Biologics and Clinical Trials: The USP Perspective

Mary Foster
Contributor: Mary Foster
Posted: 04/28/2013

Industry veteran Mary Foster is the chair of the USP's Committee on Packaging, Storage and Distribution. In advance of her speaking engagement at the BioLogistics Summit, we were lucky enough to chat with her about the regulatory challenges of transporting and distributing clinical trial materials and biologics.

Cold Chain IQ: Welcome Mary. You’re three years into a five-year commitment as USP Chair. What has the committee achieved in the last three years that you’re most proud of?

Mary Foster: I look back to the starting date when we selected the committee members that were experts in specific subjects. We went to the world to pick these people, and we also had a lot of different functional areas engaged in the committee. We ended up having industry, academia, BA participants, pharmacists, PhDs, Pharm D’s, and even regulatory agencies, so it was kind of a unique situation in that these people came from around the world with different subject matter expertise, and they didn’t even really know each other, and at the onset we developed our five year plan and today we’re at 82% completion, so we’re really rolling.

We’ve revised over 17 chapters, we’ve written three new chapters, and we’ve developed a process for providing the USP user more information in an easy to read format through the use of a sub-chapter program. So this committee of people helped the USP and I think they were really instrumental in pushing the USP to develop what will now be a standard across USP for providing material that has a large quantity and makes some chapters onerous to review. We also developed a process for collaborating across the USP with other committees, so when I think about what can we stand up and be proud about, I think it’s bringing these experts together and developing a very innovative and future forward thinking program for the end user. An example is a chapter we’re writing right now that will come out this year and be a forum on extractables and leachables. The industry’s needed this for a long time. So we’re always asking what’s next. When I think of what the outcomes have been, that’s what really puts the smile on my face.

Cold Chain IQ: Well it definitely sounds like you’ve been busy. At the biologistics summit clinical trial materials will be a major focus. What are some of the biggest regulatory challenges specific to transporting and distributing those materials?

Mary Foster: With clinical trial materials, that’s something that our committee, the packaging, storage, and distribution committee has made a goal to make sure we have that material out in front. Particularly when it comes to the transportation and distribution process, and the whole supply chain—sometimes the clinical trial material gets left out—and these conferences, I’ve learned, they want to be part of the process. They need their own uniqueness to be called out. So that’s what our process is today within the USP.

You look at the regulatory challenges and I think our committee would say the biggest challenge we see with the clinical trial material is that from the very onset of manufacturing, the very first manufacturing piece through to the end product for the clinical trial, there needs to be a process for managing transportation from the very beginning. It all gets down to product management at the end of the day and if a firm can specify what API, what dosage form, what package style, they can also specify from the onset the transportation program and build that into the whole clinical trial program so that when the product starts to move around the country and other countries the program is known. It can be very cost efficient because you get time to study it.

Most companies have to deal with a virtual program because they can’t put an employee in every entity along the supply chain. So understanding that piece as well in the project plan becomes critical for the commercial product as well as the clinical trial material. I think at the end of the day it gets down to product management—that’s the biggest regulatory challenge, because if you don’t build in from the beginning the regulations and how you’re going to meet them from a transportation point of view you’re not going to be successful at the end, or you could at the end have a real regulatory trial itself, because you haven’t thought through the best way to move your product. Obviously there’s ways to handle that with written procedures that cover transportation. Making sure you understand the current regulatory requirements—if you had to track and trace a clinical trial how would you do that? Make sure you have roles and accountability factors baked into the procedures, and make sure you execute and be sure you have a mechanism or way to cover changes because they are going to happen.

I think at the end of the day the biggest regulatory challenge with transporting the clinical trial material is working with product management from the very beginning of the trial to the very end. Making sure you have the right strategy, the right technological advances and people in place to make it cost effective.

Cold Chain IQ: Moving on to biologics, they’re taking a larger and larger share of the pharmaceutical market. Is more guidance needed on how to handle biological materials?

Mary Foster: From a USP perspective, we consider a biological product the same as any drug product, so we don’t typically call out the biological, but since we now have this new program of sub-chapters (in particular with the transportation program) we are going to write some very specific information relative to biological products, also relative to the clinical trial material.

