174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin

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Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry’s response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends.00:00 Introduction to GLP Receptor Agonists00:46 Guest Introduction: Ben Locwin01:48 Historical Context of GLP-1 Development05:54 Mechanisms and Effects of GLP-109:51 Market Impact and Manufacturing Challenges11:16 Regulatory and Advertising Considerations17:44 Sustainability and Injector Pen Issues19:40 Risk Management and Future Directions23:31 ConclusionBen 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.

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Episoder(258)

I'm Changing The Podcast

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18 Aug 2min

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...

12 Aug 11min

249 - The Best Audit Advice Nobody Told Me

249 - The Best Audit Advice Nobody Told Me

Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...

5 Aug 14min

248 - What Is a Quality Unit? QA vs. QC Explained

248 - What Is a Quality Unit? QA vs. QC Explained

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...

29 Jul 8min

247 - Why Everyone in Pharma and MedTech Should Work in Quality

247 - Why Everyone in Pharma and MedTech Should Work in Quality

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...

22 Jul 8min

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...

15 Jul 8min

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...

8 Jul 45min

244 - 5 Critical Quality Differences Between Drugs and Devices

244 - 5 Critical Quality Differences Between Drugs and Devices

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...

1 Jul 8min

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