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FAQs online signature
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What are the stages of the pharmaceutical product life cycle?
Conclusion: A pharmaceutical product's life is always complex & unique in nature and can be described in five distinct phases- development phase, approval phase, introduction phase, commercialization & quality management phase and decline phase.
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What are the stages of production in pharmaceutical industry?
Pharmaceutical manufacturing comprises physical processes such as blending, compression, filtration, heating, encapsulation, shearing, tableting, granulation, coating, and drying.
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What are the 4 phases of the product life cycle?
Product Life Cycle: The 4 Stages Explained. The 4 stages of the product life cycle are introduction, growth, maturity, and decline.
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What is the pharma supply chain cycle?
What are the main stages of the pharma supply chain? This process typically moves through research and development to manufacturing, then packaging and labeling, distribution, and dispensing. Quality assurance is included every step of the way.
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What is the lifecycle of a pharmaceutical product?
The pharmaceutical lifecycle broadly includes three stages: development, commercialization, and generic competition. From initial development to the eventual loss of market exclusivity, a pharmaceutical product's lifecycle can span several decades.
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What are the four stages of drug product development?
Drug development can be divided into four phases: discovery, preclinical studies, clinical development and market approval. The image below provides an overview of the process, including an estimated timeline for each step.
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What is sales process in pharmaceutical industry?
Pharmaceutical sales is the practice of salespeople who educate health care professionals on specific medications developed by drug companies in order to persuade them to prescribe them to patients rather than a competitor product or treatment method.
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What are the 4 stages of product life cycle in pharmaceutical industry?
Product Lifecycle (PLC): Is defined as the cycle the entire product undergoes through four stages such as introduction, growth, maturation, and decline stage.
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[Music] welcome to financial planning explain and i'm your host mike manager certified financial planner owner and founder of meninger and associates financial planning uh i'm pleased to have this week in our episode dovetailing from last week when i had shawn montague engineering director at merck he was my guest last week this week i have bob matchy who's a principal at rentec llc and i think there's a lot of dovetailing that we can do that goes from what uh sean does over at merck to what bob does and so today bob welcome to my show thank you very much thank you very much for having me mike it's pleasure to be here bob tell me a little bit about what you do and then kind of just pivot and go from there sure sure i'm a pharmaceutical consultant and rem tech llc provides technical solutions for clients that are in regulated environments and we typically bucket that in three categories we work in the project management arena where we work with capital projects manage scope schedule cost integration of the work we work in the technical services area where we provide solutions to clients that have an operational need to maybe grow their product maybe transfer from one location to another maybe optimize it maybe work on ergonomics safety those particular areas and then we also provide some consultancy in the regulatory and quality space where we work with clients to get better get a better stronger compliance position as you know being and working in the fda regulated or eu or other environments so that sounded very technical so give me an example of a project that you've worked on that did some of the things that you just said sure yeah actually i'm i'm pleased to say that we still have our first client uh work with us still do a lot of work with them i think we're on project 13 or 14. and that started out it was a medical device project and that started out where we were going to completely revamp it and go to uh you know a different generation of it because there was some issues that needed to be managed uh you know with the current product and that's very common in in the industry uh with that um i got the opportunity to work then on increasing the production of that product and through working with the the assembler and working with the device manufacturing component manufacturers able to increase the delivery of to market from nine percent to thirty percent and capture it more for that nine percent to thirty percent what right it was a life-saving drug and they needed uh to increase they wanted to increase that it was their largest product that they had at that point in time and i believe they were just bought out and now i believe it's their second uh largest revenue generating product and so adding value and and providing that technical solution for them was was one of the you know crowning moments early on uh with rem tech in the rem tech career later went on to help them when you manufacture medical device there's components that are made at various locations sometimes and are brought together and assembled to be able to provide the final product we actually focused in on one area of that took them from a very old archaic process into a new it was a stepwise change highly automated it had in-process quality checks that were not present resident with the previous generation of the of the manufacturing operation and that was a big win because when we did all the testing put together the dossier and submitted that as what's called a prior approval submission with the fda received approval inside of 22 or 24 days i i forgot wow that's impressive so that sounds like you being able to increase it sounds a lot of like industrially engine it almost ties in a lot of different areas whether it be mechanical engineering industrial engineering what's your what's your degree well i i i actually started out with a civil engineering degree okay and then i got my master's