YouSaid · the spoken record

Robert M. Califf

lines on the record: 54
first: 2020-01-14
most recent: 2020-01-14
sittings or episodes: 1
sources: podcast

Every line below is reproduced as it was said and linked to the record it came from. Nothing here is summarised or generated. Directory · Search · Corrections

“Yeah, so I think that goes back to the horse and buggy in the trucks and how information has historically gotten to the FDA. So I came from the landscape of a health tech startup company focused on data. I was recruited to FDA with the expectation that I was going to show up and focus specifically on digital innovation for the FDA and sort of went smashing into a realization that in fact the way the majority of our applications still come in is through PDFs or sort of essentially large digital representations of what used to come in on trucks. We now receive most of our drug applications, but not all in some kind of electronic format. As a matter of fact, just two weeks ago I had to approve a book of work in orphaned diseases where we're still getting things on paper as one example. But most things come in as a digital application also with some digital data but that gets stored at FDA.”
2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source
“So a couple of things. I actually think that there was a time when it probably came on horse and buggy, not just trucks. So practically speaking, I usually think about five key elements in drug and biologic product development. So there's the discovery phase, then there's time of preclinical development. After you've done adequate preclinical development in line with good laboratory practice, then you'd submit an investigational new drug application for drug or a biologic to the FDA, which gives permission then to start clinical studies with people. And a drug or biological goes through a series of clinical studies, typically phase one through three, although these days those lines are blurring, for exactly what drugs follow then by a new drug application or biologics application of BLA to the FDA. And then the final stage after FDA marketing approval would be post-marketing assessment and continuous surveillance about this particular”
2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source
“Well, so in that context, let's talk about what the FDA looks like today in those older days, the data came to the FDA by the truckload. I'm just imagining reams and reams and paper and so on. And I'm just curious to get your take for what does the current system look like? And could you take us through how this works?”
2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source
“Is the FDA still relevant So I'm going to go back that 113 years in the time the FDA was formed and continues to be the largest consumer protection agency. It's formed out of 100 laws. I think that the issue that was going on at the time was unhygienic conditions in the Chicago stockyard. And you can imagine there's been a lot of responsibilities of the FDA over time, thalidomide, et cetera. But practically speaking, the FDA is responsible as a science-based agency to protect and promote public health, including through making sure that we have safe and effective medical products to use every day with our patients, as well as through promoting innovation. Your question was whether or not the FDA is still relevant. And I would argue that in a time of rapidly emerging biology, when we've got more and more scientific innovations and potential products coming to bear, the need to make sure that we have an objective.”
2020-01-14 · a16z Podcast · Food, Drugs, and Tech—100 Years of Public Health · IDENTIFIED FROM THE TRANSCRIPT · source