Let's Combinate - Drugs + Devices

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.

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

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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)

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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.

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.

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.

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.