Podcast Episodes
Back to SearchWhat Should AI Do in a Regulated Environment?
Episode 50
To err is human. To make things up is AI. So in a regulated industry, how should the two work together?
In this episode, host Chris Adkins talks with …
8 hours ago
Mechanical or Electromechanical? Designing for the User
Episode 49
Episode Description:
Most drug delivery devices are mechanical by default: a spring, a click, a color that shifts from yellow to green. As drug delive…
1 month ago
Reducing Risk in Injectable Drug Development Starts with Primary Packaging
Episode 48
Primary packaging is often treated as a late-stage procurement decision, in reality, it can influence formulation stability, manufacturing, regulato…
2 months ago
De-Risking Early-Stage Formulation Development: Inside the Kymanox Lab
Episode 47
Every formulation decision made early in development carries downstream implications for stability, manufacturing, scalability, and analytical strate…
3 months ago
GLP-1 Ripple Effect: Reshaping Injectable Drug Delivery
Episode 46
The rapid evolution of biologics and blockbuster obesity therapies is creating an unprecedented demand on the injectable drug delivery market. As the…
4 months ago
Particles in Biologics: Advanced Analytics and Tech Transfer
Episode 45
For many teams, particles and aggregates are treated as a late-stage compliance headache or a sudden fire drill during manufacturing. But what if we …
6 months ago
What Successful CSV and CSA Teams Do Differently
Episode 44
For years, Computer System Validation (CSV) has been the standard for ensuring digital systems perform as intended in regulated manufacturing. But fo…
7 months ago
Navigating a CDMO-Based CRL: From Crisis to Compliance
Episode 43
Dealing with an FDA Complete Response Letter (CRL) is one of the most stressful challenges in drug development, but managing one that stems from a fa…
8 months, 1 week ago
5 Steps to Operationalizing FDA’s QMS
Episode 42
The FDA’s transition from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR) marks the most significant updat…
9 months, 1 week ago
In Silico Modeling: A Drug Developer's Superpower
Episode 41
Developing complex biologics and advanced therapies is historically time-consuming and material-intensive—but computational modeling is reshaping the…
10 months, 1 week ago