BioCelerate for Preclinical Collaboration

Dalvir Gill, CEO of TransCelerate, recently announced the formation of a new subsidiary, BioCelerate, aimed at increasing efficiencies of drug discovery in preclinical research. In this interview, Gill will describe BioCelerate, and elaborate on his experiences with TransCelerate.

Moe Alsumidaie: How did BioCelerate come to fruition, and who are the key personnel heading up BioCelerate?

Dalvir Gill: As TransCelerate solidifies, the governing model and how we collaborate is becoming clear (i.e., the basic belief that working together to capture efficiencies allows for better, faster and easier innovation than working completely in isolation), and we are discovering that this collaborative approach can be successfully applied to other areas across research and development.

When founded, TransCelerate focused on clinical development, as there were challenges identified most amenable to collaboration, and we believed that together, we could make a quick impact on some of the industry’s most significant issues. Because of our successes addressing shared industry challenges through TransCelerate initiatives, we realized that other parts of R&D can also benefit from a similar collaborative approach. Hence, our leadership began discussing the idea that perhaps we can leverage the learnings from TransCelerate and apply them to a different model, maybe a stand-alone entity focusing on preclinical. It quickly became clear that leveraging TransCelerate’s infrastructure, policies, procedures, methodology, successes and management, would be of interest to our membership

Subsequently, six TransCelerate Member Companies formed BioCelerate, a subsidiary to focus on identifying innovative solutions for operational challenges in the preclinical space. Those companies include Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Novo Nordisk and Shionogi. Like the TransCelerate model, each one of these companies have membership on the BioCelerate Governing Council, which consists primarily of senior-level executives (i.e., senior vice presidents, heads of toxicology, and leaders of preclinical research). I sit on that council, like I do on the Board of TransCelerate. Additionally, similar to TransCelerate, BioCelerate has initiatives, and the first, the Toxicology Data Sharing Initiative is led by Mike Graziano, Vice President, Drug Safety Evaluation, PhD, DABT, at Bristol-Myers Squibb. The knowledge gathered through the BioCelerate Toxicology Data Sharing Initiative will help with effective translation of nonclinical findings and attempt to close critical gaps that exist in understanding the relationship between patient response and preclinical toxicology findings. It will enable access to a broader cross-company set of toxicology data.

Although we are starting out with six companies, I think there'll be more, just like TransCelerate started with 10, and doubled pretty quickly.

MA: TransCelerate tends to use conferences and media as the channels to update its audiences.  What will BioCelerate use to attract new enterprises, and update its audiences?

DG: We’ve learned through TransCelerate what has worked in terms of disseminating a message. We don’t make a lot of noise unless we have something substantive to announce. I expect that there will be some silence about BioCelerate until we have further advanced the organization, perhaps it’ll be a position paper, the creation of a new data sharing repository or the launch of additional initiatives.

MA: TransCelerate has faced industry skepticism and opposition when it first launched.  Do you expect to experience similarities with BioCelerate?

DG: I would say that there wasn’t opposition per se, but there was skepticism; different people in different parts of the ecosystem were a little cynical and somewhat nervous about what we were doing, and how it might impact the clinical trials landscape. I think that's all behind us, and the realization across the industry is that it’s inevitable for us to become more efficient, and collaboration is one way to achieve efficiency. The skepticism with TransCelerate has abated and that has given birth to enthusiasm. Although BioCelerate is in a different sector, there’ll be some time before a similar level of enthusiasm generates. We have not seen any opposition or a similar level of skepticism to what we saw with TransCelerate because the collaborative model is now a proven example that we will replicate.

MA: What changes have you made to veer off skepticism?

DG: There are so many stakeholders that we proactively engage with, such as regulators, CROs and investigator study sites. I sit on the SCRS Leadership Council to make sure we listen to what sites think are important. Similarly, I sit on the Executive Committee of CTTI, and TransCelerate regularly engages CROs through the CRO Forum with ACRO. We also regularly meet with a broad set of industry organizations to ensure we’re not replicating work efforts of another entity. We are able to address different stakeholder concerns and viewpoints, and are bringing stakeholders into the ideation process rather than having them watch from the outside.

MA: How does BioCelerate’s preclinical focus relate to clinical trials?

DG: Everything that drug companies do in preclinical translates into clinical trials. If these companies can improve predictability, reduce drug attrition rates and share information to help each other, they can streamline clinical trials and develop more drugs with the same amount of resources. Our dream of helping pharmaceutical companies achieve lots of targets and turn elegant science into successful medical products is now becoming a reality. A bigger challenge involves whether companies have the resources to develop all of these great ideas. The more efficient they can operate in different parts of the R&D landscape, the more they are able to accomplish with their available resources, and that includes the preclinical space, which BioCelerate aims to address.

MA: Will there be any overlap in initiatives between TransCelerate and BioCelerate?

DG: TransCelerate and BioCelerate are two separate entities; BioCelerate will use similar infrastructures as TransCelerate, but, it will have its own projects, governance, members and funding. Right now we don’t see any overlap--a potential integration opportunity in the future could be that initiatives that could benefit from using the same database to store information, however, the information itself may not overlap across TransCelerate and BioCelerate. It’s possible for there to be synergy between the two organizations. At that time, the collaboration might be something both organizations are actively examining, such as data sharing.

MA: Can you elaborate on the Toxicology Data Sharing Project?

DG: BioCelerate’s Toxicology Data Sharing Project is aimed at sharing enormous amounts of toxicology information to improve predictability during drug discovery. In the Placebo and Standard of Care Initiative within TransCelerate, we are pooling clinical trial data from some of our member companies in a manner that is amenable for everybody to use, so that the member companies’ statisticians have access to tens of thousands of patient data points instead of a few hundred from a publication; their power increases, and their trials become more predictive. Similarly, with BioCelerate’s Toxicology Data Sharing Project, enormous data exist on the toxicological impact of different types of molecules that often resides within an individual company, and never leaves its auspices. This data can be very useful for another company so that it might avoid proceeding through the drug discovery process unnecessarily.