Podcasts about generics

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.

Wusstet ihr, dass neue PHP-Versionen nicht einfach wie ein automatischer Cronjob vom Himmel fallen, sondern von einem Team aus Menschen gebaut, koordiniert und durch Community-Diskussionen gestaltet werden? In diesem Deep Dive holen wir euch genau in diesen Maschinenraum: Wir sprechen über den Release von PHP 8.5 – aber weniger über einzelne Features als darüber, wie sie überhaupt in die Sprache hineinkommen und am Ende sicher bei euch auf dem Server landen.Unser Gast ist niemand Geringeres als Volker Dusch, einer der beiden Release Manager von PHP 8.5. Volker erzählt, wie man überhaupt in diese Rolle rutscht, warum dafür keine „Bewerbung beim PHP Elefanten“ nötig ist, welche Rolle Mailinglisten heute noch spielen und wieso ein Release Manager gleichzeitig Organisator, Gatekeeper, Kommunikator und manchmal auch Feuerwehr ist. Dabei geht es um Alphas, Betas, Release Candidates, Feature Freezes – und darum, wie man zwischen Stabilität, Bugfixes und neuen Ideen balanciert, ohne das halbe Internet kaputt zu machen.Wir schauen außerdem darauf, wie Features ihren Weg in die Sprache finden: von „unspektakulären“ Pull Requests bis hin zu großen RFCs, hitzigen Diskussions-Threads und demokratischen Abstimmungen, bei denen die Core-Contributors entscheiden, was PHP in Zukunft kann – und was bewusst draußen bleibt. Die PHP Foundation spielt dabei eine spannende, aber weniger allmächtige Rolle, als viele vermuten, und sorgt vor allem dafür, dass einige Menschen bezahlt Zeit haben, an der Sprache weiterzuschrauben, ohne dass Abkürzungen beim Qualitätsanspruch gemacht werden.Natürlich reden wir auch über Community: darüber, warum die PHP-Welt deutlich jünger und diverser ist, als ihr Ruf vermuten lässt, was Konferenzen, User Groups und Remote-Tools miteinander zu tun haben und weshalb ausgerechnet eine „alten“ Sprache wie PHP so viele Leute anzieht, die Bock auf Sprachdesign, Performance und Internals haben.Und weil es sonst nicht die programmier.bar wäre, streifen wir am Ende auch noch die Klassiker-Fragen rund um Generics, Async, Hacklang und die große „Kehren Firmen wie Meta irgendwann zurück zu Vanilla-PHP?“–Spekulation.Schreibt uns! Schickt uns eure Themenwünsche und euer Feedback: podcast@programmier.barFolgt uns! Bleibt auf dem Laufenden über zukünftige Folgen und virtuelle Meetups und beteiligt euch an Community-Diskussionen. BlueskyInstagramLinkedInMeetupYouTubeMusik: Hanimo

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.

Good afternoon, I'm _____ with today's episode of EZ News. Tai-Ex opening The Tai-Ex opened opened up 358-points this morning from yesterday's close, at 27,282 on turnover of 13-billion N-T. The positive opening came after the market tumbled more than 350-points on Monday, as investors reacted to U-S President Donald Trump's threat to hike tariffs on Chinese goods by 100-per cent. Taipei City Government and Shin Kong Life remain at odds over compensation for Nvidia land The Taipei City government is urging Shin Kong Life Insurance to accept a compensation agreement in exchange for relinquishing the surface rights of plots T-17 and T-18 in the Beitou-Shilin Science Park - where Nvidia wants to build its Taiwan headquarters. Shin Kong Life has said it's willing to directly transfer the surface rights to Nvidia, but the city government is stressing that such a move would violate the contract - as to date nothing has been built on the site. The city government has offered to pay compensation (賠償) of between 500 and 800-million N-T to Shin Kong Life and return the more than 3-billion N-T the company bid to acquire the land rights. However, Shin Kong Life is pushing for 10.7-billion N-T in compensation for terminating the contract. Generics and imports to plug gap left by departing drug makers Health Minister Shih Chung-liang says the availability of generic and imported medications mean the withdrawal of essential drugs from the Taiwan market this year is not expected to result in shortages. The statement comes after the Food and Drug Administration announced that as of last month, the makers of 47 drugs classified as essential under the Pharmaceutical Affairs Act have given the legally required six-month notice of their intention to end local sales. According to the health minister, there are generics available in Taiwan for 46 of the 47 drugs. The only drug that currently lacks a locally approved alternative is an immunosuppressant used in organ transplants manufactured by Padagis. Joy in Israel as hostages return but many bodies still missing The families of the last 20 living hostages held by Hamas in Gaza have been sharing joy and relief at their return to Israel after two years in captivity (關押，囚禁). But Israel says only four of the dead hostages have been returned after Hamas said it does not know the location of some of the other 24. Blake Sifton reports from Tel Aviv. Madagascar President Flees Country Amid Coup Madagascar President Andry Rajoelina says he has fled the country in fear for his life following a military rebellion. But he did not announce his resignation in a speech broadcast on national television late Monday night from an undisclosed location. Rajoelina has faced weeks of Gen Z-led anti-government protests which reached a pivotal point on Saturday when an elite military unit joined the protests and called for the president to step down. That prompted Rajoelina to say that an attempted coup was underway (正在進行的) in the Indian Ocean island and leave the country. The situation remains volatile, with curfews in place in major cities. That was the I.C.R.T. EZ News, I'm _____. －－－－以下為 SoundOn 動態廣告－－－－ 新感覺夾心土司，多種口味隨心挑選 讓你隨時隨地都有好心情 甜蜜口感草莓夾心、顆粒層次花生夾心、濃郁滑順可可夾心 主廚監製鮪魚沙拉、精選原料金黃蛋沙拉 輕巧美味帶著走，迎接多變的每一天 7-Eleven多種口味販售中 https://sofm.pse.is/8a2gnu -- 行人過馬路要注意安全！ 沒有路權時不要通行，穿越馬路請遵守號誌燈指示，注意來車與周圍環境，步行安全最重要，保護自己也保護他人。

