Five Year Plan

Subcommittee on Biotechnology

Note: the Five Year Plan has been superseded by the MATES IWG Terms of Reference

The term “Tissue Engineering” was coined at an NSF-sponsored meeting in 1987(1). At a subsequent NSF sponsored workshop, Tissue Engineering was defined as “the application of principles and methods of engineering and life sciences toward fundamental understanding of structure-function relationships in normal and pathological function” (2). This multidisciplinary technology involves the development of biological substitutes for the repair or regeneration of tissue or organ function and has led to a broad range of products. To date, some of these products have been approved by the U.S. Food and Drug Administration while many are under either preclinical investigation or regulatory evaluation (3, 4). Since 1990, the Tissue Engineering industry has grown to become more than a $3.5 billion worldwide R&D effort by over seventy biotechnology start-ups and business units (5, 6). Less than ten percent of this effort is funded by the U.S. government, but this contribution is rapidly increasing. The Multi-Agency Tissue Engineering Science (MATES) Working Group is proposed as a means for the various federal agencies involved in Tissue Engineering to stay informed of each other’s activities and better coordinate their efforts.

Goals of the MATES Working Group

Facilitate communication across departments/agencies by regular information exchanges and a common web site.
Enhance cooperation through co-sponsorship of scientific meetings and workshops, and facilitation of the development of standards.
Monitor technology by undertaking cooperative assessments of the status of the field.
Provide for support of Tissue Engineering research through an Interagency Announcement of Opportunities in Tissue Engineering.

Participating Agencies

Department of Commerce (NIST)
Department of Energy (DOE)
Department of Defense (DARPA)
Department of Health and Human Services (FDA, NIH)
National Aeronautics and Space Administration (NASA)
National Science Foundation (NSF)

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Relationship to Agency Mission

The early practice of medicine relied largely on palliative management of pain and distress. As science contributed to this art, pharmaceuticals which could change the body’s physiology to correct imbalances, vaccines to prevent communicable diseases, or surgery to remove diseased parts became, and in large part remain, the standard therapy. Furthermore, until very recently, most scientists and clinicians believed that damaged or diseased human tissue could only be replaced by donor transplants or with totally artificial parts. A more advanced approach in which organs or tissues can be replaced or regenerated for more targeted solutions is the promise of Tissue Engineering. This approach also responds to clinical needs, which cannot be met by individual organ donation alone.

As a result, support of Tissue Engineering is directly related to:

the NSF in its interests in science at the cutting edge, especially integration of diverse fields into new applications;
the mission of the NIH which is to improve the nation’s health through research;
DARPA which seeks for rapid and effective detection of and response to biological and chemical weapons;
NIST's mission of promoting U. S. economic growth by working with industry to develop and apply technology, measurements, and standards;
NASA in furthering its understanding of how life adapts to the rigors of space flight, and how space research provides novel applications in biomedical research;
the support for development of innovative technologies at the DOE National Laboratories;
FDA in its technology monitoring and assessment efforts and science-based product evaluation/review and approval process.

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Anticipated Synergies

Successful development of a tissue engineered product requires the integration of new knowledge across diverse fields such as materials science, cell biology, biochemistry, computing and imaging sciences, and engineering. The different departments and agencies proposed in the MATES Working Group have divergent missions, different foci, but frequently overlapping interests. As research and development of new therapies becomes increasingly expensive, it will be important to keep balanced portfolios and at the same time avoid duplicating support for research efforts when making funding decisions. The MATES group will keep communications brisk and timely to help agencies better track the total federal commitment in Tissue Engineering, thus contributing to the individual strategic funding decisions in these areas. Interagency research in Tissue Engineering will provide an opportunity for participating agencies to fund projects that they would not normally be able to support.

Development of consensus standards for this industry is another important element that could be facilitated by this group. NIST has a long history in this regard. The FDA is also keenly interested in the development of standards, consistent with the Food and Drug Administration Modernization Act (FDAMA) of 1997 that contains provisions for standards development for device products under the FDA’s jurisdiction in order to streamline product approval. Both NIST and FDA are active participants in the ASTM’s current effort to develop Tissue Engineering standards and the USP’s Cell and Gene Therapy initiative. The MATES Working Group could offer a vehicle for other agency participation.

The MATES Working Group could also allow joint sponsorship of activities or events that promote the entire science of Tissue Engineering, thus applying maximum leverage of each agency’s commitment.

