Resources for Applicants
- Research Resources
- Bridging Interventional Development Gaps (BrIDGs)
The BrIDGs program assists researchers in advancing promising therapeutic agents through late-stage pre-clinical development toward an Investigational New Drug (IND) application and clinical testing. Learn more.
- The Blueprint Neurotherapeutics Network
The Blueprint Neurotherapeutics Network provides non-dilutive support for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing. We offer funding for work that you wish to do yourself, access to NIH-funded contract research organizations (CROs) for activities that you prefer to outsource, and access to consultants with expertise in various aspects of drug discovery and development. You decide what combination of funding, CROs, and consultants will best fit your needs. Your institution gets assignment of the intellectual property rights to compounds discovered and developed within the program.
- Bridging Interventional Development Gaps (BrIDGs)
- NIH Commercialization Resources
- Commercialization Accelerator Program (CAP)
The National Institutes of Health (NIH) Commercialization Accelerator Program (CAP) is a nationwide program funded by NIH and managed by Larta, Inc. The goal of CAP is to assist some of the most promising small life science and healthcare companies in bringing their technologies to market.
The program is customized to meet the needs of participating companies in three distinct tracks, each different in its objectives and outcomes: The Commercialization Transition Track (CTT) for emerging companies, the Advanced Commercialization Track (ACT), and the Regulatory/Reimbursement Training Track (RTT) for “seasoned” companies. The available slots will be distributed among the three tracks, and it should be noted that a participant company may only be accepted into one of the three tracks.
- Commercialization Transition Track (CTT) - Applicable to the majority of HHS SBIR/STTR Phase II awardees, this track provides support to develop tools to create a solid action plan with timelines, budgets, and outcomes pertinent to the stage and background of each participant company and to receive critical feedback from industry experts at a live session. For example, it is aimed at assisting participants with evaluating their commercialization options based on their specific technologies (including the need and prospect for investment, strategic partnerships, or licensing) and to develop a solid market-entry plan ("Commercialization Roadmap" or “Strategic Action Plan”) covering an 18-month period. It also assists participants in the development of market-appropriate tools to accomplish these objectives and provides opportunities for direct industry feedback. Participants work one-on-one with a principal advisor and industry experts as needed.
- Advanced Commercialization Track (ACT) - Applicable to those applicants with previous commercialization experience and/or have generated and managed revenue streams from commercial products and services, this track will focus (with the help of an “Expert Resource” (ER)) on a specific “high value” gap or issue that needs resolution in order to accelerate commercialization of a technology. For example, they may need to address a specific applicable issue (such as a license-focused IP strategy or a term sheet for investors) whose resolution is key to their continued growth. This track specifically deploys domain experts to help participants achieve these outcomes.
- Regulatory/Reimbursement Training Track (RTT) – Applicable to those seasoned applicants with previous commercialization experience, this track will apply to a selected group of HHS-funded companies seeking regulatory approval by the Food and Drug Administration (FDA) or seeking reimbursement from CMS (Centers for Medicare & Medicaid Services) and private insurance to achieve payment for products/services provided. As in the Advanced Commercialization Track (ACT), this track will focus (with the help of an “Expert Resource” (ER)) on developing a regulatory or reimbursement outcome (a framework and/or approach).
NOTE: NIH will not provide additional funding covering your participation in CAP; however, participants with a current active Phase II SBIR or STTR award may re-budget funds within the total costs awarded to cover allowable travel expenses for CAP events without NIH prior approval unless the re-budgeting action constitutes a change in scope or if the terms of award prohibit the use of funds for this purpose. Selected companies are encouraged to contact their funding NIH institute program officer for inquires in this regard.
- NIH Niche Assessment Program
The National Institutes of Health (NIH) Niche Assessment Program for HHS (NIH, CDC, FDA) is a nationwide program funded by NIH to help jump-start the commercialization efforts of active SBIR & STTR Phase I awardees and Phase I Fast-Track awardees. NIH has contracted with Foresight Science and Technology to perform Technology Niche Analyses® (TNA®) for 177 HHS SBIR & STTR Phase I awardees.
The NIH Niche Assessment Program can help your company's commercialization efforts by:
- Providing market insight and data to strategically position your technology in the marketplace.
- Assisting in commercialization plan development for Phase II applications.
- Introducing small businesses to potential partners.
- For a full description of the program, please review the NIH Guide Notice at: NOT-OD-16-013.
All active HHS (NIH, CDC, FDA) SBIR/STTR Phase I awardees and Phase I Fast-Track awardees (by grant or contract) are eligible to apply.
