Podcasts about Manufacturing operations

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.

Every product a company ships depends on thousands of tiny decisions happening deep inside the supply chain. But most organizations are still making those decisions using stale spreadsheets, fragmented systems, and guesswork. In this episode, we explore how AI-driven procurement intelligence is changing the game – moving teams from reactive firefighting to proactive supply chain planning. Our guest today is Shardul Shah, cofounder of Veritos.AI. He breaks down the hidden risks inside modern supply networks, why so many companies still lack real-time component and supplier visibility, and how better data can prevent shortages, backorders, and costly redesigns before they happen. We discuss:Why most organizations still rely on Excel for procurement decisionsThe real reason supply chain disruptions keep catching teams off guardHow AI and real-time data can alert teams to risks ahead of timeThe growing need for operational visibility across engineering, finance, and sourcingHow procurement becomes a strategic advantage, not just a cost center If you're responsible for building products, managing vendors, scaling hardware, or supporting manufacturing operations, this conversation will change how you think about supply chain intelligence and the future of procurement. Watch Next: https://youtu.be/OI0zRk7Mau4?si=7k0htLXyYJIWolpY Key Moments:0:00 Who Shardul Is & Why This Matters2:10 The Problem That Sparked Veritos.AI6:06 Why Procurement Visibility Is Broken15:55 How Veritos.AI Works (High-Level Overview)19:40 Why Supply Chain Is So Hard to Manage22:30 Identifying Alternative Parts & Replacements26:43 Real Example: The Power of Component Visibility29:00 The Role of AI in Modern Procurement35:15 The Current State of Procurement (And Its Challenges)38:50 The Biggest Skill Gap in Procurement: Understanding Cost46:00 The Disconnect Between Engineering & Procurement50:40 The Future: AI-Powered Procurement Command Centers -- This episode of IT Visionaries is brought to you by Meter - the company building better networks. Businesses today are frustrated with outdated providers, rigid pricing, and fragmented tools. Meter changes that with a single integrated solution that covers everything wired, wireless, and even cellular networking. They design the hardware, write the firmware, build the software, and manage it all so your team doesn't have to.That means you get fast, secure, and scalable connectivity without the complexity of juggling multiple providers. Thanks to meter for sponsoring. Go to meter.com/itv to book a demo.---IT Visionaries is made by the team at Mission.org. Learn more about our media studio and network of podcasts at mission.org. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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.

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.

Natalie Walker talks about her career journey; the importance of mentors in creating space for women; the changing face of workplaces; & the future of robotics.   IN THIS EPISODE WE DISCUSS:   [04.06] Natalie's education journey, how a family friend inspired an interest in supply chain, and why international business is a crucial, but sometimes overlooked, component of the industry. “I had this abstract idea of getting into international deal-making, international negotiations… So she encouraged me to check out supply chain.” [07.47] Why supply chain is often misunderstood, and why it's a great career choice for women looking to drive meaningful change. “When people think about supply chain… especially in traditional manufacturing and operations, there's more of a connotation of heavy, manual labor… For me, it's about explaining what supply chain is and thinking about it more in a corporate sense – how to streamline and centralize operations.” [11.58] Natalie's career journey, how her intentional decision-making built a foundation for where she is now, and the biggest lessons she learned in her early years. “I started in federal utilities… And starting in the utilities space really piqued my interest in energy as this foundational thing we take for granted… And energy led me to robotics, because it's the next transformational technology that has huge energy requirements.” “Learning about myself, and how to apply my strengths to whatever position I was in, was core.” [19.14] Why collaboration is the future of technology, and the vision for how humans and machines collaborate at Cobot, Natalie's place of work. “We're not trying to design a product that looks like a human. It's designed with the intent of being safe, smart, and reliable…. And we're not saying we need to wait until a point in time, where AI is at a particular level, to make a difference. We're building a platform that can make a difference today, and improve as AI improves.” [22.55] Natalie's perspective on where supply chain is at, as an industry, with robotics. “We're talking a lot about reshoring and revitalizing manufacturing… Everyone is under a lot of pressure… Cost volatility coupled with labor shortages and the rising complexity of the environments we're working in are pushing companies to find automation solutions that are flexible, reliable and fast.” [25.09] Natalie's role as Head of Supply Chain and Manufacturing Operations at Cobot. [30.04] Natalie's experience, as a woman, working across the utilities, oil and gas, clean tech, EV and robotics industries. “How is the way I represent myself going to be perceived, and how might that affect my eligibility for the job?” [35.00] The importance of mentors, and the role they've played in Natalie's career so far. “I can't overstate the value of mentorship.” [39.20] Natalie's experience of boards, and her advice for young people looking to pursue board opportunities. [42.18] How workplaces are changing, and why collaboration and communication is key. [48.12] The future for Natalie.   RESOURCES AND LINKS MENTIONED:   You can connect with Natalie over on LinkedIn or Instagram. If you enjoyed this episode and want to hear more about robotics, check out 294: Optimize Warehouse Productivity, with Locus Robotics, 465: Your Fulfillment Transformation Starts Now, with TGW Logistics or 308: Stabilizing Safety in the Workplace, with Ideal Warehouse Innovations. Check out our other podcasts HERE.

