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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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Assessment of the
SBIR and STTR
Programs at the National Institutes of Health

Committee on the Assessment
of the SBIR and STTR Programs at NIH

Board on Science, Technology, and Economic Policy

Policy and Global Affairs

A Consensus Study Report of

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by a contract between the National Academy of Sciences and the National Institutes of Health (HHSN263201800029I, Order No. 75N98019F00860). 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: 978-0-309-27175-2
International Standard Book Number-10: 0-309-27175-4
Digital Object Identifier: https://doi.org/10.17226/26376

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Copyright 2022 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. https://doi.org/10.17226/26376.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
×

Image

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. Marcia McNutt 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. John L. Anderson 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 National 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.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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COMMITTEE ON THE ASSESSMENT OF THE SBIR AND STTR PROGRAMS AT NIH

Maryann P. Feldman, Co-Chair, University of North Carolina at Chapel Hill

Scott Stern, Co-Chair, Massachusetts Institute of Technology

Gavi Begtrup, Eccrine Systems, Inc.

Emily Cox Pahnke, University of Washington

Joshua Graff Zivin, University of California, San Diego

Amol M. Joshi, Wake Forest University

Alicia Löffler, Northwestern University

Amalia Miller, University of Virginia

Mary Pat Moyer (NAE), INCELL Corporation, LLC

Kyle Myers, Harvard Business School

Phillip Phan,* Johns Hopkins University

Bhaven Sampat, Columbia University

Stephanie Shipp, University of Virginia, Biocomplexity Institute

Clay B. Thorp, Hatteras Venture Partners

Dashun Wang, Northwestern University

*Resigned from the committee effective August 14, 2020.

STUDY STAFF

Gail Cohen, Study Director

Meghan Ange-Stark, Associate Program Officer (through July 2021)

Sophie Billinge, Senior Program Assistant

David Dierksheide, Program Officer

Frederic Lestina, Research Associate (through September 2020)

Clara Savage, Senior Finance Business Partner

CONSULTANTS

Evan E. Johnson, Principal Consultant

Lauren Lanahan, Consultant

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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BOARD ON SCIENCE, TECHNOLOGY, AND ECONOMIC POLICY

Adam B. Jaffe, Chair, Brandeis University

Noël Bakhtian, Lawrence Berkeley National Laboratory

Jeff Bingaman, Former U.S. Senator, New Mexico

Brenda J. Dietrich (NAE), Cornell University

Brian G. Hughes, HBN Shoe, LLC

Adriana Kugler, Georgetown University

Arati Prabhakar (NAE), Founder and CEO, Actuate

Paula E. Stephan, Georgia State University

Scott Stern, Massachusetts Institute of Technology

John C. Wall (NAE), Cummins, Inc. (Retired)

John L. Anderson (NAE), Ex Officio Member, National Academy of Engineering

Victor J. Dzau (NAM), Ex Officio Member, National Academy of Medicine

Marcia McNutt (NAS/NAE), Ex Officio Member, National Academy of Sciences

STAFF

Gail Cohen, Director

Meghan Ange-Stark, Associate Program Officer (through July 2021)

Sophie Billinge, Senior Program Assistant

David Dierksheide, Program Officer

Frederic Lestina, Research Associate (through September 2020)

Clara Savage, Senior Finance Business Partner

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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Preface

The Small Business Innovation Research (SBIR) program has become the largest and most comprehensive public research and development funding program for small business research in the United States, and indeed has been emulated by other countries. An underlying tenet of the SBIR program, and the related Small Business Technology Transfer (STTR) program, is that small and young firms are an important source of new ideas that provide the basis for technological innovation, productivity increases, and subsequent economic growth. Predicated on the observation that it is difficult for small and young firms to find financial support for their ideas, the SBIR/STTR programs have become known as America’s Seed Fund. Yet this characterization captures only one dimension of the legislative objectives and operation of the program. By involving qualified small businesses in the nation’s research and development efforts, SBIR/STTR awards stimulate the development of innovative technologies, help move research closer to the market, and address the needs of citizens underserved as a result of limited market incentives. Equally important, the SBIR/STTR programs aim to help federal agencies fulfill their missions and objectives, and provide a pathway for firms owned by women and socially or economically disadvantaged persons.

This report is the result of a request by Congress for an assessment of the SBIR/STTR programs at each of the principal agencies that conduct or fund research and development activities across the federal government. Specifically, this report focuses on the operation and performance of the SBIR/STTR programs across the National Institutes of Health (NIH), and so offers a timely opportunity to assess the programs in a holistic manner. Most notably, the committee convened by the National Academies of Sciences, Engineering, and Medicine to carry out this study undertook a detailed assessment of the process by which SBIR and STTR awards are made across the 24 NIH institutes and centers that participate in the programs, a survey of the landscape of awards that have been granted (broken down by geography, gender, and socioeconomic characteristics, as well as areas of research), and a detailed quantitative analysis examining the innovation and commercialization outcomes of firms participating in the

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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programs (compared with those that did not receive an award or did not participate in the programs). Collectively, these analyses, documented in this report, are intended to offer a more comprehensive and precise assessment of the SBIR and STTR programs than has been provided in previous studies of this agency carried out by the National Academies. Here we highlight three broad thematic conclusions.

