Podcasts about generics

This is a corporate-focused, conversational interview between Pharmacy Podcast Network Host, Todd Eury and Stephen Beckman, CEO of YARAL Pharma. The discussion explores YARAL Pharma's unique approach to the U.S. generics market, its commitment to innovation and accessibility, and the company's philosophy of “Doing Things Differently” by redefining what it means to be a generics partner. Stephen Beckman also shares insights into YARAL's growth and key milestones since launching its first product in 2023, including the expansion of its product portfolio, investment in business development, and focus on building a strong company culture.

My co-host Ken Suzan and I are welcoming you to episode 174 of our podcast IP Fridays! In today's interview, Ken Suzan interviews Brian McGinnis, partner at Barnes & Thornburg and co-chair of the firm’s data security and privacy practice, about why companies need to stop treating data privacy as a compliance burden and start treating it as a core business asset. McGinnis argues that data is either a managed asset or an unmanaged liability, with no middle ground. But before we jump into this interview, I have news for you! The EPO saw a Record Year with 200,000+ Patent Applications in 2025: German filings dropped 2.2% while China grew 9.7%, overtaking Japan for the first time. Germany remains Europe’s top patent nation but loses ground globally. SMEs and universities now account for nearly half of all Unitary Patents granted to European innovators. News from the UPC Court of Appeal: Non-Technical Features Count for Inventive Step. An April 17 ruling clarifies that all claim features must be evaluated in their combined effect, including non-technical ones. Companies with software-related or mixed-technology inventions pending at the EPO or UPC should reassess recent inventive step objections at the UPC in light of this decision. Nokia Withdraws UPC and Munich Suits After Global FRAND Settlement; Following a global FRAND rate-setting decision by the UK High Court, Nokia withdrew parallel suits against Warner Bros. and Paramount at the UPC and in Munich. One UK ruling resolved litigation spanning Germany, the UPC, the US, and Brazil simultaneously. China Abandons Anti-Suit Injunctions in SEP Disputes: After a WTO arbitration ruling from July 2025, China withdrew its practice of blocking SEP holders from filing suits abroad. The EU Commission continues monitoring compliance, since the former policy was largely informal rather than codified in statute. The Trump Administration has put 100% Tariffs on Imported Patented Pharmaceuticals: Based on Section 232, the Trump administration imposed 100% tariffs on patented drugs and biologics effective April 2, 2026, with a 120-day transition period until July 31. EU member states face a reduced rate of 15%. Generics and biosimilars are explicitly excluded. China Rejects 1.27 Million Trademark Applications in Three-Year Crackdown: China’s CNIPA rejected over 1.27 million trademark applications and invalidated more than 3,300 marks, targeting so-called edge-ball marks designed to mislead consumers about product quality or origin. The announcement was made at an official press conference on April 23, 2026. Now let's jump into the interview with Brian McGinnis! Brian McGinnis is a partner at Barnes & Thornburg and co-chair of the firm’s data security and privacy practice. In this episode of IP Fridays, he argues that companies treating data privacy as a compliance burden are missing the point entirely and leaving significant value on the table. Data Is Either an Asset or a Liability Most companies still treat their data as invisible and costless. They do not manage it the way they would manage a patent portfolio or a trademark. That, McGinnis argues, is a fundamental strategic error. Data is either a managed asset or an unmanaged liability. There is no middle ground. When companies invest in understanding what data they collect, how it is used, and who has access to it, they unlock opportunities to drive real revenue and growth. Done right, a data governance program is not a cost center. It is a foundation for trust, operational efficiency, and competitive advantage. One Program, Not Twenty With more than 20 US state privacy laws now in effect, and major economies worldwide introducing their own frameworks, building separate compliance programs for each jurisdiction is neither practical nor smart. McGinnis recommends a single, comprehensive governance framework designed around the core purpose and intent of privacy law, flexible enough to absorb new requirements as they emerge. Companies that threw together a quick program when California’s CCPA came into force in 2020 are now overdue for an upgrade. The goal is to move from reactive compliance to a mature, proactive program that positions the company ahead of the regulatory curve rather than perpetually catching up. Website Tracking Tools: An Underestimated Risk One of the fastest-growing areas of privacy litigation involves tracking technologies built into company websites: pixels, session replay tools, analytics scripts, and chat widgets. Legal teams are often entirely unaware of what IT or marketing has deployed. That gap is expensive. Plaintiffs’ attorneys are applying 1970s-era telephone wiretapping statutes, including the California Invasion of Privacy Act, to argue that collecting any personal information, including IP addresses, before a user has consented constitutes illegal interception. Demand letters are being sent at industrial scale, with settlements typically running between $10,000 and $20,000 per case. What makes this particularly difficult is that a company can be fully compliant with statutory privacy law and still face these wiretapping claims, because the legal theory turns on the timing of data collection rather than the existence of a privacy notice. Vendor Contracts: The Hidden Exposure Marketing and technology agreements are another major source of unmanaged data risk. When a company deploys a third-party tool that handles personal data, the underlying contract needs to define precisely who owns that data, what the vendor is permitted to do with it, and what obligations flow down to any sub-processors involved. McGinnis draws a direct parallel to IP licensing: owning valuable data and then handing it to a vendor under a poorly drafted agreement is the equivalent of signing a bad IP license. Data processing agreements need to cover ownership, use restrictions, sub-processor obligations, breach notification timelines, audit rights, and deletion obligations. Many companies simply do not have these terms in place. Without them, a vendor who suffers a breach of non-personal business information has no contractual obligation to disclose it. Consumer Rights Requests: Process Matters Privacy laws give individuals the right to access, correct, delete, and opt out of the use of their personal data. Responding to these requests effectively requires pre-built processes, trained staff, and the technical ability to locate and act on individual data across all systems and sub-processors. Most companies, before engaging in formal data mapping, are not in a position to do this reliably. Staff failing to recognize a deletion request as a legal data subject request and routing it through a standard customer service queue instead is one of the most common failures McGinnis sees. The consequences can include regulatory complaints and class action lawsuits, particularly when a company continues to send emails to someone who has already requested deletion of their data. A newer risk involves Global Privacy Controls: browser-level opt-out signals that regulators and courts are now treating as legally binding deletion and non-collection requests. Companies receiving these signals daily without acting on them face growing exposure under several state laws. AI Governance: Policy Before Tools Generative AI tools are now embedded across business functions, from contract review and customer service to content creation and internal search. McGinnis is direct: every company needs an AI acceptable-use policy, and the absence of one is not a neutral position. Without clear rules, employees will use unapproved or publicly available tools regardless, feeding proprietary and sensitive information into open models with no control over how that data is used or retained. He draws a precise parallel to patent law. Posting proprietary information into an open AI system carries the same risk as publishing it publicly, potentially destroying patentability. The distinction between closed, organization-specific AI systems and open, publicly accessible ones is something employees need to understand explicitly. Making compliance easier than non-compliance is the practical goal. The Regulatory Outlook: More Laws, More Enforcement McGinnis expects the regulatory landscape to continue expanding. The EU AI Act is already setting the direction, and several US states have introduced or are developing AI-specific legislation. The pattern mirrors what happened with data privacy: Europe leads, US states follow in a patchwork, and federal legislation remains uncertain. Enforcement of existing privacy laws is also intensifying. GDPR has been in force since 2018, CCPA since 2020, and regulators are now past the period of extended tolerance for companies that are still catching up. Companies with immature compliance programs should expect less patience from regulators going forward. McGinnis closes with a clear point of view: if you have to comply anyway, get credit for it. A well-built governance program is a trust signal to customers, a sales asset, and a foundation for responsible AI use. Compliance done right is not a tax. It is a differentiator. The Full Transcript: Ken Suzan: Our guest today on the IP Fridays podcast is Brian McGinnis. Brian is a partner with Barnes and Thornburg and a founding member and co-chair of the firm’s data security and privacy law practice group. Brian serves as a member of the intellectual property department and the internet and technology practice. Brian is a Chambers Global and national ranked privacy and data security attorney, a certified information privacy professional, and the firm’s chief privacy officer. Brian brings nearly two decades of experience at the intersection of law and technology. Brian advises on a wide range of technology-driven legal matters, including privacy and data security, intellectual property, artificial intelligence, corporate transactions, software, and internet law. His deep understanding of privacy and technology law enables him to guide clients through rapidly evolving regulatory and operational challenges. Welcome Brian to the IP Fridays podcast. Brian McGinnis: Hey, thanks Ken. I appreciate it. Great to be here and thanks for having me. Ken Suzan: Excellent. Brian, the C-suite tends to treat data privacy as a compliance tax, something to hand off to legal and forget about. But when you see how companies actually get into serious trouble, what’s really going on? Brian McGinnis: Yeah, well, it’s a great place to start Ken and looking forward to the conversation today covering some of these privacy issues and AI issues, which I found in my own practice is really bled into the straight privacy stuff. Companies can’t really handle these things in a silo anymore. It’s really about managing and coming together as a coherent program for governance for the organization. I think if you do that right, the good news is we can become revenue generators and show growth for the company and not just compliance centers and a compliance tax. But I think the core problem that we face in working with most companies is that a lot of companies still treat their data as invisible, costless. They don’t treat it, in other words, like they would a patent portfolio or trademark or other IP portfolio. It’s just not managed as an asset in the ways that we’ve seen more sophistication around IP. And it really should be. Data is either a managed asset for the company or it’s an unmanaged liability. There’s really not an in between. And so for those companies that haven’t gotten their arms around all this data and what can be done with it, I think they’re really missing an opportunity. Having an understanding of what data the organization is collecting, how it’s being used, and having the proper governance around it really unlocks a lot of opportunity for use of that data in new ways — ways that can drive revenue and growth for the company. So I approach privacy not just about compliance, not just about avoiding penalties or doing it because some law out there says that we have to do it. It’s really about knowing and controlling one of the company’s core assets. And if you’re not doing that, you’ve got unmanaged data that you’re not getting value out of and that potentially could be a huge liability for the company. Managed well, it really supports trust, efficiency, and growth of the organization. Otherwise, I think it’s a missed opportunity. Ken Suzan: Yes, well said. Now let’s talk about state laws. With 20-plus state privacy laws now in effect, how should companies build a program that actually works across the board without starting over every time a new state law kicks in? Brian McGinnis: Yeah, so the first answer is don’t build 20 separate programs. This really goes back to having a comprehensive, sophisticated, well thought out program that really takes into account not only the 20 state laws, but obviously we’ve got international exposure with laws like GDPR and upcoming privacy laws internationally. Most of the larger economies in the world have some form of laws around privacy and AI. So you can’t really anymore build programs that account for the one, two, three, four, five different laws that in the past we had experience with — where you could just treat California as its own thing, treat New York as something else, and treat Europe as something else. The laws and the pace of these have really forced companies into having comprehensive programs. I don’t expect to see fewer laws. You’re only looking at potentially additional state laws, additional federal laws here in the US, and then certainly additional laws throughout the world. So a lot of the strategy these days is not only where are we today with these laws, but how do we set up our governance program in a way that really cuts to the core of the purpose and intent behind these laws so that we can be better prepared when new laws come about in the future. Historically, at least in the US, most companies just haven’t had laws that force them into compliance postures. As these laws have started to come along, a lot of companies have been playing from behind and saying, oh, the California Consumer Privacy Act, I just read about it and it goes into effect next week — let’s throw something together and call that our compliance program. We’ve now got years of these laws being in place, CCPA came into effect in 2020, and what we’re seeing much more of are companies looking to get more sophisticated in their programs and stop feeling like they’re always rushing to catch up. The goal is to level up their program, going from level one — constantly playing from behind — to level two and then level three, so that they really feel like they’re on top of it and have a sophisticated program that not only accounts for all the various privacy requirements that come at them, but also positions them to take advantage of the data and all the things that come along with having a good governance program. Ken Suzan: Brian, there’s an explosion of litigation targeting something most companies barely think about — the tracking tools baked into their own websites: pixels, session replay tools, analytics scripts, chat widgets, the list goes on and on. What’s happening, Brian, and what should companies do? Brian McGinnis: Yeah, and I think a lot of companies — the executives, the business teams — don’t even realize a lot of these tools are on their sites. IT deployed them years ago, the web team deployed them, marketing teams are constantly using them and certainly have a good understanding of it. But in a lot of cases, legal has never touched them and has no idea what’s happening on the website. We also see a lot of cases of companies who, even if they’re generally aware these tools are in use, aren’t aware what other teams are putting on the site or what those pieces of technology