FDA 505(b)(2) Applications Seminar Part I: Where does a 505(b)(2) fit?

all right good morning everybody I'm Lewis once the president reaches technologies and we're very excited about the seminar we're an API development company that takes molecules from in the laboratory up into the factory we create the documentation that goes with it interestingly if we have three 505 BG projects going on right now and in our case there are pro drugs so I think our speakers will talk about how protons could confited this as well that the customer wants to change something on the molecule but still have the same pharmacology pathway so I'm going to give you the brief commercial and Regis and then we'll get into the talk we were formed in 1956 by my father who just returned from Florida kind of fun to have the founder in after six years uh we're at CFO especially as you need get a manufacturing process development but we also do all the the tech packet that creates your CMC section such as a analytical validation stability etc our clients are typically Pharma typically work with the smaller promo companies like in Boston and say oh please no and we also do some other life science work such imaging one of the glucose monitors our main business qubit the one simple slide here will be processed Hulman we take the molecule from the laboratory up into a ski low scale small reactors and large reactors and we're the one that fights the battles to get it there like our process chemists have have worked with a lot of different things and know that there's engineering challenges as much as their chemistry challenges to scale the molecule and will work beyond that another we're very strong in is analytical when I joined the company maybe a few years before I joined even I the analytical is TLC a melting point but now it's much more advanced the FDA will what you have very good understand of the process that understanding impurities so ever great analytical team that supports the process all the way long along with that one thing that's been interesting is its analytical impurities we've done that by separating them we also with her since this team has needs made some impurities to people and you're chose companies have a real good understanding of the process and impurities and even potential ones so sometimes a lot of us meet one that hasn't shown up but they want to prove that it's not showing up in the process one thing recently we've made an investment of potent compound sweet our projects are getting the the molecules out they were getting much smaller doses at much higher potency so you have a potent come on sweet very small scale of that's what did you leader flask but with this we've also gotten better on chemical hygiene and how we handle things to the factory so a very good understanding that and my last slide we have a video library here of different projects different seminars he had in the past actually Jason Roloff is right here Jason really understands personal statistics but there's one side evaluation of impurities structure elucidation etc so it's very good education on drug development so that's it for commercial and now we're going to find out our first speaker who is a look at its redepositing Lucas the principal consultant at Parc cell and she did experienced in the assessment of a NDA's IND is NDA's with the focus on 505 B two applications prior to part cell look was a team leader right the opposite of generic drugs FDA she was also part of Hadouken implementation which I know for really happy about their SantaBanta limitation but it is part of it and established a establishing division for drug substance DMF review at Cedars thank you thank you very much and you know it's wonderful I mean to see this gathering of really interested you know audience and so the regulatory today we are going to talk about the regulatory pathway for 505 B 2 and before I start I wanted to say that my colleague partha ro and I we are both going to talk on it but it's not going to be a separate presentation we are going to go as a continuum like you know where I stop Arthur starts because are we we realize that it's better to go that way so with that I'm going to start so the objects objectives are obviously is where does a 5 or 5 be to fit and what are the objectives of a b2 application the critical questions and challenges also a few case studies and I want to talk about the thin line between the 505 B 2 and 505 J which are the generics and this is happening a lot and being a team leader at office of generic drugs for a long time I have seen you know various occasions when companies were taken by surprise when they came with a J and we said no this is a b2 so then let's start at the very beginning what is a b2 so obviously this is the you know the definition in the 21 CFR it's an application that contains the full reports we wanted to focus on that of investigation of safety and efficacy where at least some of the information can be relied upon for approval and not conduct conducted by the applicant and for which the applicant has not obtained the right of reference or use this means that if DEA he makes another formulation of metformin it's not going to be a 505 B 2 it's going to go into the NDA but if company X tries to make another I don't know if that's even possible to make anything else with metformin but if they think about it and want to make it that could be a 505 B 2 so that's a very fine line there to with NDA 505 B once and this is a little table that shows the three of course for a B one everything needs to be there and for a J your safety and efficacy are assumed and so basically you what you want to do is you could be a bio equivalent you could be qualitatively quantitatively the same and you get a therapeutic equivalence rating 505 B two lies right in the mid middle it could or could not be bioequivalent most of the time it's definitely not q1 q2 and the possibility of the rating this is actually something that many companies are looking for now and this has become a very open area if a product approved under 505 b2 can eventually get a therapeutic equivalent rating and a B or an AP rating so basically as we were saying one end is the new drug the other is the generic and 505 B 2 is the middle and this middle part is growing and growing and growing and becoming more and more interesting as drugs get you know more and more interesting dosage forms come into the market

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