Explore every episode of the podcast CMC Live - Chemistry, Manufacturing & Controls
| Title | Pub. Date | Duration | |
|---|---|---|---|
| 025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll | 12 Mar 2021 | 00:31:51 | |
What We Covered
“The PDA was kind of the bridge. It’s the Parenteral Drug Association – its focus is sterile injectable product. But it’s into all kinds of different things.” “The biggest things that are most frequently used in my case are the media fill, as Brian mentioned, and environmental monitoring.” “When you cite regulations from Europe, it used to be you would pull the British because they were gonna be the standard. If you could pass Brit, you could worry about anybody else at all; you were fine.” “It’s an entire system that you’re trying to get where every little thing that fits into the process has been qualified and can be depended on. From the raw materials coming in the door to the viles, to the stoppers, to the machinery, the environment, the filters, the air quality and differentials – all of that stuff fitting together.” “With drug development, you’re not having a life depend on you. You’re having tens of thousands of lives depend on you.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 024 - Quality Management Systems Explained! | 05 Mar 2021 | 00:38:59 | |
What We Covered
“Quality System Management provides an infrastructure for a company to ensure the quality of your drug product with patient safety in mind as its primary function.” “It helps determine and define management’s commitment to quality. Because if you don’t have senior management commitment, all could be lost.” “To begin at the beginning, when you set up your QMS, you need to start with the procedures and processes that will reduce risk and help you prepare for your submission in the long run. That would come through managing your documents.” “Guidance documents are just an opinion. And they actually say that in the documents. So, you kinda try to do a combination of everything.” “The biggest thing is that when you have somebody who’s experienced and they’ve been through various things like FDA audits or have worked with a very small company versus a very large company, they can differentiate what you really need right now.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 015 - Outsourcing in China: How far can it go? | 13 Nov 2020 | 00:33:40 | |
What We Covered
“One of the key activities for any oversight of manufacturing and any CMO is person in-plant activities.” “You better make sure you have an easy to manage process…easily transferable, and you really do have to budget to have a presence on that floor. All these things have to be factored into your decision to move into China.” “If you’re looking for a commercial process that you might be able to take anywhere, I’m not necessarily sure that [China] is the place that you would go.” “We found it actually paid for itself in having somebody on staff who can speak the language because the communication style and the communication was very different than when we didn’t have one.” “I think if you’re planning on doing manufacturing in China, plan on being hands on.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story | 06 Nov 2020 | 00:49:53 | |
What We Covered
“I’ve never tasted cherries as delicious as the ones that were being fed and rooted from the formaldehyde and sulfuric acid that was being pumped into the soil.” “You know it’s a bad day when the local news crew is sitting in the lobby when you walk in.” “I would have to go down and walk – this is in the middle of the night, no one around – walk down to the basement, past the morgue, through the boiler room, into this dark, dank, dusty place with like rats and dig through boxes for the records.” “I’ve scared myself. I was working late one night and we had liquid oxygen on site and every once in a while you’d get a hiss or a clank or something weird. And the warehouse was making an awful lot of noise one night so I was like, ‘Ok, I’m just gonna go home.’” “In the days before corporations had things like change control, and quality groups on site and so forth, Smith-Kline and others were organized as just a bunch of chemical operators. And that was it. There was no other functions on site.” “Dave told a story about liquid ammonia and some scary situation there.” “I’ve actually been at a place where we did heavy duty analysis on bungie cords.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 014 - Why now is the most important time for selecting a CMO | 30 Oct 2020 | 00:48:01 | |
What We Covered
“A lot of CMOs are now going to a ‘one-stop shop’ type model. So basically they’ll say, ‘Yeah we’ll take you all the way from gram quantities right through commercial. We can do your API and your drug substance.’ But there’s still a lot of smaller shops out there that can do small scale pre-clinical work.” “Cost is always a factor [in selecting a solvent] but it’s not the major one.” “You’re gotta have an integrated approach all the way through the system to understand the API that you’re producing, the impurity profile, the crystal morphology, the polymorphs, that sort of thing.” “Realistically, when you look at the cost of an API as a percentage of a drug product, it’s usually fairly low.” “If the analytical people aren’t up and ready to go, then when the chemists start running stuff in the hoods, how do they analyze it? We don’t have methods, so we’re kinda going on a wing and a prayer.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola | 23 Oct 2020 | 00:41:57 | |