are tracking. And that gap can be really expensive. What we’re seeing right now — and this has been a trend for a number of months now and is really continuing to pick up steam — is a series of what I call gotcha lawsuits, where you have some enterprising plaintiffs’ counsel who have taken a look at some 1970s-era telephone wiretapping laws, including a law called CIPA, the California Invasion of Privacy Act, passed in the 70s with the idea that you shouldn’t be able to wiretap people’s telephone conversations. They’ve taken that and applied that theory to the internet. The way it works is: if a website has some sort of cookie, pixel, or other tracking technology on it that collects personal information about an individual — and that can be as simple as an IP address and device ID — and if that collection occurs as soon as the individual shows up at the website, prior to them being able to have notice provided to them or opt in and consent to that collection, then the theory under these lawsuits is that it constitutes wiretapping. We see a lot of this with the Meta pixel, with LinkedIn pixels, and the like. What they’re doing is effectively showing up and suing, threatening to sue, trying to take you to arbitration, depending upon what’s included in the company’s existing privacy notice. If you don’t have a cookie banner, if you don’t have a cookie notice, if you’re not getting opt-in on these things, they’re leaning on those failures and effectively trying to force you into a position where you are forced to make a settlement. Because the cost to litigate one of these to their conclusion would be expensive, whereas a lot of these cases will settle for $10,000 to $15,000 somewhere in that range. They’ve got technology crawling the internet looking for websites that don’t have these risks covered, sending demand letters and then collecting settlements, $10,000 to $20,000 at a time. It’s been very profitable for them and a very dangerous thing for our clients. And it’s a bit unusual because you can be fully compliant with the statutory privacy laws that require notification of the use of tracking technologies and cookies and banners — and still be subject to these lawsuits because of the wiretapping arguments being made. The timing wherein the data is collected from the individual could still subject you to these lawsuits. So it’s a tricky problem, one that I hate seeing companies get hit with and one that we spend a lot of time helping companies avoid. Ken Suzan: Yes, let’s talk about contracts, Brian, because I know you work with contracts probably on a daily basis. A lot of data risk lives inside vendor and technology agreements — the contracts companies sign with marketing platforms, analytics providers, cloud infrastructure, and SaaS tools. What should those agreements actually contain? Brian McGinnis: Yeah, so there’s quite a lot of things. You’ve got a world where marketing is constantly under pressure to learn more about their customers. The way they can do that is through any number of different tools and data gathering techniques, and we have all this technology available to help marketing and sales do better at their jobs. But we, at least in this country, got to a position where people really felt like they lost control of their information and their data. And so these privacy laws came along and really started to provide more rights to individuals — to have an understanding of what data exists within various companies that they do business with, who they’re sharing it with, trading it with, selling it to for advertising purposes; to have the right to opt out; the right to delete their information. Not checking through the agreements by which these teams are implementing these tools is a huge issue for companies. As part of an overall compliance program, having some kind of process where people who are aware of the growing numbers of privacy laws are reviewing these marketing contracts to make sure they are aligned with that program and aligned with those laws is absolutely critical. To talk about IP, given the IP Fridays audience: it’s kind of the equivalent of having really bad IP licenses. In other words, you own and control this information and data, and you need to control what the other side can do with one of your most valuable assets — or you’ve effectively given it away. So thinking about it in that way could be useful. In terms of more specifics: a big one is ownership of the data. The agreement itself may or may not have anything that addresses data. If there’s personal information involved, you probably need what we call a data processing agreement or addendum — a DPA — that specifically controls what that third party is able to do with that data, how they’re able to use it, whether they’re able to share it, whether they’re able to get value out of it on their own, or if they’re only allowed to be what we call a service provider, just providing services to the business that hired them. There needs to be explicit prohibition on retaining, using, and disclosing personal information for any purpose other than performing the exact services in the contract. Whether or not they’re permitted to sell or share data under CCPA terms is another key point. Certification that the provider will comply with any restrictions and security requirements you have on your data, and making sure those obligations flow down to any sub-processors they might use. You hire Company A, but Company A works with Company B and C to provide parts of their service. You’re effectively responsible for the protection of personal information throughout its lifecycle. A couple of other key provisions: breach notification triggers and timeline. It’s very possible under a lot of agreements that one of your vendors can suffer the world’s worst hacker breach and have no legal obligation to tell the company that hired them about it — unless there’s personal information involved. State data breach laws apply to personal information, not to other types of sensitive business information. Unless you have a contract that explicitly requires notification, there’s a good chance that vendor may not want to disclose it. And then other things like audit rights and deletion obligations go in there as well. Ken Suzan: Certainly a lot to cover. Let’s talk about privacy laws and consumer rights. Privacy laws give consumers real rights — to access their data, correct it, delete it, and opt out of how it’s being used. Most companies have a process for this on paper. What does it actually take to get it right, and what happens when it breaks down? Brian McGinnis: Yeah, it takes pre-planning. It takes a process. Some companies receive many more of these requests than others — some B2B companies receive none or a couple per year, while companies heavily involved in marketing to consumers might receive tens or hundreds a day. To be able to respond to these effectively and efficiently requires some forethought. It requires policy and procedure internally to be set up, and it requires the education of the team. Some of the common ways we see this go wrong: staff isn’t trained to know the difference between what we call a DSR — data subject request — versus a regular customer service inquiry. Maybe somebody submits what would be construed by law to be a deletion request and you just put it into your normal customer service response flow — and then you’re potentially missing timelines and the like. There also need to be systems in place to respond in accordance with the individual’s rights. Somebody submits a request saying, you have my information — what information do you have about me? Can your company determine that right now? Can you look through all your systems and down the line to all the processors and sub-processors you’ve worked with and hired, and identify what information you have about that individual? Most companies, until they engage in a governance program and data mapping, are at a real disadvantage to be able to do that. Why is that a problem? Because two weeks from now your company could be sending emails to the individual who just told you to delete their data, and they get really upset. That’s when they go and complain to regulators or start class action lawsuits. The lack of planning can be really, really expensive for a lot of companies. Making sure you’ve got some kind of process to understand what’s coming in, that the people receiving those requests know the difference between a regular customer service request and a data subject request, and that it gets to the appropriate parties for action — all of that is really, really key. Another one that we’re seeing pop up is what we call GPC, or Global Privacy Controls. It used to be that people would say “do not track” in their browser and most companies would ignore those signals. Now we’ve got advancements in law and browser technology where the browser you’re using to visit a company’s website sends a signal saying, opt me out of this. Regulators and courts are construing those as deletion requests, as opt-out requests that companies are now required to respond to. If your company hasn’t gone through an exercise to understand that, and is probably receiving GPC opt-out requests on a daily basis without acting on them, there’s some exposure there. At the end of the day, a lot of this really is about getting the appropriate people from across the organization — really each department — around a table, figuring out what data you collect, how you use it, who you share it with, where it comes from. That starts the process of your data map. Then you set about mapping that to the various legal requirements and figuring out how to respond, how to make it easy for people to exercise their rights so they’re not complaining, not suing, not going to regulators. Letting these squeaky wheels out of the process — the ones who don’t want you to be processing their information any longer — is really key. Ken Suzan: Let’s switch gears a bit and talk about AI. I know we’re hearing about it every day. Generative AI tools are now embedded in how companies work — contract review, customer service, content creation, internal search. Before employees start using these tools with customer data, confidential business information, or proprietary content, what has to be in place first? Brian McGinnis: Yeah. I think we’re long past the days when companies provided individuals access to corporate technology — computers, devices, and the like — without having some kind of acceptable use policy that governs that. We don’t want you downloading stuff that could harm our network or create security issues. We don’t want you using our technology in certain ways, whether that’s a BYOD policy or just general use of company internet or company devices. An AI acceptable use policy is really a continuation of those. Every company needs to have an AI acceptable use policy. Period. In my opinion, things like that are as important as the fire escape policy out in the hallways for these companies. I can tell you with absolute certainty: if your organization has not provided rules to your employees and personnel about the use of AI, what they can and can’t use — or if you’ve said you can’t use any AI — the personnel is still using AI. They’re just not using any approved tools. They’re probably using their own private tools that they subscribe to, or even worse, tools they don’t pay for, in which case they’re putting company information into a wide open public model. The more companies can do to think through this ahead of time, reduce it to policy, and then train and educate people on that company’s particular policy, the better. You need to make it easier for people to comply than not comply. An acceptable use policy should talk about: here’s how we can and can’t use it, here’s the data that should and should not go into the system, here’s some proper uses of AI, here’s some data that’s on the fringe that we need to keep out — more sensitive information, proprietary information, etc. Making sure you’re funneling and educating people about the difference between closed systems and open systems. In other words, this is a tool that only looks at our organization, only uses the data within a certain box, and is not publicly available — the AI system is not training on our data. You have more leeway to put more sensitive information into those types of systems than you do with open systems which potentially lose control of your data. It’s almost like a patent consideration in terms of keeping information secret. If something potentially has some patentability that you want to seek to file in the future, you can’t just go out and post it publicly and use public search engines and all this other stuff at the risk of exposing it. Similar concepts here — really getting a handle and control over what tools people can use and providing some education to them about how the company wants to think about what’s acceptable and what’s not in those uses is really the key starting point. Ken Suzan: Very useful information. Indeed, we’re coming towards the end of today’s episode. One final question for you, Brian. Where do you think we’ll be two years from now in this developing field, and how best for companies to stay ahead of the curve? Brian McGinnis: Yeah, this kind of takes us full circle, Ken. I think it’s kind of back to the beginning comments about the privacy space — and we’ve only got more of these laws coming. It’s still a developing field. We’re still really in the early days of enforcement. I mean, GDPR has been around since 2018, CCPA in the US really kicked us off in about 2020, and so there’s been a settling-in period as companies adjust and get used to having these laws and get compliance programs in place at various levels — from not at all prepared to highly sophisticated. We’re still pretty early on in terms of enforcement of these things. We’re already starting to see enforcement of more egregious violations of these various laws, and we’ll only continue to see more enforcement as the laws exist currently and as they continue to come along. The days of not having to pay attention to this are kind of over. And I always tell clients: if you’re going to have to do these things, you’re going to have to be compliant — you might as well get credit for it. By which I mean, let’s put all the policies in place, let’s do all the compliance activities, let’s have a sophisticated governance program, but then let’s also use that as a sales tool, as a way to help grow the company, as a way to sell new products and gain trust and earn trust with our customers — so that they know when they’re doing business with us, or when they’re giving us information, or when they’re using our AI tool, that we respect that and are going to take care of their information and have the structure in place internally to be able to do that. With respect to AI, what I’m seeing is very similar to what we have seen with the growth of privacy law — again led by Europe, with the EU AI Act in this case. Now you’ve got a handful of states in the US that already have AI laws, and others that are interested in continuing to roll those out. There’s friction with the federal government around whether there’s going to be a comprehensive law there. Like the privacy space, you’ve got varying factions — some of which want to develop really quickly with very little guardrails, others which say we’re threatening the future of humanity if we don’t get those guardrails in place. I think ultimately, at least in the US, we’re going to end up with another patchwork of AI laws for the foreseeable future that we’ll have to navigate. So really having a company position, a company philosophy of how do we handle all these various laws, how do we treat people’s data, how do we get our arms around it, how do we respond to whatever legal rights they currently have, and what principles do we put in place so that we can adapt for the future — and then, once we’ve done those things, how do we actually get value out of this and move the business forward. So it’s not a compliance tax, but a benefit to the business. That’s the end goal here, and I think the North Star for us. Ken Suzan: Fantastic, Brian. This has certainly been a very comprehensive interview. Really appreciate you taking the time to talk about it with us here on the IP Fridays podcast. Brian McGinnis: Happy to do it, Ken. Thanks for asking me and good to see you. Thank you.

