Let's Combinate - Drugs + Devices with Subhi Saadeh

By Subhi SaadehScience Life Sciences

Let's Combinate - Drugs + Devices with Subhi Saadeh episodes

July 12, 2023093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
Supplier Management for Combination Products

Drug & Device Analytical Testing

Considerations for Biologics

Connected/Digital Health

Changing Regulatory Landscape for Combination Products
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.
26 min
July 05, 2023 092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder
On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses:
• Distinguishing differences in framework between the Device QSR/QMS and Drug cGMP’s
• Learnings from Training FDA CDER and CBER on device requirements
• Lessons from being Head of QA at a manufacturing site and internal audit
• Teaching through AAMI and his YouTube channel: Quality Systems Explained
Aaron Snyder is a quality management systems expert and is currently VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products.
Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP’s topics on his YouTube channel: Quality Systems Explained.
42 min
June 28, 2023091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle
On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss:
Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation

Subhi's questions on each chapter

What she learned from authoring and coordinating of the book
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].
41 min
June 21, 2023 090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar
On This Episode, I was joined by Harsh Thakkar, CEO of Qualtivate. Harsh walks through:

- Automating Quality with No Code Tools
- Software Validation
- Infrastructure Software
- Out of the Box
- Configured Software
- Custom Software Systems

Harsh Thakkar is the CEO and founder of Qualtivate, a data-driven quality management consulting firm for life sciences. He is an industry veteran who has spent more than a decade in quality assurance and regulatory compliance roles with companies like Takeda, Biogen, Merck, Johnson & Johnson, and Bristol Myers Squibb. He is an American Society of Quality (ASQ) Certified Quality Auditor and Certified Manager of Quality/Organizational Excellence.

Show References:
McKinsey article: https://www.mckinsey.com/industries/life-sciences/our-insights/smart-quality-reimagining-the-way-quality-works
FDA CSA guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software
Naval Ravikant's book: https://www.navalmanack.com/

45 min
June 14, 2023 089 - Talking HealthTech Podcast, Consistency, Australian Innovation in HealthTech, Content, and Community with Peter Birch
On this episode, I was joined by Peter Birch, CEO and Host of Talking HealthTech. Peter walks through:
- Talking HealthTech Podcast with 350+ Episodes
- HealthTech Innovation in Australia
- Audience building
- Peter/TH's Creative Process for Podcasting (2/3/4 episodes per week)
Peter Birch is Founder and CEO of Talking HealthTech - a podcast and membership community to learn and connect about technology in healthcare. In addition, Pete is a director of the Medical Software Industry Association (MSIA) who are the voice of healthcare software vendors in Australia, and also director of MetaOptima Technology who are helping clinicians diagnose skin cancer using artificial intelligence. He is also on the NSW State Committee for the Australasia Institute of Digital Health, and is a NSW State Facilitator for the Australian Clinical Entrepreneurs Program (AUSCEP). He holds a Master of Business Administration (MBA), is a Certified Health Informatician (CHIA), and also a Certified Practicing Accountant (CPA).
34 min
June 07, 2023 088 - Production Part Approval Process(PPAP) with Subhi Saadeh
On this episode, I outline an introduction to one of my favorite APQP tools, Production Part Approval Process(PPAP):

- What is PPAP
- Inputs, Process, Triggers and Interactions
- PPAP Elements and Tools
- The difference between first article inspection(FAI) and Capability Studies
- Applications and Challenges in use

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.

For feedback on the show or suggestions please contact [email protected]
22 min
May 31, 2023 087 - From Crime Reporting to Regulatory Affairs and On/Off The Record with Ferdous Al-Faruque
On this I was joined by Ferdous Al-Faruque, Senior Editor at RAPS. Danny discusses:
• Landing in Medical Devices and Pharma Regulatory Affairs
• Rules of engagement
• On the record, Off the record, On Background
• Danny's Process in writing, editing and publishing
Ferdous Al-Faruque, known as Danny, is Senior Editor at RAPS and specializes in reporting on regulatory affairs, new medical device technologies such as mobile health, combination products, unique device identifiers, and issues surrounding interoperability and cyber security.
40 min
May 24, 2023 086 - Elastomers - Stopper and Plunger Manufacturing, Processing and USP 381/382 with ⁠Fran DeGrazio⁠
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions.

Fran and I discuss:
(0:00) Component Machinability
(3:47) Stopper/Plunger Coating vs Lamination
(13:22) Stopper/Plunger Manufacturing
(26:14) USP 381/382

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.
31 min
May 17, 2023085 - Digital Innovation, Proteomics, Core & Non-Core Innovation, Consulting after Academia, Democratizing Access and Clinical Trials with Jacob Laprote
On this episode I was joined by Jacob Laporte, Co-Founder of the Novartis Biome. Jacob discusses:
(1:56)Harvard PhD to Consulting in Innovation Management

(11:50)Core & Non-Core Innovation

(21:09)Digital Technologies in Pharma

(27:39)Democratizing Access and Clinical Trials

(32:35)Proteomics
Dr. Jacob LaPorte is an ex-Harvard chemist and ex-McKinsey consultant who is passionate about leading digital transformations to improve healthcare for patients. Jacob founded and led The BIOME by Novartis (aka Novartis Biome), the company’s first-ever, externally-branded innovation lab. Prior to joining Novartis, Jake founded Snapdragon Chemistry, a company focused on transforming chemical manufacturing using digital technologies and artificial intelligence.
37 min
May 10, 2023084 - Drug Discovery, Candidate Selection, Pre-Clinical Development, IND Submissions, Administration Route Selection, TPP and Toxicology with Marta New
On this episode, I was joined by Marta New, the CEO of Radyus Research. Dr. New discusses:
(0:00) Intro

(1:37) Pre-Clinical Planning

(7:15) What's the purpose of an IND?

(14:10) Administration Route Selection

(19:00) Candidate Selection and Animal Models

(30:10) Pre-IND Meeting

(44:00) IND Submissions and Approval
Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer.
51 min