Let's Combinate - Drugs + Devices

Subhi Saadeh
  • 5.0 (3)
  • LIFE SCIENCES

Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

  1. 5D AGO

    224 - ICH Q2 Explained: What Analytical Validation Really Requires

    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.

    11 min

  2. JAN 21

    223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations

    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.

    10 min

  3. JAN 14

    222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series

    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.

    12 min

  4. JAN 7

    221 - What Is ICH and Why It Matters

    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.

    15 min

  5. 12/31/2025

    220 - Managing Oneself, Reflections and a New Series on ICH

    🚀 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.

    8 min

  6. 12/24/2025

    219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

    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.

    26 min

  7. 12/17/2025

    218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)

    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.

    9 min

  8. 12/10/2025

    217 - 5 Fixable Problems Holding Back Drug–Device Programs

    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.

    18 min
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5
out of 5
3 Ratings

About

Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

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