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In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products. Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E. This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle. ⸻ Timestamps 00:00 Welcome to Let’s ComBinate 00:12 Introduction to ICH Q3 00:25 What Are Impurities and Why They Matter 00:51 Sources of Impurities and Risk-Based Control 02:11 Structure of ICH Q3 (Q3A–Q3E) 05:30 How to Read and Use ICH Q3 07:22 Q3E, Extractables & Leachables, and Drug Delivery Systems 09:21 Wrap-Up and Next Episode Preview Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products. Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products. Timestamps 00:00 Introduction to Let’s ComBinate 00:42 Purpose and importance of ICH Q2 03:11 Scope and product coverage 06:10 Key validation characteristics 08:15 Practical application and reading ICH Q2 10:23 Conclusion and next steps Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same. ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made. The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage. This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence. Timestamps 00:00 Introduction 00:36 What ICH Q1 Is and Why It Exists 02:59 Core Stability Concepts in ICH Q1 04:51 What’s Changing in the 2025 Draft 05:35 How to Read ICH Q1 07:16 ICH Q1 and Drug-Device Combination Products 09:09 Closing and What’s Next 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 continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products. Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management. Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail. In this episode, you will learn What an ICH guideline is and how it differs from regulations and standards Why guidelines still matter during inspections and enforcement How ICH organizes its guidance into Q, S, E, and M categories A high-level overview of the Quality Guidelines (Q1 through Q14), including: Stability (Q1) Analytical validation and development (Q2 and Q14) Impurities (Q3) Quality by Design and risk management (Q8 and Q9) Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12) Continuous manufacturing (Q13) How different functional teams interact with different parts of the ICH framework The next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability. Timestamps 00:00 Introduction to the Series 00:48 Overview of ICH Guidelines 01:36 What an ICH Guideline Is and Is Not 03:04 The Four ICH Guideline Categories 04:08 Quality Guidelines Overview 08:46 Safety Guidelines Overview 09:28 Efficacy Guidelines Overview 10:33 Multidisciplinary Guidelines Overview 11:28 Wrap-Up and Next Steps 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, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let’s Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What’s NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com 🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this end of year episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh reflects on the past year through the lens of Managing Oneself by Peter Drucker. Using the book’s core questions around strengths, values, learning style, performance, and contribution, Subhi shares how his thinking has evolved and how those ideas continue to shape his approach to work and learning. The episode explores the idea of learning by teaching and why podcasting has become an important way for Subhi to deepen his own understanding of complex topics. He also shares a brief life and professional update, including the launch of Let’s ComBinate BioWorks and a shift in focus toward work that bridges the drug and device worlds. The conversation closes with reflections on Drucker’s ideas about the second half of a career and introduces a new upcoming podcast series focused on ICH guidelines. Subhi outlines how the series will take a high level, practical approach to ICH, emphasizing how to read and engage with the guidance rather than treating it as a checklist. Episode Timeline 00:00 Introduction and episode overview 00:31 Introducing the upcoming ICH series 01:36 Reflections on Managing Oneself 03:27 Life and professional updates 06:59 Thinking about the second half of a career 08:19 Closing thoughts 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 is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation. They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA’s PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry. What you’ll learn -The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs) -How inspection outcomes can lead to CRLs—even when the application looks strong on paper -Why industry is talking about decoupling approval from PAI timing -The idea behind FDA PreCheck and what “facility readiness” looks like -Unannounced inspections: where they help, where they create risk -How inspection expectations compare across global regulators Chapters 00:00 Introduction and Guest Welcome 00:10 Understanding Pre-Approval and Pre-License Inspections 01:54 Challenges and Industry Perspectives 03:08 FDA Complete Response Letters (CRLs) 05:23 Unannounced Inspections: Pros and Cons 08:55 Economic and Regulatory Considerations 12:37 Onshoring and the PreCheck Program 22:51 Global Regulatory Landscape 25:11 Conclusion and Farewell 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 short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and covers the essentials quality teams care about: RTD/traceability, control strategy, and disturbances/diversion plus a quick high-level note on validation, release, and lifecycle. Timestamps 00:00 Intro 01:00 Batch vs. continuous (and batch definition) 03:00 Modes of continuous manufacturing (ICH Q13 examples) 04:30 RTD & traceability 06:00 Control strategy 07:30 Disturbances & diversion 09:00 Validation / release / lifecycle (high level) 10:00 Wrap-up Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. 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 addresses five significant quality issues in the combination product space. This episode provides practical insights and strategies for overcoming these common hurdles to enhance quality and efficiency in developing combination products. 00:00 Introduction and Host Background 00:43 Overview of Development Processes 01:51 Issue 1: Documentation Approach in Design Transfer 04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs 07:26 Issue 3: Control Strategies and Sampling Plans 10:23 Issue 4: Method Transfer and Control Planning 12:02 Issue 5: Qualification of Supplied Components 14:47 Issue 6: Monitoring Expectations in Combination Products 16:55 Conclusion and Summary Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. 