First, the NIH SBIR/STTR programs are a critical element—but only one element—within the broader U.S. health and life sciences innovation system. Specifically, the effectiveness of the life sciences innovation system depends on a productive interplay among research that is publicly funded (particularly through the overall NIH budget), research conducted within public research institutions (most notably universities and academic medical centers) as well as within NIH, and the critical role played by the private sector (including both large and small and both young and old companies). Within that system, the NIH SBIR/STTR programs provide a critical and dedicated channel through which small and young firms are able to contribute in a meaningful and sustained way to research and innovation aimed at advancing life sciences innovation and ultimately health outcomes.

Second, the effectiveness of the SBIR/STTR programs depends importantly on the operational means by which the programs are administered within NIH. This report focuses significant attention on assessing the operational performance of the programs across the 24 participating institutes and centers, including the community outreach, reviewer selection, review, and postaward processes. Based on this assessment, the report offers suggestions for improving the program operations to make better use of the public’s investment.

Third, we believe that the NIH SBIR/STTR programs are best understood on their own terms. By statute, the SBIR program is a “small business innovation research” program. While the report draws comparisons between outcomes from the Research Project Grant (R01) and SBIR/STTR programs, it is important to understand the particular needs of the innovative small firms targeted by the NIH SBIR and STTR programs. Given that these programs are intended to stimulate technological innovation by such firms that is directly linked to the broader mission needs of the Department of Health and Human Services, the report considers both traditional innovation metrics (such as patents and other markers of early-stage commercialization) and the drugs and devices that are linked to SBIR/STTR awards.

We would also like to highlight three central takeaways from the report.

First, the committee found quantitative evidence that the NIH SBIR/STTR programs fulfill their broad missions by funding U.S. small businesses to conduct high-quality and commercially relevant life sciences biomedical research that contributes to U.S. leadership in the life sciences innovation system.

Second, while the programs are to be commended for this role, their administration is both unnecessarily complex and not timely enough to serve the unique needs of small and young innovation-driven life sciences businesses.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
×

There is significant heterogeneity in the outreach and selection processes across the 24 distinct SBIR/STTR programs, leading to significant access and administration barriers for small and young firms. Moreover, despite significant improvements in the timeliness of notification and issuance of awards in other agencies’ SBIR/STTR programs, the significant length of time that elapses before NIH SBIR/STTR awardees are notified of and receive their awards is an important barrier to the programs achieving their objectives. The committee therefore recommends that Congress consider authorizing a meaningful pilot study that would allow the NIH programs to make their processes more timely and so enhance their ability to meet the needs of small and young businesses.

Finally, the NIH Small Business Education and Entrepreneurial Development (SEED) Office coordinated with other parts of NIH on the committee’s request for nonpublic data, including data that allowed the committee to assess innovation and commercialization outcomes for both firms that received an award and those that applied for but did not receive an award. While these detailed data did allow the committee to undertake a holistic yet quantitative analysis of the program outcomes, the programs’ effectiveness is likely to be improved over time through a high level of commitment to data transparency and (appropriately protected) access by independent researchers and subsequent National Academies consensus committees.

ACKNOWLEDGMENTS

We would like to express our appreciation for insights, information, experiences, and perspectives provided by invited speakers during the conduct of this study. We recognize the considerable efforts made by NIH, especially staff in the SEED Office, who both facilitated access to appropriate staff within NIH and coordinated the committee’s requests for information, with appropriate safeguards, that made this assessment robust. The committee also wants to thank Evan Johnson, principal consultant, and Lauren Lanahan for their invaluable contributions of research and technical assistance in the preparation of this report. We would like to thank Jorge Guzman for his expertise in and guidance with the Startup Cartography Project. Contributions from University of North Carolina at Chapel Hill undergraduate students Nathan Alexander and Zainab Maniya, and Massachusetts Institute of Technology undergraduate Michael Carolan advanced our work. We also thank the production staff for their assistance in preparing this report for publication. Finally, we would particularly like to recognize the leadership of Gail Cohen and the contributions of the National Academies staff, especially Meghan Ange-Stark, David Dierksheide, and Sophie Billinge.

Maryann P. Feldman Scott Stern
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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Acknowledgment of Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report: Case Cortese, California Institute of Technology; Timothy Folta, University of Connecticut; Sherry Glied, New York University; Anna Goldstein, University of Massachusetts; Lawrence Goldstein, University of California, San Diego; Melissa Graebner, University of Illinois; Nichole Mercier, Washington University in St. Louis; Todd Ponzio, Wake Forest Innovations; David Smelson, University of Massachusetts.