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.

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.

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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, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member. Jim shares the history of combination products before the term even existed, from insulin pens in the 1990s to modern platforms and on-body injectors. We cover IP battles that reshaped the industry, supply chain risks that pharma still underestimates, and why platform strategy is one of the most important decisions a company can make today.Timestamps:00:00 – Introduction & Guest Welcome02:00 – Building Lilly's device organization and launching insulin pens06:00 – Early “wild west” days of drug delivery vs. today's structure07:00 – Intellectual property as a competitive weapon10:30 – How Lilly, Novo, and Sanofi shaped the IP landscape13:00 – Device differentiation in the generic space17:00 – Portfolio vs. molecule decisions in platform strategy20:00 – Three reasons to develop your own platform23:00 – Supply chain risk and geopolitical considerations26:00 – Black Swan risks and lessons for pharma companies28:00 – Strategic suppliers vs. transactional vendors33:00 – Drug-device integration inside companies37:00 – Building organizational capability and governance38:00 – Future trends: large volume autoinjectors and connected devices43:00 – Impact of tariffs and supply chain positioning45:00 – Where to find Jim CollinsGuest Bio:Jim Collins is a veteran of the drug delivery field with more than 30 years of leadership experience. At Eli Lilly, he built and led the device organization, overseeing the launch of insulin pens, the Forteo Pen, and the Trulicity platform. Later, at Sanofi, he led drug delivery innovation and platform development, including devices for Dupixent. Today, Jim serves as a board member for Enable Injections and advises startups, helping the next generation of innovators navigate IP, supply chain, and platform strategy.Subhi Bio:Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. Subhi serves as International Committee Chair for the Combination Products Coalition (CPC), as a member of ASTM Committee E55, and previously on AAMI's Combination Products Committee. For questions, inquiries, or suggestions, visit letscombinate.com or connect on LinkedIn.

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.

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.

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.

Synopsis: When an introverted engineer becomes the President & CEO of REGENXBIO, transformation follows. Curran Simpson joins host Rahul Chaturvedi to unpack his unlikely journey from biotech operations to the C-suite—and how that hands-on experience is reshaping gene therapy's future. They dive into the evolution of REGENXBIO's pipeline, tackling ultra-rare diseases like MPS II, ambitious plans for Duchenne Muscular Dystrophy, and commercial partnerships with giants like AbbVie. Curran offers hard-earned leadership lessons, honest reflections on scaling science, and insights into how one-time gene therapies could revolutionize treatment in both rare and common diseases. From clinical nuance to strategic boldness, this is a masterclass in biotech leadership, platform focus, and staying patient-first—no matter how complex the science or market. Biography: Curran M. Simpson is the President and Chief Executive Officer and member of the Board of Directors at REGENXBIO. Mr. Simpson previously served as the Company's Chief Operating Officer. In that role, he led key business functions including Research & Clinical Development, Corporate Strategy, Manufacturing & Quality, Regulatory, and Commercial Operations. Mr. Simpson joined REGENXBIO in 2015 with extensive leadership experience across biopharmaceutical operations and served as the Company's Chief Technology and Operations Officer before becoming COO. Prior to joining REGENXBIO, he was the Regional Supply Chain Head for North America and Interim Chief Operating Officer at GlaxoSmithKline (GSK). Mr. Simpson earlier served as interim CEO of Human Genome Sciences (HGS), where he led the integration of HGS into GSK, and as Senior Vice President of Operations and Vice President of Manufacturing Operations at HGS. Prior to HGS, Mr. Simpson was Director of Manufacturing Sciences at Biogen. Earlier in his career, Mr. Simpson served in an overseas assignment at Novo-Nordisk Biochem in Denmark and in various senior development and engineer roles at Genentech, working on Herceptin and Avastin, among other roles. Mr. Simpson has an M.S. in surface and colloid science from Clarkson University and a B.S. in chemistry from the Clarkson College of Technology.