The Niche Assessment Program is appropriate for all types of technologies, (e.g., those developing clinical products, as well as those developing software, educational, and multi-media behavioral science products). The program is also appropriate for those seeking strategic alliances, investors, and/or immediate customers.
One hundred seventy-seven (177) slots are available and will be filled on a "first-come, first-served" basis. For those with multiple awards, only one project per company will be accepted for the program. The average time to complete a Technology Niche Analysis® is 2 to 3 months. Since reports will be generated in the order the applications were received, all 177 reports will be completed between November 2015 and early March 2016. However, awardees may indicate a preference when they would like to receive the TNA® report in the registration forms. NIH and Foresight will try to accommodate such preferences if possible.
The Technology Niche Analysis® report may be helpful in the preparation of the commercialization plan that is required in a SBIR/STTR Phase II application and, as such, applicants should consider the timing of their Phase II submission. The amount of time a program participant will need to expend is minimal (perhaps only a few hours) and participation is free.
- I-Corps at NIH: FOA PA-18-517
I Corps is a new pilot program for academic researchers and small businesses to support biomedical innovation and translation, with the goal of expediting new and emerging technologies.
NIH is offering this entrepreneurial training program across 17 Institute/Centers at the NIH and CDC to support NIH/CDC SBIR/STTR funded academic researchers and small businesses to accelerate the translation of innovations from the lab to clinical practice. In 2017, the I-Corps™ at NIH is expanded to offer two cohorts to SBIR/STTR Phase I grantees across 17 Institutes/Centers across the NIH and CDC.
Based on the highly successful NSF I-Corps™ program, the I-Corps at NIH curriculum is designed to provide scientists from NIH SBIR funded companies with real-world, hands-on entrepreneurship training, facilitated by domain experts from the biotech sector.
This program seeks to accelerate the development and commercialization of new products and services arising from projects supported by currently funded NIH/CDC Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards. In particular, the I-Corps™ program is designed to support training that will help project teams at NIH- and CDC-funded small businesses overcome key obstacles along the path of innovation and commercialization.Grant Supplement Awards
The selected I-Corps™ at NIH project teams will receive funding through grant supplement awards to support entrepreneurial training, mentorship, and collaboration opportunities that will assist them in translating their research ideas into viable products.
To participate in the I-Corps™ at NIH program, eligible SBIR/STTR grantees are required to assemble three-member teams that will work collaboratively to complete the activities and assignments required by the I-Corps™ training curriculum. These team members include:
- C-Level Corporate Officer: A high-level company executive with decision-making authority;
- Industry Expert: An individual with a prior business development background in the target industry; and
- Program Director/Principal Investigator (PD/PI): The assigned PD/PI on the SBIR/STTR Phase I award.
At the beginning of the training program, the I-Corps™ project teams are required to attend an evening reception and intensive, three-day “Entrepreneurial Immersion” course. Project teams then participate in an eight-week (estimated) I-Corps™ training curriculum administered via online instruction. At the end of the course, each team must attend a two-day report-out session. It is anticipated that benefits for the participating I-Corps™ teams will include enhanced understanding and validation of the key components of the Business Model Canvas, significantly refined commercialization plans, and well-informed “pivots” in the overall commercialization strategy. Please re-visit this page for updates regarding course and curriculum information.
CLICK TO SEE SAMPLE APPLICATION COVER SHEET
- Concept to Clinic: Commercializing Innovation (C3i) Program: FOA PA-18-702
The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.
Participants in the C3i Program will develop a comprehensive set of core skills that will enable them to: 1) evaluate whether or not a compelling unmet market need exists for their proposed solution, 2) assess whether there is a viable business opportunity that can be built to meet this need, and 3) build a compelling pitch presentation to secure support from potential investors and other business partners.
The selected C3i project teams will receive funding through administrative supplement awards to support participation in the program. To apply for an administrative supplement award, applicants must have received a prior grant under an eligible activity code from one of the participating ICs (please refer to Funding Opportunity below). The predicate grant must extend (at least) through March 31, 2019, and the grant should have remaining budget and R&D activities that extend at least until that date. Grant awards under a no-cost extension are eligible, provided they meet the above criteria.
- Commercialization Accelerator Program (CAP)
Additional Federal Resources
- National Institute of Standards and Technology Manufacturing Extension Partnership (NIST MEP)
NIST MEP is a public-private partnership with MEP Centers in all 50 states and Puerto Rico, providing any U.S. manufacturer with access to resources they need to succeed. MEP centers tailor service to meet critical needs, ranging from process improvement and workforce development to specialized business practices, including supply chain integration, innovation, and technology transfer.
Contact your Local MEP Center to learn how your small business can benefit from this program.