Source: SCRIP CITELINE COMMERCIAL
Jeeva’s founder and CEO talks to Scrip about how the firm’s clinical trial management platform does away with the need for numerous point solutions and vendors, enabling sponsors to undertake trials more effectively including in the complex and competitive oncology space.
As biopharma sponsors take on increasingly complex clinical trials, especially in oncology, and regulatory requirements add new expectations around improving participant diversity, innovations big and small that can shake things up or just improve efficiencies will be pivotal.
The US-based Jeeva Clinical Trials Inc believes its suite of offerings can simplify patient engagement and evidence generation, driving significant gains for sponsors.
In an interview with Scrip, Jeeva’s founder and CEO, Dr Harsha Rajasimha said that while patient recruitment and retention continues to be one of the biggest trial challenges across therapeutic areas, especially for complex oncology studies, manual repetitive tasks that need to be done at the various levels contribute to the long list of other inefficiencies. These include investigator teams having to do informed consent with patients, data capture and verifying data quality, training etc. on a regular basis throughout the study.
Rajasimha, a computer science engineer turned genomics data scientist, stated that the integration of AI and automation to tackle these aspects is happening, but only in certain areas, given that currently there are just “too many point solutions” – for instance there are distinct tools for identifying patients, recruiting them, randomizing them and so on.
“A Phase III oncology clinical trial may require at least 30 different point solutions [essentially the software tools] on an average to execute end-to-end and as a result the efficiency gains because of automation and AI is extremely limited because those are acting at the point solution level and not across the workflows,” Rajasimha explained.
Oncology trials have become increasingly complex, with growing inclusion-exclusion criteria, use of biomarkers, multiple targeted therapies and combination drugs. As of 2022, over half of oncology trials were estimated to have a biomarker-defined target sub-population, per data referenced in a McKinsey study earlier this year, while rising competition in the segment has only exacerbated trial recruitment challenges. For instance, the global management consultancy earlier indicated that the number of breast-cancer patients required for active trials exceeds the annual number of diagnoses twofold.
Unified Platform
Jeeva, which is driven by AI and technology innovation to automate manual repetitive tasks, maintains it can address some of the trial-related challenges and deliver operational gains.
First, it does away with the need for numerous point solutions and vendors, bolstering efficiency and paring costs via an innovative one-login unified software platform for end-to-end study execution.
Being patient-centric also sets the software and CRO solutions firm apart from some peers, claimed Rajasimha. Jeeva’s unified platform enables clients to bring together clinical data management, trial management or project management, the patient engagement, enrolment workflows and retention throughout the study and decentralized tools under one unified purpose-built software platform, he underscored.
“The way we have approached it is with the intention of how all these integrate and come together in a unified single login and streamlining them in a patient-centric manner in a way that actually brings value to the end users. We estimate 30-70% or more time savings when the Jeeva system is implemented,” he underlined.
Jeeva also enables efficiencies in screening and enrolling the patients once they have been identified for the most part but in certain types of studies, it can also help with identifying patients via online advertising and screening. Jeeva allows automated workflow to be defined and that workflow can be converted into a QR code or a URL which can then be used in Google/Facebook advertisements etc. For instance, if consumers are interested in a plaque psoriasis clinical trial, they can scan the QR code and come into the database. Those that get qualified can be either referred to one of the sites in the study or can even consent online and then show up at the site for further examination, Rajasimha explained.
CAR-T Studies, Patient Advocacy
Jeeva’s solutions have been deployed, among other therapy areas, across multiple studies in the oncology space, including for the first indigenously developed CAR-T cell therapy approved in India. In October 2023, India approved Immunoadoptive Cell Therapy’s (ImmunoACT), NexCAR19 (actalycabtagene autoleucel), for the treatment of relapsed/refractory B-cell lymphomas and leukemia. (Also see “India’s ImmunoACT Gears To Deliver CAR-T Therapy At Close To Transplant-Like Prices” – Scrip, 18 Oct, 2023.) (Also see “As India Scales CAR-T Efforts, Can It Innovate Commercial Models?” – Scrip, 25 Jun, 2024.)
Jeeva also had a role in delivering a simple, yet effective solution to address certain challenges at the US Children’s National Hospital in the Washington DC area.
In this particular case, the principal investigator had an ongoing long-term biospecimen collection study to advance genetic research. The specimen was already available at the hospital but to use it for research purposes, informed consent or assent from maternal and pediatric participants was required.
It entailed a repetitive task of explaining study details to each participant, who were required to travel to the hospital to provide paper-based informed consent.
Few participants were willing to travel to provide informed consent. “It’s not fair to invite the family or patient to the hospital just to provide informed consent so that sample can be used for research purposes. Those are the types of studies where remote eConsent can be fairly easy to implement,” Rajasimha explained.
Jeeva’s solutions is said to have crunched the PI’s time and effort by 80%-90% corresponding to 250 hours per year for the study and also ensured an increase in participants since travel wasn’t required.
“If the informed consent itself is implemented in a human centric, user-friendly manner, there are significant time savings for the investigator and the burden on patients. So, while I talk about unified solutions quite a bit, there is still place for point solutions,” Jeeva’s CEO said.
ImmunoAct was said to be keen on a secure, compliant, easy-to-use platform that can speed up its clinical development timelines without having to tap into a large full service CRO or major in-house IT infrastructure. Jeeva’s eClinical Cloud software platform could help the firm ensure accurate and faster patient screening, enrolment, high quality electronic data etc, thereby enabling it to go through with more efficient studies.