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by Philip Neches, California Institute of Technology. He was responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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List of Acronyms

AANAPISI

Asian American, Native American, and Pacific Islander–serving institution

AAP

Applicant Assistance Program

AI

artificial intelligence

ARRA

American Recovery and Reinvestment Act

BLA

biologics license application

CAP

Commercialization Accelerator Program

CARE

Connecting Awardees with Regulatory Experts

CRP

Commercialization Readiness Pilot

CSR

Center for Scientific Review

DOE

Department of Energy

DUNS

Dun & Bradstreet Data Universal Numbering System

EIR

Entrepreneur in Residence

ES

environmental science

FDA

Food and Drug Administration

FY

fiscal year

GAO

U.S. Government Accountability Office

GSA

General Service Administration

HBCUs

historically Black colleges and universities

HSI

Hispanic-serving institution

IC

institutes and centers

IDeA

Institutional Development Award Program

IP

intellectual property

IPO

initial public offering

IRG

Internal Review Group

K99/R00

Pathway to Independence Award program

MBDA

Minority Business Development Agency

MHS

Marine Hospital Service

mRNA

messenger RNA

MSI

minority-serving institution

NASEM

National Academies of Sciences, Engineering, and Medicine

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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NCAI

NIH Centers for Accelerated Innovations

NCATS

National Center for Advancing Translational Sciences

NCCIH

National Center for Complementary and Integrative Health

NCI

National Cancer Institute

NDA

new drug application

NEI

National Eye Institute

NHGRI

National Human Genome Research Institute

NHLBI

National Heart, Lung, and Blood Institute

NIA

National Institute on Aging

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIAID

National Institute of Allergy and Infectious Diseases

NIAMS

National Institute of Arthritis and Musculoskeletal and Skin Diseases

NIBIB

National Institute of Biomedical Imaging and Bioengineering

NICHD

National Institute of Child Health and Human Development

NIDA

National Institute on Drug Abuse

NIDCD

National Institute on Deafness and Other Communication Disorders

NIDCR

National Institute of Dental and Craniofacial Research

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases

NIEHS

National Institute of Environmental Health Sciences

NIGMS

National Institute of General Medical Sciences

NIH

National Institutes of Health

NIMH

National Institute of Mental Health

NIMHD

National Institute on Minority Health and Health Disparities

NINDS

National Institute of Neurological Disorders and Stroke

NINR

National Institute of Nursing Research

NLM

National Library of Medicine

NME

new molecular entity

NOSI

Notice of Special Interest

NSF

National Science Foundation

ORIP

Office of Research Infrastructure Programs

P.L.

public law

PAR

Program Announcement with Special Receipt, Referral, and/or Review Consideration

PAS

Program Announcement with Set-Aside Funds

PBI

predominately Black institution

PCR

polymerase chain reaction

PHS

U.S. Public Health Service

PI

principal investigator

PMA

Premarket Approval Application

POC

proof of concept

R/R&D

research or research and development

R&D

research and development

Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2022. Assessment of the SBIR and STTR Programs at the National Institutes of Health. Washington, DC: The National Academies Press. doi: 10.17226/26376.
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R01

Research Project Grant

REACH

Research Evaluation and Commercialization Hubs

RFA

Request for Applications

RFP

Request for Proposals

SAM

System for Award Management

SBA

Small Business Administration

SBC

small business concern

SBIR

Small Business Innovation Research

SCP

Startup Cartography Project

SDB

socially and economically disadvantaged small business

SED

socially and economically disadvantaged

SEED

Small Business Education and Entrepreneurial Development

SEPA

Science Education Partnership Award

SRO

scientific review officer

STEM

science, technology, engineering, and mathematics

STTR

Small Business Technology Transfer

TABA

Technical and Business Assistance

TCUs

tribal colleges and universities

URM

underrepresented minority

USC

United States Code

USPTO

United States Patent and Trademark Office

WIPO

World Intellectual Property Organization

WOSB

woman-owned small business

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The National Institutes of Health (NIH) asked the National Academies of Sciences, Engineering, and Medicine to conduct a quadrennial review of its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, in accordance with a legislative mandate. Using quantitative and qualitative analyses of data, this report reviews the operations and outcomes stemming from NIH's SBIR/STTR awards.

Drawing on published research and conducting new analyses based on both publicly available data and applicant data provided by NIH, Assessment of the SBIR and STTR Programs at the National Institutes of Health analyzes (1) the effectiveness of NIH's processes and procedures for selecting SBIR and STTR awardees; (2) the effectiveness of NIH's outreach to increase SBIR and STTR applications from small businesses that are new to the programs, from underrepresented states, and from woman-owned and minority-owned businesses; (3) collaborations between small businesses and research institutions resulting from the programs; and (4) a range of direct economic and health care impacts attributable to the programs.

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