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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
In this episode of Let’s Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one
In this episode of Let’s Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the
In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has
By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure
In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his
In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book,
In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr.
Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational
In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development
In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable