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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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SBIR/
STTR
at the
National Institutes of Health

Committee on Capitalizing on Science, Technology, and Innovation:
An Assessment of the Small Business Innovation Research Program—
Phase II

Board on Science, Technology, and Economic Policy

Policy and Global Affairs

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THE NATIONAL ACADEMIES PRESS

Washington, DC

www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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THE NATIONAL ACADEMIES PRESS    500 Fifth Street, NW    Washington, DC 20001

This activity was supported by contract number HHSN263201200074I, Task Order HHSN26300029, with the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-37877-2
International Standard Book Number-10: 0-309-37877-X
DOI: 10.17226/21811

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
×

Committee on Capitalizing on Science, Technology, and Innovation:
An Assessment of the Small Business Innovation Research Program—
Phase II

Jacques S. Gansler (NAE), Chair
Roger C. Lipitz Chair in Public Policy and Private Enterprise
Director of the Center for Public Policy and Private Enterprise
School of Public Policy
University of Maryland

David Audretsch

Distinguished Professor

Ameritech Chair of Economic Development

Director of the Institute for Development Strategies

Indiana University

Gene Banucci*

Executive Chairman, ret.

ATMI, Inc.

(Member: 6/26/2009-4/23/2014)

Thomas J. Bond*

Grant and Proposal Director

Association for Manufacturing Technology

(Member: 6/26/2009-5/21/2014)

Michael Borrus

Founding General Partner

XSeed Capital

J. Michael Brick

Vice President and Co-Director of Survey Methods

Westat

Gail H. Cassell (NAM)

Senior Lecturer

Department of Global Health and Social Medicine

Harvard Medical School

M. Christina Gabriel

President

University Energy Partnership

Charles E. Kolb (NAE)

President and Chief Executive Officer

Aerodyne Research, Inc.

Virginia Lesser

Professor of Statistics

Department of Statistics

Director, Survey Research Center

Oregon State University

Henry Linsert, Jr.

Chairman and CEO

Columbia Biosciences Corporation

W. Clark McFadden II

Senior Counsel

Orrick, Herrington & Sutcliffe, LLP

_______________

*Not involved in the writing of this report.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
×

Duncan T. Moore (NAE)

Vice Provost for Entrepreneurship

Rudolf and Hilda Kingslake Professor of Optical Engineering

The Institute of Optics

University of Rochester

Linda Powers*

Managing Director

Toucan Capital Corporation

(Member: 6/26/2009-10/13/2011)

Donald Siegel

Dean and Professor

School of Business

University at Albany, SUNY

Jeffrey E. Sohl

Professor and Director of the Center for Venture Research

Peter T. Paul College of Business and Economics

University of New Hampshire

Tyrone C. Taylor

President

Capitol Advisors on Technology, LLC

John P. Walsh

Professor of Public Policy

School of Public Policy

Georgia Institute of Technology

Patrick H. Windham

Principal

Technology Policy International

Project Staff

Sujai J. Shivakumar

Study Director

David E. Dierksheide

Program Officer

Karolina E. Konarzewska

Program Coordinator

(through September 2015)

Gail E. Cohen

Board Director

Frederic A. Lestina

Senior Program Assistant

Natacha R. Montgomery

Senior Program Assistant

(through October 2015)

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
×

For the National Academies of Sciences, Engineering, and Medicine, this project was overseen by the Board on Science, Technology, and Economic Policy (STEP), a standing board established in 1991. The mandate of the Board on Science, Technology, and Economic Policy is to advise federal, state, and local governments and inform the public about economic and related public policies to promote the creation, diffusion, and application of new scientific and technical knowledge to enhance the productivity and competitiveness of the U.S. economy and foster economic prosperity for all Americans. The STEP Board and its committees marshal research and the expertise of scholars, industrial managers, investors, and former public officials in a wide range of policy areas that affect the speed and direction of scientific and technological change and their contributions to the growth of the U.S. and global economies. Results are communicated through reports, conferences, workshops, briefings, and electronic media subject to the procedures of the Academies to ensure their authoritativeness, independence, and objectivity. The members and staff of the STEP Board* are listed below:

Richard K. Lester, Chair

Japan Steel Industry Professor and Department Head

Department of Nuclear Science and Engineering

Massachusetts Institute of Technology

Jeff Bingaman

Former U.S. Senator, New Mexico

U.S. Senate

Ellen R. Dulberger

Managing Partner

Dulberger Enterprises, LLC

Alan M. Garber (NAM)

