As budgets tighten around the world for the pharmaceutical industry, the question of which area should receive the priority for funding lingers for those designing the trials. How exactly do you balance the books – and needs of your trial – in a time of booming technology, patient-centrality, and a legion of regulatory changes and compliance issues?

Didier Basseras, vice-president of clinical supplies at Sanofi, is a firm believer that there is no magic formula for properly designing a trial that is able to achieve all the goals required for it while remaining compliant and, importantly, financially profitable for the pharma company running it.

A pharmacist by background, he’s been working at Sanofi’s French offices for several years with the idea of making sure that all these goals are not mutually exclusive, especially through the role of supply chain management, which, according to him, “has seen a big change in the past ten to 15 years”.

“There are things that have evolved a lot, so it’s important to be part of the discussion today about some of the challenges tomorrow,” he adds.

But where does the industry currently stand? With regard to trial supply management, the general feeling is that it is often hesitant to change.

“Taking a step back,” Basseras says, “We must keep our core business goals in the pharma industry in mind: to deliver more complex solutions and precise medicine to patients. This really is the core driver of our work.

“The major priority is efficiency,” he continues. “How can we be more efficient? How can we deliver a solution in a quicker way, and for the local market? We have seen an increase from around €1 billion to €2 billion in costs to go to market for one product.”

Pulling the levers

Basseras believes that there is no one way of making a trial more efficient and economical to combat this massive jump in cost, but a responsible firm looks at a strategy of pulling levers – essentially, tweaking all the different levels of cost and operations to find out where savings can go. At which point, though, will penny-pinching impinge on success? It’s this balance, Basseras believes, that can make clinical trials become more efficient. It requires a keen eye and razor-sharp focus to monitor the effects that these changes have overall but, in the long run, it can bring a trial to a more time and resource-friendly level. This can, in turn, enable a company to conduct more trials over time and help it to expand.

The need to deliver new techniques without having to pass on the cost to the patient is a sticking point in the world of trial management.

The cause for the jump in cost – and consequent need to hit the books, and make sure that trials are run as efficiently as possible – is down to a number of factors, according to Basseras. “One of the things driving up the cost is stronger regulation on safety in clinical programmes,” he says.

While these regulations and needs for compliance are generally met with consternation, the continuing involvement of a larger number of nations in clinical trials means they are essential. More emerging-market countries are taking part in clinical trials, especially as host countries, so regulators in the EU and US markets must monitor things closely. Furthermore, the impending effects of Brexit will lead to a whole new level of bureaucracy as the regulators and watchdogs must become separate, and possibly establish new UK systems and rules.

In addition, the industry has shifted in a significant trend from small molecules to biodrug delivery, Basseras explains. While they may be the way of the future, these biodrug breakthroughs do lead to a more time-consuming and expensive way of building possible vaccines and treatments.

“We grew from classical chemistry to a very diverse model to support all the biomolecules. Variation is required and we have to change the way we conduct clinical programmes,” he says. “But the development cost for the biocompounds is very different from [what we had in] the past.”

This new type of treatment is stronger than what was on offer before, but the cost can be prohibitive, so a balance must be struck. “The final objective is to be able to deliver the solution and identify a way to facilitate market access for all patients,” he adds.

Multilevel approach

The need to deliver these new techniques without having to pass on the cost to the patient is a sticking point in the world of trial management. One important way of creating efficiencies through the network, Basseras says, is to ensure that every level of the chain – from lab technicians, patient liaison officers and site managers all the way up to the executives in the pharma company – is aware of costs and pressures in other departments as well as their own. The aim is to create a culture in which all the teams realise they have to work together and prevent any one area from refusing to lean their processes.

“With biodevelopment pharmaceuticals, the teams have a chance to see how capable they are of executing the strategy. I would say that, in some situations in the past, workers have not been able to find a way to facilitate execution,” he remarks. This idea of transparency across levels is now locked in – and should be a driver to do things better and faster, bolstering the ability to execute at an early stage.

Another method for making processes more efficient is leveraging big data, which Basseras sees as the way of the future.

“Big data allows us to see where we are complicating protocol and the speed at which we can get to the end stage.

“But we need data that would never be used for other programmes. We see cases where a lot of data is collected – but for what purpose? A lot of energy is expended but, in the end, the information is of no use. [Using data correctly] is a way to save resources and influence the total cost,” he explains.

“Focusing on core processes is a great way to simplify the protocol. Using digital records, we can evaluate how certain parameters can have a major influence on the ability to recruit patients, for example,” he says. “From just one parameter to another, you can add value to processes. This can make a big difference in the field, from patient recruitment through to planning and execution.”

The next big thing

Basseras believes that over the next five years, the industry will be forced to react to many challenges. One key way it can counteract the endless rising costs is to bridge the value of the drug with additional features that are expected by the patient.

“When we speak of ‘patient-centricity’, we are talking about figuring out devices and key services around the drug that can help the patient to manage the disease,” he explains.

“It’s certainly something the industry should aim for in terms of development. The valuation is made up of different pieces that have to be part of the assessment from the beginning of a new programme or product. It’s obviously a challenge to manage all of the pieces at the same time,” he says. “Managing the development of a compound is already difficult and expensive, and becoming more so. In terms of achieving good results for the patient at the end of the trial, the challenge is greater than ever before.”

Basseras believes it’s a priority to give patients a bigger role in the trial. It must be done, despite the pressures of potential trial redesigns.

“We have to consider how to bring a drug that is accessible to all patients, regardless of economic situation, to market. It is definitely a challenge to find a major distributive route for new compounds that can treat some of the chronic diseases. It’s not only treatments for rare diseases but also some chronic diseases that present a price barrier, and we cannot ignore people who cannot afford to be treated.”

With all these competing priorities, it’s going to be difficult manoeuvring through the next decade. Prices for running trials are spiralling, but the causes of this – safety regulation and the development of new therapies – will benefit patients in the long run. Companies must start ‘pulling the levers’ wisely, making necessary tweaks in order to balance the books, and do so with an eye on the long term.