Assessment of the SBIR and STTR Programs at the National Institutes of Health (2022) / Chapter Skim
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5 Impact of the NIH SBIR/STTR Programs
5 Impact of the NIH SBIR/STTR Programs
Pages 145-218
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From page 145... ...
Entrepreneurial Quality Index. In addition, the committee relied on information provided by NIH on all SBIR/STTR applicants from 1995 to 2019 and used publicly available data in the NIH RePORTER database.
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From page 146... ...
INNOVATION AND COMMERCIALIZATION OUTCOMES One of the challenges of assessing commercialization, not just with regard to the SBIR/STTR programs at NIH or elsewhere, is the difficulty of systematically observing links between federally funded research and development (R&D) and any commercialization outcomes.
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From page 147... ...
Drugs@FDA: FDA-Approved Drugs. 5 Additionally, Annex Table 5-2.1 does not include non-NME new drug approvals; thus, it does not include new dosage forms and other line extensions associated with SBIR/STTR-funded firms, such as Adasuve and Vivitrol.
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From page 148... ...
These firms contribute to the overall knowledge stock; advance the careers of life sciences researchers, who may find new opportunities to commercialize their research; and enable innovations in other firms through knowledge spillovers. To provide a more complete picture of the impact of NIH SBIR/STTRawardee firms on early-state biotech and medtech innovation, the committee reviewed three outcomes tracked by NIH in its RePORTER database: publications, patents, and clinical studies citing support from projects.9 Note that the NIH-tracked outcomes are reported at the award level, not the firm level.
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. Appearing to reflect this gap, the RePORTER database cautions that "not all recipients of NIH funding are compliant with the iEdison reporting requirements, particularly after their NIH support has ended."11 The committee analyzed the reported publications, patents, and clinical trials of NIH Phase II awardees who received their first Phase II award between 2010 and 2015 and found that 6.5 percent of those awardees reported a patent, 42 percent reported a publication, and 7.4 percent reported a clinical study.
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Differences across ICs While the award-level analyses in the previous section suggest that publications are a more common reported outcome of SBIR/STTR awards relative to patents or clinical trials overall, breaking these data down by IC reveals interesting variation, reflecting the different foci of the ICs and the types of outputs produced by their SBIR/STTR awardees. Figure 5-1 shows a breakdown of the share of all NIH SBIR/STTR grants associated with reported patents and clinical trials for each of the 20 ICs with the largest SBIR/STTR programs.
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. SOURCE: Committee calculations based on data in NIH RePORTER.
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) , the largest shares of patents among their awardees are in the patent class of medical technology, while for other ICs (National Institute of General Medical Sciences [NIGMS]
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National Heart, Lung, and Blood Institute NHLBI Medical technology (.37) 148 Pharmaceuticals (.26)
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WIPO = World Intellectual Property Organization. SOURCE: Committee calculations based on NIH RePORTER using all years available; WIPO patent classes.
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The gold standard for causal estimation is the randomized controlled trial, in which otherwise identical participants are randomized between treatment and control groups and outcomes are compared across the two groups. When such an approach is infeasible, as is the case when studying the SBIR/STTR programs, quasi-experimental approaches are used to create comparisons that simulate randomization.
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From page 156... ...
Ex ante Quality of Firms Participating in NIH's SBIR/STTR Programs In the context of the constraints described above, the committee began its analysis by first examining the "quality" of NIH SBIR/STTR participants. To measure a firm's propensity for high growth, the committee drew on data from the Startup Cartography Project (SCP)
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NOTES: Quality index is from the Startup Cartography Project Entrepreneurial Quality Index. Observations are firm-level.
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For FIGURE 5-2 Quality of first-time applicants to NIH's SBIR/STTR programs over time, by year of first application. SOURCE: Committee analysis using NIH-provided application information and the Startup Cartography Project Entrepreneurial Quality Index.
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From page 159... ...
