The Evolution of Temperature-Sensitive Biologics

PC: Given your plethora of healthcare supply chain experience, could you describe the evolution of frozen/cold biologics in the logistics space?

Gagnon: When we started, logistics companies and transportation companies were just moving things. And as it pertains to healthcare, there was not a lot of guidance, specifically regulatory guidance. There was a lot of guidance for manufacturing, there was a lot of guidance for what I would say are the core players within healthcare, but for the logistics providers, there wasn’t.

Many of us when we first entered the logistics space, we would take GMP—good manufacturing practices—and we'd focus on those and try to interpret what the intention of those regulations and guidance points were and apply them to logistics. Over the last 15 years, there has been a lot more attention on the regulatory side. We have now GDP—good distribution practices—coming out of Europe. There’s IATA [International Air Transport Association], which is an organization that manages regulations for airlines and air transportation. They've created some guidance around cold chain, and cold chain moves. I think that as you look through the big landscape, the shift is that logistics companies used to just be told what to do by their pharmaceutical manufacturers to enable compliance, but now what you're seeing is logistics companies take a vested interest in being proactive to be compliant.

What I really like, especially over the last six to seven years, is that logistics companies are getting ahead of it because they know logistics better than anyone else. Therefore, they understand processes and what needs to be in place to be compliant. That includes the equipment we use, the standard operating procedures, practices, background checks, and all the things that enable and exude compliance. Logistics providers are now being a little bit more aggressive.

Maybe the last piece of this one is that COVID accelerated all of that learning because we had a world and many governments—many manufacturers of vaccines and biologics—that really didn't understand logistics. All they knew is the science and they needed to get this stuff out and into arms quickly. What happened is logistics companies needed to really jump in.

I'll speak for UPS Healthcare. We started investing in freezer farms because we knew that it was going to be mRNA or deep-frozen vaccines that were going to be launched first. It really forced most in the industry—if you were going to play in healthcare—to really start to invest before that first vial was shipped. I think those were the big moves over the last 20 years.