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. 4D AGO

    237 - ICH Q10: The Pharmaceutical Quality System

    his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style standard. Instead, Q10 is designed to augment regional GMPs and provide a lifecycle model for managing pharmaceutical quality. Using the Annex 2 PQS diagram, Subhi walks through how Q10 applies across pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. The episode discusses phase-appropriate GMP expectations, why Q10 does not replace GMP, and how management responsibility spans the full lifecycle, including outsourced activities and purchased materials. The episode also covers the four core PQS elements: process performance and product quality monitoring, CAPA, change management, and management review. These elements are presented as operational loops that help maintain control and drive improvement. Subhi also highlights the two key enablers of the model: knowledge management, connected to ICH Q8, and quality risk management, connected to ICH Q9. The episode closes with Section 4 of Q10, which focuses on continual improvement of the PQS itself, including management review inputs, external changes, resourcing, documentation, and communication. 00:00 Welcome and Series Setup 00:14 Why ICH Q10 Matters 01:21 Lifecycle and Phase-Appropriate GMP 02:23 GMP Foundation and the PQS Model 02:58 Management Responsibility 03:31 Core PQS Elements 04:26 Enablers: Knowledge Management and QRM 04:40 Guideline Walkthrough: Sections 1 to 3 06:37 Continual Improvement of the PQS 07:45 Wrap Up and Next Episode Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

    8 min

  2. APR 29

    236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

    ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood. In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how it’s different from ISO 14971. We cover: What “risk” means in ICH Q9 (probability × severity) The full QRM process (initiation → assessment → control → communication → review) How to actually think through risk (not just document it) Why supply disruption is a patient risk Key differences vs ISO 14971 (planning, traceability, verification) If you work in pharma, devices, or combination products, this is foundational. TIMESTAMPS 00:00 Welcome to ICH Q9 00:48 What is Risk in ICH Q9 01:44 Scope and Core Principles 03:21 Initiating QRM 05:09 Risk Assessment (Hazards, Likelihood, Severity) 07:27 Risk Control (Reduction and Acceptance) 08:46 Risk Communication and Review 10:04 ICH Q9 vs ISO 14971 11:51 Wrap Up ICH Q9(R1) Final Guideline: https://database.ich.org/sites/default/files/ICH_Q9-R1_Guideline_Step4_2023_0118.pdf ICH Q9 Briefing Pack: https://ich.org/page/q9r1-briefing-pack Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

    12 min

  3. APR 22

    235 - ICH Q8: How Pharmaceutical Development Actually Works

    This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice. ICH Q8 defines the suggested contents for CTD Section 3.2.P.2 and aims to harmonize how pharmaceutical development is presented in regulatory submissions. It primarily applies to drug product development and later-stage submissions, where a full understanding of the product and process is expected. The guideline is structured in three parts: the core sections, which outline development elements such as formulation, manufacturing, and container closure; the annexes, which introduce key Quality by Design concepts including QTPP, CQAs, risk assessment, design space, and control strategy; and a final section that explains how this information is organized across the CTD. The episode walks through the relationship between TPP and QTPP, defines critical quality attributes, explains how design space is established through prior knowledge, risk assessment, and experimental work such as design of experiments, and outlines how a control strategy is built across materials, process controls, monitoring, and testing. High Level QBD(4 min): https://www.youtube.com/watch?v=orlPpfQvb5k QBD vs. Design Controls: https://www.youtube.com/watch?v=W_LSD0kKQ34 00:00 Introduction to ICH Q8 00:42 Related QbD Videos 01:12 Structure of ICH Q8 02:28 Objective and Scope 04:49 Annexes and QbD Concepts 05:20 Quality Target Product Profile 06:33 Critical Quality Attributes 07:09 Design Space and DoE 09:17 Control Strategy 10:06 Submission and Wrap-Up Subhi Saadeh is the Founder and Principal at Let’s ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. A consultant, auditor, and trainer, Subhi has worked across companies including Baxter, Pfizer, and Gilead, supporting the development, manufacturing, and launch of medical devices and combination products for vaccines, generics, and biologics.

    11 min

  4. APR 15

    234 - ICH Q7: The GMP Framework for API Manufacturing

    In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters in practice. Covers: • Scope and where GMP begins • API starting material (core concept) • GMP scaling across the process (Table 1) • Quality unit and QMS expectations • Production and in-process controls • Validation and change control • CMOs and supply chain • Clinical trial flexibility (Section 19) Timestamps 00:00 Intro 00:13 What Q7 Covers 01:23 Scope and GMP Start 02:19 API Starting Material 04:05 GMP Scaling (Table 1) 05:30 Quality and QMS 06:58 Production Controls 08:26 Validation 09:46 Change Control 10:27 CMOs / Supply Chain 12:11 Clinical 13:12 Takeaways https://database.ich.org/sites/default/files/Q7%20Guideline.pdf Subhi Saadeh is the Founder and Principal at Let’s ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.

