Deliverable Guidance
Please review the key guidelines for all phases in the document attached below. It provides key information and guidelines you need by phase
Phase 0: Enter the Challenge
Important Notes on Submissions:
- File Naming Convention: In order for reviewers to easily identify attachments, please use the following naming convention for files to be uploaded to this attachment. 'Organization' and 'initials' must be the organization and initials of the Team Leader:
- "Team Name" - "deliverable type" (e.g. Oncolinx - Resumes)
- If there are multiple groups within the same organization with the same initials, CAI reserves the right to adjust team names
- Only one file should be uploaded for each attachment category (Resumes, Stakeholder Engagement Form and Collaborators). For example, if you are uploading resumes for each member of your Challenge Team, please combine all resumes into one file and upload that one file to the resume category
- Each attachment should try to be no more than 1-2MB in file size
- Image files and executable files will not be accepted (e.g. .jpg, .gif, .bmp, .tif, .exe)
Letter of Intent and CDA Form
To enter the Challenge, there are three simple forms that need to be completed.
NOTE: For security purposes and to safely return to your survey, you should try to access it from the same computer and browser as you first filled out your survey.
More information can be found below. At the end of the LOI will be a Confidentiality Disclosure Agreement (CDA) click-through; you must agree to the CDA's terms to participate. Please find below examples of each form. Only use the online click through as a proper submission.
- Letter of Intent (LOI) form
- CDA form for all team members
- Resumes and Optional Documents (submitted via LOI Form)
NOTE: For security purposes and to safely return to your survey, you should try to access it from the same computer and browser as you first filled out your survey.
More information can be found below. At the end of the LOI will be a Confidentiality Disclosure Agreement (CDA) click-through; you must agree to the CDA's terms to participate. Please find below examples of each form. Only use the online click through as a proper submission.
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Resume Form and Optional Documents
Your team must submit resumes for all of your team members excluding your collaborators (information on collaborators are optional and can be included in another document). Pull together all your team member resumes to be submitted with the LOI form; put in one file. Resume's are limited to two (2) pages per team member. Please include a header on the top of each resume indicating what their role is on the team (e.g. Core Team Member, Mentor, Advisor, etc.)
Detailed LinkedIn Profiles (provide link on Team Member's page) and Bios will suffice in place of Resumes. Be sure it is a good representation of the members' background.
Detailed LinkedIn Profiles (provide link on Team Member's page) and Bios will suffice in place of Resumes. Be sure it is a good representation of the members' background.
Stakeholder Analysis Tool
We also strongly urge you to perform the proper stakeholder analysis for all phases of this Challenge. We are providing a "Stakeholder Analysis Tool" for your use. The Stakeholder Analysis Tool is used to identify stakeholders, and to assess their influence and favorability. Stakeholders are individuals and groups, both inside and outside the Challenge team/start-up, who can:
The Stakeholder Analysis Process:
- influence the success of the business plan and start-up
- be impacted by the new start-up
- actively support the start-up through funding, mentoring, etc.
The Stakeholder Analysis Process:
- Brainstorm a list of stakeholders, asking, “who can influence the success of my business plan and start-up and who can be impacted by the start-up?” Segment the stakeholders into meaningful clusters as appropriate (functions such as R&D, sales/marketing; regions, etc.)
- Ask, “to what degree do they have the power to influence the success of the ultimate start-up?” Use the 1-5 scale shown on the Stakeholder Analysis Tool template
- Next ask, “what is this stakeholder’s current level of commitment to the start-up? How favorably do they view the start-up?” Use the 1-5 scale shown on the template
- Ask, “for our start-up, what does success look like to this stakeholder, what would they consider to be wins?”
- Identify proactive actions to achieve these “wins," and to engage key stakeholders to provide your perspectives on how this initiative can create a value add for them in particular
| Stakeholder Analysis Tool |
Industry and Academic Collaborators
Please also consider creating an optional document that contains all your collaborators (put all the collaborators' information in one document with headers to separate different collaborators) and their potential contribution to your team; please upload all collaborator information in one file and submit with your Resumes. See a list of types of collaborators below.
- Non-Profit
- Economic Development
- Key Opinion Leaders
- Patient Advocacy Groups
- VCs / PE / Angel Investors
- Federal Government / University Collaborators
- Pharma Collaborators
- Service Providers (CRO, CMO, law firms, accounting firms)
Phase 1: Elevator Speech
Pitch/Elevator Speech
- In a good elevator pitch you should be able to convey all the essential information about your company in a clear and succinct manner, all the while communicating in a tone that’s compelling, credible, likeable, and passionate. Most of the time, it’s good to tell a story
- Focus on why your business exists, how you make money and why you are differentiated
| Elevator Speech Template |
Executive Summary
Your Executive Summary should be succinct and to the point. With 350 words, your team will be limited with respect to properly conveying your future business plan for your technology. The summary should be a snapshot to why you believe your idea is the best for the technology, what the potential value may be, and why your team is the best to execute that idea.
Phase 2: Business Plan
Please note: provide details regarding any assumptions you have in your financial models, development plans, etc. If you create a business model canvas please provide appendices that outline your assumptions
Business Plan Guidance
- Begin with the end in mind. Make sure you understand seed funders' criteria for investment and potential licensing requirements from the technology's respective organization
- Leverage CAI’s templates/guidelines for your business plan, regulatory strategy, development plan, and commercialization plan, etc.
- Check the criteria we are using to assess deliverables
| Business Plan Example Template |
Business Model Canvas
- Slide deck (102 slides) from Steve Blank, Alex Osterwalder, and Alan Smith introduces the business model canvas and outlines 9 building blocks of a business model (overview seen on slide 46)
- A downloadable template of the business model canvas, from Business Model Generation
References
FDA In Vitro Diagnostics website:
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/default.htm
Overview of IVD regulations:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm
IVD Guidance Documents: FDA’s “Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions”:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071230.pdf
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/default.htm
Overview of IVD regulations:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm
IVD Guidance Documents: FDA’s “Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions”:
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM071230.pdf
Phase 3: Start-up
- Incorporate your start-up as soon as possible
- Revise your deliverables by gaining additional input from KOLs, payers, the FDA, VCs, potential collaborators, CROs, CMOs, service providers, etc.
- Parallel process your deliverable creation – especially seed funding and licensing application; there could be a “chicken or the egg” scenario
Find some Links below that may help you throughout the Freedom from Cancer Startup Challenge
Start-up Guidance
Lean Start-up Overview - http://practicetrumpstheory.com/2012/02/why-lean-canvas/
UNC Lean Curriculum - https://kenan-flagler.instructure.com/courses/1185876/wiki/weekly-challenges
Training on How to Create a Start-up - https://launchpadcentral.com/#testimonials
Lean Start-up Options - http://thestartuptoolkit.com/cf6JE7nxHiQt/
Branding
Create Word Clouds for your Team http://www.tagxedo.com
Get a Logo for $5 - http://fiverr.com/
Start-up Guidance
Lean Start-up Overview - http://practicetrumpstheory.com/2012/02/why-lean-canvas/
UNC Lean Curriculum - https://kenan-flagler.instructure.com/courses/1185876/wiki/weekly-challenges
Training on How to Create a Start-up - https://launchpadcentral.com/#testimonials
Lean Start-up Options - http://thestartuptoolkit.com/cf6JE7nxHiQt/
Branding
Create Word Clouds for your Team http://www.tagxedo.com
Get a Logo for $5 - http://fiverr.com/