at villanova and that was in environmental engineering water resource management and then from there i actually uh prior to that worked in the military and in the military i was in the corps of engineers so i had that civil engineering background that basis and as part of that experience i learned a lot about communicating with people leadership by 30 some people as a lieutenant i was deployed to desert storm learned a lot about myself with those types of experiences early on from that experience then i came back and i got started in sales that lasted about six months [Laughter] um and uh because it wasn't aligned with where i really wanted to head yeah yeah i'm now registered professional engineer in the commonwealth of pennsylvania i have my certified pharmaceutical industry professional what's that certification that is a competency-based uh certification that the international society of pharmaceutical engineers used to have back in the day and it was uh seven pillars of knowledge that you had to demonstrate a level of competency in and you took a test and uh and then got your designation after uh you know working uh through the program itself so uh pretty proud of that one and at this point uh like i said it's no longer offered but it's something that you're still able to carry sure that's neat well just in talking near earlier you were saying that you had different pieces of experience and just like sean had said you know when sean worked in he worked at gsk then he went to a company that did manufacturing for the pharma and his experience with the man with gsk helped that and then he went to mark yeah and just in what you were telling me there were you worked at wyeth which is now pfizer did you were you there for the crossover yes yes you were two so you did that then you had what did you do after that after wyeth yeah you were a plant manager right that is correct well after after wyeth was purchased by pfizer i was there for several years got a lot of great experience uh working with some very very talented people fighters got some great science and i'm really pleased to see that they're one of the leading candidates right the current covid vaccinations and whatnot but then after working at pfizer uh i was recruited and attracted to a company called endo local to melbourne pennsylvania and there i i ran the engineering department for the generic business inside of endo and so i had the full control of managing capital projects maintenance automation ehs and things uh you know generally reserved for that type of position uh at one point in time then i was tapped on the shoulder and said hey we have an opening in our charlotte facility and i need somebody to carry the baton there for a while so i actually was able to transition to operations and that was a real treat i really enjoyed working on the shop floor because i had a lot of the background you know from an ehs perspective very safety conscious activities i worked over in ireland uh moved my family over there ran a two-year project uh and was able to integrate and understand how operations work but i never really run operations at that point some so when you say operations you talk about you ran the plan manufacturing facility that's correct ran the client produced product reported had pnl responsibility excellent so that is a tremendous amount of experience and you having that different pieces of experience you had the ehs experience you had the experience in pharma really pulls it all together to do the plant manager now at what point in time did you spin off to begin doing what you're doing now yes well it goes it goes even a little bit beyond that because uh when i became a consultant after uh working at endo i was able to uh get a job actually as a part-time as an individual that was supporting uh you know 503 v pharmacy and there i had the ability to work in a network and finance 3b 503b pharmacy that is a compounding where they take prior approved drugs and and you um uh dilute them or put them into different configurations and then sell them from there so you're not really manufacturing you're really uh you know changing the format of changing the delivery they service hospitals and that was enacted early on uh you know it's only it's only a couple of years old at this point in time but that was enacted early on along with the serialization regulations that were signed into effect at that point i actually heard of compounding where they're literally able to take a piece of viagra and a piece of cialis and merge them together to create whatever that drug might be right i'm surprised that they don't have problems with um patents or do you or can you only do that i know we're spinning off but can you only do that with things that are off patent no um what you have to be careful of is there is a drug that has a presentation form in the same form of what you're trying to uh um and you are out of my area now of course so i may be speaking a bit out of turn but i do have some limited knowledge here uh of of the situation uh you can combine products but it has to be in a different uh format it has to be something that uh is delivered in in a way like you know an iv bag or a syringe or something like that so you're you're combining uh those activities because you're you're buying the drug right right and you can you know use it and market it and the fda did that of course to be able to allow uh you know another methodology or another pathway to be able to get life-saving drugs to the patients all right so i derailed you so you you were at the 503b pharmacy for a little while and then what'd you do after that and then i uh well after that i got back into the consulting activities and been working with a various you know uh clientele that we have uh that to again provide those technical services in the regulated environment and working in those predominantly those three areas that i had mentioned before so so how do you find your clients they that's a great question um we don't have much marketing i was talking before the show to you here this is the first time i've done something like this uh i'm not that big on social media although we do have a website you know website we do have a linkedin presence that we uh utilize but this is the first time i've done something like this and largely um you know my clients find me because i i've worked a lot in the industry i'm very proud to have worked a lot in the industry and i think it's a noble industry and uh it um i just got a call the other day from somebody uh that had referred