is a publicly funded enterprise within the NIH that provides research support to identify and validate new drugs and drug targets. This initiative addresses difficulties at the start of the drug development pipeline by expanding the potential validated drug candidates and finding additional druggable targets beyond the several hundred GPCRs, proteases, and kinases that are the focus of most current drug screening. However, the blueprint also focuses on the regulatory challenges that limit the approval and launch of new therapeutics.
The same translational research objective that includes the above initiative also mentions the NIH/FDA collaborative Regulatory Science program. Implemented to speed up development and adoption of advanced technology, such as nanotechnology and microdevices, in regulatory evaluations, this program aim to "more effectively evaluate product safety, efficacy and quality" of new drugs and diagnostics. Another objective in the plan specifically targets regulations reform "to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs...." and include several activities targeted toward streamlining and improving FDA regulatory procedures. It seems these actions might be very timely given recent criticism from some sectors that the FDA approval process is having a negative effect on drug development.
Read the National Bioeconomy Blueprint.