Similarly, 4 percent of unfunded SBIR/STTR applicants have a patent in a given year, compared with 9 percent of funded firms. Funded firms are also more likely to attract venture capital funding (4 percent compared with 2 percent of unfunded firms)
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TABLE 5-3 Firm-year Outcome Summary Statistics for Fiscal Years 2000–2018, NIH SBIR/STTR Applicants, 160 Following First Application Decision Summary Statistics for Nonzero Outcomes Percent with Positive Decision on Firm's Number of Nonzero Standard Outcome First Application Observations Outcomes Median Mean Deviation VC Funding Unfunded 136,737 2 $3,500,000 $11,290,008 $28,981,228 Funded 24,811 4 $5,000,000 $13,679,346 $22,453,088 Publication Unfunded 136,737 11 0.58 1.55 4.95 Funded 24,811 26 0.75 1.39 2.4 Trademark Unfunded 136,737 4 1 2.11 2 Funded 24,811 6 1 2.02 1.77 Patent Unfunded 136,737 4 1 2.31 4.3 Funded 24,811 9 1 2.35 3.25 Clinical Trial Unfunded 136,737 2 1 1.67 1.52 Funded 24,811 3 1 1.52 1.1 510(k) Unfunded 136,737 1 1 1.52 1.37 Funded 24,811 1 1 1.45 0.99 Device PMA Unfunded 136,737 <1 1 1 0 Funded 24,811 <1 1 1 0 Drug Unfunded 136,737 <1 1 1 0 Approval Funded 24,811 <1 1 1 0
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PMA = Premarket Approval Application; VC = venture capital. SOURCES: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data, Crunchbase, PubMed, U.S.
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From page 162... ...
Put another way, focusing only on firms applying for the first time to the NIH SBIR/STTR programs, and after including a measure to control for the growth potential of firms (measured using data from before the application to the SBIR/STTR program) , there was no statistically significant difference in outcomes between those firms that received an SBIR/STTR award on their first application and those that applied to the programs but were rejected during that application cycle.
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Specifically, this series of figures shows venture capital funding, publications, trademarks, patents, and clinical trials, comparing firms with first applications that were not discussed, firms with first applications that were discussed but not funded, firms with funded applications falling in the bottom 90 percent of support from the programs from 1995 to 2019, and firms with funded applications falling in the top 10 percent of support from the programs during those same years. These are annual rates of outcomes, where the years on the x-axes refer to years relative to a firm's first SBIR/STTR application.
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b Discussed Only Not Discussed 0.5 (Millions of Dollars) for Year‐specific Fixed Effects Received, per Firm, after Controlling Average Annual Venture Capital Funding Number of Years Relative to First Application FIGURE 5-4 Venture capital: Trends in aggregated outcome index for NIH SBIR/STTR applicants, by first application decision outcome.
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From page 165... ...
b Discussed Only Not Discussed Average Annual Number of Publications, per Firm, after Controlling for Year‐specific Fixed Effects Number of Years Relative to First Application FIGURE 5-5 Publications: Trends in aggregated outcome index for NIH SBIR/STTR applicants, by first application decision outcome. SOURCE: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data and PubMed data.
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b Discussed Only Not Discussed year‐specific fixed effects Average Annual Number for Year‐specific Fixed Effects Average outcome after controlling for of Trademarks, per Firm, after Controlling Number of Years Relative to First Application FIGURE 5-6 Trademarks: Trends in aggregated outcome index for NIH SBIR/STTR applicants, by first application decision outcome. SOURCE: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data and U.S.
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From page 167... ...
b Discussed Only Not Discussed specific Fixed Effects year‐specific fixed effects per Firm, after Controlling for Year‐ Average Annual Number of Patents, Average outcome after controlling for Number of Years Relative to First Application FIGURE 5-7 Patents: Trends in aggregated outcome index for NIH SBIR/STTR applicants, by first application decision outcome. SOURCE: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data and U.S.
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From page 168... ...
b Discussed Only Not Discussed specific Fixed Effects year‐specific fixed effects per Firm, after Controlling for Year‐ Average outcome after controlling for Average Annual Number of Clinical Trials, Number of Years Relative to First Application FIGURE 5-8 Clinical trials: Trends in aggregated outcome index for NIH SBIR/STTR applicants, by first application decision outcome. SOURCE: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data and data on clinical studies from ClinicalTrials.gov.
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From page 169... ...
Table 5-4 reports estimates for each of the eight outcomes, which were used to estimate eight separate regressions, along with the implied marginal costs based on those estimates. This table shows that increased funding allocated to an IC's SBIR/STTR programs would generate more future outcomes in the form of publications, patents, trademarks, clinical trials, and drug approvals.