us you know for some work uh at one site where they need some ehs support well having worked in the environmental industry and knowing what's required for your environmental health and safety having that individual that team report into me as you know uh running the network as a plant manager and then being able to utilize my background understanding training you know we have the capability of being right well you bring a lot of talents to the table so again doesn't matter i mean like who are your clients i'm not asking like who are your clients but who are your clients are they the mercs of this world or are they um like what type of clients are your clients sure that's a great question uh we do operate in the the branded the larger uh space but prominently our clients are in that small to mid-size operations and it's it is in the pharmaceuticals where you're looking at the rx you know prescription drug uh arena but also across uh the oil solid you know the otc over the counter drugs uh you know tylenol things like that that you buy off the counter and some of the nutraceutical space as well as working in nutraceuticals nutraceuticals performance enhancements oh okay yeah okay talk about that um but also in the um aseptic and sterile filling processing uh you know that's a big an up and coming market what is that sterile filling and aseptic filling process what in the world is that that's an injection well it sounds like it for what is that like botox yeah well it could be botox yeah something like that but uh you know the the covid vaccines those are considered sterile uh you know injectables uh in the marketplace and of course that's the one that the fda has a very um significant concern because you're bypassing you know the normal uh immune system in the body has when you ingest food that may not be uh fully ripe or anything your body has the acid to be able to break that down but when you inject it directly into the body it has a ability to provide much more of an impact if it's not gets there faster exactly yes without a doubt so here's a i don't know if you know the answer to this because i'm trying to get my arms around it like how many pharmaceutical companies are out there i mean you think you get the merc you get the pfizers but you reference the middle size small size are there like thousands of them out there thousands they really are they're really okay yes and are we in a mecca area for that because i know johnson and john merc's headquarters is right there is is that their world headquarters in in pennsylvania i i believe it's in new jersey i believe it's in white house new jersey but the the the engineering group the global engineering group is out of white uh west point west point thank you and then pfizer was out in new york and pfizer has their technical operations headquartered i believe in ppac all right but i thought wyatt wasn't that wyatt's wife's world headquarters used to be in madison new jersey and it moved down to collegeville yeah yeah yeah yes but i just there's a lot of pharmaceuticals in the delaware valley that's correct we are in the northeast quarter is known for its pharmaceutical presence it is absolutely but there's uh you know pharmaceuticals popping up all over the place now uh you know another hot spot of course is in the raleigh durham you see merck is there for last week and that's where sean operates out of uh but you know of course the west coast has a big uh presence for uh you know sterile fill and uh operations and and uh you know because it's close to the tech centers that are there because you know that's what we're all about is deploying that science so it's where all the people are exactly exactly so believe it or not we're up on break already oh so uh stay tuned we'll be back with you in a few moments great have you saved enough for retirement are you financially prepared for an emergency or unexpected event have you thought about your financial future hi i'm mike manager founder of manager and associates financial planning for over 20 years we have been answering our clients questions just like these as we develop unique and comprehensive financial plans tailored to meet their needs when addressing your financial plan we incorporate your entire financial picture including taxes estate planning as well as investment planning and retirement planning so call us today for a complimentary no obligation consultation a unique approach to financial planning [Music] welcome back to financial planning explaining i'm still here with bob matchy um we derailed a little bit when we started going down the uh uh the pharmacies and stuff like that but hey you know what it's a complex industry but you know let's let's get back to rem tuck um how long you how long has remtech been there doing what you're doing now when did you form that company sure um actually rem tech did start in 2009 but at that point in time i had started it because i was i was actually doing structural work for individuals i was i was providing you know consultant services because of the professional engineering license and it was actually more of a hobby uh in 2016 we reorganized at that point in time i have a partner uh john hartwig he complements me very well because i work with the upfront manufacturing aspects of the work he's uh automation packaging uh expertise uh and um two very complimentary very complimentary now he also has uh young manufacturing uh capability expertise and of course you know i had packaging group reporting into me as part of some of the project management experience i should say the plant management experience that i had uh previously but we provide like i said those technical solutions uh predominantly in that gmp environment for our pharmaceutical gmp uh good manufacturing uh practice oh okay and that is the guidelines that the fda has put out but it's generally known as as the the regulations across the board that regulators will come in and audit you against and determine are you in compliance or not in compliance and why and that's an ever-growing field and the compliance aspect of the industry is only getting tighter and tighter as we you know i understand the only hip right you know the financial services and hipaa are the two industries that probably have that we compete for having more compliance yes yep absolutely that is absolutely correct but you you you by the sound of it really know how to navigate him you were talking about you pulled something off at the fda in 22 to 24 days or something like that which sounds miraculous well you you