TransCelerate Carves Out New Group For Preclinical Collaboration

Goal is to streamline preclinical development through cross-company sharing of target-based toxicology datasets.

Having made substantial progress on its original goals of clinical trial coordination, the industry collaborative [TransCelerate BioPharma Inc.] is launching a subsidiary to pave some of the same ground in preclinical processes.

Launched in 2012, TransCelerate began with a task list to create a shared user interface for clinical trial site portals, a mutually recognized trial site qualification and training process, risk-based site-monitoring approach and standards, uniform clinical data standards, and a model for supplying trials with comparator drugs for control arms (Also see "Major Pharmas To Collaborate In Non-Profit Initiative To Resolve Clinical Development Hurdles" - Pink Sheet, 19 Sep, 2012.). TransCelerate CEO Dalvir Gill said the organization, whose membership comprises 19 biopharmaceutical firms, including 10 of the top 12 big pharmas, has made considerable progress in most of those goals, while also establishing some new ones.

Now, six of the member companies want to apply the model to standardizing preclinical toxicology data with a data-sharing initiative, which will be the first task for a TransCelerate subsidiary called BioCelerate. The goal is to allow members to access broad-based cross-company sets of target-related toxicology data to streamline the preclinical drug development process, hopefully leading to benefits during the clinical development process as well, Gill said.

Gill told "The Pink Sheet" DAILY that the initiative, under the direction of Bristol-Myers Squibb Co. VP of Drug Safety Evaluation Mike Graziano, is still taking shape and it's too early to discuss timelines for any deliverables. Lawyers from the six member companies – Bristol, Eli Lilly & Co., GlaxoSmithKline PLC, Boehringer Ingelheim GMBH, Novo Nordisk AS and Shionogi & Co. Ltd. – are also working out how to do this data-sharing while protecting each company's intellectual property, he said.

"What we do know today is that if there is information available within company confines that is made available to a wider set of companies in a sharing configuration, that would help those companies make better decisions when it comes to toxicity," Gill said. "What exactly that will look like is hard for me to predict."

In three-plus years, TransCelerate has roughly doubled its membership (from 10 companies to 19), increased its work to 14 projects and provided some methodologies that are reducing the time and repetition involved in setting up clinical trials – clearing trial sites, making sure clinical trial investigators are qualified.

In recent months, some of the member organizations wondered whether it made sense to set up a new organization to pursue preclinical development streamlining, but ultimately the decision was to create a subsidiary for this work that could leverage TransCelerate's learnings, infrastructure, policies and governance.

"This was the fastest and probably the most efficient route, and also one that probably had a greater chance of success than a brand new configuration somehow," Gill said. "So we created the entity with TransCelerate being its sole member, shall we say, and only TransCelerate members then are eligible to be members of BioCelerate."

The toxicology data-sharing initiative is being led by a governing board composed of representatives from the six BioCelerate member companies. In the future, however, BioCelerate probably will undertake other initiatives and have additional members, Gill said.

"The goal of this project is to allow companies to make better decisions in the case of this toxicology area," he explained. "Companies don't always have as good an understanding [as they might need] of on-target versus off-target toxicity. The amount of information that they have is limited. The more data you have, the better decisions you can make."

Sharing "Rare Findings" For Industry-Wide Benefit

Companies sometimes come up with "rare findings" in doing preclinical toxicology work, but the industry as a whole doesn't necessarily benefit, Gill continued. "The data often just sits there and isn't shared for the benefit of the wider toxicology community."

While the scope of the project "hasn't been fully defined – what we will share, how we will share it, how long it will take to build the database, whether we will partner with somebody that has work going on in this area," Gill said, at present the idea is to mimic a TransCelerate initiative under which the member companies share placebo and standard-of-care data.

"The companies within TransCelerate have agreed to load their entire placebo/standard-of-care database into a single platform, which will then allow all companies to interrogate that data at a therapeutic level," Gill noted. "That's going to be a massive amount of information statisticians can use to power studies, for example, versus their limited information [derived from] publications. For toxicology data-sharing, the same will apply."

To date, TransCelerate has made some of its greatest strides in processes for risk-based monitoring of clinical trial sites, the exec said.

"That project has already truly impacted that whole landscape," he asserted. "It's not that the team created some new methodology for risk-based monitoring, it brought consistency to the environment. So now we publish papers [that] are all in the public domain – the vast majority of what we do and wherever feasible, we make available in the public domain. Any company, anywhere can use that for their benefit if they choose."

Multiple position papers on risk-based monitoring have been developed by TransCelerate in partnership with regulatory bodies, Gill noted. These include papers on methodology for technology considerations, source document verification and centralized monitoring. "Today there are hundreds of clinical trials across the membership and probably a lot more than that across the industry using the methodology we published," he said.

Another success has been in harmonizing good clinical practice (GCP) training.

"We asked 'why do we keep training sites for GCP again and again, company to company, sometimes within [different] therapeutic areas from [the same] company,'" Gill pointed out. "Today, hundreds of thousands of GCP certifications have been issued by TransCelerate, enabling mutual recognition of training, so that essentially the member companies of TransCelerate and other companies that use those certifications are avoiding GCP training for individual investigator sites for three years on the basis of somebody else having done the GCP training that we've all agreed to in terms of minimum standards."

In addition, hundreds of transactions have occurred under a master service agreement covering the full TransCelerate membership that eases obtaining comparator drugs for trials.

"Companies are sourcing information from each other proactively with plans in place, not having to buy stock in some weird location around the world to repackage for a clinical trial, with all the stability data they need and all the temperature excursion data that they need," Gill said. "The knock-on effect of that has been pretty substantial to the industry and the companies."