Combinate Podcast - Combining Drugs and Devices Subhi Saadeh

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.

00:00 Introduction and Guest Introduction
01:21 Podcast Overview and Purpose
02:12 Importance of Lyophilization
03:04 Lyophilization Process Explained
04:35 Vial Filling and Stoppering Differences
09:44 Freeze Drying Process
15:45 Primary and Secondary Drying
16:56 Backfilling and Final Steps
30:20 Equipment and Technology
34:41 Conclusion and Guest Contact Information



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 David@lifescienceprofessionals.com

**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 contact@lifescienceprofessionals.com. For information requests, email them at info@lifescienceprofessionals.com. 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 David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery.
David and I discuss:
00:00 Introduction and Guest Overview
00:04 David DeSalvo's Career Journey
02:13 Understanding Injection Systems
04:22 Early Career at BD
10:51 Transition to SHL
17:50 Starting a New Venture
24:54 Experience at Emergent BioSolutions
29:40 Current Role at Kindeva
32:56 Book Recommendation and Conclusion
David DeSalvo is the Vice-President of Combination Product Development at ⁠Kindeva Drug Delivery⁠. He is an expert in drug delivery devices (combination products) and has invented, designed, developed and launched multiple devices. His work has resulted in dozens of highly successful unique drug-device combination products, including many industry-first innovations.
https://www.daviddesalvo.com/

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.

Alan Stevens 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.

Rumi Young, Meng, RAC is the Director of Regulatory Policy at Novo Nordisk. Rumi joined Industry from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.

On this episode of the podcast, I was joined by Ben Locwin, Executive SME at Black Diamond Networks. Ben and I discuss: 
01:53 Material Qualification Discussion Begins
02:23 Material Qualification in Drugs vs. Devices
04:00 Quality Standards in Different Industries
08:54 Quality Tools and Their Applications
11:22 Material Qualification and Supplier Management
26:37 Regulations and Quality by Design
27:45 Closing Remarks and Guest's Current Work

Ben's Article: Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)

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.

On this episode of the Combinate Podcast, I go over 6 lessons from the life and x of H. James Harrington.

Dr. H James Harrington has a decorated career with 40 years at IBM, 10 years at Ernst & Young, and has held multiple executive roles at various companies since. He's written more than 55 books on performance improvement. He was the chairman and president of ASQ and has multiple quality awards named after him. He's currently the CEO of Harrington Management systems, an International consulting firm focused on performance improvement, strategic planning, and organizational alignment for both private and public organization.