Will Clinical Trial Suppliers Move Towards a Solely Virtual Model?

Steve Jacobs, President of Global BioPharm Solutions, joins Pharma IQ to discuss clinical trial supply in Europe. To listen to the interview in full go to Has the Balance of Power Shifted Along the Clinical Supply Chain?

Pharma IQ: There has been a paradigm shift in pharmaceuticals. The Pharma we know is not the Pharma of the future. How will this directly affect the clinical trial supply area?

S Jacobs: It’s an interesting question. I think if you actually take a look, Pharma as we know it, certainly is changing in the fact that it is downsizing, or shifting and morphing, and there’s still lots of mergers and acquisitions, of course, during the recession that dropped, but it’s starting to come right back up again. And the concept is that a lot of companies have actually off-shored or outsourced their discovery, and they’ve off-shored or outsourced a lot of the other clinical supply chain as well. So what you’re seeing, really, is a lot of companies that are in many ways getting rid of their operations group that used to do the clinical supply packaging and pretty much outsourcing everything to the vendors that are in the industry. And interestingly enough, the vendors in the industry are also growing as they see huge opportunities to go ahead and really make a nice revenue stream from the way Pharma is evolving.

Pharma IQ: Will clinical trial suppliers move towards a solely virtual model?

S Jacobs: It’s a good question. I think really, when you come right down to it, clinical trial supply, and certainly the Pharma and Biotech industry, typically have been pendular in the way they actually swing. I remember years where we would outsource everything, and then we would bring it back in house, and we’d outsource everything when we bring it back in house. Recently, I think we’ve really begun to outsource everything, and with the changes in regulatory requirements I don’t know if the pendulum is going to swing back, so I really think that we are going to move faster and faster towards more virtual clinical supply oriented groups. And what that means is that, in some situations, some companies that already have some operational units internally, where they actually have directors or leaders within that unit that can show the value that unit brings versus a vendor, then they’re going to pretty much be able to avoid the virtual model. And that’s a challenge, because there’s not a lot of folks out there that are leading clinical trial supply units in their companies that sometimes have the time to really come up with a cost justification as to why it makes more sense to maintain the control and the stability internally than it is to go ahead and outsource everything.

Pharma IQ: What would you say are the most challenging areas of clinical trial supply?

S Jacobs: There’s a couple. I would say, probably number one these days is trying to create as much cost savings as humanly possible. And the challenge with that is that typically, in the past of course, we would go ahead and we’d make a huge amount of clinical supplies. We would then package a huge amount, and then we would go ahead and wind up wasting anywhere between 20% and 50% of the supply that we’d manufactured and packaged. And we’re now in the process of really moving away from that as much as humanly possible, and we’re trying to come up with ways where we can go ahead and create a situation where we can deliver the clinical supplies and get the patients in and the studies done as fast as possible in also a basically cost-reasonable way. What you’re looking at is situations where adaptive trials are becoming a hot issue these days, and the other one of course is, trying to remove the expiry date from clinical supplies globally as well as actual clinical supply pooling. So that’s one area that you have challenges, and the industry is now stepping up to try and basically mitigate those challenges.

The other one, of course, is always on the distribution side. With more and more products probably being temperature controlled, what you’ve got is you’ve got a huge challenge to go ahead and ensure that you can go ahead and maintain the temperature. Whether it be cold, frozen, or even room temperature, from the point that it actually leaves the vendor or the sponsor company, to the point where it actually hits the investigator site. And the challenge with that is, of course, that more and more clinical studies are really now shifting to the rest of the world, and more and more are growing, and certainly some of what we used to think were the emerging markets, which is Asia, Southeast Asia, Africa and Eastern Europe as well as Russia. Now the challenge, of course, of maintaining the temperature of course has always been challenging, because you have not only the storage and packaging that you have to deal with, but you also have Customs which you have to worry about, so that your material doesn’t sit someplace for too long, and actually lose its temperature and go out of spec, in which case it may no longer be good and literally directly impact how quickly you’re enrolling patients and how fast you can get the studies done.

