JR is Inteliquet’s Senior Director of Alliance Management. He is responsible for managing key partnerships in the Life Sciences space. With more than 20 years of experience in clinical development roles at major pharma organizations and CROs, JR has led clinical trial operations teams, developed and executed operational strategies to advance development programs, and supported regulatory/compliance activities across a number of roles. His current focus is to find opportunities for Inteliquet’s platform, technology, and consortium to add value to pharma and CRO partners.
What drew you to healthcare?
I stumbled on it through personal contacts, shortly after graduating from the University of Michigan. I went to work at Parke-Davis Warner-Lambert, which had its research headquarters nearby in Ann Arbor. I quickly became engaged in the R&D world, and it has been my career focus for the last 20 years.
I enjoy the work because you can easily see the impact that pharmaceuticals have on the healthcare ecosystem. And it’s wonderful to have the opportunity to work with brilliant and passionate colleagues daily to help bring new medicines to patients.
My early days began as a CRA doing site monitoring activities, which led to project management roles and then onto leading operations teams and other more strategic roles. During my time in the industry, I have been primarily involved in the operational delivery of development programs, including the last 10 years focused within oncology. I had the opportunity to be involved with the approval of two products that were at the forefront of immuno-oncology research and development. It was an exciting and rewarding time to be involved in oncology development and offer a new wave of treatments for patients.
What has changed since you started in pharma?
Certainly, we have seen significant advances related to technology and access to data across the industry. When I began as a CRA, I reviewed 6-inch thick paper charts and collected data that was entered by hand into paper case report forms (CRFs). Today, we live in an essentially digital world with eCRFs, electronic medical records, data collection through wearable devices, and a greater focus on the utilization of real-world data/real-world evidence in our development programs.
We also have seen continued expansion of the utilization of biomarkers and diagnostic testing to target specific patient populations that have a higher likelihood to benefit from a treatment. As precision medicine creates more focused patient populations, approvals are being compressed.
Specifically in oncology, the lines between the traditional clinical development phases have blurred, and we now have drugs being approved out of expanded Phase 1 trials or tumor-agnostic approvals based on a specific mutation or biomarker. The goal is to reduce cycle times in order to get drugs to patients more quickly while maintaining the proper regulatory rigor in regard to safety and efficacy.
What made you decide to join Inteliquet?
I had the opportunity to work with Inteliquet when I was on the pharma side. Their technology’s approach to matching patients to trials was innovative, as was their ability to generate analytic assessments based on real-world data to enhance informed decision making. Pharma is always chasing patients to enroll in clinical trials, and Inteliquet provides a level of specificity that cut through many of the challenges pharma has encountered when considering clinical trial matching, as well as site feasibility and trial design.
I thought I could contribute to the continued expansion of the Inteliquet platform, given my ClinOps background, and be an interface between Inteliquet and our life sciences customers. My position allows me the opportunity to manage engagements with our partners and “translate” information moving between life sciences and our Inteliquet team to ensure we maximize the value of the Inteliquet solution. We have great potential to make the process of clinical development more efficient and better-informed.
What are top challenges facing clinical sites?
The macro-challenge is finding how clinical sites and sponsors can run trials as efficiently as possible and speed the development of therapies and get them to the patients in need. Although many drugs hold great potential to help improve patients’ lives, they never see the light of day because they can’t enroll the patients necessary to get over the regulatory bar for approval. There are trials that either never enroll or don’t enroll on time, which can have negative effects on patient communities. It also has a negative impact on the sponsors and the clinical sites conducting trials. And the process feeds on itself.
What do you mean?
Sponsors invest somewhere in the range of $30,000 to $50,000 to open a single clinical site, depending on which estimates you look at, which is ultimately a completely sunk cost if a site doesn’t enroll patients onto a study. On the other side, if the site is unable to recruit patients to enroll on the trial, the site doesn’t get paid, even though they invested a lot of time working to identify patients to enroll, but with no return on that effort.
Adding in the infrastructure costs associated with participating in clinical trials, from staff to equipment to physical office space, if this scenario of non-enrollment plays out enough, participating in clinical research becomes a losing proposition, and sites may ultimately stop conducting clinical trials. Data show that the number of clinical sites exiting clinical trials is outpacing the entrance of new research sites, thus reducing the overall number of sites available to conduct trials. This puts further stress on the system, creates more competition for research sites, and creates additional barriers to patient recruitment. It’s a vicious cycle that we must break; ultimately, patients lose when they are unable to gain access to innovative treatment options.
How can that be fixed?
One way to build a more efficient process is to strengthen the knowledge and understanding of patient populations, both at the broader population level and within the patient population of a particular clinical site. This can support both parties, bridge this gap that exists, and bring more value to the equation with less upfront risk and cost. For sponsor companies, this can support the development of improved clinical trials that are consistent with current treatment paradigms and also connect them with clinical sites that are in the best position to enroll the target patient population.
Clinical sites need to have deeper insights into their overall patient population and make more informed decisions about which clinical trials they should participate in and those that they should not and support an efficient implementation of the right portfolio of studies. When we can help sites and sponsors gain new levels of clarity into patient populations, they can build toward better efficiency, which disrupts the circle of low value/high risk for all parties.
How does Inteliquet address these challenges?
Our platform provides better clarity into patient populations via EMR data interrogation from key sources that benefit sponsors and sites. We work to reduce administrative burdens and improve workflow efficiency; what took hours now takes minutes.
Through this integration, physicians can conduct patient treatment comparisons with hundreds of their peers. They can improve the ability to match patients for trials. For sponsors, they can gain valuable insight for trial design and site feasibility, as well as clinical development from R&D through to early commercial planning and post approval.
Can you talk about a recent success you had?
One of our CRO partners was managing an oncology trial that had been tracking significantly behind planned timelines. The study had been opened to enrollment for a substantial amount of time, yet actual enrollment was well behind recruitment targets; all of the “alarm bells” were going off regarding the study’s status. The CRO received pressure from the study sponsor regarding progress, and it explored available mitigation strategies to get the study back on track, so they approached Inteliquet for possible support.
We conducted an initial feasibility assessment that reviewed the required study population against data from our consortium member sites, utilizing the key inclusion/exclusion from the protocol, to identify sites with potential patient populations that could support study enrollment. Then we contacted the identified sites to gauge interest in the study. Ultimately, we added three Inteliquet consortium sites to the study.
The consortium member sites progressed rapidly through the start-up process, opened for enrollment, and quickly began to enroll patients. After only being open for about two months, Inteliquet consortium sites had contributed approximately 15 percent of the overall patient enrollment on the study. This influx demonstrated an upward trajectory of enrollment to the sponsor and was important in getting the study back on track towards meeting its enrollment targets. It was gratifying to offer our support as rapidly as we did and provide an effective mitigation strategy through the implementation of the Inteliquet platform.
What would you want clinical research sites to know about Inteliquet?
From Day One, we can help increase the effectiveness and success of clinical trial programs, so that they can make care decisions based on real-world evidence. Our platform can absorb both structured and unstructured data from a multitude of disparate sources. We can aggregate data, normalize it, and make it easily analyzable. Our technology works 24/7 to help you be more efficient in finding the right patients, which allows you to free up people and resources, and focus more time on patients.
What future development do you see improving the process of clinical trials?
Meaningful automation — that is, how do we put our innovations, technology, and data sources to the best use in order to improve the efficiency of clinical research so new therapies can reach patients faster. We must continue to focus on how we can integrate new approaches across sites and sponsors and continue to enhance collaboration and productivity and support the overall drug development process. Inteliquet’s tools, data, people, and services all can help in that area.