Alisa Wright, Steven Jacobs, Rafik Bishara
04/19/2012 12:00:00 AM EDT |
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The increasing complexity and globalization of clinical trials has changed the pre-market environment, with more companies outsourcing operations and investigating emerging markets. This leads to questions around regulation, and with high costs and strict handling requirements for many biopharmaceutical products entering clinical development, the logistics of clinical trial supplies are more critical than ever.
Pharma IQ: Welcome everyone, can I start by asking you to discuss current challenges in the clinical trials supply industry from your own organisational point of view.
R Bishara: Thank you for this opportunity and it’s a great pleasure to join my colleagues and our moderator. As far as the challenges, one of the demographics that has changed in the recent year is that clinical trials are conducted on a worldwide basis. That means a clinical trial could be conducted in up to 300 sites. In that regard it becomes a major challenge to monitor, assure the arrival of material in time, meet the enrolment target date and make sure that the supply chain is able to keep up with all those demands.
Another challenge is around regulatory requirements that are being introduced, depending on those new markets and new venues that were not used previously. To clarify that, the majority of clinical trials in the past were done either in Europe, in the United States or in the third largest pharmaceutical market in Japan.
Today many other regions in the world are available and capable to conduct clinical trials. Recently, I read, Korea is becoming one of the major areas where the growth of clinical trials is continuing and it’s becoming another venue to conduct clinical trials, the same can be said of Singapore, the surrounding area, China and so forth.
A Wright: My organisation is a contract service provider and we work with early stage companies in the early stages of clinical. Some of the challenges we’re helping them with is to figure out a better way to design their early stage supply chain which often involves both internal and external resources so that they have the opportunity to parlay that into a much broader supply chain. As they go to late stage clinical, there is a very much different approach than what the industry has used in the past; where you tend to get very specific early and even get more specific as we go closer to market and so we’re trying to make sure that there are more options available as you get closer to market as opposed to fewer options.
Pharma IQ: Steve, Global BioPharm Solutions is a consulting service, do you see a different side to what’s currently happening in the clinical trials market?
S Jacobs: The other pieces that are a huge challenge right now are comparator sourcing because, of course, more and more of our trials are all actually moving towards actually using comparators more so than placebo. Actually how to source it, how to go ahead and get it into all the different countries Rafik talked about, then how do we blend it, how do we make sure it looks just like the other products, especially in the world of biotech where you might have a vial or, even more challenging, you may have a lyophilised product, which means there’s a cake in there that has a specific colour that now has to be matched with the blinding.
And then, of course, something that Rafik has tremendous experience in is also actually trying to keep it at the right temperature, whether that’s controlled room temperature or refrigerated, throughout the entire distribution process and into every single one of these countries where you may also have issues with infrastructure, blackouts, not having a refrigerator, not even having transportation other than on the back of an animal or even a bicycle.
Pharma IQ: As Rafik mentioned and you all agreed, it’s becoming an increasingly global market. What regulations do people working in this field need to be most aware of?
R Bishara: An organisation or a trainer like Steve Jacobs can help you if you are a novice in this area. There is a foundation that you need to know – where are you manufacturing, where you are putting together the double-blind package and also how you are going to transport it to the sites. So, you need to pay attention on both sites, where are you are manufacturing, preparing the kit for the clinical trial and also where it’s being delivered.
From a logistics point of view, you also need to ensure that the transportation will be happening under the proper conditions, whether it is a frozen, refrigerated or at control room temperature. Regulators are asking per the temperature; make sure that you have the requirements as far as what is happening in the transportation, ensure that the quality, integrity and efficacy of the drug will not be influenced.
Most importantly, the sponsor of the study needs to make sure that it will be handled properly, such as when there is or when there are results and there is no efficacy it’s not because the material has been degraded but it’s because the new drug is not affected.
My recommendation is you monitor any changes in the site of manufacturing and putting together the kit, you monitor the site where you are conducting the clinical trial and you need to be in touch with consultants that are monitoring all of that from a logistics point of view, from a technical point of view and from a regulatory requirement point of view. Again, organisations like Alisa’s organisation, like Steve, are the right people to contact and to consult with.
Pharma IQ: Alisa, I’d like to direct a question to you. The increase of the East is becoming very prevalent in outsourcing and partnerships are there significant challenges around this?
A Wright: Well, I think there are multiple challenges and so I’ll stick to just a couple that I know better than the others. Companies from the Asia Pacific area wanting to reach the US market or reach the EU market may not have individuals that are familiar with how to do that best and so they tend to seek out local companies to help them at least go through their initial endeavours in that country and I’d say the same is true when trying to approach the markets, whether it be the clinical market or the commercial market in countries in Asia Pacific. I think that everyone is well served when you find somebody local that really knows how things work, to make sure that you are able to check all the boxes and don’t get delayed due to just not being familiar with the regulations.
I do think that the partnerships with doing a part of your supply chain through Asia Pacific but that’s not the intended market, there have been some increased challenges that companies have come across in doing that and we’ve seen some go that route and then back off because they haven’t had the success that they thought they were going to have in their first couple of tries. I think they’ll try again. I just think that it ends up being more difficult than we first assume when we travel down that road. I know that there have been increased desires and actually some increases in doing clinical trials in some of these countries. I hope that one of my other colleagues on the call might know what success rate companies are having in terms of doing that, even the increased focus on using good clinical practices which is a regulatory of best practices approach that you see a lot more of at this time than I have seen in the past.
Pharma IQ: Perhaps, Steven, you could come in on that, considering you do training in this area. Could you maybe talk to us a little bit about good clinical trial practices?
S Jacobs: It would be a pleasure. Actually Alisa really opened this up nicely in the fact that the challenge that we have going into all these markets, whether they be what we considered in the past the emerging markets but in BRIC countries – Brazil, Russia, India and China – and then, as Rafik mentioned, Korea, Turkey, Mexico and even now down in Southeast Asia, each of them has challenges. Both Russia and Ukraine are classic because they are consistently changing their regulations on the fly and you really need to know about those before you actually go ahead and go in. In some cases I’ve seen those regulations change on a monthly basis and even a couple of times on a weekly basis as to what the requirements are to get stuff in.
To Alisa’s point with regards to trying to get into China and India, I remember about five to ten years ago, everybody was talking about how wonderful it was going to be to get into those places and what we found out was some of the cultural challenges were staggering. Really understanding the difference in culture, understanding what they really understand about good clinical practices and how they maintain them, we found that there was tremendous variation and a lot of folks got burnt in terms of going to a place and not realising that they really needed a lot of remediation.
The good news now is that there a lot more companies that are seeing success going into those areas and a lot of it is due to good networking as well as a lot of the good publications and even podcasts like this that allow folks to find out what are the best companies to use, what are the best countries to go into and what is the best way to actually make this work.
The challenges, as Alisa said, are still staggering, even, to add on to Rafik’s point, in terms of understanding the customs issues, understanding what’s required for import licences, understanding the documentation which now consistently grows. Back in the old days it was easy. We just had to have a certificate of analysis. Now they want to know the manufacturing origin and they want to know the API origin. So, those are some more challenges as we move into these emerging markets.
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