Let's Combinate - Drugs + Devices with Subhi Saadeh

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380).

In this episode, Etienne and I discuss:

02:50 The Start of the Combinate Podcast

06:00 Efficiency and Tools in Podcast Production

08:40 Understanding Combination Products

09:43 Regulatory Frameworks and Definitions

13:46 Challenges and Misconceptions in the Industry

20:47 Evolution of Regulations: QMSR and Part 4

22:05 Exploring Unique Podcast Episodes

25:56 The Pyramid of Regulations

30:40 The Role of Coaching and Mentorship

32:59 Trends in Combination Products

35:23 Recommended Books and Final Thoughts

37:04 Encouragement for Lifelong Learning

Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. 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.

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses:

00:00 Introduction

02:29 Understanding the FDA's New Guidance:

05:05 Challenges in Supplier Management and the

08:22 Navigating Change Management

11:43 Insights on Regulatory Compliance

25:26 The Importance of Dimensional Tolerances

32:56 Closing Thoughts

Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products.

Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018.

Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses:

Maysaa Attar is the Senior Vice President of R&D at Bausch & Lomb, leading global pharmaceutical and consumer product research and development. She has held prominent leadership positions at Abbvie and Allergan and holds a PhD in Pharmaceutical Sciences from the University of Southern California (USC), where she also serves as a professor.

On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses:

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠⁠here⁠⁠ or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. Leo highlights the challenges and strategies for documenting standards assessments and emphasizes the importance of leveraging existing standards to avoid unnecessary development. The episode also covers tips for small and large companies, the significance of early research, and the essential stakeholders involved in standards assessment.

Chapters:

00:00 Introduction to the Combinate Podcast

01:03 Guest Introduction: Leo Eisner

01:19 Understanding Standards Applicability

07:45 Documenting Standards Assessments

12:03 Challenges and Best Practices

20:56 Final Thoughts and Contact Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:

Website: https://eisnersafety.com/

Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of

page (1/2 way down)

LinkedIn: linkedin.com/in/leoeisnersafetyconsultants

Contact Us: https://eisnersafety.com/contact_eisner_safety/

Schedule a call: https://eisnersafety.com/schedule-call/

On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through:

David Grosse-Wentrup PhD is a Research Director at Design Science, a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in biomedical engineering and postgraduate research at the University of Muenster, Germany, as well as work for the Centre for Global eHealth Innovation (Toronto) and GE Healthcare (Wuxi, China), he joined Design Science’s U.S. office in 2016. At Design Science, David supports clients in developing and approving medical devices and combination products for the U.S and E.U. markets. He currently is leading efforts to open Design Science’s first European office in Munich, Germany. He completed his PhD at the University of Münster in 2024.

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc.

David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of various drugs on the process, types of stoppers, and differences between lyophilized and liquid-filled vials. David shares insights on the technical aspects, including pressure, temperature, and time management, as well as equipment considerations and challenges in the lyophilization cycle.

David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠here⁠ or at [email protected]

**About David Simoens:**

David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector.

**Key Specializations:**

- Aseptic Fill/Finish including Lyophilization

- New Product Introductions

- Cytotoxic and High Potency Environments

- Integrated Commissioning, Qualification, Validation

- Radiopharmaceuticals

- Business growth and optimization

- Enterprise Quality Management Systems

- Career coaching

**Contact Information:**

For all business inquiries, please reach out to David and his team at [email protected]. For information requests, email them at [email protected]. Feel free to connect and message him on LinkedIn.

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses:

01:18 Understanding Regulatory Policy

03:18 Ryan's Career Journey

05:08 Challenges in Regulatory Harmonization

06:54 Legislative Frameworks and Regulatory Differences Globally

11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act)

15:51 International Harmonization Efforts

22:36 Combination Products and Policy Work

30:10 The Importance of Advocacy and Education

35:22 Closing Thoughts and Personal Insights

Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing

Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor’s degree in Bioengineering from the University of California, Berkeley, his doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.

On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry.

Industry Comments are DUE 9/29/2024.