Podcast

September 18, 2024

154 – IVD’s, LDT’s, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects

September 11, 2024

153 – USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio

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 explores the

September 4, 2024

152 – Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & 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

August 28, 2024

151 – Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio

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: Timestamps

August 21, 2024

150 – Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges

August 14, 2024

149 – Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens

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: 01:01 Recap of the Last Episode

August 7, 2024

148 – Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

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

July 30, 2024

147 – URRA Draft Guidance, uFMEA’s, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup

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

July 24, 2024

146 – Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water’s Triple Point with David Simoens

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,

July 17, 2024

145 – Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: Timestamps 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges

July 10, 2024

144 – Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO’s with David DeSalvo

On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: Timestamps 00:00 Introduction and Guest Overview 00:04 David

July 3, 2024

143 – New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young

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

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