Translational Science Entrepreneurship Program
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To accelerate the translation of scientific and technological innovations into practical clinical use, ITHS Technology Development Center (TDC) is developing the year-long Translational Science Entrepreneurship Program (TSEP) based on content from prior entrepreneurship workshops and year-long business courses taught by TDC staff. This leadership program will prepare a researcher for the founding and leadership of a startup company.
Application Period Closed
Key Dates
- Application Open
February 12, 2024 - Application Deadline
April 5, 2024 - Program Dates
June 18, 2024–May 27, 2025
Who Should Apply?
This program is open to all health science, life science, bioscience, agricultural science, medical technology, digital health, and public health post-doctoral scientists, PhD graduate students, and inspired faculty members from Washington, Wyoming, Alaska, Montana, Idaho, and Oregon academic and clinical entities, as well as CTSAs across the nation. The program will require each participant to bring their own project that they sincerely intend to translate into a product and company. The program is not just for people working in a lab.
We welcome people developing therapeutics, devices, and diagnostics as well as digital health, mental health, public health, and agriculture innovation applications and tools.
- This is not an introduction to entrepreneurship. This program is for people who have demonstrated sincere interest in entrepreneurship through prior engagement in NSF, NIH, or university entrepreneurship training and funding opportunities.
- To avoid redundancy, participants will be encouraged to take advantage of any and all other entrepreneurship training resources they have access to. (Regional resource lists and links will be provided.) This program is offered to guide participants through in-depth coaching in the work of building a company.
- Participants are expected to bring their own translational science, software, or engineering project that will serve as the basis of their company.
- This program is not for project teams. The sessions and mentorship supports are designed to guide and develop the skills of the one person from each project who will be the technical founder CEO of the intended spinout company.
Format
Participants will be expected to do assigned pre-work (article reading, video watching, podcast listening) prior to each session.
Sessions will be live and presented in hybrid format with some participants in the classroom and others joining remotely via zoom to enable geographically broad real-time participation.
Sessions will be 2 hours. The session topic will be elucidated in a 15-20 minute presentation that will be recorded, followed by 20-30 minutes of Q&A.
In the second hour, participants will be introduced to and get started working on the next commercialization activity so they can complete it prior to the next session. Ad hoc virtual “office hours” will be offered to assist participants as needed between sessions.
Recordings of topic presentations will be made available to the public. Discussion of participant projects will not be recorded. To protect project confidentiality, participants will be instructed not to discuss scientific and technological details of their projects. These details are not needed to work through the strategic problems. Working sessions will not be recorded.
Sessions will be hosted biweekly over the summer and monthly during the academic year.
This is not a lecture series. Active participation in all sessions is required.
Application
Applicants will be asked to provide the following:
- Participant CV (Only the intended technical founder CEO of the project should apply.)
- NON-Confidential description of the project you intend to build a company around. The project description should be approximately 250 words and may be distributed to match you and your project with mentors and funding sources.
- Description (approximately 100 words) of how your innovation can affect delivery and cost of health treatment, therapy, or other health benefit. Consider who will implement or use your solution and what patient population will benefit from it. How will you maximize the chances that your innovation is delivered equitably? How will you minimize the chances that your innovation will lead to inequity or cause harm? You might consider patient populations, representation in research, geography, socioeconomic factors, ability/disability, care-delivery setting and access, environmental factors, etc.
- List of your prior entrepreneurial training and activities (e.g. I-Corps, Gap Funding, NIH REACH, pitch competitions, 3 Minute Thesis, commercialization fellowship, or other entrepreneurial training)
- Name and contact information for technology transfer innovation manager (when applicable)
- Confirmation of IP disclosure to applicant’s institution technology transfer office (when applicable)
- List of any co-inventors or co-investigators (when applicable)
- List of any existing funding sources (Funding is NOT required to participate in this program.)
- Signed release for ITHS to make recorded live sessions publicly available. (Note that we would also like to occasionally interview participants to capture their impressions of the program and perceptions of its impact. Participation in these recorded one-on-one interviews is NOT required to participate in this program.)
- Signed informed consent to participate in research evaluation of this program and its outcomes
Applications are closed for the 2024–2025 program. We will begin accepting applications for the 2025–2026 program in mid-February.
Prerequisites
- Relevant IP must already be disclosed to institution (when applicable)
- Prior entrepreneurial training or experience with I-Corps, REACH, Gap Funding, pitch competitions, 3 Minute Thesis, commercialization fellowship, or other entrepreneurial training
Cost
Free of charge to all participants. This program neither receives fees from nor provides funding to participants. Initial experiences with this inaugural program will support future application for R25 Research Education grant funding.