In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00 Protocol Design and Regulatory Considerations 08:40 Patient Preferences and Vendor Selection 18:53 Types of Clinical Trials 23:01 Understanding BA and BE Studies 24:39 Clinical Coordination of BA/BE Studies 25:15 Infrastructure and Emergency Management in Clinical Trials 26:19 Addressing Mistrust in Clinical Trials 29:54 Ensuring Diversity in Clinical Trials 32:41 The Rise of Decentralized Clinical Trials 39:06 Challenges and Solutions in Decentralized Trials 42:49 Technology and Regulation in Clinical Trials 47:28 Final Thoughts and Contact InformationArchana Sah is a Clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals including Tecentriq® in multiple indications and combinations, Alecensa®, Polivy®, Hemlibra®, Gazyva®, Pixuvri®. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies. She has also worked in healthcare technology as the Senior Vice President of Digital and Decentralized Solutions at Medable Inc. She is now an independent strategy consultant and Board Advisor and provides strategic advisory services to pharma, biotechs, digital healthtech software companies, venture firms in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development and featured in PharmaFEATURES on Oncology drug development and Digital Health technology.She has routinely led several industry collaboration consortiums. She is the co-founding chair and member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She is a current Mentor for the CancerX Moonshot program dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA) and as their Evidence/Publications Librarian. She also serves as an Advisor to American Cancer Society Cancer Action Network (ACS CAN) and is a reviewer for the international Journal of the American Cancer Society "Cancer". Invited advisor and keynote/speaker at several industry conferences.Contact: archana.sah@aspharmaadvisors.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just as a tool for finding your next job, but as a foundation for building a meaningful and resilient career in pharma and medtech.Mike shares what it's like to develop life-changing devices like Amgen's Auto Click autoinjector, how he built credibility across R&D and regulatory teams, and why asking good questions and being generous with your time pays off more than any formal title. If you've ever struggled to balance technical depth with approachability or you're trying to navigate CROs, design controls, or cross-functional chaos, I hope you enjoy this conversation! ⏱️ Timestamps00:00 Welcome and introduction00:56 Why networking matters01:57 Life-changing moments in engineering09:45 Challenges and innovations in autoinjectors14:47 CROs, sponsors, and collaboration18:22 Mike's favorite projects and final thoughtsAbout Mike Denzer:Mike Denzer is a mechanical engineer, inventor, and combination product leader with over 20 years of experience in drug delivery system development. He's held leadership roles at companies like Amgen, Teva, Bristol Myers Squibb, and Kymanox, and is credited as an inventor on five U.S. patents related to autoinjector platforms and delivery technology.He's the founder of Combo Products LLC, where he now consults on combination product design, human factors strategy, and technical development. Mike is widely respected for his collaborative style and clear communication across engineering, clinical, regulatory, and quality functions.Contact Mike: mdenzer@comboproductsllc.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

In this episode of Let's Combinate, host Subhi Saadeh is joined by Kirk Petyo, Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. If you're a bioengineering student, recent grad, or early-career professional trying to break into medical devices, biotech, or pharma—this one's for you.With extensive experience recruiting for regulated industries like aerospace, medical devices, and pharmaceuticals, Kirk offers grounded, actionable insights for early-career professionals and hiring managers alike.This episode covers how to craft a strong resume, the importance of knowing your career “why,” how to stand out to recruiters, and why onshoring and shifting regulatory trends matter for the next generation of talent in life sciences.Timestamps00:00 – Welcome and Guest Introduction 00:35 – Kirk's Career Journey and Advice 02:18 – Navigating Early Career Challenges 03:12 – Building a Strong Resume and Networking 04:38 – The Importance of Specificity in Job Applications 08:56 – Recruitment Insights and Industry Trends 12:05 – Personal Experiences and Lessons Learned 18:49 – Advice for Upcoming Graduates 23:18 – The Importance of Passion in Job Interviews 24:00 – Evaluating Candidates Beyond Experience 24:58 – Personal Stories and Career Choices 30:55 – Bioengineering vs. Mechanical Engineering 41:34 – Industry Trends and Onshoring 44:18 – Entry-Level Opportunities and Recruitment About Kirk PetyoKirk Petyo is the Managing Partner at Talent Factory Medical and founder of Talent Factory Recruiting. He has spent his career recruiting top talent in highly regulated industries like aerospace, medical devices, biotech, and pharma. Known for his ability to bridge business needs with real human connections, Kirk helps companies grow stronger teams—and helps candidates navigate complex career decisions with clarity and purpose.About the Host Subhi Saadeh is a Quality Professional and host of Let's ComBinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

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.

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

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi 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.

