Assessment of the SBIR and STTR Programs at the National Institutes of Health (2022) / Chapter Skim
Currently Skimming:
3 NIH SBIR/STTR Processes
3 NIH SBIR/STTR Processes
Pages 49-108
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 49... ...
that administer awards through the programs.1 It also considers the impact of NIH processes on the participation of woman-owned firms and firms owned by socially and economically disadvantaged individuals. The principal sources of data for this chapter were discussions between committee members and SBIR/STTR program managers and staff from each of the NIH ICs that issues SBIR/STTR awards.
|
From page 50... ...
Most SBIR and STTR applicants apply electronically through the omnibus solicitations, also known as Omnibus/Parent Funding Opportunity Announcements or simply Parent Announcements. The most recent Parent Announcements for the SBIR/STTR programs were released on July 8, 2021, with the three application cycles ending September 5, 2021; January 5, 2022; and April 5, 2022.4 Applications received in response are then sent to a centralized review center, the Center for Scientific Review (CSR)
|
From page 51... ...
ICs also offer FastTrack awards for which both Phase I and II applications are submitted and reviewed as a single application, which can reduce or eliminate the funding gap between phases. In addition, some ICs offer Phase IIB awards, which provide Phase II awardees with follow-on funding of up to $1 million per year for up to 3 years.
|
From page 52... ...
The SEED Office manages and recently updated the NIH SBIR/STTR website, which, among other things, includes illustrative "success stories" about SBIR/STTR awardees and wideranging information resources about the program. The SEED Office is funded through NIH's pilot administrative funds.
|
From page 53... ...
The SBIR and STTR programs are funded as a fixed percentage of each IC's extramural budget, thus the annual budgets differ substantially across the 24 ICs that offer SBIR and STTR awards. While the overall budget of the NIH SBIR and STTR programs is about $1 billion each year, the annual IC budgets range from more than $140 million for the largest institutes to just over a $1 million for the smallest (see Table 3-1)
|
From page 54... ...
National Cancer Institute NCI Lead, conduct, and support cancer research 142,920,000 across the nation to advance scientific knowledge and help all people to live longer, healthier lives. National Institute of Allergy and NIAID Conduct and support basic and applied research 140,879,000 Infectious Diseases to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.
|
From page 55... ...
National Institute of Child Health NICHD Lead research and training to understand human 43,151,000 and Human Development development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. National Institute on Drug Abuse NIDA Advance science on the causes and consequences 29,802,000 of drug use and addiction and apply that knowledge to improve individual and public health.
|
From page 56... ...
National Institute of Arthritis and NIAMS Support research into the causes, treatment, and 17,853,000 Musculoskeletal and Skin prevention of arthritis and musculoskeletal and Diseases skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. National Institute on Alcohol NIAAA Generate and disseminate fundamental 15,173,000 Abuse and Alcoholism knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of
|
From page 57... ...
National Institute of Dental and NIDCR Improve dental, oral, and craniofacial health. 12,704,000 Craniofacial Research National Institute of Biomedical NIBIB Improve health by leading the development and 12,143,000 Imaging and Bioengineering accelerating the application of biomedical technologies.
|
From page 58... ...
Office of Research Infrastructure ORIP Advance the NIH mission by supporting research 7,324,000 Programs infrastructure and research-related resource programs and by coordinating NIH's science education efforts. National Institute of Nursing NINR Promote and improve the health of individuals, 4,557,000 Research families, and communities.
|
From page 59... ...
While all IC program managers mentioned to the committee conducting outreach through attendance at scientific meetings, a wide variety of outreach approaches are used across the ICs to reach potential SBIR/STTR applicants. Applications and Solicitations The NIH SBIR/STTR process is perhaps most uniform in its omnibus solicitations.
|
From page 60... ...
The quality and number of applications received through targeted solicitations versus the omnibus solicitations varies across ICs, but targeted solicitations seem to attract more new applicants in some ICs.
|
From page 61... ...
