NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award (R41/R42 Clinical Trial Optional)

Active
No
Status
Closed
Release Date
August 15th, 2023
Open Date
September 26th, 2023
Due Date(s)
October 26th, 2023
Close Date
October 27th, 2023
Topic No.
RFA-AG-24-043

Topic

NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award (R41/R42 Clinical Trial Optional)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: STTRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NIA Research and Entrepreneurial Development Immersion (REDI): Entrepreneurial Small Business Transition Award. This award aims to support the transition and experiential entrepreneurial career development of early-career scientists while providing funding for small business research and development activities. The goal is to facilitate the development and commercialization of academic technologies that address significant unmet needs, particularly in the field of neurodegenerative diseases and aging-based research. The award allows for both Phase I and Fast-track applications and emphasizes the importance of mentorship and entrepreneurship training. Eligibility is limited to early-career scientists, including late-stage graduate students and postdoctoral fellows, with a focus on individuals from diverse backgrounds. The proposed projects must align with the mission of the National Institute on Aging and fall within the scope of the traditional SBIR/STTR grant mechanisms. Applicants are encouraged to partner with existing NIH and other federal resources and programs to leverage entrepreneurial training activities. The application deadline is October 26, 2023. For more information, visit the solicitation agency URL provided.

Description

Background and Need

The number of available tenure-track faculty positions has not kept pace with the growing�number of Ph.D. graduates in recent years. This imbalance has created a highly competitive job environment, making it increasingly difficult for Ph.D. graduates to transition to academic appointments. Doctoral and post-doctoral training programs have heavily revolved around developing skill sets that are directly relevant to academic research activities, such as the ability to publish rapidly and secure research funding. Given that most of the available National Institutes of Health (NIH) training programs and fellowship opportunities are in place to train scientists for an academic career, these trainees may then lack the soft skills, such as the business acumen to think entrepreneurially and to innovate, and the know-how to transition to other scientific positions. Also, modern academic positions have evolved to often include roles that are multidisciplinary and focused on translational research. These roles are optimally suited for individuals with a broad skill set and understanding of the cross-sector landscape.

University research fosters a substantial portion of industrial research and development (R&D) in the biotech industry, and university spin-offs employ high-tech talent, generate taxes, and act as economic hotbeds for the local economy. Also, spin-offs frequently catalyze the formation of technology-focused geographic clusters. �The biotech community has been essential in catalyzing academic discoveries and commercializing them into needed solutions that improve public health. This is especially true for neurodegenerative diseases and aging-based research, where there are significant unmet needs and the opportunities for product development are rapidly expanding. Therefore, this STTR initiative addresses the need to facilitate the development and commercialization of academic technologies by supporting the transition and experiential entrepreneurial career development of early-career scientists while providing funding for small business R&D activities that could ultimately lead to commercialization of innovative technologies that address significant unmet needs.

Given their scientific acumen, early-career scientists have emerged as vital stakeholders in the spin-off generation process, as they have the potential to address the need for entrepreneurs in the aging research ecosystem. The crucial role that early-career scientists play in the formation of spin-offs is mainly due to three factors: the accelerated rise of early-stage biotech investing, the rapid expansion of biotech incubators, and an increase in the number of early-career researchers with more varied career interests. Since new biotech and medical tech companies require skilled researchers who can also perform duties related to business and product development, providing early-career scientists with entrepreneurial training and mentorship will broaden their career options and give the companies access to new workforce talent. Therefore, supplementing the traditional postdoctoral or early-career research experience with training in entrepreneurship and innovation can help provide early-career scientists with both the scientific acumen and business skillset that may play a key role in turning an idea with translational potential into a commercialized innovation that adds major value to older adults and the longevity economy. This training experience will not only increase the number and health of academic spinoffs but will also empower and enhance the employability and value offered by early-career scientists beyond academia.

Purpose & Objectives

The National Institute on Aging (NIA) seeks to use this initiative to address the growing need to foster the advancement and accelerate the commercialization of technologies generated�from academic research laboratories by supporting both the transition of translational research into commercial products and services and the entrepreneurship training and mentorship of future and early-career scientists emerging as key leaders of the biotech landscape. This NOFO utilizes the R41/R42 STTR Award to provide small business concerns (SBCs) the opportunity to increase their scientific staff by supporting the hiring and salaries of early-stage researchers, including late-stage graduate students and postdoctoral fellows, as Program Directors/Principal Investigators (PDs/PIs). It is expected that each SBC will ensure robust entrepreneurial training for the PD/PI, while the PD/PI will bring extensive research knowledge and experience, as demonstrated by patents and publications and/or relevant technical training, to the SBC. The PD/PI may contribute to the SBC by increasing the technical know-how of the SBC and serving as a bridge between the SBC and academic institutions. Analogous to other STTR opportunities, the award, as well as ensuing data generated by the award, will be retained by the SBC. This STTR NOFO will allow both Phase I and Fast-track applications. A key difference between this award and other STTR awards is that this opportunity is specifically aimed at early-career scientists that are interested in entrepreneurial training and mentorship. Additionally, this award provides an opportunity for them to grow their entrepreneurial skills while serving as PDs/PIs.