Key Dates
- February 12, 2024: application period begins
- February 27, 2024: TSEP virtual open house (9–10am PST)
- March 5, 2024: TSEP virtual open house (9–10am PST)
- March 8, 2024: TSEP virtual open house (3–4pm PST)
- April 5, 2024: applications due
- April 15–May 3, 2024: applicant interviews
- May 17, 2024: participant notification
- June 3, 2024: pre-work and pre-reading distributed
- June 18, 2024–May 27, 2025: program dates
- Mid-February, 2025: application period begins for 2025–2026 TSEP
Topics
Welcome to Startup Life (06.18.24)
Speaker: Bill Mahoney, PhD
Vice Chair of the National Postdoctoral Association and Associate Dean for Student and Postdoctoral Affairs at UW, Director, Molecular Medicine and Mechanisms of Disease, Associate Professor of Pathology
- mentorship
- imposter syndrome
- confronting fear of failure
- knowing when you’re ready to transition from the lab to a startup
- getting support from your advisor/PI
HOMEWORK: Self-assessment survey for accountability group formation and mentor matching
READING for next session: “Knowing Yourself” by Warren Bennis (18pp PDF, sent by email); “How to Become a Better Leader” by Ginka Toegel and Jean-Louis Barsoux (12pp PDF, sent by email)
How to Think and Act Like a Leader (06.25.24)
Speaker: Ken Myer
Interim Executive, Leadership Advisor and Lecturer, Commercialization Advisor
- making the mental and emotional transition from following a plan to creating a plan and inspiring others to follow
- how does a leader act?
ACTIVITY: Accountability group match announcements, giving time to groups to setup regular meetings
HOMEWORK: Complete confidentiality agreement
SUGGESTED OPTIONAL READING: Journey to the Emerald City by Roger Connors and Tom Smith (ISBN 9780735203587)
Inter-Disciplinary Communication (07.09.24)
Speaker: Teddy Johnson
ITHS Director of Technology Developement
Effectively sharing ideas and working with people of differing expertise
- self-awareness of language, work-style, cultural norms
- bridging professional cultures
- embracing ignorance as inspiration for curiosity
- bringing knowledge from other disciplines to accelerate innovation in your own field
- practices to navigate the unknown
ACTIVITY: Identifying people you can efficiently work with by itemizing your normal and preferred communication and work-styles
ACTIVITY: Mapping the skillsets you need to add to your team now, in 6 months, next year
Customer Discovery and Market Needs Assessment (07.23.24)
Speakers: Terri Butler, PhD
Manager, ITHS Drug and Device Advisory Committee; Associate Director of Outreach, Partnerships and Biomedical Entrepreneurship Training, ITHS
Margaret Rosenfeld, MD, MPH
Professor and Associate Vice-Chair for Clinical Research, Department of Pediatrics and Center for Respiratory Biology and Therapeutics at Seattle Children’s Hospital
Considering market needs, personal interests, and health equity in your search for the optimal customer
- understanding the customer situation: problems/ pains, desires, financial constraints, workflow requirements, decision-making hierarchy
- understanding specific feature, function, access, workflow, service needs of customers
- realizing opportunities in underserved patient populations and markets
- understanding how cost, product format, and access affect health equity
- defining critical customer needs and market segments and choosing yours
- staying on top of a changing landscape, sources of information, continuous customer discovery
ACTIVITY: Creating lists of people (with contact information) for customer discovery interviews
HOMEWORK: Conduct customer discovery interviews
SUGGESTED OPTIONAL READING: The Lean Startup by Eric Ries (ISBN 9780307887894)
Quality Management Systems & Developing Products for Regulated Markets (08.06.24)
Speaker: Maren Nelson
Quality Management System Consultant; Alliance of Angels Life Sciences Screening Committee Co-Chair; Chief Operating Officer of Glidance, Inc.
Proving the patients need and the market will pay for your product
- understanding what “quality” means
- understanding quality system requirements in a regulated industry
- developing products that satisfy customer needs
- ensuring product quality, safety, and reliability by design
- quality considerations outside the product design
- user experience feedback and product improvement
Market Validation and Timing (08.20.24)
Speaker: Teddy Johnson
ITHS Director of Technology Development
Show me the money!
- market sizing by segment and geography
- competitive analysis
- pricing strategy
- market access and opportunity assessment
- considerations unique to medical products — insurance reimbursement, health economics, value committees
ACTIVITY: Building a realistic market model
HOMEWORK: Continue building your own market model to quantify the revenue potential of your market segment
Development Planning (09.17.24)
Speakers: Teddy Johnson
ITHS Director of Technology Development
Itemizing costs and staffing requirements to develop your product
- understanding startup business costs
- deciding what capabilities and areas of expertise to develop in-house vs. acquiring via contract manufacturing or consulting
- choosing your manufacturing methods and finding early development partners
- understanding development and manufacturing costs and service considerations
- establishing quality control systems
- planning consultant and staff hiring to meet development needs while retaining the ability to run lean in financially challenging times
- scheduling product design and manufacturing development (calendar vs. “logarithmic” scheduling)
ACTIVITY: Building a development cost model and hiring plan
HOMEWORK: Build your own cost model and hiring plan
HOMEWORK: Watch “Navigating America’s Seed Fund at NIH” in preparation for Funding Strategy session on October 15
Funding Strategy (10.15.24)
Speakers: Melissa Vaught, PhD
ITHS Director of Research Development
Stephanie Fertig
NIH Director Small Business Program
Steve Flaim, PhD, FACC, FAHA
NIH NHLBI Investor-in-Residence, NuFund Venture Group Chair Emeritus
- 8:30–9:00am Q&A with Melissa Vaught
- 9:00–9:30am Q&A with Stephanie Fertig
- 9:30–10:00am Q&A with Steve Flaim
What is the right type of funding for each of your development phases?