What We Covered
“I think the experience level of that regulatory point person during the submission is really critical.” “Oftentimes we find that clients are also looking for a submission to be a learning opportunity for their own people.” “When you’re preparing to undertake this preparation to write this, the first and probably the most critical step is to engage across disciplinary teams.” “One of the things that I think is often a recipe for anxiety and stress is not understanding roles and responsibilities.” “One of the areas that’s really essential when you’re putting together your authoring team is to have somebody at the client that truly understands where the skeletons are.” “Over the years we’ve worked to build in efficiencies that take a lot of the guess work out of compiling the submissions.” “I think respecting the experience of the people that brought the project to this point is critical.” “Planning is probably a better option than chance.” “Typically what I would do if I was moving on from an IND and starting to develop an NDA, I would start from ground zero, making sure I at least have an outline chart with all of the ECTB sections outlined in that manner.” “I think it’s important to note that the cost of doing an incomplete filing is monumental.” “Regulatory authorities are part of the team. They’re your friends. Seek advice, ask for their advice and also educate them.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference? | 16 Oct 2020 | 00:44:38 | |
What We Covered
“If they all beat together at the same time, instead of taking sixteen years for penicillin to come to market it would take maybe four years.” “The main point between strategic supply team management is you actually engage with the end user of your product the same way as Apple would or any company who really builds value into their products.” “The value that you add – the money you bring in – has got to be less than the cost that you incur in the business and then you obviously make a profit grow.” “In terms of procurement, the industry has outsourced this critical asset.” “The problem with pharma is that there is no competition because once you’ve got a patented molecule approved, the most that’s gonna happen is you get an oligopoly where two or three companies make blockbuster revenue.” “The body is the most complex, connected thing in the world.” “The other thing that people have noticed is that you can develop a drug now without being a pharma company.” Relevant LinksDesign Space InPharmatics - LinkedIn Design Space InPharmatics - Twitter Hedley’s Book – Taming the Big Pharma Monster By Speaking Truth to Power Cutting Through the QBD Foliage, Aiming for the Roots Article | |||
| 011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros | 09 Oct 2020 | 00:41:49 | |
What We Covered
“I think it’s never too early. Ideally you want to have the story of the development program pretty much summarized by the time you’re making an NDA submission.” “A good development program is gonna do risk assessments at certain points along the way and assess what are the major concerns associated with developing this drug product.” “Particles tend to de-mix and segregate based on size.” “Some reviewers, it seems, can be primarily box checking, take less of a holistic risk based approach, which has been the trend for some time now. I try to focus on what is actually important for this particular product and has that been explored appropriately.” “If you’re not gonna have a working development report, what you need to have is a working document repository with a file structure that can be easily followed so that you can go back and know what you have and piece together a report or a submission from that.” Relevant LinksDesign Space InPharmatics - LinkedIn Design Space InPharmatics - Twitter Kyriakos Michailaros on LinkedIn Link to Hey Google, Tell Me About the Importance of Living Development Reports | |||
| 010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok | 02 Oct 2020 | 00:39:40 | |
What We Covered
“The White Coat Effect is real. Even in a good facility it’s absolutely real. When operators find out the client is coming they behave very differently and the level of detail is much more.” “Probably the most touching was I spent a lot of time on an API facility on the East Coast and, on the last day, their process chemist said, ‘I want to thank you. You’re the first person in plant who’s ever actually helped me.” “I warn them, ‘I’m gonna be there when you don’t really want me there.’” “Just because you walk out the door of the plant and you go to the airport and get on the plane, it [the process] shouldn’t be done or finished for us.” “I think one of the myths people have is that a CMO absolutely knows their equipment all the time and the process is going to be run the same every single time.” “It changes, it’s going to be fluid in this industry. Things happen. Things go wrong.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola | 25 Sep 2020 | 00:50:50 | |
What We Covered
“Filing an IND is important to get a trial started. And folks start clinical trials for a variety of reasons.” (05:43) (Ed) “Out of academia we see a lot of this very little information filed into an IND, and then very little information generated up to the point where you get to a Phase Two or Three where you see efficacy data and then suddenly you have to file an NDA.” “It’s hard to become an expert. There’s no real training. I think a lot of it is just experience. It’s going into meetings with FDA when you don’t have all the data.” “Make sure it looks good, because it does reflect on the actual data and content in there, just like anything in life.” “As the author goes through the process with the client, there’s still another piece. And that’s the publishing group.” “One way to alleviate that [stress] is to be able to give an update on any given subject or any given section at any given time.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 008 Trust the Process with a CMC Process Champion - Dave Adams | 18 Sep 2020 | 00:49:26 | |
What We Covered
“Manufacturing of APIs was very much a technical job, not a scientific process.” “In production, time is money. The longer it takes to run the process, the more it’s going to cost your company or the more that a CMO is going to charge you to manufacture your product.” “You need to very carefully scout your suppliers and make good agreements with what it is they’re going to be supplying to you.” “So yes, you need to investigate every ramification of development. And some of them might lead to surprises – you see in new impurities or new emulsion – and so you’re going to have more development.” “It helps to have somebody on your side who understands production and knows when you’re being taken advantage of and even upfront when you’re making your contracts.” “It is very important to have one process owner – process champion – one person who represents the process.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer | 11 Sep 2020 | 00:45:49 | |
What We Covered
“If you put the effort into getting a very detailed and exact request for proposal written, then the CDMO that is reviewing the request can determine if they have the resources to actually accomplish the task that you’re looking for.” “The nice thing about having a good network is that you can certainly weed out the ones that you don’t want to be involved.” “Every company wants everything yesterday.” “Tell you what, the money they’ll spend on consultants early on is a drop in the bucket compared to change orders and change of scope and misunderstandings that occur later on.” “You can tell a lot about an organization if they’ll let you take a look at their regulatory history, for instance, and look at their maintenance history. Those are two really key things.” “Most of the CMOs, they’re not working at one hundred percent capacity. If they can get seventy or eighty [percent] they’re pretty happy.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel | 26 Feb 2021 | 00:43:53 | |
What We Covered
“Validation’s very formal. Validation really, in a stage analogy, is Opening Night. This is where the critics are all present, everybody’s breathing on you, you’re gonna be in the headlines the next day and everything needs to go right. So, when you think about it in that context, the validation batches are very visible to regulatory authorities.” “Your batch record really is a document that’s going to evolve. And if you look at the batch record for even the same step of a process, what that’s going to look like when you’re in the early phases of clinical development is different from what it’s going to look like towards the end. It’s going to be much more refined.” “There is a point where the process is the process. And as inefficient as it may be, it’s what you have.” “Yes, your validation batches certainly count as launch stock as long as they pass all specs.” “When you go into validation, you’ve gotta have your suppliers identified. And quality plays a huge role in assessing your suppliers” “What it all comes down to is that preparing for the validation is something that you should be thinking about as you’re making your later clinical batches, your Phase 2 batches especially.” “When you’re in Phase Three it’s not a place to be penny-pinching. The old saying is, ‘you drive for show, you put for dough.’ When you’re validating, you’re putting for dough.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 006 Analytical Method Development - Colman Byrne | 04 Sep 2020 | 00:50:05 | |
What We Covered