Entrepreneurial training and mentoring will be critical components of the peer review. It is expected that the SBC ensures participation of the PD/PI in entrepreneurial training activities by utilizing locally and/or widely available entrepreneurship-focused courses and training programs, as well as by assembling a mentoring team that supports the career growth and development of the PD/PI. The proposed scientific projects must be in line with the stated purpose of this NOFO and the mission of NIA. Therefore, applicants are encouraged to contact NIA program staff, using the information listed in Section VII of this NOFO, to discuss both their R&D ideas and career development plans.

Key Components

A. Mentorship�

One primary criterion of this NOFO is mentorship. To be competitive, applications must identify at least one mentor. The mentor will ensure the successful completion of the project, both from the technical and commercial points of view. In doing so, the mentor will also equip the PD/PI with key technical and business acumen. A letter of support from the mentor highlighting their commitment to the project, as well as to the PD/PI's professional growth, is required. The mentor can be a co-founder, owner, or C-level executive in the SBC, although that is not necessary. The mentor is expected to have prior experience in mentoring entrepreneurs. Other mentors or mentoring teams that may provide additional focal points of guidance may be included by the applicant.

B. Entrepreneurship Training

Another key component of the program is entrepreneurship training. Submission of a career development plan is required, and it should include a combination of coursework and workshops. Mentors should play a key role in identifying appropriate coursework, training programs, and workshops to bolster both the technical and the business acumen of the PD/PI as well as the business development prospects of the proposed research.

C. Eligibility

Given that this NOFO supports the transition of early-career scientists into industry, the eligibility of the PD/PI is limited to early-career scientists, including late-stage graduate students and postdoctoral fellows. E�arly-career scientists from diverse backgrounds�, including�individuals from groups underrepresented in the U.S. biomedical, clinical, behavioral, and social sciences research enterprise, which includes individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from disadvantaged backgrounds (see�Notice of NIH's Interest in Diversity, NOT-OD-20-031), are encouraged to apply. The transition candidate must be listed as the PD/PI on the application and is encouraged to be primarily employed by the SBC at the time of the award. Additional investigators can serve as co-investigators and provide support to the transition of the early-career scientist to a PD/PI role within a small business.

C. Scientific/Technical Scope

Applications will be considered if they fall within the mission of NIA and the proposed technology falls within the scope of the traditional SBIR/STTR grant mechanisms.

Applicants are encouraged to partner with existing NIH, or other federal, resources and programs and leverage existing entrepreneurial training activities from both federal and private-sector partners, such as the NIH Proof of Concept Network which encompasses the NIH Centers for Accelerated Innovations (NCAI), NIH Research Evaluation and Commercialization Hubs (REACH), and the National Institute of General Medical Sciences' IDeA Regional Entrepreneurship Development (I-RED) Program; the National Science Foundation�s Innovation Corps (I-Corps?); the A2 collective; and the National Center for Advancing Translational Sciences' Clinical and Translational Science Awards (CTSA).

Clinical Research Operations Management System NIA utilizes a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. NIA Clinical Research Operations & Management System (CROMS) is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. NIA investigators of grants, contracts, and cooperative agreements that are active as of July 1, 2021 and support human subjects research as defined by the DHS HHS OHRP regulations at 45 CFR 46 will be required to interact with and use existing and future components of CROMS as required by NIA throughout the lifecycle of the grant and as described in NOT-AG-23-017.�Data to be submitted to NIA CROMS includes those elements reported in the standard NIH requirement annual progress report (GPS 4.1.15.7). Details regarding the standard operating procedures for CROMS can be found on the�NIA CROMS website.

When applicable, all NIA grantees must ensure:

  1. The study�s Informed Consent Document (ICD) lists �The National Institutes of Health (NIH) and its authorized representatives� as one of the organizations that may look at or receive copies of information in participants� study records. According to�DHS HHS OHRP 45 CFR 46 �46.116, all ICDs must contain��A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained.� If using the�NIA informed consent template�please see Section 6: Statement of Confidentiality.�

  2. An assigned NIH ClinicalTrials.gov identifier (NCT number) is reported in its respective CROMS study record within three months after assignment, and�the reporting of final enrollment data to CROMS is consistent with final enrollment data reported in ClinicalTrials.gov.

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