For a small biotech company, going from preclinical research into clinical trials is an important milestone. But it’s also a costly and complex step in drug development. Historically, companies have had two options for making this leap — build their own internal infrastructure or rely on outsourcing. Vishal Mehta, MSHS, Founder and CEO of Ubuntu Research, developed a third option: his company’s subscription-based model to create streamlined, cost-effective clinical trials. Cure spoke with him about his approach.
This conversation has been edited for length and clarity.
Cure: What is the idea behind your model for clinical development?
Mehta: We developed our model and our business service by looking at how we can do things faster and mitigate risk along the journey. It takes a lot of effort for small companies to identify the resources and talent to establish the business processes that are necessary to run clinical trials in a highly regulated environment. We have taken a holistic look at this and combined it in one product, a subscription model called Dimension-T™.
This means that you only buy or use as much as you need to reach the next business milestone, which may be a proof-of-concept or a Phase 1 or a Phase 2 readout. You pay as you go rather than having to invest upfront in developing a full-scale clinical program. Biotechs don't necessarily have to reinvent what has already been created in the larger ecosystem.
What are some examples?
If a company is at a pre-IND stage, just ready to file the IND or want to start the clinical trial, there are different aspects of people, process and technology that we would embed in those scenarios.
On the technology side, we've created standardized databases. We have a library of case report forms. We've created a data product that allows the assimilation of all the data that's collected in a clinical trial, specifically in cell and gene therapies. It's more than just the clinical data. It's manufacturing, quality, process control data — that all becomes part of the package that you submit to the FDA. We've created many platform-level solutions that allow companies to feel comfortable to partner with us, not just on a service basis, but truly on an end-to-end basis from IND to BLA filing.
What advice do you have for entrepreneurs who are looking to execute a clinical development program?
We hope that entrepreneurs are attuned to the idea of “fail fast, fail early.” What I add to that is “fail cheap,” because what you want to do is not invest too much of your resources in fixed infrastructure, should you not succeed in Phase 1 or have to go back to your labs and do some more product development work. Using clinical services in a subscription-oriented way allows them to have flexibility, the nimbleness to grow their business as they reach important business milestones.
How is this different from a Clinical Research Organization?
CROs typically provide tactical services. We're more of an internal think tank that helps plan the clinical strategy, the regulatory strategy, the market access strategy. We have partnerships with CROs to enable the execution where we have streamlined downstream activities. Again, the idea is that we don't want to recreate this for every biotech.
What’s next for your company?
We're in conversations with venture capital firms to see if we can create this in a way that allows all the portfolio companies within the venture capital group to be able to take advantage of this resource on a more centralized basis. With a more standardized tool set, they can start to build confidence around the execution of these programs, which is key to delivery, particularly in cell and gene therapy in the oncology field. You may have the greatest of science, but if you can't get it through the different stages of clinical development, you're not able to translate that into patient benefits.