Ever wondered who's really behind the regulations you follow in pharma and medical devices? In this episode of Let's ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when you're reviewing SOPs, guidance docs, and regulatory submissions.00:00 – Intro01:23 – Regulatory Bodies04:03 – Harmonization Organizations10:01 – Standards Organizations12:07 – Pharmacopoeias13:59 – Industry Groups16:11 – Wrap-up and TakeawaysSubhi 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—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi outlines what separates good auditors from great ones, shares lessons from his own audit experiences, and breaks down how AI might streamline parts of the audit process. But he makes a clear case: while AI can assist, it can't replace the critical thinking, real-time risk judgment, and systems awareness that human auditors bring. The episode wraps with practical advice on how to embrace AI as a tool—without losing the edge that only people have.00:00 Introduction to Auditing and Certification00:43 My Auditing Journey and Experience02:40 The Importance of Technique in Auditing03:26 Real-World Auditing Insights04:59 The Value of Certification07:16 Key Qualities of a Great Auditor10:48 The Role of AI in Auditing12:18 Why AI Won't Replace Human Auditors15:26 Conclusion and Future OutlookSubhi 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's the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let's Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the space in between, this episode will help you:-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)-See how each system addresses user needs, therapeutic effects, and process control-Apply both systems effectively in combination product developmentTimestamps:00:00 – Intro: Why Compare QbD and Design Controls?01:31 – Philosophical Differences: Process vs. Product Control03:10 – Practical Examples: Drugs vs. Devices05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)15:39 – Final Takeaways: How to Use Both in Combination ProductsSubhi 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.------------------------ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction and Purpose of the Episode00:36 Tip 1: Start Publishing Early04:26 Tip 2: Learn How Industry Really Works06:14 Tip 3: Build Skills Across Disciplines09:00 Tip 4: Find Mentors and Network12:08 Conclusion and RecapSubhi 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.

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.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 welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace.The discussion explores Skip's career transition from Eastman Kodak to the medical device sector, the importance of structured program management, phase gate processes, and the balance between going fast and ensuring thorough planning.Skip also delves into the differences between simple and complex projects and the necessity of having tailored project management templates for various project scales.The episode concludes with insights into how to manage risks effectively through tools like project and portfolio FMEAs, and the importance of data-driven decision-making in project execution.Timestamps:00:00 – Introduction and Guest Welcome00:19 – Skip's Background and Experience01:10 – Transition to Medical Devices and Pharma03:35 – Program and Project Management Insights06:03 – Phases and Gates in Product Development08:59 – Challenges and Strategies in Project Management10:51 – Examples of Project Management in Action13:28 – Importance of Planning and Risk Management18:10 – Templates and Tools for Effective Project Management29:49 – Final Thoughts and Contact InformationAbout the Host:Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.For questions, inquiries, or suggestions, please visit letscombinate.com or connect on the show's LinkedIn page.

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GDP (Good Distribution Practice), explaining their roles, regulations, and importance in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals. He discusses how these frameworks integrate to form a comprehensive approach that governs the lifecycle of medical products from preclinical research to post-market surveillance. Additionally, Subhi delves into GAMP (Good Automated Manufacturing Practice) and GVP (Good Pharmacovigilance Practice), emphasizing their significance in maintaining data integrity and patient safety. This extended episode aims to provide early professionals with a robust understanding of these critical regulatory standards and their real-world applications in industry.00:00 Introduction to GXP02:22 Understanding GMP: Good Manufacturing Practice09:21 Exploring GLP: Good Laboratory Practices17:57 Diving into GCP: Good Clinical Practices24:00 Ensuring Quality with GDP: Good Distribution Practices29:32 Overview of GVP and GAMP33:48 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, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer mentors. He provides practical advice on lowering your expectations, focusing on value and repetition, being mentor-able, and leveraging non-traditional forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources.00:00 Introduction: The Power of Mentorship02:06 Lesson 1: Different Types of Mentors05:04 Lesson 2: Lower Your Bar for Mentors07:51 Lesson 3: Focus on Value and Repetition09:37 Lesson 4: Be Mentor-able11:37 Lesson 5: Look Sideways, Not Just Up12:58 Lesson 6: Don't Wait for a Formal Title15:01 Lesson 7: Mentors Can Be Dead16:41 Conclusion: Recap 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.

