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I'm speaking at the Tufts COVID-19 Research Symposium next week on the challenges associated with developing *commercial products* (not just publishing papers) in an academic lab... on an accelerated timeline... in the middle of a pandemic. 1/11
There is a clear need for more COVID-19 diagnostics. Moving the testing modality out of the clinical lab to the point-of-care could have massive public benefit. Maybe that means relying on standard technology (like lateral flow). Maybe that means being innovative. 2/11
If you're shooting for innovative, you have a long road ahead of you. Even if your target price point is low, you need to raise substantial funding for manufacturing (comes first!) before you get to clinical testing. 3/11
There are very good reasons the bar for the EUA is low, with regards to test validation. However, those tests must still be performed on 'final' lots of devices. And that's where the academic/commercial barrier is the largest. 4/11
Academics may be able to demonstrate new and exciting tech, but those assays will all be performed using prototypes that aren't being manufactured under a quality management system... so then it needs to be done all over again. 5/11
The process handoff to turn prototype into product still needs to be made after the concept has been minimally de-risked in the lab. That's not cheap. And if your device needs *new* infrastructure to produce/scale up or hits a supply chain problem... whooooo. 6/11
To all my colleagues working on this problem — thank you and good luck. Even if your approach can't impact the testing gap for the current pandemic, think about the benefits of your strategy further down the road. 7/11
And please keep two things in mind regarding any test that you may want to develop: (i) manufacturing strategies and (ii) instructions for use. If you think either "aren't your problem to figure out", then you're basically signaling that your primary goal is just to publish. 8/11
Which is fine! But acknowledge your need for external assistance to meet your ultimate goal. This is all really hard to do correctly. It is not a sign of weakness to know when you need help or additional expertise, which can be clinical, manufacturing, regulatory, or other. 9/11
Frankly, that's where we are in our efforts to make a COVID diagnostic, too -- the "needing a lot of help" stage. And we've been at this since May! My lab/collaborators (including @The_SilkLab) have done a lot of amazing work, but we're not at the finish line yet. 10/11
Maybe we will get there, maybe we won't. But we are trying to both make a difference. I know a lot of my colleagues elsewhere are also putting in a lot of effort here. It will make for a number of interesting stories when this is all over. 11/11.