Provost

Harvard University

Ralph E. Gomory (NAS/NAE)

Research Professor

IOMS Department

Stern School of Business

New York University

Michael Greenstone

The Milton Friedman Professor in Economics and the College

Director, Energy Policy Institute at Chicago

Department of Economics

The University of Chicago

John L. Hennessy (NAS/NAE)

President

Stanford University

David T. Morgenthaler

Founder

Morgenthaler Ventures

Luis M. Proenza

President Emeritus

University of Akron

Kathryn L. Shaw

Ernest C. Arbuckle Professor of Economics

Stanford Graduate School of Business

Stanford University

_______________

* As of October 2015.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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Laura D’Andrea Tyson

Professor of Business Administration & Economics

Director, Institute for Business & Social Impact

Haas Business & Public Policy Group

University of California, Berkeley

Jay Walker

Chairman

Patent Properties, Inc.

STEP Staff

Gail E. Cohen

Director

Paul T. Beaton

Senior Program Officer

Aqila A. Coulthurst

Associate Program Officer

Sujai J. Shivakumar

Senior Program Officer

David E. Dierksheide

Program Officer

Frederic A. Lestina

Senior Program Assistant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
×

Preface

Today’s knowledge economy is driven in large part by the nation’s capacity to innovate. One of the defining features of the U.S. economy is a high level of entrepreneurial activity. Entrepreneurs in the United States see opportunities and are willing and able to assume risk to bring new welfare-enhancing, wealth-generating technologies to the market. Yet, although discoveries in areas such as genomics, bioinformatics, and nanotechnology present new opportunities, converting these discoveries into innovations for the market involves substantial challenges.1 The American capacity for innovation can be strengthened by addressing the challenges faced by entrepreneurs. Public-private partnerships are one means to help entrepreneurs bring new ideas to market.

The Small Business Innovation Research (SBIR) program is one of the largest examples of U.S. public-private partnerships. An underlying tenet of the program is that small businesses are a strong source of new ideas, and therefore economic growth, but that it is difficult to find financial support for these ideas in the early stages of their development. The SBIR program was established in 1982 to encourage small businesses to develop new processes and products and to provide quality research in support of the U.S. government’s many missions. By involving qualified small businesses in the nation’s research and development (R&D) effort, SBIR grants stimulate innovative technologies to help federal agencies meet their specific R&D needs in many areas, including health, the environment, and national defense. The Small Business Technology Transfer (STTR) Program was created in 1992 by the Small Business Research and Development Enhancement Act to

_______________

1See L. M. Branscomb, K. P. Morse, M. J. Roberts, D. Boville, Managing Technical Risk: Understanding Private Sector Decision Making on Early Stage Technology Based Projects, Gaithersburg, MD: National Institute of Standards and Technology, 2000.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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expand joint venture opportunities for small businesses and nonprofit research institutions by requiring small business recipients to collaborate formally with a research institution. This report provides an analysis of how well the NIH SBIR and STTR programs are fulfilling their congressionally mandated goals.

In the SBIR Reauthorization Act of 2000, Congress tasked the National Research Council (NRC)2 with undertaking a “comprehensive study of how the SBIR program has stimulated technological innovation and used small businesses to meet federal research and development needs” and with recommending further improvements to the program.3 In the first round of this study, an expert committee prepared a series of reports from 2004 to 2009 on the Small Business Innovation Research program at the Department of Defense (DoD), the National Institutes of Health (NIH), the National Aeronautics and Space Administration (NASA), the Department of Energy (DoE), and the National Science Foundation (NSF)—the five agencies responsible for 96 percent of the program’s operations.4 When reauthorizing the SBIR and STTR programs in 2011, Congress expanded the study mandate to include a review of the STTR program.5

Building on the outcomes from the first round, this second round examines topics of general policy interest that emerged during the first round as well as topics of specific interest to individual agencies. The results will be published in reports of agency-specific and program-wide findings on the SBIR and STTR programs to be submitted to the contracting agencies and Congress. In partial fulfillment of these objectives, this volume presents the committee’s review of the NIH SBIR/STTR program operations.6

PROJECT ANTECEDENTS

The current assessment follows directly from an earlier analysis of public-private partnerships by the Board on Science, Technology, and Economic Policy (STEP). From 1990 to 2005, the Committee on Government-Industry Partnerships prepared 11 volumes reviewing the drivers of cooperation among industry, universities, and government; operational assessments of current programs; emerging needs at the intersection of biotechnology and information technology;

_______________

2Effective July 1, 2015, the institution is called the National Academies of Sciences, Engineering, and Medicine. References in this report to the National Research Council are used in an historic context identifying programs prior to July 1.

