The name alone excites many in clinical research. It’s the first—or so far best promoted—consortium consisting only of high-level people from big biopharmaceutical companies, each vowing to be deeply “pre-competitive” with one another while trying to rework some of the redundant and wasteful practices endemic to clinical research.

The nonprofit TransCelerate bills itself as not just 21 executives discussing change but, rather, 21 executives actually attempting to dismantle inefficient processes as soon as possible, redesign better ones and then implement more logical methods for the industry to use.

TransCelerate launched in 2012, and the industry has been waiting eagerly for the group to make good on its promises to bring innovation to the bottlenecks in R&D. In its three years, what has TransCelerate accomplished thus far?

At its inception, the group’s members chose projects they thought would have fast turnaround, said Dalvir Gill, TransCelerate’s CEO.

“To start, we selected five areas that seemed eminently doable that had, to a significant extent, reasonably short runways and would take a year to a year and a half to accomplish,” he said.

Those were:

• Risk-based monitoring (RBM)
• A shared investigator portal
• Site qualification and training
• Clinical data standards
• Comparator drugs.

TransCelerate rolled up its sleeves and got to work, with members meeting frequently. But none of those problem areas was as easy to transform as originally thought. On each, TransCelerate has had incremental wins, but work on all of them continues three years later, said Gill, formerly president of PharmaNet/i3’s phase II-IV development.

For example, take RBM—the concept of monitoring clinical trials centrally via data collected through electronic data capture (EDC) systems rather than by monitors visiting each site every six to eight weeks.

Since the FDA and EMA said in 2011 those in the clinical research space should begin implementing RBM, pharma companies and CROs have been scratching their heads about exactly how that should be structured and what regulatory bodies would accept. Within about eight months, Gill said, TransCelerate came up with a prescriptive position paper on how exactly to go about instituting RBM. As with most of TransCelerate’s accomplishments, the learnings were placed in the public domain.

The group’s biggest win thus far: its paper on RBM, available on the TransCelerate website. So far it has had 2,000-plus downloads.

But some in the industry say TransCelerate’s work on RBM hasn’t been groundbreaking.

“The papers were interesting, but not revolutionary,” said a source who asked not to be named. “There may have been some incremental process improvement there. That’s what a lot of their agenda is so far: looking at incremental improvements—nothing huge. Now, if they are successful in coming up with something like a common protocol template, that could be really impactful. That could be huge.”

But there’s more to come on RBM, Gill said. TransCelerate member companies are conducting 26 pilot studies on their use of TransCelerate’s RBM model to see if it actually works and is, in fact, worthy of widespread adoption. So far, results are looking good, he said.

“Overall, we’re seeing a reduction in effort using our method,” said Gill.

Still to come: the group’s shared investigator portal, due to launch this summer, and a position paper on quality management, also due out soon. Work is underway on a protocol template. And the group now also is looking at returning clinical trial results to patients, clinical trial diversification and increasing efficiencies in pediatric trials.

Hurrying an organization like TransCelerate is not realistic, said Hani Zaki, a pharma industry veteran and consultant.

“I think we were all expecting there to be some immediacy to these initiatives,” said Zaki. “But in an organization like this, people need to feel their way in the beginning. Infrastructure needs to be built, as does trust. Initiatives have to be assessed, directions decided. Plus, there are politics and agendas to sort out as the largest biopharmaceutical companies in existence try to sit down at the table together. It’s a Herculean task. To expect miracles in the first one or two years is asking too much.”

The group is making headway as fast as it can, said Gill.

There’s the data standards project, in which TransCelerate now works with the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute (C-Path) and others to develop industry-wide data standards in important therapeutic areas. This would speed research by supporting the exchange and submission of clinical research and meta-data.

“CDISC has a target of 55 therapeutic standards in five years, which they are unlikely to achieve,” said Andy Lee, head of global clinical trial operations at Merck, which is a new TransCelerate member. “TransCelerate brings together experts in data standards to help the effort go faster. In collaboration with CDISC, we have completed 12 therapeutic standards, and seven more are slated for this year. That’s incredible work.”

“We’re moving the speed at which therapeutic areas are developed, as opposed to letting it go at the usual speed,” which is very slowly, said Gill.

Another area in which Gill says the group has made strides is its Comparator Drugs for Clinical Trials Initiative. And the progress there was against the odds, he said.

“This is the project that everyone said would never work,” said Gill. “They said, ‘There’s no way biopharmaceutical companies will share their drug with a competitor company working on a competitor drug.’”

But that has not turned out to be the case. In the two and a half years since its launch, an unnamed subset of TransCelerate members have participated in about 50 transactions that have made it easy for competitors who also are TransCelerate comparator drug network members to get their drugs used in the comparator arms of trials.

The upsides, said Gill, include reducing the delays that often result when a sponsor orders comparator drugs through a third-party intermediary instead of directly through the drugmaker itself, and avoiding the inadvertent use of counterfeit drugs, which is common and fouls the accuracy of the trial.

Getting the drugs directly from the drugmaker increases speed and accuracy of that arm of a trial.

“People said this couldn’t be done because it cuts to the core of what we consider competitive,” said Gill. “But when you really dissect it, you realize it’s not competitive at all. It’s not as if your competitors are not going to get your drug to use as a comparator. They are. The question is: How painful do you want it to be?”

