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

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 very 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 NIH training programs and fellowship opportunities are in place to train scientists for an academic career, these trainees may then lack the soft skills 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 R&D in the biotech industry, and university spinoffs employ high-tech talents, generate taxes, and act as economic hotbeds for the local economy. 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. Given their scientific acumen, postdoctoral scientists have emerged as vital stakeholders in the spinoff generation process as they have the potential to address the current need for potential entrepreneurs in the aging research ecosystem. The crucial role that postdocs play in the formation of spinoffs 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 postdoctoral 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 postdocs 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 to 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 should also empower and enhance the employability and value offered by early career scientists beyond academia. This Funding Opportunity Announcement (FOA) is intended to support both the product development efforts proposed as well as the mentored transition of these early career scientists as they transition to more entrepreneurial positions Purpose NIA seeks to address the growing need to accelerate commercialization from research laboratories by supporting both the transition of translational research into commercial products and services and the entrepreneurship training of early career scientists using this initiative. This FOA utilizes the R41/R42 STTR Award to provide a small business concern (SBC) the opportunity to increase its scientific staff by supporting the salaries of postdoctoral fellows and early stage researchers as Program Directors/Principal Investigators (PDs/PIs). It is expected that the 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) to the SBC. The PD/PI may contribute to the SBC by increasing the technical know-how of the SBC, facilitating SBC licensing of intellectual property from their prior institution, and serving as a bridge between SBC and academic institutions. Analogous to other STTR opportunities, the award as well as the ensuing data generated by the award will be retained by the SBC. This STTR FOA will allow both Phase I and Fast-track applications. A key difference exists between this program and other STTR awards in that this program 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 leadership skills while serving as PD/PI. 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 projects must be in line with the aim and mission of NIA. It is therefore encouraged that the applicant contacts program staff listed in Section VII to discuss both their R&D ideas and career development plans. Objectives The objective of this FOA is to address the growing need to accelerate commercialization from research laboratories by supporting both the transition of translational research into commercial products and services and the entrepreneurial training of early career scientists using this initiative. It seeks to address both the need to foster the advancement of technologies generated from academic research laboratories while also mentoring future scientists who will emerge as key leaders of the biotech landscape. Key Components A. Mentorship One primary criterion of this FOA 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 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, which 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 As this FOA supports the transition of early career scientists into the industry, the eligibility of the PD/PI is limited to early career scientists, including postdoctoral fellows. We encourage women and individuals from underrepresented racial and ethnic groups as well as individuals with disabilities to apply (see: NOT-OD-20-031). The transition candidate must be listed as PD/PI on the application and must be primarily employed by the SBC at time of 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. The 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 including NIH Centers for Accelerated Innovations (NCAI), NIH Research Evaluation and Commercialization Hubs (REACH) and NIGMS IDeA Regional Technology Transfer Accelerator Hubs, NSF-I-Corps, and NCATS Clinical and Translational Science Awards (CTSA). Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.