Last week, Slope announced the appointment of its new Vice President of Scientific Operations and Development, Mark Melton. As the founder of consulting firm ClearPath Biomarker Ops, Mark joins the ranks of Slope’s leadership as the organization works toward delivering a comprehensive solution for clinical trial execution from study start-up to study close. Mark’s consultative services and support in areas like biomarker operations and data management will augment Slope’s software platform by facilitating study planning, operational decision-making, and site-to-lab data management for its customers.
We sat down with Mark to glean his perspective on the greatest challenges pervading today’s clinical trials, what he thinks makes Slope’s clinical trial execution platform so disruptive, and what his new role will entail.
Why did you join Slope?
When you look at all of the tech solutions that are out there for clinical trials, most of them are segmented and fragmented in the market because they don’t talk to each other and only solve part of the overall problem. Moreover, the vast majority of services are sponsor-facing and CRO-facing. The site was an afterthought. Some solutions offer integrations for sites, but they don’t have site-centric technology that sites would want to use. Instead, various systems are forced on them as a part of running a trial.
What’s great about Slope is that it already has such a large presence in the site world, and it is still growing. By marrying my knowledge of the sponsor and CRO side of the business with a site-centric software platform, Slope could offer the first-ever end-to-end solution for clinical trial execution. Slope already has a tool that enables the user to follow a sample from the site all the way to testing labs. It is digitizing the lab manual and other standard documents, thereby reducing the paperwork and the back-and-forth that is involved in study execution. Service expertise is one essential piece of the puzzle, but we should also be leveraging technology in every corner of the industry where it makes sense.
What do you believe are the most pervasive challenges in clinical research today? And what do you believe are some of the root causes of those challenges?
The most obvious challenge that comes to mind is study complexity that has developed in response to precision-based medicine. In the past, our industry embraced a model where we discovered a drug, looked at its safety profile and pharmacokinetic modeling, but did not use the trial to demonstrate its precise mechanism of action. With the rise of precision-based medicine, we are now zeroing in on specific genes, proteins, and other biomarker targets. We need to be able to demonstrate a drug’s ability to stimulate these mechanisms of action, and regulatory bodies are increasingly requiring data that supports the safety and efficacy of these treatments. As a result, we have all of these new sample types — and with those new sample types come more complex logistics, more vendors, and biomarker assays that now support secondary and primary endpoints. Now you have all of these emerging players who have the ability to test biospecimens using these highly specific biomarker assays. As clinical research continues to grow overall, these new vendors are rapidly rising to prominence because of the science that they are doing and their global presence. The problem is that many organizations are not able to handle the processes that we were previously doing well as an industry when it came to data management, sample management, and global logistics.
We have now entered the world of combining biomarker-driven scientific design with scientific execution on a global scale. Scientists are designing these complex assays, but many of them lack experience in managing the elaborate workflows that go into making a reality out of their vision for testing biospecimens over the life of a study. That’s the biggest challenge — how do we manage central labs, clinical research sites, and third-party lab vendors, all of whom are interconnected but have different end goals, different systems, and different processes? That’s where we need organizations who understand the intricacies of our industry and are vendor-agnostic, so that they can facilitate solutions for the sponsors, CROs, and sites that support clinical trials.
Ultimately we are not going to be able to force individual companies to integrate with each other in order to make things easier on the sponsor. That still doesn’t negate the reality that everyone has to work together in order for studies to operate at their full potential. The key to doing that is managing the samples and therefore the data that drives all trials.
In what ways do you think your consultative services and support will deliver a more complete solution for clinical trial execution? In what ways do you see your services augmenting the capabilities of Slope’s software, and how will the two interact?
I have spent my entire career in this space, and I have worked with many of the key contributors across the clinical trial landscape — including central labs, biomarker and PK labs, and the supporting functions. I am able to learn from the mistakes I made on the biotech and CRO side to formulate best practices for other folks who are in these same positions today, so that they are able to achieve their end goals. Through my experience, I have also cultivated a professional network that collectively offers a depth of knowledge that I believe is hard to counter in our industry.
What does this look like in practice? I will be collaborating with customers on their day-to-day transactional tasks that may be administrative in nature, but are extremely important nonetheless — examples include, but are not limited to: best practices around data transfer specifications; sample metadata reconciliation; selection of proper lab vendor partners; and the optimization of biomarker and bioanalytical strategy during study startup and study execution. This kind of support translates to more efficient clinical trial execution that is tailored toward the central lab, biomarker, and PK lab space. All of this is augmented by Slope, which is a site-centric platform that we will be utilizing to bring everything together.
Over the course of your career, you have had a lot of experience with data management and sample tracking on clinical trials. How do you see Slope being a disruptor in these modalities?
I have seen certain software products that have been touted as being able to ingest data across various vendors in order to make sense of it. The problem is that all of these vendors are separate companies with their own databases, and most of them are not data companies. They are actually in the business of gathering samples, testing them, and providing ancillary services.
Let’s say you are working with 6 lab vendors on a study, including a central lab and various specialty labs. If you are a sponsor who is trying to track samples, how are you going to handle 6 disparate data inputs that look different, are not fully automated, and are mostly manual data entry? How are you going to piece together a unified sample life cycle?
What makes Slope special is that it provides source data. A lot of these other specimen-tracking solutions offer data aggregation, but they are not a source for data. On the other hand, if you are working on a trial that is contracted with Slope services, sites are utilizing the platform for inventory management, protocol compliance, and as close to real-time data entry as I have seen. Now we have a tool that digitizes processes that were very manual for sites beforehand, allowing for an input that is more up-to-the-minute than the EDC (and actually integrated with EDC systems). Compared to the competition, Slope provides more real-time data insights and offers a platform to increase protocol compliance and enable sample processing. From the onset of a sample collection, Slope is making sense of that data because we are a platform that is alleviating the inventory and sample management burden for sites. That means this isn’t a platform being forced on a site, but one they are choosing to use independent of the actual trials.
What is your vision for this exciting new chapter at Slope?
We want our software platform to be ubiquitous in the clinical trial space, while elevating Slope to a full-service clinical trial execution organization. With my addition, what we are going to build out is a service that is tailored to precision-based medicine needs within the industry. This means having the ability to even further expand Slope’s collaborations and integrations with central labs, third-party labs, and EDC systems in order to facilitate more efficient global operations and logistics — all in one platform that handles your specimen-related data and reconciliation. We will also be offering consulting services, staff augmentation through an FSP, and even outsourcing services that will consist of Slope setting up and managing your lab vendors and related data. All of this will be backed by technology that is going to continue to grow to make everything more streamlined.
To learn more about Mark Melton and his recent appointment as Slope’s VP of Scientific Operations and Development, click here.