Fredrik chats to Shawn Wildermuth about evolving in the world of software development, small changes adding up, developer hiring, not chasing the new thing, and quite a bit more. Fredrik is still hoping for the last episode of Shawn’s old podcast. Making sure you use your time in a way that’s right for you. Whether it’s spending lots of time learning new stuff or getting deep into the tech you really enjoy. Recorded during Øredev 2025. Thank you Cloudnet for sponsoring our VPS! Comments, questions or tips? We a re @kodsnack, @tobiashieta, @oferlund and @bjoreman on Twitter, have a page on Facebook and can be emailed at info@kodsnack.se if you want to write longer. We read everything we receive. If you enjoy Kodsnack we would love a review in iTunes! You can also support the podcast by buying us a coffee (or two!) through Ko-fi. Links Shawn Shawn on Github Shawn’s old podcast Hello world Richard Campbell and Carl Franklin, of the .NET rocks podcast Science Friday, from PBS What’s new in C# 14 and .NET 10 - Shawn’s presentation at Øredev 2025 .NET core Blazor ASP.NET Null forgiveness .NET conf Nullable reference types Objective-c Tell the C# compiler to act like older versions Generics Nullable value types Pluralsight Windows phone Foxpro Impostor syndrome Shawn’s film Hello world - confronting bias in software development Support us on Ko-fi! Oslo Winfs Practical file system design with the Be file system - The Beos file system book by Dominic Giampaolo Beos GEOS Silverlight Open sourced Webassembly-based Silverlight version Kotlin CLR Fortran COBOL MUMPS Vue Cosmos DB Azure foundry Eleventy Titles I feel like I never did a podcast Edit the last one What’s your focus? There’s not enough to talk about here Null forgiveness Talk about nullability The next fifteen years Where I’m best used Paid to learn the new stuff I’m just happy to be around Those quiet voices Win the design meeting Wrong about Webassembly Actual system languages Five years from being useful A two-IDE person

