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Overview

Background

Nanomedicine, an offshoot of nanotechnology, refers to highly specific medical intervention at the molecular scale for curing disease or repairing damaged tissues, such as bone, muscle, or nerve.  A nanometer is one-billionth of a meter, too small to be seen with a conventional lab microscope.  It is at this size scale – about 100 nanometers or less – that biological molecules and structures operate in living cells.

The NIH vision for Nanomedicine is built upon the strengths of NIH funded researchers in probing and understanding the biological, biochemical and biophysical mechanisms of living tissues.  Since the cellular machinery operates at the nanoscale, the primary goal of the program - characterizing the molecular components inside cells at a level of precision that leads to re-engineering intracellular complexes - is a monumental challenge.

The teams selected to carry out this initiative consist of researchers with deep knowledge of biology and physiology, physics, chemistry, math and computation, engineering, and clinical medicine.  The choice and design of experimental approaches are directed by the need to solve clinical problems (e.g., treatment of sickle cell disease, blindness, cancer, and Huntington’s disease).  These are very challenging problems, and great breakthroughs are needed to achieve the goals within the projected 10 year timeframe.  The initiative was selected for the NIH Roadmap (now Common Fund) precisely because of the challenging, high risk goals, and the NIH team is working closely with the funded investigators to use the funds and the intellectual resources of the network of investigators to meet those challenges.

10 Year Program Design – High Risk, High Reward

The Centers were funded with the expectation that the first half of the initiative would be more heavily focused on basic science with increased emphasis on application of this knowledge in the second five years.  This was a novel, experimental approach to translational medicine that began by funding basic scientists interested in gaining a deep understanding of an intracellular nanoscale system and necessitated collaboration with clinicians  from the outset in order to properly position work at the centers so that during the second half of the initiative, studies would be applied directly to medical applications.  The program began with eight Nanomedicine Development Centers (NDCs), and four centers remain in the second half of the program.

Clinical Consulting Boards (CCBs)

The program has established Clinical Consulting Boards (CCBs) for each of the continuing centers.  These boards consist of at least three disease-specific clinician-scientists who are experts in the target disease(s).  The intent is for CCBs to provide advice and insight into the needs and barriers regarding resource and personnel allocations as well as scientific advice as needed to help the centers reach their translational goals.  Each CCB reports directly to the NIH project team.

Translational Path

In 2011, the PIs of the NDCs worked with their CCBs to precisely define their translational goals and the translational research path needed to reach those goals by the end of the initiative in 2015.  To facilitate this, the NIH project team asked them to develop critical decision points along their path.  These critical decision points differ from distinct milestones because they may be adjusted based on successes, challenges, barriers, and progress.  Similarly, the timing of these decision points may be revised as the centers progress.  Research progress and critical decision points are revisited several times a year by the CCB and the NIH team, and when a decision point is reached, next steps are re-examined for relevance, feasibility and timing.

Transition plan

Throughout the program, various projects have been spun off of work at all the centers and most have received funding from other sources.  This was by design as work at each center has been shifting from basic science to translational studies.  Centers will not be supported by the common fund after 10 years.  It is expected that work at the centers will be more appropriately funded by other sources.  Pre-clinical targets will likely be developed, and the work at each center will be focused on a specific disease so the work will need to transition out of the experimental space of the common fund.  

Support for the NIH Nanomedicine Initiative is provided by the NIH Common Fund, and a team of staff members from across the NIH oversees the program.  You may direct questions or comments on the NIH Nanomedicine Initiative to Dr. Richard S. Fisher, Nanomedicine Project Team Leader (nano@nih.gov).

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