Let's Combinate - Drugs + Devices with Subhi Saadeh

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 [email protected]

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let’s Combinate, 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.