“One of the difficulties is that when you’re starting off with a molecule, you know relatively little about it. And, over the course of the development project, as you go further and further through pre-IND to Phase 1, Phase 3 and eventually into commercialization, you’re constantly learning more and more about the molecule and about what can happen to it under different circumstances.” “It’s typically less expensive to develop a solid test method than it is to develop a drug substance manufacturing process or to go through and manufacture bunches of batches of drug products. And so, it is really a question of trying to spend the appropriate resources at the appropriate time.” “Typically, you’re looking at seven different parameters. The first one – one of the more important ones – is specificity, showing that you can, with a particular test procedure, separate out whatever you’re looking to quantitate with that test method.” “You don’t know and you can’t know everything upfront, right away. You’re always going to find more things out. Ideally, they’re not going to be bad things that you have to do a lot to resolve. But, sometimes, that’s what happens due to situations that are outside your control.” “You try to minimize the frequency in which you have these unfortunate learning experiences, but sometimes they’re unavoidable. And by focusing your development upfront and looking at the available information and the potential pitfalls, then you can minimize the possibility of having what we call these unfortunate learning experiences that will cost time and money and cause potential delays.” “A validation of a test method should be a smooth process because you should expect that you know everything that could possibly gone wrong and will have addressed those before you do the validation. A validation is ideally just a rubber stamp to show that you have done, under control conditions, all the work that’s needed to show that your data is accurate and precise and linear.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard | 28 Aug 2020 | 00:35:21 | |
What We Covered
“You need to be very careful what you’re going to put in a dossier during the product development.” (08:07) “And that’s where the interaction with the FDA is critical. So, the sooner, the better. You need to be upfront when you go to those meetings with the FDA. However, you don’t ask a question for which you don’t want to hear the answer.” (09:04) “So, it’s not because you’re going to get a breakthrough or a fast track that you’re going to cut the corner and not have all the appropriate information that is required or expected by the FDA. However, what you could do is do a science-based or some justification that you could propose to the FDA to mitigate the risk and ensure that your product meets always the same quality and strength.” (17:52) “There are times where, as a consultant, you could provide the best of your knowledge, but then the sponsor will decide, ultimately, what to do and when to do it.” (27:00) Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan | 21 Aug 2020 | 00:33:15 | |
What We Covered
“The person [auditor] needs to be able to communicate properly. So, build a rapport with the auditee. When you build that rapport, auditees tend to tell you more than just your basic questions.” “So, if you have to cover manufacturing, analytical and all the quality systems in one day to do a thorough audit, there’s no way you can do it with just one person. You need to have the other experts.” “The other issue is going to an audit. If you’re from a location like where I live, I have to be in quarantine for two weeks before I can even go into an audit. And then I have to be in quarantine for two weeks after. It’s not feasible. And there are a lot of states like that where we have personnel that need to be able to audit and they can’t.” “How do you get the site that you’re auditing to work with you? It’s showing them that you’re willing to work with them.” “A paper audit is never as effective as a virtual or on-site audit. A paper audit a lot of times can be used in conjunction with the on-site or virtual audit.” Relevant LinksDesign Space InPharmatics - LinkedIn | |||
| 003 Effective Strategies for Early Stage Drug Development - Judy Magruder | 14 Aug 2020 | 00:28:41 | |
What We Covered
“Think big picture first and then all the minutia and the smaller, what I call micro-plans, come later. And, I think that when companies take the time to do that upfront and build a registration strategy, ya know, ‘What does the product need to look like when it hits the market,’ all the plans underneath that become that much more valuable and realistic.” “So, things change all the time. And so, whether you do a weekly meeting or a daily meeting or a sub-team, I just love that people know number one, what the change is because communication is the key. It’s so multi-disciplinary. All these different disciplines depend on each other, so communicating change in a succinct way is very important.” “There’s so many different ways to communicate what’s important, what’s the critical path, what are the milestones and what’s important to focus on today.” “It’s like anything in life. Unless you have a plan, there’s no guarantee you’re gonna get there. If you want to increase the probability that you’re going to succeed, you need a plan that shows how you’re gonna get there.” Relevant LinksInternational Council fo Harmonisation Design Space InPharmatics - LinkedIn | |||
| 002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel | 07 Aug 2020 | 00:35:16 | |
What We Covered
“It takes a fair bit of time to develop a package to support a regulatory starting material proposal to an agency. And the better packages are ones that are supported by data…The reason this is important is because the stronger your package is, the more likely you are to be successful in your proposal.” “I see this as like being an advanced scout watching another team play ball. If you can stand at the field and watch how they approach and do things, you’re prepared when you face that team yourself. And I think if you can approach the FDA and say, ‘Look, here’s what we have based upon the guidance. What do you think?’ I think you’re better off than waiting until you face them now and when you have to do it because you’ve run out of time and you’re really not prepared.” “One of the crux issues with choosing a starting material is the whole case you can make about how you purge the impurities from that point forward.” “I think it’s [the ICH Q11] is a great document. And I think that any process chemist should read it and understand what’s being looked for.” “What it really comes down to is you want to try to understand what’s making your process tick. If you get some new impurity, the process is telling you something. Where is it coming from? Sometimes you get impurities you can’t get rid of. How do you deal with an impurity that does not go away?” Relevant LinksInternational Council fo Harmonisation Design Space InPharmatics - LinkedIn | |||
| 001 Expedited Drug Development - James Mencel | 31 Jul 2020 | 00:18:51 | |
What We Covered
“When you are in a program that gets expedited, the attention is for the program to move quickly. And there are several ways in which it can move quickly. But almost all of them lead to a very shortened timeframe for CMC. So what it gets you is the FDA’s aware that there is stress on CMC.” “If you know you’ve got a receptor site – a validated model – some sponsors know from the outset they’re going to approach the FDA even before they go into Phase One because they have a receptor site model. And if they get a model that hits then they’re going to request some sort of expedited status.” “The first question to ask yourself is, ‘Can this process do the job?’ Because, if this program goes expedited, this process that I’m running right now may be the commercial process whether I like it or not.” Relevant LinksLeadership - https://dsinpharmatics.com/leadership/#leadership Project Management - https://dsinpharmatics.com/leadership#projectmanagement Analytical - https://dsinpharmatics.com/leadership#analytical Drug Substance - https://dsinpharmatics.com/leadership#drugsubstance Drug Product - https://dsinpharmatics.com/leadership#drugproduct Regulatory - https://dsinpharmatics.com/leadership#regulatory Quality Assurance - https://dsinpharmatics.com/leadership#qualityassurance Biologics & Microbiology - https://dsinpharmatics.com/leadership#biologics Formulation & Clinical Ops - https://dsinpharmatics.com/leadership#formulation Design Space InPharmatics - LinkedIn | |||
| Welcome to CMC Live! | 04 Jul 2020 | 00:13:59 | |
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| 022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly | 19 Feb 2021 | 00:32:10 | |
What We Covered
“I highly recommend reaching out to the filter vendors. They’re your best support, especially with this process.” “Most people when you start with a drug process you’re looking less than a hundred liters, knowing that your commercial back size could actually be 1500 liters. And then the question comes down to are you doing redundant filtration, are you utilizing two filters, are you utilizing one? To understand your product, I think the filter vendor can definitely still help with that.” “Normally if you’re utilizing a sterilizing filter, you definitely have to run it through some type of sterilization process.” “A Bubble Point test is related to the micron-size of your filter, meaning if you have a 0.2 or a 0.45, those bubble points are gonna be different.” “I think utilizing your filter validation in conjunction with your media fill program – whatever that may be – they have to be synced and in alignment.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola | 12 Feb 2021 | 01:00:18 | |
What We Covered
“If anyone’s listening and not familiar with the drug development process, the one area that’s most important is the FDA guidance.” “Characterization is, in my mind, one of the fundamentals of a product and a process and a program. If you don’t know what you’re dealing with to start, it’s hard to catalog it, make it consistently and answer questions about it.” “This is probably, in some folks’ minds, the most important. It’s the manufacturing of the drug substance and the drug product. If you don’t have a process, you don’t have a product.” “There are a few caveats to excipients. One of the things you’ll want to recognize and a question that might come up is ‘are they of human or animal origin?’ And the other big thing is ‘are they novel?’” “Any changes to anything in the program – process-wise or control-wise – late in the game could be a problem because you’re gonna have to generate additional data. There’s an unknown there. What does that change mean?” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke | 29 Jan 2021 | 00:48:13 | |
What We Covered