I do think there is a need for more guidance. Telling a company this is what you should be looking at, but not how a company should determine the way to get it done. I think another thing that the biologics group needs to consider, and what we’re doing at USP, is providing a repository of resources. So we have not only this sub-chapter that will be very specific to biologics and what’s needed for storage, packaging, and distribution, but there will also be this repository on the USP website that provides everything possible that we can find written on the biologics subject matter, relative to packaging, storage, and distribution. So that USPN user then has at hand, this is what USP does with the guidance, but also here’s what they helped read and use, and what other countries are doing. It’s not that we’re trying to endorse the material, but we don’t want to create and rewrite just for the fact of having it in USP. We want to be able to reference other resources. I know some companies like PDA can get into very specific case studies and very specific information on what’s needed for biological product that we at USP may not be able to do because our material is more overarchingly standard guidance in a chapter above 1000, so I think the subchapter program for biologics and the repository are needed, because the biologic is only growing, and as you ask in your question, with growing market share they’re going to want to know more and more what is expected of us.

Cold Chain IQ: Changing pace for a second, what are some of the most innovative packaging solutions that Aphena Pharma Solutions is working on?

Mary Foster: Aphena is a contract manufacturing and packaging business. We have a real unique opportunity to see what the latest and greatest is that the companies are doing relative to packaging.

My only problem is I can’t really share what those are because of my contract. We are spending a lot of time, I see a lot of companies working on liquids and semi-solid packaging ideas, when it comes to drugs or cosmetics, the next generation of not only what the package is going to look like, but materials, is I think going to be very exciting in the next couple of years.

We do also have a product line of private laurel solids we manufacture laxatives and inhalers for the private label industry. We work with a rare combination of contract services and private label companies to the local retail pharmacy that really gives a thing that kind of a unique view of the pharmaceutical world, but there’s not a lot I can share relative to that because of the contractual agreements.

Cold Chain IQ: When it comes to packaging and repackaging, what are some of the main stumbling blocks companies run into when trying to remain compliant?

Mary Foster: I’ve spent thirty years of my life working in this industry—particularly working in the packaging and repackaging arena. At the end of the day, when I look back, I really do think one of the biggest failures in packaging and re-packaging in the pharma industry is the inability of this industry to stay focused. Companies get excellent FDA outcomes and they start to lose their focus and even the biggest companies can’t stay sustained, so I think the compliance focus is one of the biggest issues relative to a company staying successful.

I even looked back at the generic drug scandal and the years that passed where firms had to literally close because they weren’t compliant. Big companies got major warning letters, and it got down to not only packaging and repackaging compliance, but the general focus on quality in a drug company.

I think it’s all about recognizing that there’s an expectation that companies use that C in CGNPs and stay current in what it means to be compliant. So if you stay focused on the basics and getting the right person in the right room at the right time doing the right thing and you cover your project management like we talked about earlier with clinical trials, I think at the end of the day there’s going to be success and that focus on written procedures and metrics will lead to sustainable compliance, and packaging and repackaging fit perfectly in with that overall mindset.

Cold Chain IQ: Lastly, you’ve spoken at a lot of different supply chain and distribution events. What do you try to get out of these different speaking engagements and appearances?

Mary Foster: My main goal is to get the word out about what the USP’s currently working on. I’d like for the participants in the conferences to understand here’s what we’re working on, does it meet your need?

And I ultimately will get feedback from participants either by mail or right after I’ve spoken or during the conference that this subject is near and dear to their hearts, or this is an issue specific to the subject that they’re working on. So understanding what is currently important to the participants, and it’s also a good way to recruit and think about what or who would be interested in the next five year cycle for the USP to help write these chapters and think to the future as to what the industry needs to have as guidance.

Cold Chain IQ: Great. Thanks for your time today, Mary.

Mary Foster: I enjoyed it.

Interview conducted by Shawn Siegel

The Cold Chain BioLogistics conference takes place June 3-5, 2013 in San Francisco. For more information or to request the brochure, please email

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Mary Foster
Contributor: Mary Foster
Posted: 04/28/2013


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