The R01 RFA is focused on developing novel acoustic signal processing algorithms for speech enhancement to improve future generations of hearing aids, cochlear implants, and other devices.16 The parallel SBIR RFA likewise targets the development of and support for open-source portable acoustic signal processing tools to improve speech enhancement software and thus accelerate the translation of research to the market.17 In summary, NIH uses various mechanisms to promote the SBIR/STTR programs and award their funding to address a range of needs. Omnibus solicitations support investigator-driven research guided by NIH topics and priorities (a bottom-up approach)
|
From page 62... ...
NCI outreach is often focused on attracting junior scientists and postdoctoral fellows, so many of the mentoring aspects of the NIH Pathway to Independence Award (K99/R00) program are built into Phase I STTR awards.18 NIAID and the National Institute of Biomedical Imaging and Bioengineering (NIBIB)
|
From page 63... ...
Science Education Partnership Award (NIGMS) SOURCE: Based on the committee's discussions with NIH institute/center SBIR/STTR program staff and may not reflect all outreach activities 63 conducted by ICs.
|
From page 64... ...
uses this mechanism to bring together an SBIR program manager and experts on regulatory affairs and business development to take calls and answer questions about the program's application process. External outreach includes such high-touch activities as attending and speaking at scientific conferences about the NIH SBIR/STTR programs; having an NIH SBIR/STTR booth at conferences to meet potential applicants; and partnering with local incubators, local biotechnology innovation associations, and key cancer centers (NCI)
|
From page 65... ...
Outreach to Improve and Diversify the Applicant Pipeline Efforts to increase the diversity of awardees at NIH do not appear to have been successful, and there appears to be little systematic centralized outreach to potential NIH SBIR/STTR program applicants in underserved communities, including woman-owned small business owners, socially and economically disadvantaged small business owners, and small businesses in historically underutilized business zones. Outreach to potential SBIR/STTR applicants relies on individual IC program managers' initiative and engagement.
|
From page 66... ...
talks about diversity in the "How to Apply" section: "One of the goals of the SBIR and STTR programs is to encourage participation in innovation and entrepreneurship by socially and economically disadvantaged small businesses (SDB) and women-owned small 25 The authors did find that proposals with excellent priority scores were equally likely to be funded regardless of race.
|
From page 67... ...
. The business development manager focuses primarily on investor events oriented toward minorities.
|
From page 68... ...
https://grants.nih.gov/grants/guide/pa-files/PA-16-288.html. 32 Small Business Administration, SBIR/STTR Interagency Policy Committee Report to Congress: Outreach, 2014.
|
From page 69... ...
. NIH SBIR/STTR Awards Process NIH's complex multistage process for reviewing SBIR/STTR grant applications and making funding decisions reflects the agency's complex organization.
|
From page 70... ...
First Level of Review: CSR Review and Scoring As illustrated in Figure 3-2, once CSR has received grant applications from the Division of Receipt and Referral, it assigns each application to one of the five CSR divisions. The directors of each CSR division then further assign each application to an Internal Review Group (IRG)
|
From page 71... ...
NOTE: CSR = Center for Scientific Review; IRG = Internal Review Group; and SRO = scientific review officer.
|
From page 72... ...
Notably, these are the same five criteria used for evaluating NIH's R01 grant applications. NIH's current system for reviewing SBIR and STTR applications is based on its system for evaluating R01s and is heavily focused on the science behind the proposals.36 This is the case because NIH classifies SBIR and STTR applications as research grant applications based on the SBA SBIR/STTR Policy Directive.37 Peer review criteria for all of NIH's research grant applications and R&D contract projects are dictated by Section 492 of the Public Health Service Act38 and the federal regulations promulgated under this act.
|
From page 73... ...
Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?
|
From page 74... ...
In many cases, there is no hard cutoff for considering applications for funding; rather, applications with scores within a "zone of consideration" -- a narrow band of scores -- are considered. ICs' reliance on the CSR priority scores to determine TABLE 3-4 IC Approaches to Making Funding Decisions Approach to Funding Decisions Factors Considered Payline Payline+ Internal Review Priority Scores X X X Fit with IC portfolio X X Additional review X PI's response to X X reviewer comments Spending set aside X X X ICs that primarily NHLBI, NIAMS, NCI, NIAID, NIA, NIMH, NICHD, use this approach ORIP, NIDDK NEI, NIAAA, NIDA, NIEHS, NIBIB, NINR, NHGRI, NIDCD, NCCIH, NLM, NIDCR, NCATS, NIHMD, NIGMS NINDS NOTE: This typology is based on the committee's discussions with NIH institute/center SBIR/STTR program staff.
|
From page 75... ...