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.

Walmart offers up to a 30-day supply of over 300 different generic medications for $4 per prescription. They also offer a 90-day supply of many generic medications for $10. These prices do not apply to prescriptions filled by mail order. Prescriptions refills may be ordered online or by telephone, but Read More Shared by United Resource Connection August 8, 2025

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.

An airhacks.fm conversation with Maurice Naftalin (@mauricenaftalin) about: Java generics history and introduction timeline, the Pizza paper proposal by Phil Wadler and others, Type erasure vs Reification debate, binary compatibility considerations, Java Community Process politics and Apache Harmony licensing issues, evolution from JCP to JEPs process, legacy collection types like Vector and Hashtable with small 't' naming inconsistency, thread safety removal in Java 2 collections, generics applied to classes methods and constructors, unusual generic constructor example, Covariance and contravariance, invariant covariant and contravariant types, array covariance and ArrayStoreException, wildcards with extends and super bounds, PECS (Producer Extends Consumer Super) principle by Josh Bloch, Get and Put principle alternative, sealed interfaces potential impact on generics, reflection access to generic type information despite erasure, Class generification and type literals, raw types vs unbounded wildcards distinction, reifiable types definition, unchecked warnings importance, Service Loader usage with generic type checking for plugin systems, minimalist Java SE approach for long-lasting enterprise projects, syntactic sugar as code generation, records implementation as constrained classes, comparison of C++ templates criticism to Java generics adoption, the Java Generics and Collections book Maurice Naftalin on twitter: @mauricenaftalin

In this episode of Let's Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination product development.Mark, an expert in mechanical modeling & finite element analysis (FEA) and a licensed professional engineershares how modeling can dramatically reduce prototyping cycles, support regulatory submissions, and lower test burden when applied appropriately.Mark disucsses:Why modeling is often misunderstoodWhen it can replace (or complement) traditional testingWhat makes a model “credible” under ASME V&V 40How to build internal processes for regulatory-grade modelsAnd what every skeptic (or startup) needs to know before adopting modeling⏱️ Timestamps:00:00 Introduction and Guest Welcome00:17 Mark's Expertise in Mechanical Modeling01:28 Subhi's Foundational Experience04:09 The Importance of Modeling in Engineering05:44 Challenges and Misconceptions in Modeling10:52 Life Cycle and Inputs of a Model16:21 Types of Models and Their Applications17:49 Numerical Solvers and Sensitivity Analysis21:28 CAD, Fluid Properties, and Starting a Model22:00 Defining the “Question of Interest”23:21 Modeling Cycle and Initial Steps24:35 Verification and Validation in Modeling25:40 Assessing Model Risk and Credibility31:43 Regulatory Guidelines and Industry Practices39:15 Implementing Modeling in Product Development42:17 Conclusion and Contact InformationMark is a product development consultant with over 15 years of experience in the Medical and Combination device sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, computational modeling and simulation, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark's background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.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 highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the historical context of QSR and ISO 13485, their 1996 origins, and the drive for harmonization that began in 2018. Key insights include the alignment with ISO 13485, additional FDA-specific expectations, the continued importance of risk management, the removal of certain industry exemptions, and the urgent two-year compliance timeline ending in February 2026. Subhi emphasizes the necessity of updating internal quality management systems and training staff to meet these new regulatory requirements.Timelines:00:00 Introduction to FDA QMSR00:29 Historical Context and Timeline02:22 Key Takeaway 1: Harmonization with ISO 1348504:06 Key Takeaway 2: FDA's Additional Expectations05:18 Key Takeaway 3: Risk Management Expectations06:18 Key Takeaway 4: Removal of Exemptions07:44 Key Takeaway 5: Compliance Deadline09:13 Conclusion and Final ThoughtsSubhi 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 breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document that defines GxP responsibilities between parties—such as sponsors, product owners, and contract partners. It doesn't cover business terms like payments or IP: instead, it focuses on quality responsibilities and operational accountability.Subhi explores regulatory expectations from the FDA, ICH Q10, and ISO 13485, emphasizing that even when work is outsourced, responsibility always stays with the product owner. He outlines five key sections every quality agreement should cover:-Deviation & Non-Conformance Handling-Change Control-Audits & Regulatory Inspections-Complaint Handling & Field Actions-Documentation & Record RetentionThis episode highlights common pitfalls, vague language to avoid, and why quality agreements must be clear, specific, and actionable—especially when something goes wrong.⏱️ Timestamps00:00 – Intro: Why Quality Agreements Matter01:23 – What Is a Quality Agreement?03:24 – Regulatory Expectations (FDA, ICH Q10, ISO 13485)04:51 – FDA's Quality Agreement Guidance Explained06:34 – Common Pitfalls & Misunderstandings08:00 – The 5 Critical Sections Every Agreement Needs12:34 – Final Thoughts: Make It Real. Make It WorkSubhi 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, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs. Greg Slabodkin Read by Brittany Duncan  https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply 

