Eric Sexton

On Mutual Respect

I treat everyone that I interact with as if they know something that I don’t. I take the same approach with everyone that I speak to regardless of their financial status, job, personal history or background. People are much more willing to listen to you if you demonstrate that you are willing to listen to them.

On Meaning

I’ve found that meaning can only be found by identifying the things that I know I should do but I’m too afraid to do…and then doing them. In fact, this approach has been so successful for me (both personally and professionally) that whenever I begin to fear some new obstacle I push that task to the top of my to-do list. It’s not that I have no fear. I find many things to be terrifying. But I’ve found that meaning results when I tackle those things head on.

On EcCENTRICITY

All of us have unique talents and abilities. Whether we choose to manifest those in life and make some kind of impact is entirely up to us. We shouldn’t be afraid to think differently than the people around us. If you think like the average person and behave like the average person then that’s exactly what you will become — average.

pRODUCT lIFECYLCE

I think about development, tech transfer, and commercial manufacturing through the lens of Quality by Design (ICH Q8), Quality Risk Management (ICH Q9), and Quality Systems (ICH Q10). I’ve worked with clinical and commercial biotech manufacturing processes. This isn’t just about compliance with regulatory expectations. When these basic principles and best practices are not followed, it’s obvious to the end users of the process. The only path to a robust manufacturing process which reliably produces quality product is an emphasis on process understanding and building quality into the product early in the product lifecycle.

rISK mANAGEMENT

Risk Management in pharma/biotech is relatively immature. That’s due in large part to the complexity of the manufacturing processes required to produce cell and gene therapies. I work on the assumption that regulatory bodies’ approach to risk is moving in the direction of more mature approaches to Risk Management. Risk Management and Knowledge Management can be incredibly powerful tools when properly integrated into the quality system.

Systems-fOCUSED

Companies are collections of systems. Some are well designed and interconnected. Others are not. This is what separates great companies from mediocre companies. Sure, hiring the right people matters. In fact the only thing more important than robust systems are the people in control of their design and implementation. However, when companies or programs fail, poorly designed or underutilized systems are often a contributing factor to that failure.