Thus they needed to look at applications with higher priority scores to find good proposals to fund. Internal Review Decisions ICs that use an internal review approach to making funding decisions may use priority scores as one factor in their decision process, but they often conduct extensive additional review and due diligence before making award decisions.
|
From page 76... ...
IC staff can also help identify funding opportunities that fill gaps in the IC's portfolio and collect additional information needed to analyze commercial potential. These additional insights can then be used along with the priority scores to make funding decisions.
|
From page 77... ...
For example, the John McCain National Defense Authorization Act for FY 2019 requires the Department of Defense to establish a pilot program aimed at reducing the time for SBIR and STTR awards.41 Congress could call for NIH to establish such a pilot program. NIH could choose how best to implement such a pilot, but initiatives at other agencies may offer some ideas for accelerating 41 P.L.
|
From page 78... ...
TABLE 3-6 Distribution of NIH SBIR/STTR Award Notification and Issuance by Number of Months (fiscal years 2016–2018) Number of Months Number of Award Notifications Number of Awards Issued Since Solicitation Closing Date 3 110 96 6 1,870 667 9 1,207 1,752 12 564 832 15 77 307 18 6 145 18+ 6 41 SOURCE: GAO, 2019, p.
|
From page 79... ...
As described in detail in Chapter 5, the SBIR/STTR awards provide a signal of scientific validation, but if they are to achieve their congressional objectives, review criteria and expertise for selection decisions need to address the translation of science into marketable products and services. As discussed earlier in this chapter, the evaluation of NIH SBIR/STTR applications is carried out in accordance with Section 492 of the Public Health Service Act42 and the federal regulations promulgated under this act pertaining to research grant applications and R&D contract projects.
|
From page 80... ...
As shown in this chapter, NIH SBIR/STTR program staff and reviewers of SBIR and STTR applications tend to lack small business or startup experience. To attract program managers and scientific reviewers with relevant experience, the NIH director might wish to introduce rotating of SBIR/STTR program managers, similar to NSF's use of temporary workers under the Intergovernmental Personnel Act or Visiting Scientist, Engineer, and Educator programs.
|
From page 81... ...
Needs manufacturing plans, and business Phase II, Direct Assessment models to-Phase II awardees TABA Funding For those awardees who do not use Vendor is selected Phase I – up to the Needs Assessment: applicant by awardee and $6,500/year must provide the name of the vendor must be external to and a detailed description of services awardee Phase II – up to and benefits at the time of the $50,000 per application award Mentoring/Networking C3i Commercialization training for Developed by Pilot: R01 PIs, medical devices, NIBIB; open to C3i Program, other approx. 7 ICs Accell: Phase I & 3-level course: Pilot, C3i Program, Phase II Accell awardees I-Corps (NCI version)
|
From page 82... ...
Corps Entrepreneurs in One-on-one coaching for product and SEED Office and Phase I and II Residence (EIRs) business strategy, networking, individual ICs awardees competitive analysis, deal review, regulatory and reimbursement planning Investor Initiatives, Education and networking events; SEED Phase I and II Showcases, Funding and mentoring assistance to awardees commercialization aid companies in presenting to third workshops party investors and strategic partners Connecting Awardees Pilot regulatory support program to NCI Phase I and II with Regulatory encourage communication between awardees from Experts (CARE)
|
From page 83... ...
While federal agencies had previously been allowed to use some of their SBIR and STTR allocations to enable applicants to obtain technical assistance from external vendors, the John McCain National Defense Authorization Act for FY 2019 increased the amount of money available for this purpose and expanded use of the funding to include business assistance to awardees, such as assistance with product sales, intellectual property protection, market research, market validation, and development of regulatory and manufacturing plans.44 This additional money for awardees is known as Technical and Business Assistance (TABA) funding.
|
From page 84... ...
. The SEED Office website mentions that a new program, TABA Consulting Services, will also be available for Phase II and IIB awardees, but no information about that program was available at the time of this writing.
|
From page 85... ...
During the interviews, for example, program managers from 11 ICs reported that their IC does not participate in the CRP program, and few appeared to be familiar with the training/networking programs as a whole. Some program managers expressed confusion about the role of the NCI or SEED Office programs.
|
From page 86... ...
In conclusion, the postaward commercialization programs offered by NIH SBIR/STTR programs are duplicative, fragmented within the agency, and not distinctive relative to programs provided by regional and local biotechnology incubators and accelerators. These programs can also be administratively expensive and misaligned with current capabilities within the ICs and may detract from the IC missions.
|
From page 87... ...
For the STTR program, the mission also includes contributions to technology transfer through cooperative R&D between small businesses and research institutions. SBIR/STTR success stories are displayed on the SEED Office and IC websites and were highlighted during the committee's discussions with the program managers.
|
From page 88... ...
Finding 3-2: SBIR/STTR program managers and NIH leadership lack a systematic approach for outreach to potential NIH SBIR/STTR program applicants from underserved groups, including women who own small businesses, socially and economically disadvantaged small business
|
From page 89... ...
There is some skepticism within ICs that the review panels convened by CSR, particularly the scientific reviewers, have expertise in assessing the clinical and commercial potential of applications. Finding 3-5: Commercialization programs offered within NIH for SBIR/STTR awardees are duplicative and fragmented across the ICs, as well as programs offered by regional and local life sciences incubators and accelerators.
|
From page 90... ...
c. The SEED Office and IC SBIR/STTR program managers should partner with existing networks serving disadvantaged populations, such as the Society of Women Entrepreneurs, the Society of Hispanic Professional Engineers, and local or regional small business development centers.
|
From page 91... ...
Specifically, it should help ICs create metrics and track awarded firms over the long term to better measure the impact of SBIR/STTR awards and programs. The NIH SEED Office should work with the NIH ICs to develop and promote success stories and role models that are diverse and aligned with the objectives of the ICs.
|
From page 92... ...
iv. Do you rely on the omnibus solicitations / when do you issue targeted requests for proposals?
|
From page 93... ...
Was it impactful based on technology, team, commercial potential, societal potential, PI's reputation, track record of previous awards, minority or woman-owned company, or match with Institute's own program priorities?
|
From page 94... ...
NIDDK 5/13/2020 NIDDK (Danny Gossett) ; SEED (Kate Fritz, Stephanie Fertig, Chris Sasiela)
|
From page 95... ...
NINR 5/21/2020 NINR (Kristopher Bough, Augie Diana) ; SEED (Kate Fritz, Stephanie Fertig)
|
From page 96... ...
device for resuscitation from cardiac arrest Affymetrix CA Commercial success Research tool -- microarrays NHGRI No No (initial public offering [IPO]
|
From page 97... ...
algorithms to search for malignant agent to use in breast cancer therapies Arima Genomics CA R&D milestone Research tool -- for scientists NHGRI No No who study genetic diseases Ascent Bio-Nano NC Product in patients Research tool -- ORIP Yes Yes Technologies acoustic-based innovations for research Avid PA Commercial success Medical device -- molecular NIA No No Radiopharmaceuticals (Lilly acquisition) imaging AxoSim LA R&D milestone Research tool -- NCATS, No No human nerve cells accelerate NIEHS the development of new drugs Behavior Imaging ID R&D milestone Diagnostic -- NIMH Yes No (approved for use)
|
From page 98... ...
BioSensics MA R&D milestone Medical device -- wearable NIA No No sensors and digital technologies BlueWillow MI R&D milestone (Phase I Drug -- over-the-counter nasal NIAID No No Biologics clinical trial and antiseptic that reduces the risk commercial sales) of respiration infection BrightOutcome IL R&D milestone Digital health -- NCI No No (approved for use)
|
From page 99... ...
easy-to-use birth control Diagnostics for the CA Public good and R&D Diagnostic -- NIAID No No Real World milestone molecular HIV testing for the (approved for use) resource-poor Dovetail Genomics CA Product in market Research tool -- genomic tools NHGRI No No and services Duality Technologies NJ Product in market Digital health -- private health NHGRI No No data emocha Health MD R&D milestone Digital health -- NIDA No No therapy adherence program EnChroma CA Product in patients Medical device -- glasses for NEI No No the colorblind Endomet Biosciences CA Commercial success Drug -- NICHD Yes No (IPO)
|
From page 100... ...
