212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, ...
5 Nov 202525min
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA’s Office of Combination Products (OCP). Mark takes us on a deep dive into the ...
30 Okt 202546min
210 - The 8 Roles You MUST Understand in Pharma & MedTech
I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What’s Regulatory Affairs? How does R&D fit in...
22 Okt 202519min
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield
As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersectio...
15 Okt 202522min
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way. We cover risk culture, CSV vs. data integr...
8 Okt 202522min
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design
In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the proces...
1 Okt 202528min
207 - What 99.999% Reliability Really Means
In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA intr...
24 Sep 202523min
206 - Will AI Decide Your Next Drug/Device Approval?
Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let’s Combinate, Subhi Saadeh sits down with Domin...
17 Sep 202531min