Host: Cindy Allen Published: April 3, 2026 Length: ~15 minutes Presented by: Global Training Center Summary In this week's episode of Simply Trade: Cindy's Version, Cindy Allen breaks down a major shift in trade operations as CBP moves closer to launching the CAPE system for IEEPA duty refunds—while at the same time, new Section 232 actions signal that trade enforcement is far from slowing down. CBP has indicated it is on track for an April 20 rollout of CAPE, with key components nearing completion. However, Phase 1 will only cover certain entries, leaving many importers navigating critical decisions around protests and timing. At the same time, new developments in pharmaceutical tariffs and steel and aluminum revisions suggest that, despite recent legal challenges, trade enforcement is evolving—not retreating. Inspired by Taylor Swift's Begin Again, Cindy walks through why this moment feels less like closure—and more like the start of a new phase in global trade compliance. This Week in Trade • CBP signals April 20 target for CAPE rollout tied to IEEPA refunds • Phase 1 expected to cover ~63% of entries, excluding many already liquidated cases • Judge highlights importers' right to file protests, raising strategic considerations • Strait of Hormuz disruptions continue to create supply chain uncertainty • No movement on key legislation including First Sale and Foreign Importer of Record rules IEEPA Refunds & CAPE: Where Things Stand CBP continues to make progress toward launching CAPE (Consolidated Administration and Processing of Entries): • Claim portal (~85% complete) • Mass processing of entries (~60% complete) • Review and liquidation (~80% complete) • Refund processing (~75% complete) Phase 1 will: • Focus on unliquidated entries and those within voluntary reliquidation windows • Exclude fully liquidated entries, protests, drawback, and certain AD/CVD cases ⏱️ Timeline: • Target launch: ~April 20 • Estimated processing: up to 45 days post-launch Section 232: We're “Beginning Again” This week brought significant new developments under Section 232: Pharmaceutical Tariffs • 100% duty on name-brand pharmaceuticals • Generics excluded • Implementation expected within 180 days Key complexity: • Importers must now identify brand vs. generic at entry • Multiple exemptions and reduced rates tied to reshoring and trade agreements Steel & Aluminum Updates • 50% duty remains for core steel/aluminum products • 25% duty on derivative products (full value) • New de minimis exemption for products with

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we've always used this” or rely on a molder's preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk.Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle.The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation.⏱️ Timestamps 00:00 Welcome and Guest Intro00:43 Why Materials Drive Cost02:17 Common Selection Pitfalls03:35 Data-Driven Framework06:10 Early Choices Prevent Rework09:17 Processing Methods Overview10:23 Polymer Categories Explained12:58 Regulatory Risks and PFAS19:26 GRAS and Prop 65 Basics23:21 Biocompatibility Early Screening28:55 ISO 10993 Updates30:36 What Toxicologists Do33:41 Where to Find Lucas34:07 ClosingLucas Pianegonda Website: https://www.gradical.ch/Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQISO 10993 Overview: https://www.iso.org/standard/68936.htmlCalifornia Prop 65: https://www.p65warnings.ca.gov/GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-grasLucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

First, we talk to The Indian Express' Sukrita Baruah about veteran Congress MP Pradyut Bordoloi joining the BJP and being fielded as a candidate from the party in the Assam polls. She talks about him and his stint in the party and the significance of this change. Next, we talk to The Indian Express' Anonna Dutt about weight loss drug Semaglutide and its availability due to the expiration of its patent. She talks about the medication, its impact, and the rising problem of obesity in India and the world. (11:31)Lastly, we talk about a case of manual scavenging that cost three people their lives in Raipur. (20:35)Hosted by Niharika NandaProduced by Shashank Bhargava and Niharika NandaEdited and mixed by Suresh Pawar

In a category dominated by generics (60%) and fixated on ever-faster pain relief, Nurofen escaped the category's tropes with a message that connected with women in a deeper, more meaningful way. I'm joined by McCann London's CEO, Mel Arrow and Strategy Partner, Jocelyn Major. 

What does it take to get a life-changing medicine from regulatory approval to the patient who needs it? Isabell Remus, Global Head of Biosimilars at Sandoz, reveals why being approved and affordable isn't enough – and how the biosimilar industry learned that trust and education must come before market access. With $320 billion in biologic medicines losing patent exclusivity over the next decade, she explores the strategic complexities of launching at the exact moment a patent expires, the role of diversified manufacturing in strengthening supply chain resilience, and why expanding access to essential medications requires both purpose and commercial viability. An eye-opening conversation on making affordable healthcare a reality for millions of patients worldwide.

