The proportion of clinical trials using comparators has increased in recent years, partly because there are now so many products on the market that sourcing quality drugs can be inefficient and unreliable. But the climate in the industry is changing, and TransCelerate’s Comparator Network has set up a hub for biopharma companies to trade project-saving information and improve business practices.
“One of the major things the Comparator Network did was to set a stage to improve the industry on something as sensitive as sharing medicine with each other,” says Terry Walsh, supply chain senior director of TransCelerate. “We’re competitive companies, yet, we’re sharing each other’s pharmaceuticals because it’s better for the patients. We’re competing in the discovery stage and the market, not beforehand.”
When the network started, Walsh says there was a definite goal of trying to cut down costs for the companies involved. But the focus on financial incentives has subsided due to the company’s realisation that the true benefits lie in the relationships between its users.
Trust your competitors
TransCelerate began building trust between companies from the get-go, encouraging transparent sharing of protocols. “Initially, we had company representatives together around the table and everybody had their arms crossed, sitting there with one eyebrow raised and thinking, ‘Hey, what’s this guy talking about?’,” he reveals. But soon, barriers were broken down and connections were being made.
“Where we are today has changed so much because, now, it’s no problem to just pick up the phone to call another company and ask questions: ‘How do you outsource?’, ‘What’s your process for storing materials?’,” he says. “Everybody’s just opened up to share ideas and data with each other. Companies realise that the environment we’re working in is changing – why can’t we just share information?”
Much of the information shared across the Comparator Network, such as product-specific documentation, has opened up a culture of trust and an incentive to improve business models. 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.
“There’s no ‘I’m not sharing this because somebody wants to break it down and get competitive intelligence on it’,” says Walsh. “Companies are sharing information to improve logistics, products and studies, and get it all to the patient faster.”
There are a lot of regulations in importing and exporting medication, and having access to all the relevant information smoothes out minor hurdles so that products can be distributed across countries much easier.
Counterfeit drugs
One of the big benefits for companies joining the network is the security of supply. Avoiding counterfeiters is a small part of this, but the major upside lies in the ability to declare the parameters of a clinical study, and then work directly with another company to get the required medicine available in correct quantities and on time.
Before the network was established, biopharma companies would have to contact multiple vendors and wholesalers, purchasing drugs in different countries to try to get the amount of product needed.
“You would have to maybe buy 2,000 units out of Estonia, 2,000 out of Italy and so on, pulling material from different sources and potentially creating shortages for the patients,” Walsh explains. “But if a vendor has a forecast for how much product is going to be used in a particular region or country, then they can get units to the correct location much quicker, without the need for all these plans and source purchasing, and greatly decreasing the risk of going out of stock during a study.
“Right now, because of the network, you can go directly to another company and say ‘I need 10,000 vials of product before this deadline. Can you provide it?’.”
It can be difficult to obtain the correct paperwork required when purchasing medicines on the open market; many countries require documents such as import and export certificates of analysis, and TSE certification. Temperature and stability data can be almost impossible to get hold of unless you happen to be on good terms with someone at a competing organisation. Now, the Comparator Network is making a significant impact on this issue.
“One of the data documents we have is how to deal with bottles or vials being stored outside of their recommended temperature range,” Walsh explains. “This means we can make an analysis on whether a product is still good despite temperature changes, right there and then, so the patient isn’t inconvenienced. For example, if a patient is told by a physician at the clinic that their site had a power outage over the weekend and the product became too warm, the site can call the company’s sponsors and say, ‘We’ve had a power outage and we want to know if the product is still okay; it’s sat at 10°C for this many hours’. The sponsors can look at the data and reliably say [whether it is fine to use].”
The Comparator Network has helped enhance patient safety by providing information on the sources of materials and comparator drug documentation. This has limited the chance for counterfeiters to enter the supply chain and allows the continuity of drug supply for products used in studies. The network can prevent counterfeit products because it enables biopharma companies to work directly with manufacturers.
“I can know exactly what I’ve ordered, when it was manufactured, even the shipping company that’s bringing it to us,” says Walsh. “I can get a PO, I know the batch numbers – all of this data is available to me ahead of time. If you’re manipulating cells, you either want to do it on site with the patient standing next to you or, if you have to send it away, you want it sent back to the exact same patient with no potential for a crossover.”
Clarity and specificity are paramount. With so many criminal organisations out there creating counterfeits, it’s hard to tell which node of the supply chain they’re going to break into. What the network has helped to do is shorten the supply chain so that it consists of only two points: the manufacturer and the sponsor of the study.
“Now, there will be emails directly from one company to another on the network asking, ‘How do you benchmark the price?’, ‘How do you ensure quality control?’,” Walsh explains. “Traditionally, if you had asked these questions, you’d either get no response or you might get one person answering quite vaguely and refusing to divulge too many details.” Now, the TransCelerate Comparator Network has annual or biannual meetings hosted by a company on the network, where various speakers will present from across the industry. “We’re not sharing secrets or things like that but discussing different parts of the industry, and I really think that’s a huge benefit for all involved,” says Walsh.
Prepare to adapt
Walsh feels there are still some logistical problems that the network must overcome, such as working on the best way to distribute cold products. “Some of the new dosage forms we’re going to be looking at will be frozen products,” he says. “We will need to know the best way to get that from the sponsor’s depot to the patient, and the quickest way to do it. That’s going to be another big challenge.”
For TransCelerate, the modus operandi is eliminating the faux secrecy of the process; after all, companies are aware when their rivals are purchasing their products because they publish the fact that they’re entering phase-III trials.
“We all have supply chains, and there are unknowns that happen every day – it’s just the way it works,” says Walsh. Companies can now make specific requests for information to compare processes and the other manufacturer will be able to provide it.
“The relationships that have been forged between the companies are probably what I’m most proud of,” he remarks. “We’ve had cases where, for example, one company lost a whole bulk shipment of product because there was a mistake in the logistics. The medicine was left on the tarmac overnight in a very hot region for two days and everything failed. Even with the stability data, you can only do so much. But another company was able to provide their product instead. It’s about working together as opposed to saying, ‘That’s your problem, not mine’.”
For biopharma companies, one of the givens of the industry is change. How ready is TransCelerate to deal with future developments? “With the relationships we have with the companies on our network, we can get a different set of eyes on every problem, and I think that really makes any solution we come up with so much more solid,” he concludes. “So I think that whatever comes, we’ll be able to act.”