genetic database to help clinicians diagnose diseases GigaGen CA R&D milestone Drug -- immune system NIAID, NCI, No No disorders NICHD Hearphone (BOSE) CA Commercial success Medical device -- hearing aid NIDCD No No (acquisition)
|
From page 101... ...
accelerate vaccine production Intrinsic Lifesciences CA Product in patients Diagnostic -- test underlying NIDDK Yes No causes of anemia; hepcidin diagnostics Liftware Spoons (Lift CA Product in market Medical device -- tremor- NINDS No No Labs) canceling spoon for patients with tremors or limited hand/arm mobility Litron Laboratories NY R&D milestone Medical device -- identify toxic NIEHS Yes No substances (Continued)
|
From page 102... ...
malaria, and more Mapp CA Public good and R&D Drug -- infectious diseases in NIAID, NIA, No No Biopharmaceuticals milestone the Third World NCI MBF Bioscience VT Product in market Research tool -- image analysis NIMH No No for neuroscience research MedShape GA R&D milestone Medical device -- shape- NIAMS No No (approved for use) memory polymers Megadalton Solutions IN R&D milestone Medical device -- product NIGMS No No extension for mass spectroscopy Micatu NY R&D milestone and Research tool -- collaboration NCI No No collaboration between industry and academia (approved for use)
|
From page 103... ...
patients with coronary heart NIDCR disease Nanovis, LLC IN Commercial success Medical Device – spinal NIAMS No No (Food and Drug implant nanosurface to speed Administration bone growth after surgery clearance) Navidea OH R&D milestone Diagnostic and drug -- diagnose NIAMS, No No Biopharmaceuticals and treat cancer and NHLBI immunodiseases (Continued)
|
From page 104... ...
Neurocrine CA R&D milestone Drug -- neurological and NINDS, No No Biosciences (approved for use) endocrine-related disorders NICHD OpenBeds DC R&D milestone Digital health -- platform to NIDA Yes No streamline health referral services Qrono PA Clinical milestone Drug -- immunotherapy drugs NIGMS, NCI No No to activate the immune system Patient Insight CA R&D milestone Digital health -- platform to NIBIB No Yes screen drugs Percepta CA Clinical milestone Diagnostic -- lung cancer NCI No No diagnosis Photonicare IL Product in patients Diagnostic -- middle ear NHLBI No No infections Pinnacle Technology KS R&D milestone Medical device -- brain disorder NINDS, NIA, Yes No (approved for use)
|
From page 105... ...
digital therapeutics RIVANNA VA R&D milestone Medical device -- ultrasound- NIBIB, NCI, No No (approved for use) based spinal navigation device NIGMS for placing epidurals Sanaria MD R&D milestone Drug -- malaria therapy NIAID No No Scarless Laboratories CA R&D milestone Drug -- scar healing NIDCR No Yes Science Takeout NY Public good and R&D Research tool -- tool for NIEHS Yes No milestone teaching science Selexys OK R&D milestone Drug -- improves blood flow for NHLBI, No No (approved for use)
|
From page 106... ...
Sharklet CO R&D milestone Medical device -- imitation NIDDK, No No Technologies (approved for use) sharkskin to prevent infections NIAMS, NHLBI Sober Grid MA R&D milestone Digital health -- substance NIDA No No abuse app Stratatech WI Clinical milestone Drug -- skin substitute as NIAMS, NIA No No Corporation alternative for skin grafts for thermal burns Sylvatica Biotech SC R&D milestone Medical device–extend the NINDS, NCI, No Yes shelf life of donated organs NICHD, NIDDK, NIGMS, NIBIB Talaris Therapeutics KY Clinical milestone and Drug -- stem cells to reduce NIDDK, Yes No venture capital funding immunosuppressant use in NHLBI transplant patients Tetra Therapeutics MI Commercial success Digital health -- cognitive NIMH No No (acquisition)
|
From page 107... ...
SOURCE: "Success Stories" page on the NIH SBIR/STTR website, https://sbir.nih.gov/successstories, and committee discussions with NIH institute/center SBIR/STTR program staff.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.