Pharma IQ: Has the balance of power shifted along the clinical supply chain?

S Jacobs: It’s a good question. I think in this situation, as more and more companies are going virtual, the balance of power is changing in the fact that in the old days, of course, the sponsor companies, especially the larger ones, would go ahead and call up the vendors and demand. Now there is a real shift in terms of trying to partner much more with the vendors so that there is more collaboration, more communication, and that you can actually get the job done as... more of a team than there was in the old days. The other shift in the balance of power is between clinical supplies moving off to sourcing and procurement. Some companies actually have a very strong sourcing and procurement group, because of course they’re all trying to save money as much as they can, and sometimes sourcing and procurement is actually becoming more of a power base than the clinical supplies folks are, and that just depends on the size of the company. Midsize and small companies, it’s not an issue; with the larger companies, it’s much more of an issue.

Pharma IQ: What would you say is new on the horizon? Looking at, for example, technology or strategies.

S Jacobs: Probably electronics, and interactive response technology. That’s certainly a very nice shift as we move more and more towards interactive web response systems versus interactive voice response systems. That’s key. But the amazing thing with technology is that there’s two kids in a garage someplace right now that are coming up with something that could be tremendously helpful in terms of delivering drug that will be available within the next five to ten years. And the good news with that is that there’s more investors that are less scared to invest these days, and that there’s really neat new technology that’s coming out in terms of a lot of the new area of medicine. Whether it’s nanobots that actually can clean arteries, whether it’s tests where you can actually breathe into a device and have it diagnose whether you have cancer, whether you have diabetes, to literally the concept of cybernetics where you’ve got new arms and legs and prosthetics that not only move the way the brain wants them to, but even they’ll sense things. So technology’s shifting beautifully and it’s just a matter of us being able to incorporate it into the clinical supply chain, and what that means sometimes is that some companies have to be... have the foresight to go ahead and invest in it to really make a difference.

I remember when we… a company came out with a device where when you actually popped a pill out of a wallet or a blister card it would record the date and time and actually show compliance in a very, very real and very impressive way. And what ended up happening was a lot of the companies that took a look at it didn’t have the foresight to realise that the cost savings that they would get out of it more than covered the cost that they would have to pick up at the beginning, so I think that two things are occurring. Not only is technology starting to help us out, but, also, I’m hoping that leaders within the Pharma and Biotech industry are actually looking farther than one quarter down the line, and I’m really hoping that that eventually will evolve, because they all have challenges, and that’s a fact that unfortunately most markets only look a quarter down the line. And that’s interesting because, if you take a look, countries like India and China have a much more long-term orientation than certainly Europe and the US do, and that, at this point, gives them a huge advantage and a fantastic opportunity, certainly in the world of clinical supplies, clinical development and really new drug and new molecular NRV discovery.

Pharma IQ:  I understand that you will be speaking at Clinical Trial Supply Europe, which will be hosted from 29^th -30^th January 2011 in Rotterdam, for anyone interested in attending the event, what would be your key take-home message?

S Jacobs: I think what’s nice about Clinical Trial Europe is that there’s going to be a lot of really good practical and tactical examples of what challenges are within the industry, and then that’s really what all of us want. We all want to know the things that we can do to make ourselves more successful. We certainly want to hear other people’s mistakes, because when we hear other people’s mistakes the good news is we don’t make them, and that’s, I think, one of those key takeaways – you learn from everybody. Some people you learn what to do, and some people you learn what not to do. But in both situations, the nice thing about this is that going to a conference like this is going to allow you to go back to your company a little smarter, with a little bit more experience, and these days that’s so important. With companies downsizing their workforces, the greater the value you can have, the better off you are for the future. Whether it allows you to stay at the company you’re at for longer, or even allows you to switch to another company where you feel you can actually make more of a difference. That’s the kind of stuff that this conference will be able to give you.

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