On this week's podcast we have all the latest news, prioritise jobs when weather allows for fieldwork and look at the grain trend and weather reports. Our guest this week is Alison Bosher, country manager with Life Scientific in Ireland and the UK, on generic plant protection product production. The Tillage Podcast is supported by Bayer Crop Science. Hosted on Acast. See acast.com/privacy for more information.

The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.

Fortran. Eine Sprache von 1957. Und trotzdem taucht sie im TIOBE Index plötzlich auf Platz 12 auf. Zufall, Messfehler oder ein echtes Comeback in High Performance Computing? Wenn du Fortran bisher in die Schublade Legacy und Lochkarten gesteckt hast, wird diese Episode deine Perspektive ziemlich sicher verschieben.In dieser Interviewfolge nehmen wir Fortran auseinander, aber fair. Mit dabei ist Martin Diehl, Professor an der KU Leuven, Materialwissenschaftler und Open-Source-Contributor. Wir klären, warum Fortran für wissenschaftliches Rechnen gebaut wurde, warum Performance und Memory Layout bis heute zählen und weshalb du bei NumPy und SciPy oft indirekt Fortran-Code nutzt. Dazu geht es um Modern Fortran, Rückwärtskompatibilität, Module, Typensystem, Tooling, den Fortran Package Manager FPM sowie neue Compiler wie Flang und L Fortran auf LLVM-Basis.Zum Abschluss wird es HPC konkret. OpenMP für Shared Memory, MPI für Distributed Memory und als Fortran-Spezialität Co Arrays – quasi Shared-Memory-Feelings im Cluster. Wenn du wissen willst, ob Fortran Teil des Problems oder der Lösung im Two-Language-Dilemma ist, dann hör rein.Bonus: Naming is hard, aber F minus minus war schon eine Ansage.Unsere aktuellen Werbepartner findest du auf https://engineeringkiosk.dev/partnersDas schnelle Feedback zur Episode:

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.00:00 Intro to ICH Q500:25 Meet the Host00:32 Why Biologics Need Q500:56 Key Risks Explained02:11 What Q5 Covers02:40 Scope and Structure03:19 Q5 A to E Breakdown04:19 How to Read Q505:05 Q5 for Combination Products05:59 Wrap Up and Next EpisodeSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Pink Sheet Executive Editor Derrick Gingery, Editor-in-Chief Nielsen Hobbs and special guest Dave Wallace, executive editor of Generics Bulletin, discuss the generic industry's future direction and priorities (:27) and the impact of recent policy moves on the biosimilar industry (12:28) following their trade association's annual meeting, as well as US Food and Drug Administration Commissioner Martin Makary's comment on compassionate use and the concern it may have caused industry (20:23). More On These Topics From The Pink Sheet The State Of The Off-Patent Union: AAM's Murphy Sets Out US Achievements And Obstacles: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/the-state-of-the-off-patent-union-aams-murphy-sets-out-achievements-and-obstacles-in-us-IHJH2CZBX5GGTI6UJQVE2WO2G4/ ‘Biology Is Dirty': HHS's Principal Deputy Counsel On How Biosimilar Firms Can Help US FDA: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/biosimilars/biology-is-dirty-hhss-principal-deputy-counsel-on-how-biosimilar-firms-can-help-us-fda-2GEAUSXNMRCYNIXPS7P6IAYESE/ Makary's Compassionate Use Comments, Later Clarified, Still May Startle Industry: https://insights.citeline.com/pink-sheet/rare-diseases/makarys-compassionate-use-comments-later-clarified-still-may-startle-industry-XPBVZ6MH7FC7JKP2XEL4ZESWSE/

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem Statement Basics27:48 Wrap Up and Where to FindGeorg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA.The conversation explores why Western companies often underestimate China's regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T).The episode dives into China's local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration.Elaine also outlines how China's quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers.Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China's device classification system can influence regulatory strategy.⏱️ Timestamps00:00 Welcome + Meet Elaine (MedTech Chopsticks)00:38 Why China Is Different: Local Standards vs EU/US Assumptions03:35 GB & YY Standards Explained (National vs Industry Standards)05:07 Local Type Testing & PTRs: Building China Product Technical Requirements06:52 China GMP Updates: Key Differences vs ISO 1348512:42 China Agent vs EU Authorized Rep: Roles & Responsibilities15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks24:43 China Certification & Device Classification Changes (Class I/II/III)28:38 Where to Find Elaine + ClosingSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions. The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3.ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelinesICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdfTimestamps00:00 Introduction to the ICHQ Series00:03 What Pharmacopeial Harmonization Means00:42 Why ICH Q4 Exists01:55 ICH Q4 Framework and Structure02:54 Understanding Q4A, Q4B, and the Annexes03:59 Practical Examples (Particulates, Disintegration)08:05 Conclusion and Next StepsSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products.Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E.This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle.⸻Timestamps00:00 Welcome to Let's ComBinate00:12 Introduction to ICH Q300:25 What Are Impurities and Why They Matter00:51 Sources of Impurities and Risk-Based Control02:11 Structure of ICH Q3 (Q3A–Q3E)05:30 How to Read and Use ICH Q307:22 Q3E, Extractables & Leachables, and Drug Delivery Systems09:21 Wrap-Up and Next Episode PreviewSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

David Kaplan checks in at the NYSE desk and provides a check-up on healthcare giant Merck (MRK). The company reported a slight beat in its 4Q earnings figures, and Kaplan says its Keytruda product pipeline will be important as it starts to face generic competitors. He notes headwinds in the vaccine business and weakness in China due to regulations impacting its ability to market pharmaceutical products. Kaplan discusses the M&A activity in the biopharma space and how Keytruda combination therapies will be something to monitor. ======== Schwab Network ========Empowering every investor and trader, every market day.Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – / schwabnetwork Follow us on Facebook – / schwabnetwork Follow us on LinkedIn - / schwab-network About Schwab Network - https://schwabnetwork.com/about

In this special episode of the Inside Java Podcast, Nicolai Parlog talks to Adam Bien about scripting with Java, to Maurice Naftalin about the history and tradeoffs of the collections framework and erasure, and to Tom Cools about the innovative way the Belgian Java User Group organizes itself.

In this episode of Let's Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products.Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products.Timestamps00:00 Introduction to Let's ComBinate00:42 Purpose and importance of ICH Q203:11 Scope and product coverage06:10 Key validation characteristics08:15 Practical application and reading ICH Q210:23 Conclusion and next stepsSubhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Coming to you from the #NCPA2025 expo floor, host John Beckner and co-host Ed Cohen chat with Bill Locke, vice president of trade services at Prasco, to discuss Prasco's deep commitment to community pharmacy. The conversation explores Prasco's authorized generic business model and how it helps advance pharmacy practice while supporting independent pharmacies.