“I look back on my career and I kind of made a few big mistakes. For example, I went into the office of the Vice President at this company to resign. I was a kid and I was just upset about certain stupid little things. And, when I walked in there, instead of leaving the job, I made a connection with him as another lifelong mentor.” “Comparing INDs, NDAs, BLAs, I’ve always had this fascination with putting stuff together into a story.” “I hope I look back in fourteen years and say, ‘These are the best days of my life.’” “One of the things I have to remind myself every day is that life really hasn’t changed, I have.” “Everything I learned that is valuable and dicey and on the edge I learned from Dan [Torok].” “My goal, hopefully, is to grow CMC Live, make it more interactive and maybe have a live audience with questions.” “To truly build trust, I learned it’s better for my colleagues to get to know me as a person.” “Two things control the way we operate and who we are: our brains and our gut.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 019 - Complexity of Project Management in Drug Development with Paul Long | 22 Jan 2021 | 00:43:17 | |
What We Covered
“We’re fairly comfortable with the virtual environment that allows us to be flexible in who we staff. That’s a plus. It allows us to be flexible in our time when there is a global project. That flexibility has always been there at DSI.” “It’s similar to managing the communication prior to the COVID environment. You have to establish how the person wishes to communicate, what level they wish to communicate on. So, when I meet a client, I ask them these questions directly. ‘Are you comfortable with this kind of communication? Do you want a weekly update? What’s the cadence for meetings?’” “I have to integrate our team and the client’s needs into a common goal and make sure we’re meeting that.” “The challenges haven’t changed with COVID, but our work environment has.” “Again it comes down to communication, transparency and open discussion. And that’s one of the things I try to drive as a project manager.” “Keeping the communication up avoids risk. We don’t want surprises, unless they’re good.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola | 08 Jan 2021 | 00:52:38 | |
What We Covered
“One of the things that resonated with me on that particular podcast was how Dave [Adams] took a step back and said, ‘You really can’t underestimate the importance of the skilled technicians that actually run the process.’” “The reality is they still need that person-in-plant. So, I think what Dan [Torok] brings to the table is what a lot of clients look for. Some clients don’t have that infrastructure and they blindly trust the CMO – and sometimes not always to the right result.” “I think people are now realizing that they do need to take a lot of different factors into consideration when selecting their CMO and they might need that assistance from experts like us.” “If you know that you have properly identified and characterized the development history of your product, and its pitfalls, and its areas of concern – and you’ve explored those – it really makes for a much more robust filing that stands up to scrutiny.” “We had a special external guest, Hedley Rees, who talked a bit about supply chain and how to create a value chain.” “Our job as regulatory reviewers, strategists, authors, CMC experts, is to decipher what the data is saying.” “I think that’s the experience that Judy brought to bear is that holistic approach to a client’s program.” Relevant LinksDesign Space InPharmatics – LinkedIn Design Space InPharmatics – Twitter Meranda Parascandola on LinkedIn zcTR6b8N5mnoOKtALIZa | |||
| 017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know | 04 Dec 2020 | 00:34:30 | |
What We Covered
“We’re certainly seeing a very rapid change in the API/CMO world. I think if you went out with an RFP maybe two years ago and you threw this RFP out to eight vendors, you’d have eight proposals back fairly rapidly.” “I don’t know how many of you guys have been involved in plant build outs and plant qualifications. It is not a slam dunk, especially when you’re trying to retrofit an existing site.” “The number of people in the U.S. who have manufacturing backgrounds in small molecules is just small and diminishing rapidly because all the jobs have been offshored.” “Good operators are worth their weight in gold.” “I think what has to happen [in the future of API manufacturing in the U.S.] is that the industry has to know that the demand is there.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||
| 016 - Brexit: What You Need to Know for Drug Development | 20 Nov 2020 | 00:32:41 | |
What We Covered
“In principle, there are three procedures for obtaining market authorization in EU. One is the mutual recognition procedure. The second one is the decentralized. And then the third one is the centralized procedure.” “If you get an approval in Europe, there are testings that you have to do for EU.” “Effective planning is the key. Because then basically you know when you’re going to get approval and you’ll know when you will be able to market.” “So, what is happening now, people who have filed in the UK can no longer sell their products in EU because UK walked away from the European Union. So now they are setting up their own procedures because, by the end of this year, they will be fully separated from the European Union.” “The mutual recognition that is between the FDA and EU, I see that as becoming more and more the norm.” “Once you get the approval [in the EU], you get it in all twenty-seven countries, including Norway, Iceland and I think Lithuania.” Relevant LinksDesign Space InPharmatics – LinkedIn | |||