Better together - rapid sourcing of quality drugs

Nowadays, it's often not sufficient to prove your product works better than a placebo, it must be trialled against a marketed drug. Meanwhile, regulators have little interest in approving a drug, or buyers paying for it, if it is less efficacious or has higher risks than an existing alternative.

Moreover, as more organisations tackle chronic and terminal illnesses, trials where some participants take a sugar pill may be unethical. Additionally, as cocktail regimens for certain diseases become more popular, sponsors must source the co-therapies to run alongside their investigative compound.

However, in spite of the mounting interest in comparative effectiveness, finding the necessary comparator drugs remains a challenging undertaking. From difficulties obtaining product documentation to poor supply chain visibility and even counterfeit worries, there's plenty to be concerned about.

But it's not necessarily a losing battle, according to Terry Walsh, head of global comparator strategy and planning at GlaxoSmithKline. On secondment as head of the comparator network at TransCelerate BioPharma, he's spent the last 18 months learning that collaboration could be the key to overcoming clinical supply hurdles.
"My heart has always been in clinical supplies," reveals Walsh, who has been with GSK for almost two decades.

"In 2007, the clinical folks at the company approached me. They presented a global study of 8,000 patients over five years using a new oncology product vs one we had in development. We had to source the comparator drug, but it was hard to get because it was somewhat new on the market and very expensive. And it was a heck of a lot of drug we were going to need."

Friends with benefits
Walsh had a former colleague at the rival company, and wrote him a letter explaining the situation. Soon after, phone calls were exchanged between GSK's president of oncology and his rival counterpart. They came to an agreement and Glaxo was able to source the product directly in the amounts its clinical team required.
But what if you don't have a friend working for the competitor? In many instances, sponsors are unable to secure comparators directly and often need to source product on the open market. As new therapies entering the market take increasingly sophisticated forms (cell therapies for example), the cost for obtaining comparators is likely to increase sharply. And emerging markets make it harder to be sure you're getting a secure drug supply.

"Knock on wood that no one has any counterfeits in their clinical trials, but the risk, albeit small, is there because vendors can go out to different markets and purchase," says Walsh. "So there are a lot of nodes in the supply chain, and every one of those steps decreases the robustness of the chain and increases the risk," explains Walsh.

The proportion of clinical trials using comparators has increased in recent years, partly because there are so many products on the market. These days, it's hard to find a disease that doesn't have at least one therapeutic compound available for it.

"The other thing is the global footprint; not only is the number of trials getting bigger but so is the size of the trials," he adds. "Because you want to include the population of the world, you're looking at different countries and different patient populations."

It became clear to Walsh that the mechanisms to acquire clinical trial comparator drugs and co-therapy compounds are inefficient and unpredictable. Without some arrangement in place between rival companies, sponsors would have to explore securing product from less secure and predictable sources. This creates uncertainties around obtaining an adequate and timely supply of drugs, and consequently the potential for substantial study delays.

Present and correct
Another big challenge is that it can be difficult to obtain the paperwork required when purchasing on the open market. Many countries require that documents such as import and export certificates of analysis and TSE certification are present. While temperature and stability data can be practically impossible to get hold of, unless you're on good terms with someone at the rival organisation.

"A lot of companies weren't really into working together," Walsh reveals. "There were some that would maybe do an agreement, like we did with the first company I mentioned, but everything was very one-off."

Something had to change. The formation of TransCelerate BioPharma, a non-profit organisation focused on advancing innovation in research and development and further improving patient safety was the catalyst. Evolving from discussions at various R&D forums about common challenges, TransCelerate launched in the summer of 2012 with the support of ten founding biopharmaceutical members. Since its conception, the organisation has added new members and continues to refine its focus. And when the group looked into improving supply chain activities, Walsh had an idea.

"I said to them, 'let's get these ten companies working together and let's create a network where they can sell each other comparator drugs,'" he explains. "We can get them direct, working with the commercial organisations of each company. The purchasing member will provide the supplying member with the dates and the quantity needed, and they can enter into straight negotiation with each other."
Not everyone was convinced, however. Walsh reveals several board members were sceptical of the feasibility of the project. Some people didn't think it made business sense.

"I remember presenting to the commercial unit and some of them saying: 'are you out of your mind? You think we should send our products to our competitor?'."
But Walsh was able to make his case, put forward the substantial benefits of the scheme and eventually, after receiving support from other executives, the initiative took shape.

"Granted there was a time when I had 24 lawyers on the phone for four hours, but we got through it," he says.

In summer 2013, TransCelerate announced its Clinical Trial Comparator Network initiative. A master service agreement affirming a mutual commitment to offer secure and rapid supply of comparator drug products was executed by several member companies and the first network-based transaction was initiated.

Peer-to-peer perks
Companies participating in the network can now source comparator drugs directly from each other. They're able to secure supply when they need it, in the quantities they require, mitigating the counterfeit risk. In addition, the network means improved access to comparator drug stability and regulatory data. This will enable member companies to reduce waste by allowing for better management of temperature excursions.

"We have now created an excellent collaboration culture," says Walsh. "When people get together you just hear the conversations about how to make things more efficient. They're talking about inefficiencies with regard to the comparator supply chain and how to resolve them. And everybody realises they all have the same problem, they're just all called different things."

"We've saved a few bucks along the way, but the point is that we're changing the industry, and it's all about altering that landscape and experience, and just saying 'why don't we all work together? We're all doing the same thing'."

It's about forgoing the faux-secrecy in the process. After all, organisations know when their rivals will be purchasing their products; because pharmaceutical companies publish the fact they're entering phase-III trials.

"You know it; everybody knows it, so why aren't we doing it? Because we have this false sense this might slow the other company down, but it really doesn't," explains Walsh.

When TransCelerate's Comparator Network was first announced, six companies had signed up, but at the time of writing there are ten members. Walsh says he hopes it will gain another four in the next year as a way to expand the network and increase its efficiencies. "One of the companies that joined had said to me: 'Look, we believed in what you were doing, but we never thought you could actually do it'."

He cautions, however, that the network is not there to replace the vendors. He admits that not every company in the industry will join the network. From this point on, TransCelerate will continue to look into adding value to the industry, never forgetting that, at the end of every supply chain, is a group of patients.

"Yes, we're all competitors at a certain level, but this is about the patients," Walsh says. "Let the marketing folks do what they need to do but, here in R&D, our prime concern is helping to get drugs out to help patients and get them out there faster."