Pharma & drug development

Could cutting out mediators let cancer research off the leash?

University of Texas MD Anderson Cancer Center has been talking about its innovative approach to cancer research. By connecting pharma companies with academics, rather than relying on CROs, the team says clinical trial costs can be reduced and drug development accelerated. Abi Millar finds out more about this collaborative approach.

In 2014, Bristol Myers Squibb (BMS) and The University of Texas MD Anderson Cancer Center announced a pioneering research collaboration. They would evaluate multiple immunotherapy drugs as potential leukaemia treatments, running a number of studies in tandem.

This collaboration was notable for several reasons. Firstly, it dispensed with the usual one-drug, one-cancer approach to clinical trials, by testing several drugs (both in mono and combination regimens) at the same time. Secondly, it didn’t involve a contract research organisation (CRO), but rather brought academia and industry together directly.

“Collaborations between industry and academia can offer a faster and broader spectrum of clinical trials to benefit patients,” said Hagop Kantarjian, chair of leukaemia at MD Anderson, as the partnership got underway. “We hope innovative collaborations such as this can help lead to a higher likelihood for success across the board and will speed up the clinical development of new compounds for delivery to the patients who need them.”

Since then, the partnership has reaped impressive results. Already, it has led to a new standard of care for chronic myeloid leukemia, by optimising the dosage of dasatinib to make the therapy more effective and less toxic. As patients typically take this therapy on a long-term basis, any reduction in side effects will have a major impact on their quality of life.

On top of this, the research model itself has proven highly effective. Both Bristol Myers Squibb and MD Anderson are now applying it elsewhere: BMS is working with other academic institutions and MD Anderson with other pharma companies. According to Ferran Prat, senior vice president for Research Administration and Industry Ventures at MD Anderson, strategic alliances of this kind have clear benefits for all involved.

“We are not smart enough alone and nor are the pharmaceutical companies – we have complementary skills,” he explains. “Everybody knows and accepts that, yet the business framework we were using till now didn’t reflect that.”

Cutting out the middleman

Together with primary author Hagop Kantarjian and several others, Prat recently produced a paper assessing their alternative research model. The paper, published in the journal Cancer in May, runs through the ways cancer research has evolved over time and explains why today’s standard methodologies are not necessarily the best option.

For background, recent decades have seen a strong shift towards pharmaceutical outsourcing, with pharma companies contracting ever more of their workload to CROs. This enables them to tighten their focus on late-phase drug development and marketing, while giving them access to resources and skills they may not have in-house.

However, according to the MD Anderson team, this methodology can often backfire: it limits patient access to studies, slows down drug development and inflates costs.

“When a CRO is involved in the trial, academic researchers are almost completely cut off from the pharma company – you have an organisation in the middle whose goal, almost by design, is for you not to ask questions,” says Prat. “We don’t think that’s efficient or serves patients well. Cancer is already very complex and we need all the help we can get.”

Believing that this model is inefficient, and the separation between investigator and sponsor artificial, MD Anderson’s Strategic Industry Ventures group has been working for some time to cut out the middleman. The group now has more than 50 research partnerships and alliances with pharma companies.

“The Bristol Myers Squibb collaboration was the first one where we had equal say on the trials that get done and how they’re designed and executed,” says Prat. “If it’s not strategic for the pharma company they won’t want to do it, and if we think it’s going to compromise the patient safety we’re not going to do it, so it needs to be agreed by the two.”

As he explains, BMS made a financial commitment to cutting bureaucracy, allocating a set level of funding to the programme at the outset. This meant there was no need to waste time negotiating on a trial-by-trial basis. What BMS got in return was scientific expertise from the researchers who were actually conducting the studies.

“Under the old framework, companies would have scientific advisory boards that meet maybe once a quarter – that doesn’t cut it,” he says. “Here the people who are doing the work are the ones who advise on the protocol design, the challenges and toxicities that are anticipated, and how we handle that. A close interaction can bring all these aspects together in a more efficient fashion.”

A flexible approach

Perhaps the clearest advantage of this research model, however, is the fact it allows researchers to arrive at findings more quickly, speeding up the notoriously protracted drug development process.

“Our idea was to explore the power of checkpoint inhibitors in certain leukaemias,” says Prat. “If we had done this one-by-one, the way it’d have been done traditionally, it would have taken forever. But since we ran several trials at the same time, we’ve already seen several positive signs of efficacy.”

On top of this, the researchers were able to widen access to their trials, to include certain high-risk patients who would have been ineligible under CRO restrictions. This is particularly advantageous in the case of rare diseases like leukaemia, where patient recruitment can be tricky.

Because this cancer research model is flexible and modifiable, the MD Anderson team believes it is well suited to more widespread use. Prat thinks we may see a movement towards deeper collaborations in future.

“It’s not for everybody – for example the BMS collaboration would not have been possible in many places because you need a certain number of patients,” he says. “If you’re a centre that sees relatively few patients, then a different model is needed that pools your resources with other institutions and then things get more complicated. But for elite centres with the volume and expertise, I do think this is the way to go.”

He feels that, while using a CRO might be justifiable for a 50-site phase 3 trial, it’s not the most efficient approach in the earlier stages of research – in fact, he describes their use in proof-of-concept studies as completely counterproductive.

He also thinks that historical tensions between industry and academia are starting to be put to rest.

“Decades ago there was a slightly antagonistic relationship between research institutions and the pharmaceutical industry, where industry was seen as a little bit of a necessary evil,” he says. “I think that’s changed, and it’s changed completely at centres like ours, where we see industry as a partner. If we want to defeat cancer we need all the smart people we can use.”

This article appears in the August 2018 edition of Pharma Technology Focus

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