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  "documentTitle": "Berkeley Lights (BLI)",
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  "presentationDate": "2021-09-15 00:00:00",
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      "text": "The data integrity problems flagged by ex-employees are not only devastating enough to prevent adoption, but they make the machine a non-starter for any FDA-related submission, according to a former BLI executive, who indicated that customers therefore won't take the risk of using it.",
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      "text": "The data integrity problems flagged by ex-employees are not only devastating enough to prevent adoption, but they make the machine a non-starter for any FDA-related submission, according to a former BLI executive, who indicated that customers therefore won't take the risk of using it. A former BLI scientist elaborated further, stating that the company still needs to validate that data from the instrument can be used in an FDA new drug filing. We struggle to understand how BLI's product is viable if it creates FDA issues for large pharma/biotech customers, for whom the entire point is getting new drugs through approval.",
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      "text": "Former executive suggests the machine is a non-starter for any FDA-related submission; customers won't take the risk of using it. \"They've got these ideas around cell therapy - I laughed when I took a peek at their S-1...\"",
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      "text": "Former BLI scientist indicates they still need to validate that data from the instrument can be used in an FDA new drug filing. \"A lot of work was focused on generating datasets that could confirm that the Beacon platform could generate data...\"",
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      "text": "\"They've got these ideas around cell therapy - I laughed when I took a peek at their S-1. That's so far out. Not only do you have to get a pharma to buy this thing and use it, you have to get somebody to take it through the FDA, a novel device. Is Berkeley Lights going to pay for that? Are they going to do their own first to get it approved in some application? A pharma company who's building the therapeutic has to take the risk of using something new at the FDA. The FDA could be like, 'Nah, no. We don't know about that. That sounds complicated.' It's just a risk. In cell therapy to introduce new modes of testing or production are likely going to take a very long time and I think it's going to be hard to get the incentives appropriately. Who are the companies who are going to build knowing that's a risk? That's a platform risk. They will crawl up the rear end as a class 1 device. It's a heavy lift.\" — Former executive; \"A lot of work was focused on generating datasets that could confirm that the Beacon platform could generate data that would support an IND filing with the FDA, comparable to traditional methods that are employed right now. They got to a point where they really needed to prove that you could replace completely the standard cell line development workflows with the Beacon workflow and have the same likelihood of success with the FDA or, in general, with a pharma company. That was mostly the focus.\" — Former employee/scientist",
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      "text": "Source: Scorpion Capital consultation calls with experts",
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      "text": "Part 2) Former BLI employees/executives: Data integrity issues create obstacles for FDA use",
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