This Startup is on a Mission to Decentralize Cell and Gene Therapy Clinical Trials

For the cell and gene therapy revolution to be fully realized, physicians, research scientists, biomanufacturing experts, advocacy groups, regulatory bodies like the Food & Drug Administration (FDA) and other key stakeholders have to “Think Different”, as Apple famously encouraged.

The “vein-to-vein”, one batch to one patient formula of personalized medicine is radically and rapidly forcing changes on biomanufacturing where cell and gene therapy best practices are not yet calcified and are changing as we speak. Personalized medicine supply chain challenges are emerging and still being worked through and the high cost of these therapies remains a daunting challenge for life science companies and patients.

Cell and gene therapy challenges across R&D, manufacturing, commercialization, and supply chain — as well as bioethical challenges yet to be fully confronted or resolved — have been well documented and discussed by experts across the BioHealth Capital Region (BHCR).

One company — Jeeva Informatics Solutions, Inc. (Jeeva) in Herndon, Virginia — is developing Big Data solutions for a less publicized but equally urgent cell and gene therapy challenge: How to manage a radically new form of clinical trial that could span decades. Founder and CEO of Jeeva, Harsha K. Rajasimha, is building a company that leverages Big Data, AI and mobile tech to decentralize clinical trials. Jeeva’s goal is to make it easier for biotech companies to collect, aggregate, analyze and report required clinical trial data while helping patients stay enrolled and compliant over longer periods of time with little travel from the convenience of their homes.

The FDA recently passed new industry guidelines requiring long-term follow up (LTFU) periods of up to 15 years for gene and cell therapies, representing a sea change for how clinical trials will operate in the future.

“The cell and gene therapy space provides significant hope for cures that can reverse genetic mutations. This space is growing. There are more than 900 clinical trials ongoing. Hundreds if not thousands of genetic diseases are likely to have therapies for the first time in our lifetime,” stated Rajasimha.

“At Jeeva, we are trying to solve a number of issues but have focused on one particular problem that needs to be addressed if these cell and gene therapies are going to be delivered to patients: No one knows the long term implications of these therapies because they are a one and done type treatment. If a patient receives therapy today, they are done, and so the FDA has mandated that recipients need to be monitored for up to 15 years. We are looking to address this issue with digital health technologies and AI,” he added.

Jeeva believes that these long-term monitoring challenges can be managed by making clinical trial participation easier via mobile applications, video conferencing consultations and centralized scheduling, to name just a few of Jeeva’s product features. Leveraging digital health tech can reduce the need for travel and eliminate inconveniences that might cause a patient to become non-compliant or, worse, drop out of a trial altogether.

Decentralized clinical trials eliminate the heavy burden of patient travel and makes the process simpler and more efficient. Utilizing a Bring-Your-Own-Device (BYOD) approach and an eVisit consultation model to create decentralized trials can reduce brick and mortar visits by 20% to 80%, according to Jeeva.

The new FDA guidelines is the latest attempt to grapple with uncharted safety protocols for cell and gene therapies. Clinical trial challenges are not new to the biotechnology industry, however; rather, the approach to clinical trials has been inefficient and static for decades, leading to industry-wide problems with clinical trial enrollment and recruitment that has a domino effect that lengthens the commercialization process and increases drug development costs.

“We want to be a catalyst for accelerating the drug development and delivery process. Patient recruitment is a huge barrier and has made the biopharmaceutical industry unsustainable. The average cost of bringing a drug to market is $2.5B and takes 10-15 years to get to market. We feel that by educating and informing the global community about clinical trials and enrollment opportunities using AI and digital health tech, we can help all stakeholders in getting people earlier access to treatments and getting the treatments to markets faster,” Rajasimha said.

Jeeva not only can help small to midsize biotechs improve trial recruitment and longer-term safety monitoring, but the company uses AI to improve clinical trial operations. By using AI and high tech tools, biotech companies can leverage historical trial data to shape new trials while empowering real-time adjustments to trials based on real-time monitoring to improve overall success rates.

Rajasimha continued, “We have been building AI tools to solve our customer’s specific needs, not just for AI’s sake. We surveyed our customers last year and they told us ‘Every single clinical trial seems like the first trial ever conducted by mankind.’ Even companies like Pfizer and Novartis, which have been conducting hundreds of trials for decades, feel that when they launch a new trial…it is no more efficient than the previous trial.”

“So, we have been building an AI assistant that learns from past clinical trials data to make the next trial more efficient,” he added. Rajasimha quickly reinforced patient centricity by saying “it is not something you fix with an all technology solution, unless the robustly tested technology solution is combined with the human elements and focus on patients’ perspectives. Having been a global patient advocate in the U.S. over the past six years has given me a unique perspective on how to integrate technology in the lives of patients and caregivers. Moreover, a growing number of trials are recruiting patients from multiple countries and reducing international travel burden on patients over extended durations will be critical to achieve enrollment.”

While the concept of virtual clinical trials might seem futuristic, Rajasimha and the Jeeva team believe the market is ready for change.

“A number of pilot projects or proof of concept clinical trials, about 20 of them, have been published where patients didn’t go to the clinic at all. The feasibility of conducting such remote patients studies has been validated multiple times by the industry now. The tipping point has arrived. One of the key barriers for widespread adoption of decentralized clinical trials was a lack of FDA guidelines. Now the FDA has clarified its expectations about how the industry and stakeholders can share the responsibility to reduce the burden on patients. Enough validation and regulatory guidelines have put us in a position to give our customers what they need,” stated Rajasimha.

Rajasimha sees partnering with smaller to midsize biotechs early on in the drug development process — meaning well before the start of Phase II or III trials — as an inflection point where it can deliver the greatest impact. In addition, we are seeing some initial interest from the Medical Cannabis industry, opioid crisis intervention for chronic pain management, and patient advocacy groups, where patients often live in remote, rural areas, can also benefit from decentralized, hybrid virtual clinical trials. Finally, real-world evidence studies, or longitudinal cohort studies, is also a growing market because companies need to collect and manage patients across longer time horizons, which is Jeeva’s sweet spot.

Rajasimha and Jeeva are starting to see this growing market interest manifest itself in new funding partnerships. Jeeva recently announced that CIT GAP Funds had invested in the company. Jeeva is currently in an early-stage investment round and the company is in active product development with a validated prototype. Jeeva is seeking new customer pilot projects to add to its ongoing pilots, which include chronic pain, medical cannabis, oncology and cell, and gene therapy products. Later this year, the company plans to complete multiple pilot projects and have validation in Good Clinical Practices (GCP) settings.

Rajasimha and his Jeeva team are certainly embracing a “think different” approach to the future of clinical trials. Jeeva and its AI-driven, virtual clinical trial model is poised to help biotech companies thrive and meet the unmet medical needs of more patients across the globe.

You can listen to Rajasimha’s interview with podcast host Daniel Levine earlier this month on iheart radio here.

Team Jeeva is seeking customer pilot projects and strategic partners to join the journey and will be exhibiting at the National Institutes of Health Rare Disease Day event on Feb 28, 2020. Rajasimha will also be delivering a keynote speech on “AI in rare diseases” at the BIO-IT World West Conference at San Francisco on March 3rd, 2020.

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