In this episode of Let's Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made.The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage.This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence.Timestamps00:00 Introduction00:36 What ICH Q1 Is and Why It Exists02:59 Core Stability Concepts in ICH Q104:51 What's Changing in the 2025 Draft05:35 How to Read ICH Q107:16 ICH Q1 and Drug-Device Combination Products09:09 Closing and What's NextSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products.Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management.Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail.In this episode, you will learnWhat an ICH guideline is and how it differs from regulations and standardsWhy guidelines still matter during inspections and enforcementHow ICH organizes its guidance into Q, S, E, and M categoriesA high-level overview of the Quality Guidelines (Q1 through Q14), including:Stability (Q1)Analytical validation and development (Q2 and Q14)Impurities (Q3)Quality by Design and risk management (Q8 and Q9)Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12)Continuous manufacturing (Q13)How different functional teams interact with different parts of the ICH frameworkThe next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability.Timestamps00:00 Introduction to the Series00:48 Overview of ICH Guidelines01:36 What an ICH Guideline Is and Is Not03:04 The Four ICH Guideline Categories04:08 Quality Guidelines Overview08:46 Safety Guidelines Overview09:28 Efficacy Guidelines Overview10:33 Multidisciplinary Guidelines Overview11:28 Wrap-Up and Next StepsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Sometimes we don't realize that we're using a trademarked term differently from those around us.

This interview was recorded for the GOTO Book Club.http://gotopia.tech/bookclubCheck out more here:https://gotopia.tech/episodes/406Maurice Naftalin - Architect, Trainer & Co-Author of "Java Generics & Collections"Stuart Marks - Java & OpenJDK at Oracle & Technical Editor of "Java Generics & Collections"RESOURCESMauricehttps://bsky.app/profile/mauricenaftalin.bsky.socialhttps://x.com/mauricenaftalinhttps://github.com/MauriceNaftalinhttps://www.linkedin.com/in/maurice-naftalinStuarthttps://bsky.app/profile/smarks.bsky.socialhttps://mastodon.social/@stuartmarkshttps://x.com/stuartmarkshttps://github.com/stuart-markshttps://www.linkedin.com/in/stuart-marks-17a71a2https://stuartmarks.wordpress.comDESCRIPTIONMaurice Naftalin and Stuart Marks discuss the second edition of "Java Generics and Collections", published 19 years after the original. The conversation explores how Java programming has evolved from Java 5 to Java 25, covering major shifts like the move toward immutability, the introduction of sequenced collections, streams, and unmodifiable collections.They delve into critical design topics including encapsulation of collections, the anemic domain model anti-pattern, the controversial unsupported operation exception, and the challenges of null handling. The book includes new chapters on usage guidance and design retrospectives that reflect decades of accumulated wisdom about the Collections Framework.RECOMMENDED BOOKSMaurice Naftalin & Philip Wadler • Java Generics and Collections 2nd ed • https://amzn.to/47dOp9tMaurice Naftalin & Philip Wadler • Java Generics and Collections 1st ed • https://amzn.to/42JI03iJoshua Bloch • Effective Java • https://amzn.to/4oFbdoiVictor Grazi & Jeanne Boyarsky • Real-World Java • https://amzn.to/4oCEeBRKevlin Henney & Trisha Gee • 97 Things Every Java Programmer Should Know • https://amzn.to/3kiTwJJChristian Clausen • Five Lines of Code • https://amzn.to/3s2zjygNicolai Parlog • The Java Module System • https://amzn.to/3xFggR4BlueskyTwitterInstagramLinkedInFacebookCHANNEL MEMBERSHIP BONUSJoin this channel to get early access to videos & other perks:https://www.youtube.com/channel/UCs_tLP3AiwYKwdUHpltJPuA/joinLooking for a unique learning experience?Attend the next GOTO conference near you! Get your ticket: gotopia.techSUBSCRIBE TO OUR YOUTUBE CHANNEL - new videos posted daily!

In this episode of Let's Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let's Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What's NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on Most Favored Nation (MFN) drug pricing and its knock-on effects for jobs, state budgets, and the generic supply chain. Over the past year, proposals to link U.S. prices to those in other countries have collided with inflation pressures, tariff debates, and reshoring efforts, creating new uncertainty for manufacturers, payers, and policymakers. In an environment where expectations about future returns are shifting, and the rules of the game are still being defined, this episode is designed as a year-end guide to what MFN-style policies could mean in practice and how to think about the tradeoffs. Throughout 2025, we our research on MFN-style reference pricing with a series of podcast episodes where host Duane Schulthess sat down with leaders across the generic, distribution, and policy landscape. In this highlights episode, we revisit several of those conversations: Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks Patrick Kelly: Inside the Generic Supply Chain Squeeze John Murphy: Generics, Biosimilars, and U.S. Policy VT’s Grumpies (Harry Bowen, Joe Hammang) Talk MFN Key Topics: MFN Mechanics Explained: How tying U.S. prices to the lowest GDP-adjusted price in a reference basket translates into steep cuts for top-spend medicines in Medicare Parts B and D and shapes expectations across commercial and Medicaid contracts. Jobs, Earnings, & State Budgets: What our modeling suggests about potential impacts on employment, earnings, and tax revenue under MFN-style reference pricing, and how those effects concentrate in R&D-intensive regions and manufacturing hubs. Spillovers Into Medicaid, 340B, & ASP: Why MFN in Medicare does not stay in Medicare, how Medicaid best price and 340B ceilings pull discounts across programs, and what lower ASP add-ons could mean for hospital and community oncology margins. Generics, Shortages, & Tariffs: How razor-thin margins for sterile injectables and generic manufacturers interact with purchaser consolidation, tariff shocks, and price referencing, raising the risk of exits, inventory write-downs, and persistent shortages. Global Competition & Offshoring: How aggressive reference pricing can accelerate shifts in trials, licensing, and high-value manufacturing to countries that offer more predictable returns, and what that implies for long-run U.S. competitiveness. Alternatives To MFN: Ideas from our guests on value-based approaches, targeted incentives, and other tools that can improve affordability without hollowing out domestic capacity, innovation, and resilience in the generic and biosimilar supply chain. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what's changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation.They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA's PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry.What you'll learn-The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs)-How inspection outcomes can lead to CRLs—even when the application looks strong on paper-Why industry is talking about decoupling approval from PAI timing-The idea behind FDA PreCheck and what “facility readiness” looks like-Unannounced inspections: where they help, where they create risk-How inspection expectations compare across global regulatorsChapters00:00 Introduction and Guest Welcome00:10 Understanding Pre-Approval and Pre-License Inspections01:54 Challenges and Industry Perspectives03:08 FDA Complete Response Letters (CRLs)05:23 Unannounced Inspections: Pros and Cons08:55 Economic and Regulatory Considerations12:37 Onshoring and the PreCheck Program22:51 Global Regulatory Landscape25:11 Conclusion and FarewellBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Richard Saynor reflects on what it takes for leaders to combine accountability, clear decision-making, and the humility to change course. Hosted on Acast. See acast.com/privacy for more information.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways.They discuss:- The hidden costs of regulatory failure and how to avoid them- Why early engagement with regulatory agencies is critical- Global regulatory models, including emerging markets like China and the UAE- A clear explanation of UDI and serialization- How regulatory impacts extend beyond compliance teams- The role of LinkedIn and storytelling in regulatory careers- Steven's experience running for the European Parliament and what it taught him about policyTimestamps00:00 – Introduction and Guest Welcome00:38 – The Hidden Costs of Regulatory Failure03:47 – Engaging with Regulators Early05:26 – Global Regulatory Models and Emerging Markets10:07 – Understanding UDI and Serialization15:16 – The Power of LinkedIn and Personal Stories17:11 – Running for European Parliament and Policy Insights21:18 – Conclusion and Contact InformationConnect with Steven O'RourkeWebsite: https://clarifi.fiLinkedIn: https://linkedin.com/in/sorourkdeSubscribe to Let's Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy.Stephen O'Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development.00:00 Welcome and Introduction00:48 The Impact of CQE Certification02:23 Applying DOE in Quality Engineering05:42 Top ASQ Certifications13:35 Non-ASQ Certifications and Leadership15:55 Cross-Industry Learnings18:45 Conclusion and Contact InformationAndy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy's work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year?In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars.They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases.This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention.Topics include:-How to select the right generic molecules beyond patent expiry-Early success with isoproterenol and API sourcing-Why Nexus turned down acquisition offers-Building a commercial salesforce from scratch-Designing a facility with high speed prefilled syringe and lyo capacity-Why most other sterile sites failed-The billion dollar sale to Lilly-Launching Quetzal and developing oral arsenic for APL-The brain-eating amoeba drug and ultra rare disease strategy-Faith, confidence, and decision making under pressureTimestamps: 00:00 Introduction and Guest Welcome00:24 From Wall Street Finance to Pharma01:42 How Usman Selected Winning Generics02:58 Early Challenges Building a Generics Company05:29 Family R&D Expertise and Business Dynamics11:44 First Generic Launch and Commercial Impact16:28 Building Sterile Injectable Manufacturing Capacity18:16 Sterile Facility and Equipment Strategy22:40 Prefilled Syringe and Vial Line Capabilities23:07 Big Pharma Interest and Selling the Facility26:02 Nexus Pharma Services and the Lilly Deal27:23 Post‑Sale Reflections and New Ventures28:30 Launching Quetzal Therapeutics and Rare Disease Focus33:30 New Challenges and Confidence in Drug Development39:55 Importance of People, Teams, and Relationships41:40 Books That Shaped Usman's Thinking42:29 Where to Connect with UsmanLearn more: https://quetzaltx.comConnect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928More episodes: https://letscombinate.comUsman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.Leonel shares how integrating Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP) is essential to successful combination-product development. He discusses his journey from chemist to regulatory-affairs expert, uncovering common disconnects between pharma and device cultures, and the critical role of design controls, risk management, and timelines.The conversation also explores GMP and process validation, IDE vs. IND pathways, the challenges of rare-disease programs, and how understanding the cost of quality can reshape testing strategies. Leonel closes by reflecting on becoming a Lean Six Sigma Black Belt and what continuous improvement really looks like in combination-product development.⏱ Timestamps00:00 – Welcome & Introduction00:52 – Integrating GLP, GCP & GMP02:22 – Challenges in Developing Combination Products04:02 – Device-Led Combination Products07:35 – Working with Rare Diseases09:58 – GMP & Process Validation15:08 – Clinical Trials: Drug vs Device19:22 – Cost of Quality & Six Sigma25:12 – Conclusion & Contact InformationLeonel Venegas is the Founder of Precision Regulatory Consulting LLC and an expert in quality and regulatory affairs with over two decades of experience across six global pharma and medtech leaders, including Alexion, Merck, Johnson & Johnson (Ethicon & Cordis), Amgen, and Medtronic.He is certified by ASQ as a CMQ/OE, CQE, CBA, and CSSBB, and holds an M.S. in Regulatory Affairs. Leonel specializes in combination products, medical devices, and IVDs, integrating GLP, GCP, GMP, and GVP principles into complex global development programs.