- mapping funding types to development stages
- trends in research grant funding
- success with SBIR/STTR grant applications
- initial equity investment, including friends and family and angel investment
- venture investment
- corporate investment
Intellectual Property (11.12.24)
Speaker: Fiona Wills, PhD
Associate Vice Provost for Innovation Development & Commercialization, University of Washington Technology Transfer Office
What IP is and why you need it
- company as repository of IP and assets
- getting help from your tech transfer office
- licensing — what and when you should do it
- freedom-to-operate
- US and international considerations
Company Formation & Composition (12.10.24)
Speaker: Jesse Houchens, JD
Senior Corporate Associate, Wilson-Sonsini (advising clients on corporate goevernance, venture financing, mergers, and acquisitions
Who’s in, who’s out, and how to navigate changes
- making good legal decisions fo future success and fewer problems
- identifying and selecting a cofounder/CEO
- knowing when to take an IP license and spin-out a company
- managing conflict of interest and getting university permission to do “outside work”
- planning founder/employee stock allocation
- matching geographical location to development needs
- in-person vs. virtual collaboration
- finding an appropriate facility/commercial space
Clinical and Regulatory Strategy (01.07.25)
Speakers: Teddy Johnson
ITHS Director of Technology Development
Lynn Rose, PhD
Affiliate Associate Professor of Pharmacy in Regulatory Affairs at University of Washington and former Chief of Scientific Administration at Benaroya Research Institute at Virginia Mason
Optimizing your clinical-regulatory program to achieve commercial goals
- defining clinical indications and marketing claims needed for market success
- designing a study to validate marketing claims
- understanding inclusion/exclusion criteria to facilitate clinical and market success
- understanding impacts of product labeling on market access
- identifying clinical influencers
- creating opportunities for new clinical influencers through new science and technology research
- choosing the right PIs for this multi-year engagement
- understanding the impact of good vs. bad site selection
HOMEWORK: outline your protocol with inclusion and exclusion criteria to support future marketing claims
Market Entry Strategy (02.04.25)
Speaker: Teddy Johnson
ITHS Director of Technology Development
How do you decide where to get started? Is the biggest market the best place to start?
- selecting and sequencing markets based on regulatory constraints, timing of staff hiring, team capabilities, and market opportunities
- creating opportunities for new clinical influencers through new science and technology research
- understanding impacts of health economics and pricing in the context of regional healthcare trends
- customer service, distribution channels, shipping, and tariffs
Storytelling and Fundraising (03.04.25)
Speaker: Lisa Stromme Warren
ITHS Director of Communications; former Strategic Media Relations and External Communications Manager for Washington State Department of Health; former Executive Producer for KIRO 7 news
What’s the title and take-away of your story? How to tell your story in 3 memorable, repeatable points
- identifying interested audiences
- developing a concise, compelling, and memorable story (customized for each audience)
- identifying the right investors by understanding their needs
- pitch deck elements and pitch deck development
HOMEWORK: Create your pitch
Pitch Workshop with Advice from Mentors (04.01.25)
Speaker: Teddy Johnson
ITHS Director of Technology Developement
Steve Flaim, PhD, FACC, FAHA
NIH NHLBI Investor-in-Residence and NuFund Venture Group Chair Emeritus
Additional guest to be announced
- working with nervous energy
- researching your audience in advance to understand what to focus on
- reading your audience during the pitch to understand what stories resonate with them
- receiving and responding to questions with a focus on fostering future partnership
- distilling your story down to its outstanding elements
- refining your pitch for time and clarity
ACTIVITY: Pitch practice
HOMEWORK: Refine your pitch
Launching a Product (04.29.25)
Speaker: Teddy Johnson
ITHS Director of Technology Development
Making a name for yourself as you make a big splash in the market
- company and product brand strategy
- creating opportunities through clinical study
- converting clinical sites into customers
- pricing
- optimizing promotional activities for your market segment
- positioning your company and product for partnership, acquisition, or IPO
ACTIVITY: Defining your brand to engage your market
HOMEWORK: Develop your brand and market strategy
Investor Pitches and Program Close (05.27.25)
Speaker: Teddy Johnson and invited guests