say you but i was i was a part of a team right that's right yeah that actually did that and and your credit to the project manager credit to the the client credit to uh you know the um um regulatory people inside organization that drove that uh because that was that was fairly miraculous that's not something that uh you see every day particularly for you know this was a sterile injectable product and it's something that we are pretty proud of but it took a lot of work it took a lot of understanding the details and that's what makes a successful project having a very fixed view of where you're going and then managing the change as it goes along so there's a clear understanding of what that impact is and making sure that change is relatively understood you know through uh you know the the management chain it can be very very tough and in particular as clients are looking for you know greater value greater flexibility greater ability to to use and gain you know competitive advantages for the facilities that they're building all while still making sure that it's it's safe it's compliant and it's going to you know meet the intended outcome of course well those that's an aspect of the overall project is the fda your ehs experience is that something that you just find that adds to it or do companies actually hire you for the ehs we do both we do both um you know just before this i got a call from one of my mentors who i've been staying in contact with uh for several years several decades now and uh you ask you know hey do you have someone that can help us out looking at a process hazardous analysis on this particular operation and yes we do we have people that have worked in pharma companies have had these types of systems that they had to make sure we're safe and and that is a big part when i talked to project teams you know the first thing i say is and and you know as a plant manager i first stand up in front of people i say listen my priorities in this order are your safety i want you to come go home the way you came to work i think that's very important uh but then the next thing i say is and followed right behind that very close to that is quality and quality is is is is meeting requirements but is in the context of safety of the patients and the patient safety you know we uh and then of course we talk about the delivery and making sure that we commit to delivery we deliver on time and of course the cost has to be there to round it all out of course those are the general principles that that i lay out there because i you know it's important to establish what the priorities are and and making sure that everybody understands and rallies behind what that project is to do but setting you know safety up in front as a value is one of the first things then becomes execution delivery cost okay so do you find that you work on one big project at a time or a multitude of little projects at a time what do you find yes with you yes right yes so we uh we have a number of projects where we have people that are embedded right now and helping like i said there's uh we have one client that we're improving their compliance position at this point in time we're helping them look at their sops whether their method development their lab operations uh we've done a number of projects with them my partner actually installed a new packaging line for them as well as you know provided them with health hazard assessments so we provided a very broad range of services to them that we're very proud of the capability to do that but it's because of the networks that we've built we don't necessarily have all of those capabilities in-house because some of them are very special you need a medical doctor a toxicologist to you know a health hazard assessment we have those contacts to be able to bring those to bear to be able to provide that value to the client at the end of the day and so they see us as solution providers for them that allow them to contact us and say hey can you help me with this what's the regulation around that so those are small projects that we kind of work towards when you a new capability inside a facility then you're talking a larger project because that needs to be planned it needs to be programmed you understand what your outcome is and what the potential future you know build out might be looking down the road and that's all crystal ball stuff and that all takes alignment because you're going to have people that are looking at it from the perspective of well i want to use it for development purposes or perhaps i want to use it for manufacturing purposes or it's going to support the growth of the product or it's going to provide a mechanism to allow us to optimize the existing products that we have in the network right now so those are all things that need to be defined and determined up front because invariably uh you know as things change and they will because business change it's not a static object you need to be in a position where you can make those changes uh in a controlled fashion of course well you know consultings and i i was in consulting the first 12 years of my career environmental engineering and one of the things i've come to the realization is the value of a consultant is more than you know because i know that i'm not good at certain things you hire somebody who is good at it because quite frankly they're going to get it done faster and cheaper than i would in other words stay in your lane right and i learn and understand you think about it i'm a consultant as a financial planner accountants are consultants and you know almost amazing how many people that you deal with on a daily basis is a consultant so clearly that's the value that you're bringing to the table and i can see just in our discussion here today and before the show the value you bring because you have such a plethora of experience your your time at the gsk i'm sorry the wyeth um the plant manager your ehs your time at the core of engineers it's just remarkable all the different things you bring to the table and i just think that's excellent now you had even said that you worked with sean and that you hired yonkers which means that you guys were effectively serving as the project manager for a substantially larger project weren't you that is correct yeah i was for time in pfizer i was working down to puerto rico and they had several facilities down there uh one of which they were closing and they were transferring products from one location to another and i was actively engaged uh in a number of those activities and that's