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Subscribe to UnitedHealthcare's Community & State newsletter.In this episode, Rob Lott interviews Jennifer Kao of the UCLA Anderson School of Management in front of a live audience about her paper in the October 2025 issue of Health Affairs exploring the impact of risk evaluation and mitigation strategies on generic approvals of US pharmaceutical products.Order the October 2025 issue of Health Affairs.Currently, more than 70 percent of our content is freely available - and we'd like to keep it that way. With your support, we can continue to keep our digital publication Forefront and podcast Subscribe to UnitedHealthcare's Community & State newsletter.

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.Key topics covered:- Current applications of AI in GMP, including CAPA and deviation management- The role of validation and why algorithmic opacity poses regulatory challenges- How Process Analytical Technology (PAT) enables real-time release decisions- The importance of Design of Experiments (DOE) for process optimizationContinuous manufacturing and how yield can signal process performanceChapters00:00 Introduction to AI in Pharma00:40 Current Applications of AI in GMP02:32 Challenges and Validation in AI03:22 Process Analytical Technology (PAT)09:50 Design of Experiments (DOE) in Pharma13:27 Continuous Manufacturing Explained15:40 Yield Calculation in Manufacturing22:12 Conclusion and Contact InformationBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with John Murphy, President and CEO of the Association for Accessible Medicines (AAM), to discuss how U.S. purchasing dynamics and thin margins drive shortages, the evolving biosimilar landscape amid insurer vertical integration, the Inflation Reduction Act (IRA)’s ripple effects on plan risk and rebates, Most Favored Nation (MFN) policy proposals, and what it will take to reshore capacity while preserving competition and patient access. Key Topics: Generic Pricing Pressures: Purchaser consolidation, sterile injectables, margin squeeze, and exits. Drug Shortage Economics: Quality investments, underpriced redundancy, lessons from saline disruptions. Biosimilar Market Dynamics: Private-label payer programs, rebate tactics, chilling pipeline investment. Inflation Reduction Act (IRA) and Coverage: Part D risk shift to plans, negotiation uncertainty, and Medicare access delays. Tariffs and Reshoring: API onshoring realities, carve-outs to avoid shortages, resilient capacity building. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biological pathways, the difference between structure-based and phenotype-based drug design, and the role computational methods play in drug development. The conversation also explores the challenges of crossing the blood-brain barrier, the importance of validating target response, and the complexities of progressing from a theoretical compound to preclinical studies. Additionally, Jesse touches on the significance of target product profiles, CNS drug design characteristics, and the iterative nature of medicinal chemistry. He concludes by discussing his current projects at Cortex, including fundraising strategies and timelines for drug development.00:00 Introduction to Medicinal Chemistry00:37 Drug Discovery Approaches02:01 Computational Methods in Medicinal Chemistry03:21 Challenges in ALS Drug Discovery04:23 Blood-Brain Barrier and Drug Design05:29 Key Properties for CNS Drug Design08:58 Day-to-Day in Drug Discovery09:45 Early Stage Drug Development12:28 Validating Drug Targets16:15 From Theory to Animal Testing22:46 Funding and Timeline Considerations25:45 Regulatory and Manufacturing Considerations28:32 Conclusion and Contact InformationDr. Jesse Gordon-Blake is an independent biotechnology and drug discovery consultant with expertise in medicinal chemistry and neurotherapeutics. He has led efforts in small molecule and peptide therapeutic development, AI-enabled drug discovery, and biotech startup formation, and currently serves as the CSO of Cortexa Therapeutics. He earned his PhD in Medicinal Chemistry from the University of Illinois at Chicago, focusing on developing innovative small-molecule enzyme modulators for Alzheimer's disease.https://www.linkedin.com/in/jesse-gordon-blake-phd-52a26274/https://www.cortexatherapeutics.com/Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Generics Bulletin editor Dave Wallace talks to John Murphy III, president and CEO of the US Association for Accessible Medicines, about the association's latest annual savings report and key topics affecting the US off-patent market.