“This way,” he continued, “you know where your drugs are going, and those using them know they’re not sourced from some weird place on the other side of the planet. This is one of the ways we’ve been able to build economies of trust with one another.”

Added Lee, this initiative has been particularly useful when it comes to acquiring innovator drugs—biologics that are hard to transport and which become useless if stored at the wrong temperature.

“This program allows you to make sure the product is a stable, controlled drug and that it arrives on time and in the right number,” Lee said, adding that the savings thus far among companies in the network has been about $10 million.

Unlike all of TransCelerate’s other programs, papers and learnings, though, this one is not in the public domain. To gain access to the comparator network, one has to be a TransCelerate member. And that costs money.

While the group does not make its membership costs public, one source said membership dues are $1 million a year and companies must commit for five years. Membership also reportedly is structured on a sliding scale, so smaller sponsors pay less.

Briggs Morrison, chairman of TransCelerate’s board and executive vice president of global medicines development at AstraZeneca, said many member companies calculate return on investment to make sure their membership is not just a good thing to do for the future of the industry, but also that it’s benefitting them financially. And the comparator drug initiative is very popular from that standpoint.

“A lot of them report that program alone already has given them enough of an ROI to make membership worth it,” he said.

Is TransCelerate really as unique as its proponents say? Yes and no, said Melissa Stevens, deputy executive director for FasterCures.

“We all know the status quo in drug research: It takes 15 years and a billion dollars to get from the bench to the finish line, and only one in 10,000 molecules makes it,” she said. “That is not sustainable.”

But crisis breeds creativity, she said, and now groups in which competitors become collaborators are “the new normal.”

FasterCures last year found 367 such “pre-competitive” biopharma-focused consortia have launched since 1995, 50 of them in 2012 alone—the year TransCelerate launched.

But, said Stevens, TransCelerate is unique in that it allows only pharma company execs at the table—no CROs, sites or FDA members.

That could change, though.

“So far, they’ve just been an operations-efficiency play, working on administrative things,” said Stevens. “With a narrow scope like that, it might make sense for them to have just pharma companies as members. But as they begin moving toward the higher-hanging fruit, I wouldn’t be surprised to see them expand and bring others to the table.”

This year, TransCelerate cracked open the door for CROs to have some input, with the launch of its CRO Forum, a group organized through the Association of Clinical Research Organizations (ACRO). The forum now is working with TransCelerate to add CRO perspective and insight on four “work streams:” RBM initiatives, site training and qualification, quality management systems and a common protocol template.

“It took about two years for ACRO to agree with TransCelerate about how it would participate,” said Alan Metz, Quintiles’ senior vice president and managing director of  strategic partnerships, and chairperson of the TransCelerate/ACRO forum. “During that time, there was a gradual recognition on behalf of TransCelerate that it didn’t have the depth and breadth in these particular areas and it needed to work with CROs if it was going to accomplish what it set out to accomplish.”

But will CROs—and others in the R&D ecosystem—ever be at the table as full members?

Maybe not, said Metz. As TransCelerate is currently structured, he said, not all of its work streams intersect with the purview of CROs, including the comparator drug initiative.

But TransCelerate has said it is open to talking to the CRO Forum about additional work streams in which the two can work together, Metz added.

TransCelerate currently has 21 members. Many non-members—including Amgen, Celgene, Novartis, Otsuka, Takeda, Shire and Immunogen—declined to be interviewed about why they have chosen not to join.

Morrison said there are many reasons a company might not sign on. “There are people who say, ‘This is expensive, and what am I going to get for it? What will I do better and faster if I join?’ And then there are others who say, ‘I’m doing this for the good of all, and my return on investment today isn’t necessarily the be all and end all.’”

He said others decline because they know the lion’s share of what TransCelerate accomplishes will end up in the pubic domain anyway. And others don’t join because they can’t spare their top people for as much time as TransCelerate asks them to spend at the table with the consortium, Morrison added.

The point of TransCelerate, said Morrison, is to bring some logic to an industry that was developed in a hodge-podge way, and, because of that, now is deeply inefficient and needlessly slow.

“If you look at the way we develop drugs, it wasn’t designed,” he said. “It grew organically. What TransCelerate is trying to do is put some logic and standardization around it so we can all go back to competing with each other on molecules and not waste so much of our time on all the processes.”

If TransCelerate succeeds, in a few decades there no longer will be any need for the group to exist.

“By the 10-year point, I think we’ll have made some significant changes to the way we all work,” said Morrison. “In 20 years, I suspect clinical research will look nothing like it does now, and TransCelerate, having accomplished what it meant to, will be gone.” 

 

Suz Redfearn is an award-winning journalist and former senior staff writer for ClinPage.com. Her articles have appeared in numerous publications, including the Atlantic.com, the Washington Post, Slate, Salon, Politico, Men’s Health, MedPage Today and Physicians Practice. Suz holds a degree in print journalism from Loyola University in New Orleans and has been a medical writer since 1990, focusing on clinical research since 2007. Email suzredfearn@gmail.com.

This article was reprinted from Volume 22, Issue 06, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>