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From page 170... ...
Dollars/outcome 4.54 0.715 1.53 -7.32 2.53 263.4 2,228 368.9 million million million million million million million Number of 760 760 760 760 760 760 760 760 observations Adjusted R2 0.62 0.92 0.69 0.83 0.80 0.72 0.19 0.19 SOURCE: Committee calculations based on fiscal year 2000–2018 NIH SBIR/STTR application data. NOTES: Observations are at the IC-year-group level, where the two groups are aggregations of all firms that either ever receive funding or never receive funding.
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. The estimates for clinical trials and drug approval outcomes are positive and statistically significant, suggesting that NIH's SBIR/STTR programs provide funding that helps firms make important strides in the testing and commercialization of medical therapies.
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From page 172... ...
Nonetheless, the lists of these outputs provide an overview of the product space for funded firms. Monitoring and tracking of trademarks could inform NIH's own collection of "success stories'' by linking the SBIR/STTR programs to products.19 The committee's analysis provides evidence that increases in SBIR/STTR funding allocations at the IC level led to statistically significant increases in publications, patents, clinical trials, and drug approvals.20 With the exception of the last of these measures, none has been directly validated as a "surrogate endpoint" or proxy for improved health outcomes.
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From page 173... ...
Updating these data in RePORTER, as well as augmenting such innovation and commercialization metrics as trademarks, 510(k) 's, and PMAs for SBIR and STTR awards, would help NIH understand the impact of its SBIR and STTR programs.
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Finding 5-3: The NIH SBIR/STTR programs are attracting applicants that are more likely to be high-growth companies relative to the general biotech startup population, and the quality of awardees has been increasing over time. Finding 5-4: NIH SBIR/STTR-funded firms do better than unfunded applicants on various commercialization metrics and outcomes.
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From page 175... ...
The PMA pathway is used for Class III devices -- those that "support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury." The committee collected information on PMAs for Class III medical devices from the FDA: https://www.fda.gov/medical-devices/device
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Clinical Trials The committee collected data on clinical trials from the Aggregate Analysis of ClinicalTrials.gov (AACT) database, which includes all studies registered in ClinicalTrials.gov.
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Startup Cartography Project Entrepreneurial Quality Index To create a proxy for firms' underlying quality, the committee relied on the Startup Cartography Project (SCP) Entrepreneurial Quality Index (Andrews et al., 2020)
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Alexion 1994 2007 Soliris eculizumab BLA Indicated for the treatment of Acq. by Pharmaceuticals 2006 paroxysmal nocturnal AstraZeneca, Cheshire, CT hemoglobinuria to reduce 2021 hemolysis.
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. Alexion 1994 2018 Ultomiris ravulizumab- BLA Indicated for the treatment of Acq.
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imaging of the 2010 Inc. brain to estimate beta-amyloid Philadelphia, PA neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD)
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BioMarin 1998 2018 Palynziq pegvaliase-pqpz BLA Indicated to reduce blood BMRN Pharmaceutical 2002 phenylalanine concentrations in Novato, CA adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.
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BioMarin 1998 2003 Aldurazyme laronidase BLA Indicated for patients with Hurler BMRN Pharmaceutical 2002 and Hurler-Scheie forms of Novato, CA Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms.
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. Corixa 1994 2003 Bexxar tositumomab, BLA Indicated for the treatment of Acq.
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Savella is not 2010 approved for use in pediatric patients. Diatide 1993 1998 AcuTect technetium Tc- NDA Indicated for scintigraphic Acq.
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1986 1998 Thyrogen thyrotropin alfa BLA Indicated for use as an adjunctive Acq. by Sanofi, Boston, MA 1990 diagnostic tool for serum 2011 thyroglobulin (Tg)
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. Genzyme Corp.
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Gilead Sciences 2000 2012 Stribild elvitegravir, NDA Indicated as a complete regimen GILD Foster City, CA 2004 cobicistat, for the treatment of HIV-1 emtricitabine, infection in adults who are tenofovir antiretroviral treatment-naïve. disoproxil fumarate (Continued)
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genotype 1 infection in adults. Gilead Sciences 2000 2015 Genvoya elvitegravir, NDA Indicated as a complete regimen GILD Foster City, CA 2004 cobicistat, for the treatment of HIV-1 emtricitabine, infection in adults and pediatric patients 12 years of age and older
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Gilead Sciences 2000 2016 Epclusa sofosbuvir and NDA Indicated for the treatment of GILD Foster City, CA 2004 velpatasvir adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection -- without cirrhosis or with compensated cirrhosis -- with decompensated cirrhosis, for use in combination with ribavirin.