In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what it means for life-saving products like epinephrine and naloxone injectors.Alan explains how manufacturers can demonstrate reliability through fault tree analysis, robust process controls, and challenge testing—without needing impossible sample sizes.If you work in pharma, medtech, or quality, this episode will help you understand what “five nines” really means and how to meet FDA expectations while ensuring patient safety.Chapters00:00 – What is Five Nines Reliability?Intro to 99.999% and why it matters for medical devices.00:33 – FDA Guidance & Common Misconceptions2020 draft guidance, sample size myths, and industry confusion.01:17 – How to Demonstrate ReliabilityFeasibility, practical approaches, and FDA expectations.02:31 – High-Stakes Use CasesEpinephrine, naloxone, glucagon injectors.04:00 – Fault Tree Analysis ExplainedBreaking down failures and linking to design/manufacturing.05:25 – Why FDA Chose Five NinesBalancing feasibility, safety, and ISO 14971 influences.09:02 – Verification vs. ReliabilityDesign verification testing vs. true reliability demonstration.23:16 – Key Takeaways for IndustryClosing thoughts on meeting and maintaining reliability standards.Alan Stevens CAPT is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let's Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory submissions, and quality oversight — and what strategies regulators and companies need to make sure speed doesn't come at the cost of trust.We explore:- Why pharma's unique risk profile makes AI regulation different from other industries-How ICH guidelines and process validation can be applied to AI systems-What “combinatorial problem sets” mean for pharma and AI models-The role of AI in regulatory affairs and dossier preparation-How regulators may use AI to accelerate reviews and approvals-The balance between speed, accuracy, and zero hallucinations in regulatory contexts-The future of AI in quality control, biologics, and beyondIf you work in pharma, medtech, or drug/device combination products, this episode will give you a clear look at how AI could change your world and what needs to happen before it earns the regulator's trust.Episode Chapters00:00 Introduction: Regulating AI in Pharma/MedTech01:01 Pharma's Unique Risk Profile02:14 AI in Regulatory Affairs03:44 Combinatorial Problem Sets in Pharma04:24 ICH Guidelines and AI Regulation08:22 Process Validation in AI10:20 AI in Regulatory Submissions15:54 Ensuring Accuracy and Consistency17:02 Regulatory Agencies and AI18:28 Accelerating Drug Approval with AI21:36 Time Savings in Dossier Formation25:44 AI in Quality Control for Biologics27:42 Challenges in AI Integration29:25 The Future of Pharma & MedTech with AI30:40 Where to Find Dominick RomanoDominick Romano is the founder and CEO of Drainpipe.io, focused on building trustworthy AI systems for regulated industries like pharma and medtech. A graduate of Full Sail University in video game development, his career spans game design, programmatic advertising, and voice applications before moving into AI. He was named one of Technology Innovators' Top 50 AI CEOs and has contributed to global initiatives such as the WHO/ITU AI for Health program. Today, he helps organizations explore how AI can be validated and integrated without compromising compliance or trust.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven't even reached the planning stage. In this conversation, Larry Mager breaks down what Quality 4.0 really is, why life sciences lag other industries, and how to move from compliance-only thinking to a business-driving quality strategy. We cover digital twins, data continuity, culture change, and Larry's Quantum Quality Management (QQM) framework as a practical roadmap.Timestamps00:00 Introduction to Quality 4.000:20 Defining Quality 4.001:39 The Role of Quality Professionals02:50 Industry Examples & Cultural Differences04:04 Implementing Quality 4.0 (people, process, tech)08:49 The Digital Twin Concept (why legacy EQMS falls short)13:34 The Importance of a Roadmap 30:28 Quantum Quality Management (5-phase framework)35:05 Final Thoughts & Contact InformationLarry Mager is the Founder and Principal at MGMT-CTRL, where he specializes in applying strategic quality management that goes beyond mere compliance. With three decades of experience in the medical device industry, Larry has held leadership roles spanning quality systems, operations management, CAPA, supplier control, risk management, lean manufacturing, and continuous improvement. He is also the architect of the Quantum Quality Management (QQM) framework, a phased methodology that marries people, process, and technology to help organizations adopt Quality 4.0, drive operational excellence, and use quality as a strategic business advantage.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They discuss the intricacies of risk assessments for medical devices and drugs, focusing on differences and improvements in methodologies over the years. Joey shares insights on the challenges of aligning risk processes across different organizations and the importance of adaptable strategies. He also recounts his unique career path that blends design engineering with extensive process and risk management expertise. The conversation covers trends such as the shift toward off-the-shelf platforms and the balancing act between innovative design and market readiness. Joey emphasizes the value of stepping into roles and tasks that others may overlook, which has been key to his professional growth.00:00 Welcome and Introduction00:49 Discussing Risk Assessments in Med Tech04:34 Challenges in Aligning Risk Processes09:44 Understanding P1 and P2 in Risk Management12:55 Joey's Career Journey and Strategic Choices24:12 Trends in Combination Product Design31:48 Conclusion and Where to Find JoeyJoey Frechin is a technical program lead in the medical device and combination product development space.https://www.linkedin.com/in/joey-frechinSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products.Jeff takes us inside FDA warning letters, consent decrees, and massive remediation efforts—including the 1,400 DHF Zimmer Biomet project and achieving 99.999% reliability with the EpiPen. He shares the CAPA playbook he's refined over decades, the high-stakes negotiations with FDA, and the critical role of containment, third-party reviews, and inspection readiness.The conversation shifts to Quality 4.0 how electronic batch records (EBRs), AI, and digital systems can move quality from reactive to preventive. Jeff also introduces his new Quality 4.0 Consortium, designed to bring proven digital solutions to small and mid-sized pharma companies.Timestamps:00:00 – Introduction & Guest Welcome00:42 – Facing a Warning Letter: The Zimmer Experience02:05 – Remediation Strategies & Challenges06:03 – Orthopedic Industry Insights09:58 – Transition to Pfizer & Meridian12:54 – Navigating FDA Negotiations16:18 – Balancing Risk & FDA Visibility16:55 – Implementing Quality Systems & Processes18:15 – Leveraging Third-Party Reviews & Audits20:26 – Inspection Readiness & CAPA Processes25:08 – Mergers, Acquisitions & Facility Upgrades27:32 – Digital Transformation in Quality Management31:12 – The Future of Quality Systems & AI Integration33:01 – Benefits of Electronic Batch Records34:13 – Conclusion & Contact InfoJeff Gensler is a veteran quality and regulatory executive with more than 30 years of leadership experience in MedTech, pharmaceuticals, and combination products. Over his career, Jeff has navigated some of the industry's most complex compliance challenges, including FDA warning letters, consent decrees, and large-scale quality system remediations. He has held senior leadership roles at Zimmer Biomet, where he oversaw the remediation of 1,400 design history files involving $300M in resources and 1,500 contractors, and at Pfizer's Meridian Medical Technologies, where his team achieved 99.999% reliability for the EpiPen through advanced quality processes and close FDA engagement. Jeff later served as Vice President of Quality at Kindeva Drug Delivery, where he helped lead a state-of-the-art facility buildout recognized by ISPE as a Facility of the Year finalist. A recognized advocate for modernizing quality systems, Jeff has championed Quality 4.0, integrating electronic batch records, AI, and advanced analytics to shift organizations from reactive to preventive quality management. Most recently, he founded the Quality 4.0 Consortium, a collaborative platform bringing proven digital solutions to small and mid-sized pharma companies.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this milestone episode, I reflect on what it's taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products.I share three hard-earned lessons not just about the industry, but about how we grow, lead, and keep learning inside it. From the sheer scope of the work to the surprising, non-linear paths people take, and the difference between credentials and true insight this episode is about what finally clicked… and what still hasn't.It's a thank-you to you, the listener, and a reminder that mastery isn't a finish line it's a mindset.

Matthias Endler, Rust developer, open-source maintainer, and consultant through his company Corrode, speaks with SE Radio host Gavin Henry about prototyping in Rust. They discuss prototyping and why Rust is excellent for prototyping, and Matthias recommends a workflow for it, including what parts of Rust to use, and what parts to avoid at this stage. He describes the key components that Rust provides to help us validate ideas via prototypes, as well as tips and tricks to reach for.  In addition, the conversation explores type inference, unwrap(), expect(), anyhow crate, bacon crate, cargo-script, Rust macros to use, generics, lifetimes, best practices, project layout styles, and how to design through types. Brought to you by IEEE Computer Society and IEEE Software magazine.