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Proposed Activities

Since a primary goal of the group will be one of communication, the objective will be to meet periodically throughout the year. Each participating agency will host the meeting on a rotating basis, and deliver periodic reports on tissue engineering activities within their agency. Representatives will also discuss possible jointly scheduled activities, such as scientific meetings or commissioned studies. The Chair will rotate periodically through participating agencies.

As a part of their effort to increase and integrate communication, the MATES Working Group has set up a common web site to help academic and industry participants in this newly coalescing field find the most up-to-date information about federal funding, scientific meetings, regulatory guidance and standards development, and other information in a single search. It could also be expanded to house a bulletin board where prospective collaborators might find each other. In other words, such a web site will provide “one-stop shopping” for academe, industry, and the involved federal agencies. This web site has been co-developed by the MATES Working Group members, and is maintained through the NSF.

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Funding

The MATES Working Group is proposed as a mechanism for communications about existing funding efforts across agencies. Future funding suggestions could emerge from studies supported by MATES Working Group members, the results of which will be shared by all members. Thus, interagency funding initiatives would also spring from the MATES Working Group. Representatives from the various participating agencies would need release time to organize/attend MATES Working Group activities throughout the year. Though some programs like the Advanced Technology Program, would not be able to participate in an interagency funding initiative in the traditional way, MATES will continue to support communications about funding opportunities like the ATP as they are announced. These types of interagency funding initatives have historically worked well in other multidisciplinary areas like Metabolic Engineering and Plant Sciences to facilitate quality peer review and interagency coordination for the best use of federal funding resources.

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Timeliness and Responsiveness of Participating Agencies

The cumulative Federal Government investments with sustained efforts in Tissue Engineering and related activities through 2000 have totaled $24.7 million from NSF, $80.8 million from NIH, and $59.0 million from DARPA. In addition, FDA spent $15.75 million in 2001, the result of several years of increasing FDA involvement in the field. NIST's current annual investment is approximately $2.5 million of appropriated funds in NIST Laboratory work related to tissue engineering, with approximately an additional $600 thousand of NIST work funded by other agencies. Within the Advanced Technology Program at NIST, Tissue Engineering continues to grow with industry interest, 20 projects totaling $39.6 million in ATP funding have been completed as of the end of FY2001, and 30 projects with $58.0 million in total ATP funding are currently active in FY2002. While there is no formal program in Tissue Engineering at the National Aeronautics and Space Administration (NASA) or the Department of Energy (DOE), many projects in these agencies involve Tissue Engineering principles and practices. Examples are the multiple uses being found for the microgravity bioreactor developed at NASA. As technologies rapidly advance in so many areas of this new intersection of engineering and biology, the research dollars will surely increase, as they have across the Government since 1988. New developments in combinatorial methods to discover new biomaterials, cell cycle control and stem cell biology, responsiveness of cells in their extra-cellular matrix, mass culture of cells with defined phenotypes, gene expression profiles in response to cytokines, and so much more will keep scientists and those who fund them actively engaged for the foreseeable future.

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References

Heineken FG and Skalak R. Tissue Engineering: A Brief Overview, Journal of Biomechanical Engineering 113, 111 (1991).
Skalak R and Fox CF, eds. Tissue Engineering, Proceedings for a Workshop held at Granlibakken, Lake Tahoe, California, February 26-29, 1988, Alan Liss, New York.
Hellman KB, Knight E, and Durfor CN. Tissue Engineering: Product Applications and Regulatory Issues, pp. 341-366, Frontiers in Tissue Engineering, Charles W. Patrick, Antonio G. Mikos, and Larry V. McIntire (eds.), Amsterdam, Elsevier Science (1998).
Hellman KB., Solomon RR, Gaffey C, Durfor C and Bishop JG, III. Tissue Engineering: Regulatory Considerations, Principles of Tissue Engineering, 2nd Edition, Robert Lanza, Robert Langer, and Joseph P. Vacanti (eds.), Academic Press, San Diego, California (in press).
Lysaght MJ, Nguy AS, and Sullivan K. An Economic Survey of the Emerging Tissue Engineering Industry, Tissue Engineering: 4, 231 (1998).
Lysaght MJ, and Reyes J. The Growth of Tissue Engineering, Tissue Engineering:

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Questions? Comments? Contact the MATES IWG