    14 min

  5. APR 8

    233 - Most Teams Misunderstand Specifications | ICH Q6

    ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1) In this episode of Let’s ComBinate, Subhi continues the ICH Q-series with ICH Q6 and explains why specifications are central to defining and controlling drug products and drug-device combination products. He breaks down how ICH Q6 formalizes: • what to test (attributes or CQAs tied to safety and efficacy) • how to test (methods and procedures) • what is acceptable (acceptance criteria or limits) All of which come together to support the release decision. He also covers the difference between ICH Q6A (small molecules) and ICH Q6B (biologics), highlighting the increased variability in biologics and the greater reliance on characterization and process understanding. Finally, he summarizes key themes from the 2024 ICH Q6(R1) concept paper, including: • alignment of shared principles across Q6A and Q6B • expanded scope to include new modalities and combination products • linkage to ICH Q12 lifecycle management and established conditions • a shift toward more science and risk based approaches with less reliance on routine batch testing ⸻ Key References • ICH Q6 Guidelines (Q6A and Q6B): https://www.ich.org/page/quality-guidelines • ICH Q6(R1) Concept Paper (2024): https://www.ich.org/page/quality-guidelines (navigate to Q6 revision concept paper) ⸻ Timestamps 00:00 Intro to ICH Q6 00:36 Host background 01:05 Why specifications matter 01:49 Q6A vs Q6B overview 02:33 Purpose of ICH Q6 02:59 What is a specification 04:27 Q6 R1 update themes 05:49 Lifecycle and risk based specifications 06:29 Wrap up and next steps Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains.

    7 min

  6. APR 1

    232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

    Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we’ve always used this” or rely on a molder’s preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk. Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle. The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation. ⏱️ Timestamps 00:00 Welcome and Guest Intro 00:43 Why Materials Drive Cost 02:17 Common Selection Pitfalls 03:35 Data-Driven Framework 06:10 Early Choices Prevent Rework 09:17 Processing Methods Overview 10:23 Polymer Categories Explained 12:58 Regulatory Risks and PFAS 19:26 GRAS and Prop 65 Basics 23:21 Biocompatibility Early Screening 28:55 ISO 10993 Updates 30:36 What Toxicologists Do 33:41 Where to Find Lucas 34:07 Closing Lucas Pianegonda Website: https://www.gradical.ch/ Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/ Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQ ISO 10993 Overview: https://www.iso.org/standard/68936.html California Prop 65: https://www.p65warnings.ca.gov/ GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-gras Lucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

    34 min

  7. MAR 25

    231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

    This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings. Access the full CQA course here: https://cqeacademy.teachable.com/p/the-cqa-master-class-course I break down key terms like finding, nonconformity, observation, and noncompliance, and explains that everything must tie back to requirements and objective evidence. The episode covers when to write a nonconformity vs an observation, common severity levels (critical, major, minor), and how to structure clear findings. I also cover how to sequence audit results and where auditors often go wrong, especially when they insert opinion or recommend solutions. Timestamps 00:00 Course preview 00:42 Key audit terms 01:56 What makes findings reportable 04:16 Severity classification 06:42 Writing findings 07:57 Structuring reports 10:38 Auditor boundaries Subhi Saadeh is a certified ISO 13485 Lead Auditor, CQE, and CQA with experience leading audits and building quality systems across medical devices and combination products at companies like Baxter, Pfizer, and Gilead Sciences. Through Let’s ComBinate, he focuses on bridging the gap between pharma and devices through educational content, industry collaboration, and consulting.

    12 min

  8. MAR 23

    230 - How Pharma Misses Critical Market Signals with Joe Luminiello

    In this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why most companies get it wrong. Joe introduces a practical framework built on three pillars: data (scientific publications and congresses), signal intelligence (press releases and filings), and human intelligence, which provides the context needed to interpret what those signals actually mean. While data and AI tools are becoming more accessible, Joe explains why interpretation and real-world insight remain the true differentiators in strategic decision-making. The conversation covers real-world applications across pharma strategy, including evaluating low-cost API suppliers, make-versus-buy decisions, competitor assessments, and forecasting. Subhi and Joe also discuss how cultural incentives and assumptions often shape forecasts more than data, and why even well-built models can miss significantly. Timestamps 00:00 Introduction 00:51 What is competitive intelligence 02:57 Human intelligence in practice 05:37 How insights are sourced 07:59 Validating and triangulating data 12:37 Forecasting and key assumptions 18:01 Common client blind spots 20:31 Speed of change in pharma 23:56 Why context matters more than raw data 27:27 Tools, congress strategy, and wrap-up Links RCG Intel: https://rcgintel.com/ Joseph Luminiello on LinkedIn: https://www.linkedin.com/in/joeluminiello/ Joseph Luminiello is the CEO and Co-Founder of RCG Intel, a boutique competitive intelligence consultancy serving the pharmaceutical and biotech sector. With more than 40 years of experience across healthcare, biopharma, and strategic intelligence, Joe has built his career around what he calls prescience, the ability to synthesize disparate data points and anticipate how they will shape the future. Before launching RCG Intel, Joe served as CEO of multiple biopharma companies, including AVM Biotechnology and Third Coast Therapeutics, where he raised capital and advanced drug development programs. As Founder and CEO of SmartHealth Catalyzer, he built a 150-member senior executive operations team and sourced over 130 intellectual property projects from Midwest universities. Earlier in his career, he spent six years at Takeda Pharmaceuticals, where he rose to Vice President of Business Development, contributed to diligence for Takeda’s acquisition of Nycomed, and helped launch Takeda Canada as its second employee. Subhi Saadeh is the Founder and Principal at Let’s ComBinate BioWorks. He is a Certified Quality Auditor and ISO 13485 Certified Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences. Subhi has extensive experience across drug-device combination products, including supplier quality, development quality, design controls, purchasing controls, audits, and management of contract manufacturers and external partners. Through Let’s Combinate, he is focused on bridging the gap between pharma and devices by creating educational content, participating in industry groups, and providing consulting support to align development, quality, and regulatory expectations.

    31 min
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Ratings & Reviews

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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