In addition, Stambaugh elaborates on continued expansion of clinical trials into new countries and what cold chain logistics companies are doing to stay ahead of the curve in emerging markets where the infrastructure for typical means of transport are simply not an option for biologics.

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Length: 5 min, 43 sec

PDA Report Changes Cold Chain Shipping – Cryoport Podcast Series

Rob: Hello, this Rob Wright, Chief Editor of Life Science Leader Magazine and I want to welcome to you our podcast today with Larry Stambaugh, President and CEO of Cryoport, a Life Sciences Global Frozen Logistics provider. Welcome Larry, and thanks for being with us today.

Larry: Thank you, Rob.

Rob: Larry I understand that the Parental Drug Association (PDA) has recently issued a technical report on good distribution practices. How will that impact temperature-sensitive shipping now and in the future?

Larry: That’s correct, there’s a new technical report number 52 that’s just been issued in the last three months on good distribution practice and an additional technical report 53 on stability with more reports to be issued.

And the work is to harmonize the standards around the world for good distribution practice because there’s today set company by company, country by country and there’s a lot of differences. And they especially are focusing on temperature-sensitive drugs and samples and that’s because of more biologics in development were there, more sensitive and volatile.

Regulators are also encouraging these guidelines so that there’s a more harmonized set of guidelines that they can hold companies to. And so the industry will be changing a number of their processes to comply with these new technical bulletins and they’re going to need some additional technology and a lot of outsourcing help to put a lot of this in place.

Rob: Now, Larry, in the United States we often don’t think about some of the shipping issues that exist in other countries. And as clinical trials expand and more into new countries worldwide, what are some of the specific cold chain logistic challenges company face today?

Larry: It’s even more than just the U.S. We as an industry have typically done our trials in the United States and Western Europe. And as of July this year, according to clinicaltrials.gov, there’s about 80,000 trials going on in the US and Western Europe. And interestingly and unprecedented, over 40,000 trials taking place outside of those two regions.

That increase is the challenges for moving our, our investigative drugs, our drugs and samples, and those include custom delays, permits are required, varying regulations, and underdeveloped logistics sources in places like the Mid-East and Asia, where there airport facilities and knowledge of the distribution process, just really aren’t up to speed.

And that’s part of why the PDA and the World Health Organization are working to help harmonize standards. In the meantime, there’s a lot of outsource companies that are working with the industry to help address some of those challenges.

Rob: Well thanks for clarifying that for me, Larry. I understand that reliability and integrity in cold chain is important. So what are companies doing to stay ahead of the curve in some emerging markets where the infrastructure for typically means of transport are simply not an option?

Larry: You know I just travelled around the world looking at that myself and I’m finding that many of the industry companies are increasingly relying on contract research organization, central laboratories and third party sources to help them with the challenging regions.

It’s difficult to stay up on all the permits required, the differences in customs, know who need is brokers. And also we’re seeing that there’s a need for an advanced technology in packaging required and I’m seeing some moves in those areas to get longer reliable holding times and better stabilities and temperatures. So it’s a - it’s an emerging area.

Rob: Any advice for people that are going into those emerging markets on, on a key business partners or websites to find additional information?

Larry: To my knowledge, there isn’t really a good single source today a website of central knowledge, and it’s an area that a lot of the larger contract research organization, larger central laboratories, are working themselves to try to become experts in as we are company.

And because we do it day-in and day-out where many of the companies have many countries they’re trying to deal with, they can’t keep up on the regs. So I think probably the best advice is to go to some of the larger organization that are working globally today.

Rob: Okay, we’ve got about time for one more question, Larry. In, in your recent global travels, did you discover anything new and exciting regarding Coal-Chain shipping and what it might mean specifically to your organization?

Larry: Well, you know, what’s new and exciting is that we are doing more trials outside of the US and Western Europe and that’s speeding up the trials.

There’s an explosive growth in the number of biological drugs and the challenges addressing those, and all of that is forcing the industry really to come up with improved standards of good distribution process to look for new technologies.

And we’re involved in that, in that process ourselves with development of a new nonhazardous, ten-day frozen container by fully outsourced shipping handling that, that’s being responded to by the industry very well, and we’re replacing things like dry-ice and taking care of these - harmonization requirements now that the industry is requiring.

So I think it’s an improvement for all of us in how well we’ll be able to move trials all over the world.

Rob: So Larry, if somebody wanted to learn more about this shipping container that you’ve developed at your company, Cryoport, where would they go to find out additional information?

Larry: They could go to www.cryoport.com and it talks a lot about the technology, the specification and the challenges and how we address those.

Rob: Okay. Well, that’s all the time we have for today. I want to thank you, Larry, for taking the time to be with us. And thanks to everybody for listening to this Life Science Leader podcast. I’m Rob Wright, and we’ll see you next time on Life Science Leader, the industries essential business source.