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. 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, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The episode emphasizes that while all employees play a role in quality, true ownership lies with top management. Subhi also highlights regulatory frameworks like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire consequences of poor quality management. The episode concludes with a call to shift the mindset from 'everyone owns quality' to 'leadership owns quality.' 00:00 Introduction to Quality Ownership04:10 Regulatory Frameworks and Quality Management05:14 The Flaws in 'Everyone Owns Quality'06:45 Case Study: Ranbaxy Laboratories08:49 The Importance of a Strong Quality CulturePrevious Episodes:Joanna Gallant: https://www.letscombinate.com/076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant/Katherine Eban: https://www.letscombinate.com/115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pros-with-nyt-be/Links: ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdfISO13485: https://www.iso.org/standard/59752.html21CFR820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B/section-820.20BBC Article: https://www.bbc.com/news/world-asia-india-22520953Bottle of Lies: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781Subhi 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.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.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 and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.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.

Today Ashley sits down with Kyle Quinn, the ExxonMobil IT Leader for Supply Chain, Commercial, Manufacturing Operations and Trading. In this role, he is accountable for end-to-end digital solution delivery across ExxonMobil's global footprint. He has worked at ExxonMobil for 24 years with prior roles including IT Strategy and Upstream Operations IT. Kyle has a Bachelors of Computer Science from the University of Manitoba and an MBA from the University of Calgary.

Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry's response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends. 00:00 Introduction to GLP Receptor Agonists 00:46 Guest Introduction: Ben Locwin 01:48 Historical Context of GLP-1 Development 05:54 Mechanisms and Effects of GLP-1 09:51 Market Impact and Manufacturing Challenges 11:16 Regulatory and Advertising Considerations 17:44 Sustainability and Injector Pen Issues 19:40 Risk Management and Future Directions 23:31 Conclusion Ben 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 Let's Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3 Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelly also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements. 00:00 Welcome to Let's Combinate 00:13 Pioneering in Reproductive Health 00:42 Early Challenges and Opportunities 02:10 Breaking Barriers in IVF 04:52 Career Reflections and Lessons 06:40 Conference Planning Insights 13:37 Overcoming Shyness and Networking 19:11 Retirement and Career Advice 26:21 Innovations in Women's Health 30:26 Future Technologies and Closing Thoughts Shelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women's health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field. 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 Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA's review processes, the importance of validation, and the practical application of AI in regulatory work. 00:00 Welcome and Introduction 00:07 Meet Doug Mead: Regulatory Expert 00:58 Understanding the Drugs at FDA Database 01:25 Navigating Review Memos and Regulatory Strategies 04:18 Challenges and Limitations of the FDA Database 07:23 Advanced Search Techniques and AI Integration 10:58 Developing a Specialized AI Search Tool 14:57 Practical Applications and Client Benefits 33:22 Conclusion and Contact Information Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments. www.cppathways.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. Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI

In this episode of Made in America, we're joined by Mike Calorossi, VP of Manufacturing Operations at MannKind Corporation, to discuss the transformative power of pharmaceutical manufacturing. From recognizing the value of diverse teams to always staying a step ahead in operations, Mike shares lessons that have shaped his leadership philosophy and career success. Tune in to hear why staying proactive and playing to your team's strengths is a “superpower” in today's fast-paced manufacturing world.

In this special edition of Diabetes Core Update, host Neil Skolnik, MD, explores the timely and critical topic of compounded medications in diabetes care. Dr. Skolnik is joined by John Hertig, PharmD, MS, CPPS, Associate Professor at the Butler University College of Pharmacy and Health Sciences, and Ed Hernandez, Executive Vice President and President of Manufacturing Operations at Eli Lilly & Company. Together, they discuss the role of compounded medications, the benefits and risks associated with their use, and the importance of ensuring quality and safety standards in the compounding process. This episode offers valuable insights for clinicians navigating the complexities of compounded therapies and provides practical considerations for patient care. This special edition of Diabetes Core Update is supported by Lilly. Presented by: Neil Skolnik, MD – Professor of Family and Community Medicine, Sidney Kimmel Medical College, Thomas Jefferson University; Associate Director, Family Medicine Residency Program, Abington–Jefferson Health John Hertig, PharmD, MS, CPPS – Associate Professor, Butler University College of Pharmacy and Health Sciences Ed Hernandez – Executive Vice President, Eli Lilly & Company; President of Manufacturing Operations at Lilly Selected References: Compounded GLP 1 and Dual GIP/GLP 1 Receptor Agonists: A Statement from the American Diabetes Association. Diabetes Care December 2, 2024;  dci240091 https://doi.org/10.2337/dci24-0091 PubMed: 39620926 FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.  US FDA Website ( current as of 12/18/2024)

In this episode, Liz Hutson, Principal Consultant and Owner of EGH, LLC, shares her expertise on successful manufacturing operations transitions. She explores key reasons for these changes, including acquisitions, redundancy, cost, and geopolitical instability, while emphasizing the importance of strategic planning, cross-functional team engagement, and effective communication for seamless execution.