3See the SBIR Reauthorization Act of 2000 (H.R. 5667, Section 108).

4For a list of publications from the first round review, see Chapter 1, Box 1-1. For an overview of the programs at the five leading SBIR agencies, see National Research Council, An Assessment of the SBIR Program, Washington, DC: The National Academies Press, 2008. See also National Research Council, An Assessment of the SBIR Program at the National Aeronautics and Space Administration, Washington, DC: The National Academies Press, 2009. The committee also prepared reports on the SBIR program at DoD, DoE, NIH, and NSF.

5SBIR/STTR Reauthorization Act of 2011, P.L. 112-81, December 31, 2011.

6The formal Statement of Task is presented in Chapter 1 of this report.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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the current experience of foreign government partnerships and opportunities for international cooperation; and the changing roles of government laboratories, universities, and other research organizations in the national innovation system.7

This analysis of public-private partnerships includes two published studies of the SBIR program. Drawing from a 1998 workshop, the first report, The Small Business Innovation Research Program: Challenges and Opportunities, examined the program’s origins and identified operational challenges to its future effectiveness.8 The report also highlighted the relative paucity of research on the SBIR program.

After the release of this initial report, the DoD asked the committee to compare the operations of its Fast Track Initiative with those of its regular SBIR program. The resulting report, The Small Business Innovation Research Program: An Assessment of the Department of Defense Fast Track Initiative, relying on case study and survey research, found that the DoD SBIR program was achieving its legislated goals. The report also found that the Fast Track Initiative was achieving its objective of greater commercialization and recommended that it be continued and expanded where appropriate.9 The report recommended that the SBIR program overall would benefit from further research and analysis, a recommendation subsequently adopted by Congress.

ACKNOWLEDGMENTS

On behalf of the National Academies of Sciences, Engineering, and Medicine, we express our appreciation for and recognition of the valuable insights and close cooperation extended by NIH staff, the survey respondents, and case study interviewees, among others. The committee gives particular thanks to its lead researcher, Robin Gaster of Innovation Competitions LLC, and to Peter Grunwald of Grunwald Associates LLC, which conducted the surveys and described the results presented in this volume. Rosalie Ruegg of TIA Consulting provided valuable assistance in revising the draft report in light of comments received from reviewers. The presentation of the report has also been enhanced by the diligent copyediting of Nancy Tuvesson. David Dierksheide of the STEP staff is especially recognized for his dedication and important contributions to the operation of this study and the preparation of this report.

_______________

7For a summary of the topics covered and main lessons learned, see National Research Council, Government-Industry Partnerships for the Development of New Technologies: Summary Report, Washington, DC: National Academy Press, 2002.

8See National Research Council, The Small Business Innovation Research Program: Challenges and Opportunities, Washington, DC: National Academy Press, 1999.

9See National Research Council, The Small Business Innovation Research Program: An Assessment of the Department of Defense Fast Track Initiative, Washington, DC: National Academy Press, 2000.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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ACKNOWLEDGMENT OF REVIEWERS

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Academies of Sciences, Engineering, and Medicine’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We wish to thank the following individuals for their review of this report: Wendy Baldwin, Population Reference Bureau; Richard Bendis, BioHealth Innovation, Inc.; Georges Benjamin, American Public Health Association; Marjorie Bowman, Wright State University; Erik Fatemi, Cornerstone Government Affairs; Robert Genco, State University of New York at Buffalo; Michael McGeary, Institute of Medicine (retired); Mark McLaughlin, Modulation Therapeutics; John Scott, Dartmouth College; and William Sly, St. Louis University.

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Edwin Przybylowicz, Eastman Kodak Company (retired), and Irwin Feller, The Pennsylvania State University. Appointed by the Academies, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Jacques S. Gansler Sujai J. Shivakumar
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. SBIR/STTR at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/21811.
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The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs provide federal research and development funding to small businesses. In 2008, the National Research Council completed a comprehensive assessment of the SBIR and STTR programs. The first-round study found that the programs were "sound in concept and effective in practice." Building on the outcomes from the Phase I study, this second phase examines both topics of general policy interest that emerged during the first phase and topics of specific interest to individual agencies, and provides a second snapshot to measure the program's progress against its legislative goals.

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