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent trap,' finding mentors, valuing feedback, mastering systems, and taking responsibility for their careers. Subhi emphasizes that these lessons can significantly accelerate growth and career advancement for newcomers to the industry.Link to course: subhisaadeh.gumroad.com/l/6figurebiomedical00:00 Introduction: Starting Your Career Journey00:54 Lesson 1: Your Role Can Have a Big Impact02:55 Lesson 2: Adopting a Professional Mindset04:06 Lesson 3: The First 90 Days Are Crucial05:09 Lesson 4: Avoiding the Silent Trap06:35 Lesson 5: Finding the Right Mentors07:14 Lesson 6: Embrace Feedback as Fuel07:51 Lesson 7: Mastering the Systems08:47 Lesson 8: Taking Responsibility for Your Career09:19 Conclusion and Additional ResourcesSubhi 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.

If you've ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It's meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I'm Subhi Saadeh, and I've spent my career in drug-device combination products. In this short reference video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how components are combined- The difference between drug-led and device-led products- Examples of single-entity, co-packaged, and cross-labeled products00:00 Introduction to Drug Device Combination Products00:31 Defining Combination Products00:54 Philosophical Factors of Combination Products01:10 Drug-Led Combination Products01:51 Device-Led Combination Products02:32 Combination Configurations03:50 Summary and ConclusionAdditional Resources: - 21 CFR Part 4 FDA regulation on Current Good Manufacturing Practice (CGMP) requirements for combination products https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4- FDA Guidance: Current Good Manufacturing Practice Requirements for Combination Productshttps://www.fda.gov/media/90652/download- FDA Combination Products Overview Page https://www.fda.gov/combination-products- 21 CFR Part 3 Regulations on combination product classification and primary mode of action (PMOA) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3- EU MDR Article 117 Requirements for drug-device combinations under the European Medical Device Regulation (Regulation (EU) 2017/745) https://health.ec.europa.eu/system/files/2021-10/md_mdr_2017-745_en_0.pdfSubhi 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.Health Affairs' Rob Lott interviews Keith Drake of Greylock McKinnon Associates about his recent paper that explores trends in authorized generic drug launches and the effects observed on competition in pharmaceutical markets in the US. Order the June 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.

You've heard it before: If it's not documented, it didn't happen. But in life sciences, documentation isn't just a formality—it's the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they're applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn't taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the Global Generics & Biosimilars Awards 2025, providing all the key details of the event coming up in Frankfurt this October, along with tips on how to make the most of your entries and opportunities to get more involved with the event.

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.

In this episode, Tudor and Tim Murtaugh discuss the implications of the Biden pill penalty, a provision in the Inflation Reduction Act that negatively impacts the pharmaceutical industry and healthcare costs. They explore how this legislation discourages the development of cheaper, more effective medications, leading to increased healthcare costs and lost life years. The conversation also touches on the role of China in pharmaceutical development, the unintended consequences of legislation, and the importance of intellectual property laws in protecting creators. The Tudor Dixon Podcast is part of the CLay Travis & Buck Sexton Podcast Network. For more visit TudorDixonPodcast.comSee omnystudio.com/listener for privacy information.