NIA Research and Entrepreneurial Development Immersion (REDI): Mentored Entrepreneurial Career Development Award (K01 Clinical Trial Not Allowed)

Funding Opportunity Description The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Extramural Training Mechanisms website. The objective of the NIH Mentored Research Scientist Development Award (K01) is to provide salary and research support for a sustained period of protected time (3-5 years) for intensive research career development, under the guidance of an experienced mentor, or sponsor in the biomedical, behavioral or clinical sciences leading to research independence. The expectation is that, through this sustained period of research career development and training, recipients will launch independent research careers and become competitive for new research project grant (e.g., R01) funding. The objective of this Funding Opportunity Announcement (FOA) is to provide entrepreneurial development support, salary, and research support for a sustained period of protected time for intensive research career development, under the guidance of an experienced mentor or sponsor in the biomedical, behavioral, or clinical sciences, leading to independence. Unlike candidates funded through the parent K01 FOA, it is expected that candidates funded through this FOA may pursue careers other than academic research, including, but not limited to, research careers in industry and scientific business development, including small business development activities and the future submission of NIH small business grant applications. Background and Need While the number of Ph.D. graduates has rapidly increased in recent years, the number of available tenure-track faculty positions has remained stagnant. 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 that mentors deem important, 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 focused on translational research and teamwork with multidisciplinary teams. These roles are optimally suited for individuals with a broad skillset 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 spinoffs employ high-tech talents, 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 substantial 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. 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 the increase in the number of postdoctoral researchers with diminishing academic job prospects. Since new biotech and medical tech companies require skilled researchers, providing postdoctoral researchers with entrepreneurial and related career development support will broaden their career options and provide industry stakeholders access to new workforce talent. Therefore, supplementing the canonical postdoctoral experience with training in entrepreneurship, business development, scientific communications, and scientific policy can provide both the scientific acumen and business skillset to turn an idea with translational potential into a successful startup enterprise. This training experience is designed to empower and enhance the employability and value offered by early-career scientists beyond academia. Purpose To boost the number of university startups in the field of aging, and to facilitate various career opportunities for early- career scientists, NIA seeks applications from candidates proposing a varied set of experiential learning activities geared towards gaining a broad set of skills and knowledge required of translational scientists and entrepreneurs. This skills and knowledge base includes scientific communications, an understanding of the intellectual property process and landscape, regulatory and reimbursement pathway knowledge, the ability to identify unmet needs within markets and define value propositions, and a clear understanding of the biomedical development path, financing sources, and challenges. The selected candidates should receive structured career development experiences wherein translational aging research is combined with entrepreneurial communications, and/or policy training. The experimental research is expected to be supplemented with participation in entrepreneurial training and business development course-based and experiential learning programs (including relevant certificate programs, mentoring programs, etc.), external seminars, invited lectures, and networking with industry. The research development program of the candidate should be based on the candidate's scholastic background, previous research experience, and past achievements. Interest in translational research and commercialization should be an important consideration. This FOA supports key areas that represent the mission of NIA, including Alzheimer's disease (AD) and AD-related dementias (ADRD). Applications pertaining to AD/ADRD are encouraged. For details on the key divisions of NIA, visit NIA's research divisions webpage. Optimal candidates for this opportunity are experienced postdoctoral researchers (two years minimum) and/or recently appointed junior faculty members (usually with Ph.D. degrees) in biomedical, social, or behavioral sciences who are interested in entrepreneurial training and are pursuing careers in research areas supported by NIA. All postdoctoral researchers and junior faculty from diverse backgrounds are encouraged to apply, including individuals from groups underrepresented in the U.S. biomedical, clinical, and behavioral 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). Prospective applicants are strongly encouraged to contact the Scientific/Research Contact, provided in Section VII. Agency Contacts, early in the application preparation phase to discuss the application. Non-Responsiveness Criteria The following types of applications will be considered non-responsive to this FOA, and will be withdrawn prior to review: Applications in areas that are primarily within the missions of other ICs. Applications without adequate mentorship plans. Applications without entrepreneurial training, as broadly defined above.