An Interdisciplinary Training Program in Entrepreneurship and Translational Research for Alzheimer’s Disease and AD Related Disorders
Program Overview
I2SEED is an entrepreneurship focused education program which provides training to help develop and commercialize diagnostic, supportive or therapeutic interventions for Alzheimer’s Disease and AD Related Disorders (ADRD).
Participants who complete this program will gain the skills necessary to successfully submit a highly competitive NIA SBIR or STTR grant. We also offer sustained engagement and support to assist with a resubmission, if necessary. The ultimate goal of this program is to maximize the likelihood that participants will be able to obtain seed funding through a combination of SBIR/STTR grant(s) and investor funding so that trainees can successfully transition to a funded career path that focuses on moving ADRD research from the bench to the bedside via a successful business plan.
This program is designed for pre- and post-doctoral trainees interested in exploring opportunities to commercialize ADRD diagnostics/therapeutics/devices
Pre-doctoral trainees must be enrolled in a Master's level or higher degree program
Post-doctoral trainees must have completed a PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or foreign academic institution
As per NIA guidelines, trainees must be US citizens or permanent residents
Five to ten trainees will be enrolled in the program each year and expected to participate in the program for two years (approximately 2-8 hours per week). This program is funded by the NIA and available at no cost to trainees.
Targeted education on biomedical entrepreneurship in a small group setting
Networking opportunities
Experiential learning with start-ups and commercial ventures
Long term mentorship
Travel funds for relevant conferences
STTR/SBIR grant writing assistance
Assistance developing and refining an investor pitch deck
Curriculum
This curriculum was designed to ensure that the projects designed and implemented by trainees take into account the myriad of factors relevant to the complex characteristics of biomedical entrepreneurship and important considerations of developing preclinical and late-phase ADRD trials. The core curriculum will include the following elements:
Didactics will begin as Topic Overview Sessions. These will consist of mini interactive overviews of the core domains of:
Ideation
Intellectual property and regulation
Finance
Team building and scientific cooperation
ADRD Specific Topics
Each session will be approximately 30-45 min in length. Topic Overview Sessions will occur via video conference and be scheduled based on trainees availability. At the conclusion of each lecture trainees will be asked to rate their interest in each topic covered, this rating will be used to design the boot camp curriculum.
The curriculum will also ensure that trainees are exposed to a broad range of skill sets required for ADRD biologic and therapeutic development through entrepreneurial and commercialization pathways.
The Bootcamp for the 2023-2024 class will be held: September - October 2023
After the Topic Overview Sessions, we will hold mini boot camp sessions on each topic.
The bootcamp is intended as an intensive introduction to more complex concepts related to entrepreneurship, product development, commercialization, and the unique demands of developing novel ADRD-related technologies and therapeutics. The feedback from Topic Information Sessions will be used to design a boot camp curriculum that is valuable to trainees. We anticipate 2-8 hours of lectures per week, interspersed with team-building activities such as social events, and networking opportunities to engage with other faculty.
Once the bootcamp is completed we will transition to focus on SBIR/STTR grant writing. Workshops will be hosted by Dr. Gooneratne via videoconference. These grant workshops will be held weekly and may occur more frequently when the group approaches grant submission deadlines.
Workshops will guide trainees through the complex process of preparing and submitting a SBIR/STTR grant and will include:
Instruction on required SBIR/STTR components: i.e., NIH biosketch, specific aims, research strategy, resources and human subjects; and key elements necessary for ADRD research
Review and discussion of successful ADRD SBIR/STTR applications
Guided writing/timeline: trainees will first prepare their Specific Aims, to be discussed by all trainees and faculty in the workshop.
Continuous Feedback: trainees will present their writing progress to faculty once per month; including a discussion of timeline, milestones, and progress to further refine project/grant.
Mock Review: approximately 4 weeks before submission trainees will submit for a mock study section by mentors and other trainees that will provide insight into grant review process and allow for further refinement of grant
Sustained engagement in the following year of the program to assist with the SBIR/STTR A1 grant resubmission, if necessary
Nondisclosure Agreements (NDAs)/Confidential Disclosure Agreement (CDAs)The I2SEED program will not request any IP ownership or equity ownership of any IP or startups from trainees in the program; all IP and equity remains with the trainees and their University as per their University guidelines. Our primary objective is to maintain fairness and ensure future students have the opportunity to participate in our programs, especially since we focus on the specialized area of ADRD. To protect these opportunities, faculty members and trainees in education programs typically do not sign Confidential Disclosure Agreements (CDAs) or Nondisclosure Agreements (NDAs).Confidentiality During Program Activities: There is no requirement to disclose any information about your startup or IP during the didactic sessions or the SBIR/STTR workshop; you may keep your information private if you wish.Option for Privacy in the SBIR/STTR Workshop:
If you decide to participate in the SBIR/STTR grant writing workshop, you are not obligated to share any documents with faculty or peers. You are welcome to develop your grant independently without seeking feedback, allowing you to benefit from the educational content.
If you wish to receive editorial feedback from the I2SEED program on your grant text, you are welcome to place any documents in a secure folder that will only be reviewed by the course instructors.
This approach ensures that all participants can benefit from the program's educational content.
Approximately once every two months, we will invite guest lecturers to present at a State-of-the-Art Research seminar on ADRD. Trainees will hear from the brightest minds in the field from across multiple institutions who will be presenting on recent developments in the three core areas of disease biology, data sciences and drug discovery related to ADRD.
These talks will include discussions of novel neuroimaging methods, data analytic tools, animal models, and other recent developments to ensure that trainees are exposed to cutting edge research that may impact their application.
This seminar will also serve as a helpful networking opportunity for the trainees to connect with top researchers in the field.
Fundamental to this program is its innovative mentorship framework that extends beyond a research mentor and business mentor to include a clinical mentor with experience in ADRD to provide a unique perspective that is central to commercial success. Trainees will be encouraged to maintain prior connections as mentor candidates. The I2SEED program will also connect trainees to mentors with expertise in their area of interest. The curriculum includes regular meetings with the trainee and their mentors to provide feedback and track progress.
This will also include experiential learning opportunities such as clinical shadowing, industry externships and networking to facilitate patient and caregiver stakeholder interactions for the trainee as appropriate.
Academic Entrepreneurship for Medical and Health Scientists eBook will serve as the content source for much of the didactic material. It is a free open-education resource, which was developed by Dr. Gooneratne and several other colleagues to fill a training gap in the commercialization of biomedical advances.
Dr. Gooneratne is an Associate Professor at the University of Pennsylvania and the Associate Director for the Master's of Science in Translational Research at the University of Pennsylvania. He is a board-certified sleep disorders physician. His research includes a multi-site NIA intervention study on sleep apnea in Mild Cognitive Impairment and he has been the PI on two NIH Small Business Grants.
Dr. Reuther is the Executive Director of the Penn Center for Health-Devices and Technology (Penn Health-Tech) and on the faculty of the School of Engineering and Applied Science as Practice Associate Professor in Bioengineering. She also has experience as a co-founder of Syntegrity Biomedical, an orthopedic medical device start-up.
This program is supported by the National Institutes of Health’s National Institute on Aging, grant R25AG078147. This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health’s National Institute on Aging.