Rajasimha said that ImmunoAct chose to be “actively involved” and manage the study directly using the tools and platform themselves. “They did not fully outsource [activities] to a CRO and there having an efficient unified system helped them a lot to manage the end-to-end study in one place,” he pointed out. In another instance, Jeeva’s remote video eConsenting could help deliver efficiencies for a client. (See side box)
On how Jeeva was helping to improve participation in oncology trials, especially in underrepresented communities, Rajasimha underlined patient advocacy (and ‘doing the right thing’) in addition to the technology and CRO solutions that can optimize and make the process efficient.
The executive, for instance, earlier co-founded the Organization for Rare Diseases India but in 2019 stepped out to found the Indo US Organization for Rare Diseases (IndoUSrare), a non-profit focused on advancing research and advocacy for rare genetic diseases, including rare cancers. (Also see “It Takes A Village: Roche’s India Rare Disease Approach, Crowdfunding Support” – Scrip, 2 May, 2022.)
Those efforts came against the backdrop of a heart-breaking personal experience. Rajasimha had lost a child to Edwards Syndrome, a rare congenital disease.
“That experience taught me that, like Edwards Syndrome, there were 7,000 rare diseases back then and today there are close to 11,000 named rare diseases. Most of them still don’t have even a single treatment option approved by the FDA,” he stated. (Also see “Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER” – Pink Sheet, 27 Mar, 2024.)
Rajasimha went on to underscore the need to make global clinical trials more “accessible, affordable and inclusive” with various languages, so patients can be engaged in the native language that they are comfortable in and not have English speaking/reading/writing as inclusion criteria which automatically eliminates a huge proportion of them”.
Jeeva’s technology can empower patient engagement in over 100 languages, addressing under-representation in research.
Rajasimha also referred to the US Food and Drug Administration’s Oncology Center of Excellence (OCE) Project Asha, an initiative in collaboration with the White House Cancer Moonshot Program that aims to increase oncology clinical trial access in India. Just 1.5% of global trials are conducted in India, which accounts for close to 20% of the world’s population. (Also see “India Clinical Trials Scenario: Leaders From Novartis, IQVIA, PwC Signal Winds Of Change” – Pink Sheet, 23 May, 2023.)
Project Asha expects, among other efforts, to identify collaborative opportunities that foster more inclusive and equitable participation in international cancer research and clinical trials. “These collaborations will involve cross-border data transfer, aiming to maximize scientific cooperation while upholding stringent privacy protections,” the agency said.
Jeeva’s CEO noted that these types of regulated global networks for clinical trials is something that the FDA has been working on over the years.
“We have provided public comments and inputs when those requests have been put out and that’s a very important component because we can’t really keep expecting to come up with some magic technology solution that will address the problem of lack of patients,” he added. (Also see “ISCR’s Davis On Pandemic Adaptations, Value Of Multi-Regional Trials” – Scrip, 26 Apr, 2021.)
Single Subject Studies
Jeeva is also doing its bit when it comes to supporting the increasing trend of N-of-1 or single subject clinical trials in the US.
Rajasimha said that Jeeva expects to make its software platform freely available for all N-of-1 trials indefinitely.
Such trials, which focus on evaluating investigational drug products developed for an individual patient and are often conducted by academic investigators, may find it tough to engage a full service CRO, or use licensed software and “so we want to be part of that solution and collaborate with the trials as well,” he said.
N-of-1 trials entail multiple crossover trials, usually randomized and often blinded, conducted in a single patient. Antisense oligonucleotide drugs are among those that have seen advances in the space.
“It really matters to us that we care about bringing new medical innovations through the valley of death as quickly as possible to the patients who are waiting, especially with rare and genetic diseases.”
Use of Gen AI
On how Jeeva is moving towards the use of generative AI to bolster its offerings, Rajasimha signaled the need to be cautious about how such new technologies are built and integrated into the regulated clinical trials space. (Also see “Life Sciences Scaling Adoption Of New Metaverse, AI Tools” – Scrip, 2 Oct, 2023.)
“On one end there is the investor community that wants to invest in innovative new ideas. On the other hand, we have real world scenarios where there is resistance to adopt certain things right off the bat and for good reason. They are asking all the right questions,” he pointed out.
One of the “low hanging fruits” Jeeva has been focused on is language translation to make it more inclusive at the same levels where the industry is right now in terms of English.
“We have integrated some level of natural language processing and Gen AI in language translation which is integrated into the software itself. We have an expert language translation company that is engaged to provide certification where necessary,” the CEO indicated.
Jeeva is also looking at translating audio and video content, multimedia content in addition to the text, which it believes can bring more tangible value for certain type of studies. “Even within the US, cities like New York, Los Angeles where the entire global diversity is represented within the metropolitan areas, can benefit from having these inclusive platforms with all the language support,”Rajasimha pointed out.
Jeeva also uses Gen AI tools iteratively with a human involved to generate an initial protocol “which is maybe 50% there”.
“At least it provides all the sections and the structure and high-level constructs, but it still needs good bit of clinical oversight to iteratively use Gen AI in a responsible way to make sure the protocol itself is finalized eventually,” he explained.
He added that while AI can sometimes be the solution, over the last six years “having been in the trenches, there are simple challenges that makes trials inefficient and people don’t pay attention to the human issues of what each actor in their own role need to complete.”
