1. Sample Development Plan and Timeline (CYCLE 5)
“No Go” due to movement artifacts in infants
Clinical Study: B-adrenergic Stimulation of Sweat Glands in Infants
IRB Approval
Clinical Study: Sweat Rate Test in Infants
Prepare IRB Submission
Fabricate Prototype
Explore Alternative Probes/ Modifications
Test Probe Options (3)
(technical activities)
Sample of current project plan. Milestones for the same project are also depicted on next slide in the milestone dashboard, along with other activities supporting achievement of milestones eg. preparing an IRB submission.
INSTRUCTIONS
Please update this slide with your project plan using the style/formatting guidance below:
Please provide research activities and milestones above the horizontal bar –pre-clinical technical tasks in blue, clinical and regulatory tasks in purple, manufacturing and quality systems tasks in orange,
Please provide the IP/business/commercialization milestones below the horizontal bar in gray/black.
Please provide fundraising effort last in green
Prepare you word document application (LIMIT 6 PAGES) and include these two slides. You may submit as separate documents or make a PDF of the three documents.
Save the file(s) and your full proposal with attachments to
Design Controls
<Q216
Q316
Q416
Q117
Q217
Q317
Q417
(IP and business activities)
CYCLE 4
File Non-Provisional
Feedback from Potential Licensees
Discussions with Potential Licensees

2. Sample Milestone Dashboard (CYCLE 5)#
Status
Milestone
Comment
Est. Date
Complete
Y/N
4.1
Probe Selection: Test three technology probe approaches and select the best one for sweat rate measurement (spectal imaging, evaporation, and Cl quantitation).
Q316 N
4.2
Modify/Build Prototype: engineer a suitable housing for the probe selected for use in human testing.
4.3
Obtain IRB Approval: prepare and submit clinical protocol to IRB for feasibility testing of novel device in humans.
Q416
4.4
Human Proof-of-Concept: test probe on human subjects to demonstrate feasibility in terms of safety and efficacy.
Q117
4.5
Progress Business Development: engage with candidate companies, share clinical data and discuss licensing options.
Q217
Please use as a TEMPLATE for your milestones. Everyone can start out green and then if your timeline to achieving the milestone slips, it can turn yellow or red. This will be iterated on quarterly reports and so the date stamp in the lower right is important.
Incomplete
Delayed
In progress
Date: