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

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️

Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/

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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Jaksot(247)

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances a...

3 Kesä 11min

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a ...

27 Touko 10min

239 - ICH Q11 in 6 Minutes

239 - ICH Q11 in 6 Minutes

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Touko 6min

238 - 6 Audit Strategies Every Auditor Should Know

238 - 6 Audit Strategies Every Auditor Should Know

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Touko 10min

237 - ICH Q10: The Pharmaceutical Quality System

237 - ICH Q10: The Pharmaceutical Quality System

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Touko 8min

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Huhti 12min

235 - ICH Q8: How Pharmaceutical Development Actually Works

235 - ICH Q8: How Pharmaceutical Development Actually Works

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines...

22 Huhti 10min

234 - ICH Q7: The GMP Framework for API Manufacturing

234 - ICH Q7: The GMP Framework for API Manufacturing

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read ...

15 Huhti 13min

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