where we interviewed several firms uh you know for the the handful of projects that we had and sean and his firm eventually came out on top for uh you know one of the works one of the uh projects that we had down in barceloneta so it was an opportunity yeah uh you know to be able to to work with him uh that was nice do you still do that type of thing with rem tech sure absolutely yeah yeah we do partner with uh you know various uh organizations and uh and that's what i'm saying you know yes i have a varied background but you know it's really the strength and the skill of the team of course that you bring together to be able to you know solve the need and that's you know speed to market is is everything in the pharmaceutical industry you know where i often look at what we do as a necessary evil because we're we're spending money but at the end of the day you're gaining that value and and to make sure that you get there as quickly as possible with the least amount of investment necessary to be able to have a great flexible facility i'm working on one project right now where they're putting a totally new uh delivery a new product into the facility and it's it's got some potent aspects associated with it they hadn't done something like that before well it's something that a very small amount has a pharmacological effect so if you get a whiff or something like that you may have a reaction to that particular product that is being manufactured so obviously what's very key there is making sure that the worker is protected of course in that environment so we uh you know i was brought in to look at how that facility was laid out uh and had some immediate changes which were a value-add because i i was very involved in an organization called the international society of pharmaceutical engineers and i got to work with some very talented people that developed this oral solid dose manufacturing baseline guideline it was called and i wrote co-wrote with some very uh knowledgeable people from astrazeneca and sanofi the section around managing potent compounds so i was very intimate with the knowledge of how to you know make sure that you're able to manufacture because it's not just um you know the equipment operation but when in a contained environment but you've got a sample you've got to take data you've got to maintain uh all of those things that you know shawn talked about last week that having that experience and working in that environment and knowing the impact of decisions that are being made now programming that into the engineered solution gives you a much better chance of success in driving revenue output capability at the back end of the project of course well if you go back to the qaqc part is it's important that the output meets certain specifications because if not it the company is not making money throwing batches out that's correct yeah so what do they do when they throw a batch out did they grind it up and put it back into their original or do they literally just throw it away well no that you know you don't literally throw it away most most of it gets incinerated but it doesn't get ground up into its original component no no no no that would be reprocessing and uh you have to have procedures around that that allow you to do something along those lines but generally reprocessing material is not done in the pharmaceutical industry it's it's not that that's like testing quality into your product though if it doesn't pass that was the big bar laboratories lawsuit that actually formulated much of the basis of the law around how pharmaceuticals uh you know govern and operate what they're able to put onto the marketplace and that was simply around the fact that they kept testing and testing oh it passed when we can release now yeah that was what was so in our closing minute tell me what you think is the coolest thing that you've ever encountered or did or oh if there's one minute that could be yeah no i tell you some of the stuff that's coming to fruition these days with uh um uh you know shirt sleeve manufacturing and and with uh uh you know single single processing and being able to push a button have a tablet come out the other end the automation the the internet of things the the the in processing capability for defining how your product is coming out and looking at the uh you know how the the quality is being measured and then being able to react real time for real-time release activities it's astounding it's astounding and you know the amount of data and information uh and coupling that aspect of it with how's your facility operating right now am i using too much utility uh yeah i didn't even think about that as another yeah yeah and and you know what looking at it from the perspective of analyzing you're the maintenance of your operations am i getting the most value am i having it you know the up time that i need if i'm not what's causing that activity am i re over calibrating this particular device uh can i go for less calibration because you know what i find every time i calibrate it it's in calibration so why calibrate four times a year maybe i can ratchet that back to six months a year and all of that has um when you're when you're talking about um your cost of goods and you're talking about patient access and you're talking about you know lower costs so that those patients can have access all that goes into that equation it also comes down to the bottom line that's it that's exactly it that's what i'm saying if you can produce a lower cost drug then that directly translates to patient access patient access directly translates to a healthier world yeah well that's good well thank you very much bob i'd like to take a moment i want you to look in the camera and tell people how they can get a hold of you um you can reach us best uh my email is is rmachi at remtechllc.com uh we do have a web website it's .remtechllc.com well bob thank you very much i appreciate it thanks for your time uh thank you very much for joining us this week uh we hope you had a pleasure learning a lot about what bob does as a as a consultant to the pharmaceutical industry they bring it sounds like a tremendous amount of value to the table in an area that i have to be honest with you i'm not extremely knowledgeable about so some of the things that he said went right over my head but it's all good uh sounds like me with my financial plan well thank you very much for joining us this week and we look forward to seeing you next week have a great week everyone you
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