Welcome. thank you guys for joining us today, so today it's going to be Kelly and I speaking,uh, my name is Katie Lyons, so I have been in and around industry since 2000. And before that I was a clinical pharmacist, I taught a little bit and so had a variety of things. So in the industry I was out in the field. I was working, I was helping investigators, develop investigator initiated trials, helping figure out, look at sites, for the pharmaceutical company to figure out if a site was appropriate to be a phase three site for us or a phase four site for us. Then I worked in-house. And in-house, I helped with medical strategy led global publication plans, helped to figure out kind of what we needed strategically and what questions we needed to ask and how we plan in the future that way in the medical aspect. And then I turned and began working in regulatory and in regulatory what you're looking at is from the rules and regulation aspects. Really what's going on and why do we, why are we limited by the facts of what we're limited when we're looking at phase three research and phase four research is particularly what I did. So if you look at the regulatory realm you have the regulatory requirements all the way through the spectrum. And I looked more at the end of commercialization specifically regulations around that. worked closely with the commercial colleagues in the company. So, with that, that's the introduction of me. I'm going to let Kelly introduce herself and she's going to start and then we're going to have the both of us get ready because we're going to ask lots of questions. [LAUGH] >> Good afternoon, my name is Kelly Hogan, I'm a pharmacist. Came from the Midwest, graduated from Saint Louis College of Pharmacy. So as I spoke to my mother today, they're expecting an ice storm and I'm extremely excited to be with you here in San Diego. So its a marked improvement of where I came from. my background is, is that I started in an AIDS clinical trials unit and then I went to make rounds with a, a critical care trauma surgery team. So my academic career started pretty early. I, I joined when I was 18 and then I started in the pharmaceutical industry, about the same time Katie did around 1999, 2000 but my whole spectrum of career has been around, phase three clinical trial work. So Katy and I are going to sort of divide our lectures today to our strengths. So you get the both, the breath of 26 years of experience although we don't look that old. I am certain. [LAUGH] So, so for the most part we hope that you enjoy our lectures and that you get all your questions answered. So thanks for letting us come and talk to you today. >> Regulatory was actually more interesting than I was, I got into regulatory, just FYI because, I was the person in there always asking questions because I was a medical reviewer in there and I'm looking at this. And they're saying 'you can do this'. And you can't do that and I was always going, well, why can't we do that? I mean, you know, well, well, give me reasons. No one answered my questions appropriately so I went to find the answers myself. drug approval requirements. So, we're looking at certain parameters. We're looking at, is it safe enough given the parameter, you're going to look and your approval's going to be based on that phase three population. So, if you looked at a patient population that was narrow then your indication's going to be narrow. And and if you sometimes, the other thing you have to consider is if you evaluated the surrogate marker instead of a clinical marker then you might get a different type of approval. What's called a subpar H approval. And you won't get a full approval until you have more data. So those are other things to kind of keep in mind. And why that's important is in the subpart H approvals. FDA has to approve and look at all your materials before you can send them out and try to promote on them and all those things. So, but you have to have the adequate manufacturing, your labels has to be appropriate and it's all going to pend again on how those studies are designed. And so this is the one I wanted to change. How did FDA gain the authority? So this is back where we're getting into the attorneys, so the attorneys are going to love this slide. [COUGH] There's always typically some political thing that's going on, right? So, in 1906 we had the Pure Food and Drug Act that was passed. You know, we're trynig to prevent the snake oils and all that stuff from going interstate commerce, right? But the problem with that law is there was no teeth. There was no way if someone violated that law that you could actually hold 'em accountable for violating that law. So there's tons of people upset about that and you heard it was going around around in congress and they were trying and they were looking for something to go and looking for something to do. And how do we get this through? And how do we make it a better law? They couldn't get it through and they couldn't get it through. Roosevelt people in his cabinet we're trying for years and it didn't happen. Well then this thing happened and, and this will happen again and again and you guys have seen it recently even. If something happens where death is involved especially death of kids, people's ears seem to go up and they seem to pay a little bit more attention. Well, in 1937, a 107 kids died because they used antifreeze as a solvent. Not the best choice you would think now. But, you know, it's [LAUGH] they used that tasted good. >> Oh yeah, yum. So anyway, we have results and the effect that we have is the Food Drug Cosmetic Act. and then what, what happened with that, is this was the first time that a drug actually had to be safe. prior to the fact that you could market it. crazy but true. And so what this was doing is this also then is really what really established the FDA. And so this is what you'd be in to establish that kind of regulation on a regulatory effect that kind of went on. Now a lot of regulations that actually came out of the FDA and how you were actually regulated in the promotional real with drugs actually came to be written after the 1962 key for Kefauver-Harris Amendments. And what happened with that is there's a lot of push Sulfanilamide was causing some birth defects in Europe and it was up for approval in the United States. And they prevented based on all of that, they prevented the approval in the United States. And we saw the changes in the amendments there. And here we're dealing with they have to be effective and safe. And that's where we, we saw some changes. But amiss is then where we began to have the regulations, as I mentioned, for, the promotion and what related to that. Now, what we see then Is we have the Modernization Act of 1997 and this deals with how you talk about products and can a pharmaceutical company communicate about a product before it's launched. And how do you communicate that way? But the other thing that's very important is with the laws, no, no that you guys need to think about is and it's going to actually I'm going to wait on that because it's going to come up on the next thing. So here the New Drug Application. So that's the NDA. And when we're putting the NDA together we're going have again another meeting with the FDA. We're going to say here this is my packet. I'm going to give it to you a month ahead of time. I have all my stuff here. I'm going to have all the clinical data, I'm going to all the pre-clinical date. I'm going to have all the statistics. It's this huge file. And you're going to talk to them and you're going to say is everything in here? So FDA has three different stages when they do that. They're going to have this receipt. So, you're going to send it to the FDA they're going to check to make sure they've received your million-plus pages. And then in 60 days they're going to say, yes, we've received them. Then, they're going to kind of look to make sure you have all the main components. Once you have all the main components, they're going to say yes, you've filed. And then what they could also do too is, say we are refusing to allow you to file this because there are key components that you need in this submission, that you failed to submit. >> Katie, if I am on Novartis and I am watching Pfizer, what goes public? So if I want to spy on my competition, what part goes public? >> You will notice, well, the press releases are going to go public, right? because those are considered and then you will see a notification that a submission has occurred. You will not see anything after the fact that a submission has been received anything on how that process and review is going until it actually occurs. So these are some of the contents again, like I had already talked about all that preclinical duff, all of the pharmacokinetics, all of the clinical information. Any of the patents because it's very important the attorneys can fight over the patents later. I mean, and the proposed drug labeling and the proposed labeling, I'm actually working on a product now with a company and how long do you think that proposed label is? Have you guys seen any labels lately? The proposed label to the FDA is 51 pages long. Now that shows, if that's the main thing that a physician uses to gather their data about the product. Last time I checked most physicians do not have time on their schedules to look at 51 pages, to really analyze [LAUGH] 51 pages to get what's going on. And that was part of what was also seen with the physician drug labeling changes that happened eh, about ten years ago.
