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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: leonel@precisionregulatory.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: 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 Mark.Kramer@greenleafhealth.com
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.
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!
Timestamps
00:00 Introduction and Background
01:07 Overview of Industry Roles
02:43 Quality Assurance
06:14 Regulatory Affairs
08:22 Research & Development
09:46 Clinical Affairs
11:07 Manufacturing & Operations
12:09 Quality Control / Analytical Testing
14:05 Supply Chain & Procurement
15:13 Validation & Technical Services
16:39 Career Path Insights and Conclusion
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.
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 optimization
Continuous manufacturing and how yield can signal process performance
Chapters
00:00 Introduction to AI in Pharma
00:40 Current Applications of AI in GMP
02:32 Challenges and Validation in AI
03:22 Process Analytical Technology (PAT)
09:50 Design of Experiments (DOE) in Pharma
13:27 Continuous Manufacturing Explained
15:40 Yield Calculation in Manufacturing
22:12 Conclusion and Contact Information
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, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way.
We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tips for newcomers.
Key topics include:
• Encouraging diverse perspectives to combat group think
• Why data integrity is broader than CSV
• The pyramid structure: data integrity at the top, CSV & validation as elements
• ALCOA++ and traceability in real-world systems
• Practical CSV and validation workflows
• Common audit pitfalls and how to strengthen governance
⏱ Timestamps
00:00 – Intro: Group Think & Risk Appetite
00:41 – Data Integrity in Consulting
01:41 – Encouraging Diverse Perspectives
02:37 – CSV vs Data Integrity
03:13 – The Role of Data Stewards
03:54 – The Pyramid: Data Integrity, CSV & Validation
04:45 – ALCOA++ and Core Data Integrity Elements
13:59 – Real Examples: CSV & Validation Workflows
17:40 – Common Audit Pitfalls & Data Governance
22:50 – Advice for Newcomers + Wrap-Up
Monika is the Principal at Dunamis Compliance. She has over a decade of experience in formulating and executing strategies for data integrity and data governance assessments and remediation, risk management and computerized system validation within the pharmaceutical sector. She has worked within Quality, Technical Operations, Automation and Regulatory Affairs to execute and deliver compliant system solutions in regulated GXP environments.
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 Chemistry
00:37 Drug Discovery Approaches
02:01 Computational Methods in Medicinal Chemistry
03:21 Challenges in ALS Drug Discovery
04:23 Blood-Brain Barrier and Drug Design
05:29 Key Properties for CNS Drug Design
08:58 Day-to-Day in Drug Discovery
09:45 Early Stage Drug Development
12:28 Validating Drug Targets
16:15 From Theory to Animal Testing
22:46 Funding and Timeline Considerations
25:45 Regulatory and Manufacturing Considerations
28:32 Conclusion and Contact Information
Dr. 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.
Chapters
00:00 – What is Five Nines Reliability?
Intro to 99.999% and why it matters for medical devices.
00:33 – FDA Guidance & Common Misconceptions
2020 draft guidance, sample size myths, and industry confusion.
01:17 – How to Demonstrate Reliability
Feasibility, practical approaches, and FDA expectations.
02:31 – High-Stakes Use Cases
Epinephrine, naloxone, glucagon injectors.
04:00 – Fault Tree Analysis Explained
Breaking down failures and linking to design/manufacturing.
05:25 – Why FDA Chose Five Nines
Balancing feasibility, safety, and ISO 14971 influences.
09:02 – Verification vs. Reliability
Design verification testing vs. true reliability demonstration.
23:16 – Key Takeaways for Industry
Closing 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 beyond
If 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 Chapters
00:00 Introduction: Regulating AI in Pharma/MedTech
01:01 Pharma’s Unique Risk Profile
02:14 AI in Regulatory Affairs
03:44 Combinatorial Problem Sets in Pharma
04:24 ICH Guidelines and AI Regulation
08:22 Process Validation in AI
10:20 AI in Regulatory Submissions
15:54 Ensuring Accuracy and Consistency
17:02 Regulatory Agencies and AI
18:28 Accelerating Drug Approval with AI
21:36 Time Savings in Dossier Formation
25:44 AI in Quality Control for Biologics
27:42 Challenges in AI Integration
29:25 The Future of Pharma & MedTech with AI
30:40 Where to Find Dominick Romano
Dominick 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.
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 Chapters
00:00 Introduction and Welcome
00:25 The Lexicon Problem in Drug-Device Combination Products
01:01 Historical Efforts and Challenges
02:12 Regulatory Frameworks and Definitions
04:47 Industry and Regulatory Alignment Issues
06:55 Science and Risk-Based Perspectives
10:08 Terminology and Definitions in Practice
14:05 Global Regulatory Differences
17:22 Challenges in Harmonizing Standards
23:13 Key Terms and Their Impact
32:23 Conclusion and Contact Information
Susan 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 Welcome
02:00 – Building Lilly’s device organization and launching insulin pens
06:00 – Early “wild west” days of drug delivery vs. today’s structure
07:00 – Intellectual property as a competitive weapon
10:30 – How Lilly, Novo, and Sanofi shaped the IP landscape
13:00 – Device differentiation in the generic space
17:00 – Portfolio vs. molecule decisions in platform strategy
20:00 – Three reasons to develop your own platform
23:00 – Supply chain risk and geopolitical considerations
26:00 – Black Swan risks and lessons for pharma companies
28:00 – Strategic suppliers vs. transactional vendors
33:00 – Drug-device integration inside companies
37:00 – Building organizational capability and governance
38:00 – Future trends: large volume autoinjectors and connected devices
43:00 – Impact of tariffs and supply chain positioning
45:00 – Where to find Jim Collins
Guest 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 Introduction
00:49 Discussing Risk Assessments in Med Tech
04:34 Challenges in Aligning Risk Processes
09:44 Understanding P1 and P2 in Risk Management
12:55 Joey's Career Journey and Strategic Choices
24:12 Trends in Combination Product Design
31:48 Conclusion and Where to Find Joey
Joey Frechin is a technical program lead in the medical device and combination product development space.
https://www.linkedin.com/in/joey-frechin
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.