Breaking Down Translation Barriers: Investigator’s Perspective

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Science Translational Medicine  03 Sep 2014:
Vol. 6, Issue 252, pp. 252cm7
DOI: 10.1126/scitranslmed.3008252


  • Fig. 1 More talk, more action.

    (A) Shown is a simplified scheme of U.S. biomedical discovery research and regulatory science processes. Funding comes from three sources—government agencies (federal and state), nonprofit institutions (private philanthropies and disease-focused foundations), and the private sector (investment from venture capital and industry). R&D is carried out in both industry (pharmaceutical and medical technology companies) and academic centers, which also conduct increasing amounts of public health and new-product implementation research that require policy changes rather than FDA approval. Over the past 50 years, the relative return on biomedical research investment has declined (as measured by FDA submissions and product approvals) and the rate of knowledge transfer (translation) from discovery to improvements in clinical medicine has not improved. Bottlenecks include lack of knowledge in academia about the regulatory process; the essential requirement for acceptance and coverage of a new product by the CMS in order for it to be widely implemented; and the miniscule amount of prospective planning among academia, industry, FDA, and CMS. (B) Strengthening of communication pathways—most of which converge on individual institutions and investigators—can accelerate the pace of translation. Federal funding agencies and FDA also should exchange information about strategic priorities and required regulatory expertise in the funding review and regulatory approval processes.


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