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Gilead Sciences 2000 2020 Veklury remdesivir NDA Indicated for the treatment of GILD Foster City, CA 2004 coronavirus disease 2019 (COVID-19) requiring hospitalization in adults and pediatric patients (12 years of age and older and weighing at least 40 kg)
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1985 1996 CEA-Scan arcitumomab BLA Indicated for use in conjunction Acq. by Gilead Morris Plains, NJ 2013 with computerized tomography Sciences, 2020 scans to detect recurrent or metastatic colorectal cancer.
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MacroGenics, Inc. 2002 2020 Margenza margetuximab- BLA Margenza is indicated in MGNX Rockville, MD 2004 cmkb combination with chemotherapy, for the treatment of adult patients
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NPS Pharmaceuticals 1990 2015 Natpara parathyroid BLA Indicated as an adjunct to calcium Acq. by Shire, Salt Lake City, UT 1998 hormone and vitamin D to control 2015 hypocalcemia in patients with hypoparathyroidism.
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the management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Neurocrine 1994 2017 Ingrezza valbenazine NDA Indicated for the treatment of NBIX Biosciences, Inc.
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Orphan Medical 1996 1998 Sucraid sacrosidase BLA Indicated for treatment of the Acq. by Jazz Minnetonka, MN genetically determined sucrase Pharma, 2005 deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID)
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2000 2011 Adcetris brentuximab BLA Indicated for treatment of patients SGEN Bothell, WA 2005 vedotin with Hodgkin's lymphoma (HL)
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Seattle Genetics, Inc. 2000 2020 Tukysa tucatinib NDA Indicated in combination with SGEN Bothell, WA 2005 trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti HER2-based regimens in the metastatic setting.
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SOURCE: NIH RePORTER, Small Business Administration Awards Database, and FDA data.
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2008 System the anatomy for diagnosis and treatment Vista, CA Angel Medical 2001 2009 AngelMed Guardian System Implantable medical devices to detect 2015 N/A Systems, Inc. 2015 heart anomalies Eatontown, NJ Cardiofocus, Inc.
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1999 2001 Dexcom G4 Platinum Medical sensors to measure glucose 2012 DXCM San Diego, CA Contiuous Glucose content in human body Monitoring System Dexcom, Inc. 1999 2001 Dexcom STS Continous Medical sensors to measure glucose 2005 DXCM San Diego, CA Monitors content in human body Genzyme 1981 1988 FocalSeal-L Synthetic Polymerizable material for sealing air 1999 Acq.
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Glaukos, 1998 2002 Glaukos iStent Trabecular Ocular implants and devices for screening 2008 GKOS Corporation 2005 Bypass Stent Model and treating glaucoma San Clemente, CA GTS100R/L Hyperbranch 2003 2005 Adherus Autospray Dural Synthetic liquid hydrogel-based sealant to 2013 Acq. by Medical 2006 Sealant create watertight seal for surgical and Stryker, 2018 Technology, Inc.
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by St. Corporation 1998 Assist System pumps either pneumatically or Jude Medical, Pleasanton, CA electrically actuated 2015 Thoratec 1976 1985 HeartMate 3 Left Ventricular Heart assist devices, namely, blood 2016 Acq.
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2005 Newark, DE SOURCE: NIH RePORTER and Food and Drug Administration data.