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 Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. They discuss: - The hidden costs of regulatory failure and how to avoid them - Why early engagement with regulatory agencies is critical - Global regulatory models, including emerging markets like China and the UAE - A clear explanation of UDI and serialization - How regulatory impacts extend beyond compliance teams - The role of LinkedIn and storytelling in regulatory careers - Steven’s experience running for the European Parliament and what it taught him about policy Timestamps 00:00 – Introduction and Guest Welcome 00:38 – The Hidden Costs of Regulatory Failure 03:47 – Engaging with Regulators Early 05:26 – Global Regulatory Models and Emerging Markets 10:07 – Understanding UDI and Serialization 15:16 – The Power of LinkedIn and Personal Stories 17:11 – Running for European Parliament and Policy Insights 21:18 – Conclusion and Contact Information Connect with Steven O’Rourke Website: https://clarifi.fi LinkedIn: https://linkedin.com/in/sorourkde Subscribe to Let’s Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy. Stephen O’Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don’t more technical people lead audits?” This episode explores the gap between technical expertise and true audit competency. Subhi explains how engineers who combine their technical background with audit training often become the most effective auditors. They gain a system-level perspective, understand how design decisions ripple through the QMS, and can identify systemic root causes that others overlook. He also clears up common misconceptions about auditing, including the idea that it’s just paperwork or checklist work, and reframes it as one of the fastest ways to build regulatory fluency, strengthen quality systems understanding, and expand career versatility across industries. The episode closes with practical steps for how engineers can get started: shadowing internal audits, learning audit frameworks and methodologies, taking formal training, and seeking mentorship from experienced auditors. Timestamps: 00:00 – Why Engineers Should Consider Auditing 01:10 – How Auditing Expands Technical Perspective 05:26 – Misconceptions & Why Engineers Avoid Auditing 11:25 – How to Start Your Audit Journey 13:27 – Final Thoughts: Seeing the System, Not Just the Spec Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and the host of Let’s Combinate: Drugs + Devices. With a background spanning Quality, Manufacturing Operations, and R&D, he has supported the development and launch of hardware devices, disposable systems, and drug–device combination products across vaccines, generics, and biologics at some of the industry’s largest medical device and pharma organizations. Subhi currently serves as the Working Group Chair for the Rx-360 Combination Products Working Group and previously served as the International Working Group Chair for the Combination Products Coalition (CPC). He has also contributed to ASTM Committee E55 and AAMI’s Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development. 00:00 Welcome and Introduction 00:48 The Impact of CQE Certification 02:23 Applying DOE in Quality Engineering 05:42 Top ASQ Certifications 13:35 Non-ASQ Certifications and Leadership 15:55 Cross-Industry Learnings 18:45 Conclusion and Contact Information Andy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy’s work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year? In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars. They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases. This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention. Topics include: -How to select the right generic molecules beyond patent expiry -Early success with isoproterenol and API sourcing -Why Nexus turned down acquisition offers -Building a commercial salesforce from scratch -Designing a facility with high speed prefilled syringe and lyo capacity -Why most other sterile sites failed -The billion dollar sale to Lilly -Launching Quetzal and developing oral arsenic for APL -The brain-eating amoeba drug and ultra rare disease strategy -Faith, confidence, and decision making under pressure Timestamps: 00:00 Introduction and Guest Welcome 00:24 From Wall Street Finance to Pharma 01:42 How Usman Selected Winning Generics 02:58 Early Challenges Building a Generics Company 05:29 Family R&D Expertise and Business Dynamics 11:44 First Generic Launch and Commercial Impact 16:28 Building Sterile Injectable Manufacturing Capacity 18:16 Sterile Facility and Equipment Strategy 22:40 Prefilled Syringe and Vial Line Capabilities 23:07 Big Pharma Interest and Selling the Facility 26:02 Nexus Pharma Services and the Lilly Deal 27:23 Post‑Sale Reflections and New Ventures 28:30 Launching Quetzal Therapeutics and Rare Disease Focus 33:30 New Challenges and Confidence in Drug Development 39:55 Importance of People, Teams, and Relationships 41:40 Books That Shaped Usman’s Thinking 42:29 Where to Connect with Usman Learn more: https://quetzaltx.com Connect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928 More episodes: https://letscombinate.com Usman 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. ⏱ Timestamps 00:00 – Welcome & Introduction 00:52 – Integrating GLP, GCP & GMP 02:22 – Challenges in Developing Combination Products 04:02 – Device-Led Combination Products 07:35 – Working with Rare Diseases 09:58 – GMP & Process Validation 15:08 – Clinical Trials: Drug vs Device 19:22 – Cost of Quality & Six Sigma 25:12 – Conclusion & Contact Information Leonel 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. 📩 Connect with Leonel: [email protected] Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh welcomes 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 Welcome 00:35 Historical Background of Combination Products 03:05 Creation of Office of Combination Products (OCP) 04:29 Early Challenges and Developments 04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact 14:24 Defining Primary Mode of Action (PMOA) 18:35 OCP’s Role & Responsibilities 26:49 Industry Adoption & Challenges 38:48 Regulatory Gaps & Future Directions 46:00 Conclusion & Contact Information Contact & Resources: Connect with Mark Kramer on LinkedIn or via email at [email protected] Mark 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.