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TABLE 5-2.3 Random Sample of NIH SBIR/STTR-Awarded Firms Linked to 510(k) Medical Devices SBIR/STTR Awards 204 Year (First funded year– Approval Publicly Company Name Founded Last funded year)
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[SMTI] acquired certain assets of Rochal Industries in 2021 Vidacare Corporation 1999 2004–2006 Humeral Head, Manual 2006 For emergency vascular N/A San Antonio, TX Driver access when standard venous Acquiring Co: access is not possible Teleflex [TFX]
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1991 1992–2000 Picosure Workstation 2018 Product for treating CYNO Bedford, MA pigmentary conditions, tattoo Acquiring Co: removal, and skin Hologic revitalization Year of Acquisition: 2017 Hologic sold Cynosure in 2019 InBios International, 1996 2000–2020 Cl Detect Rapid Test 2014 Product for rapid detection of N/A Inc. Leishmania species antigen in Seattle, WA ulcerative skin lesions Candela Corporation 1970 1983–2004 Candela Gentlemax 2014 Laser used to treat a variety of CLZR Wayland, MA Family Of Laser System dermatology conditions Merger Co: Syneron Medical [ELOS]
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viral RNA using real time RT-PCR Rochal Industries, 1986 2008–2020 Rochal Antimicrobial 2020 Management of ulcers, first- N/A LLC Wound Gel and second-degree burns, Sanara San Antonio, TX partial- and full-thickness MedTech Inc. wounds, large surface area [SMTI]
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Year of Acquisition: 2005 Genzyme 1981 1983–1997 Genzyme Osom 2006 Rapid diagnostic test for the GENZ Corporation Influenza A & B Test detection of influenza A and Acquiring Co: Boston, MA influenza B from nasal swab Sanofi-Aventis specimens Year of Acquisition: 2011 Cepheid 1996 1998–2006 Xpert Xpress Flu/Rsv, 2018 Rapid molecular testing for a CPHD Sunnyvale, CA Xpert Nasopharyngeal variety of sicknesses such as Acquiring Co: Sample Collection Kit, influenza and RSV Danaher Xpert Nasal Sample [DHR] Collection Kit, Year of Genexpert Xpress Ii, Acquisition: Genexpert Xpress Iv 2016 Lambda S.P.A.
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aureus and MRSA with Acquiring Co: results within an hour Danaher [DHR] Year of Acquisition: 2016 Intuitive Surgical, 1995 2004–2006 Da Vinci S/Si 2017 Robotic endoscope ISRG Inc.
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1970 1983–2004 Candela Gentlelase Gl 1997 Laser used to treat a variety of CLZR Wayland, MA Dermatological Vascular dermatology conditions Merger Co: Lesion Laser Syneron Medical [ELOS] Year of Merge: 2010 Vident 1984 2002 Vita Pm 7 (20 Gram 2005 Porcelain powder for clinical N/A Brea, CA Bottles)
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Large Clip Applier, for trained physician use Sunnyvale, CA Single-Site Cadiere Grasper, Single-Site Fundus Grasper, Single Site Crocodile Intuitive Surgical, 1995 2004–2006 Da Vinci Single-Site 2013 Robotic surgical instruments ISRG Inc. Instruments And for trained physician use Sunnyvale, CA Accessories Nephros, Inc.
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Fluoroscopy System continuous X-ray image Los Gatos, CA SOURCE: NIH RePORTER and Food and Drug Administration data.
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1974 1994 GPS Enzymes and precursors for 1998 N/A Ipswich, MA 2013 in vitro genetic engineering use Polyglot Systems, Inc. 2001 2005 TIMEVIEW Patient health care record 2014 Acq.
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by Sanofi, Boston, MA 1997 for treatment of articular 2011 cartilage disease Natus Medical Incorporated 1989 1995 EC2 Cream used when applying 2001 NTUS Pleasanton, CA electrodes to human body to monitor brain activity Mesa Tech International, 2004 2011 OSCAR Chemical test kits for in vitro 2012 Acq. by Thermo Inc.
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2006 2008 TARGA Scanners, light sources 2013 N/A Beaverton, OR composed of light emitting diodes Genzyme Corporation 1981 1983 BRINGING Scientific research in 2001 Acq. by Sanofi Boston, MA 1997 BIOTECHNOLO biotechnology and surgery GY TO SURGERY Idea International, Inc.
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From page 216... ...
1992 1997 ADENOSERVE Chemical analysis of 2009 N/A Malvern, PA 2003 adenoviral vectors for gene therapies and vaccines Pacific Bioscience 2004 2007 PEDI Foot peels, scrubs, and 2013 PACB Laboratories, Inc. moisturizers Bellevue, WA Home Access Health 1996 2003 LAB TEST AT Stool sample collection kit for 2010 Acq.
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by Renovis, Inc. 2000 2002 Sunnyvale, CA SOURCE: NIH RePORTER and U.S.
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