Skip to content
Decentralized Clinical Research Software as a Service Logo
  • About
    • Team Jeeva
    • Careers
  • Jeeva eClinical Platform
    • eConsent as a Service
    • ePRO as a Service
    • TRIALMAGNET
  • Who We Serve
    • CRO Partnership Program
    • Patient Groups
    • Researchers
    • Sponsors
  • Resources
    • Blogs
    • Case Studies
    • Events
    • News
    • Podcasts & TV Interviews
    • Testimonials
  • Contact
    • Schedule A Meeting
    • Subscribe to Newsletter
  • Request Demo
  • Free Trial
  • Menu
This Startup is on a Mission to Decentralize Cell and Gene Therapy Clinical Trials

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

Posted on February 5, 2020May 25, 2021

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

Author: Steven Surdez, Principal at StoryCore; Article originally published on Biobuzz.io

Feb 2020

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.

Steven Surdez

Principal at StoryCore

Steve has over 20 years experience in copywriting, developing brand messaging and creating marketing strategies across a wide range of industries, including the biopharmaceutical, senior living, commercial real estate, IT and renewable energy sectors, among others. He is currently the Principal/Owner of StoryCore, a Frederick, Maryland-based content creation and execution consultancy focused on telling the unique stories of Maryland organizations.

Posted in All of us, Blogs, Cell and gene therapy, Clinical Research Software, Clinical Trials, Cohort studies, Observational study, Patient registry, Precision Medicine, Rare disease, Thought Leadership.

Post navigation

Enabling precision medicine cohort studies… →

Recent Posts

  • DTRA Looks At The Future Of Decentralized Trials
  • Validated Solutions to Optimize the Future of Clinical Trials
  • Removing Socioeconomic Barriers and Increasing Diversity in Clinical Trials Would Have a Positive Economic Impact
  • The Rare Disease Diversity Coalition Webinar
  • Pivotal Cell And Gene Therapy

Recent Comments

  • Glory on Data ownership as leverage in accelerating rare disease drug development? Finally, there’s a cloud software that empowers patient groups!

Archives

  • January 2023
  • December 2022
  • November 2022
  • October 2022
  • September 2022
  • June 2022
  • April 2022
  • January 2022
  • October 2021
  • September 2021
  • May 2021
  • February 2021
  • December 2020
  • July 2020
  • February 2020

Categories

  • All of us
  • Blogs
  • Cell and gene therapy
  • Clinical Research Software
  • Clinical Trials
  • Cohort studies
  • Informational content
  • Natural history study
  • News
  • Observational study
  • Patient Diversity
  • Patient registry
  • Precision Medicine
  • Rare disease
  • Thought Leadership
  • Uncategorized

Meta

  • Log in
  • Entries feed
  • Comments feed
  • WordPress.org
  • About Us
  • Jeeva eClinical Platform
  • News
  • Blogs
  • Contact
  • Jeeva’s Sitemap for Clinical Trials Researchers, Sponsors, Patient, CRO
  • FAQ
  • Privacy

Newsletter

Enter Your email address below to subscribe to our newsletter and keep up to date with discounts and special offers.

Company

Jeeva Informatics Solutions Inc.

10432 Balls Ford Rd Suite 300 Manassas, VA 20109 703-968-7023 info@jeevatrials.com

Resources

Sitemap

Privacy Policy - Participants

Terms of Service

Newsletter

Enter Your email address below to subscribe to our newsletter and keep up to date with discounts and special offers.

Copryright © 2023 Jeeva Informatics Solutions Inc.Jeeva Privacy Policy
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT
Dr. Sweta Sneha

Dr. Sweta Sneha is the Founder and Executive Director of Healthcare Management & Informatics and Professor of Information Systems & Security at Kennesaw State University. A globally recognized expert with a passion towards equity and diversity, Sneha is a strategic leader with two decades of experience in technology and informatics. She is a recipient of Distinguished Service Award, KSU Collaboration Award, NCWIT RISE-IT Award, and WIT Honoree, WIT Finalist (2018, 2019, 2020, 2021, 2022). Dr. Sneha has published over 100 peer-reviewed research; authored a book on revolutionizing healthcare; delivered panel sessions, workshops, and keynotes; in addition to serving on several boards. Dr. Sneha serves as editorial steward and university ambassador for Blockchain in Healthcare Today; editorial board for Health Systems Journal; co-chairs Health IT at AMCIS, and HICSS. Her leadership has led to enhancing KSU’s footprint on diversity and equity, STEAM education, and outreach. She has a PhD in Computer Information Systems from Georgia State University and a BS in Computer Science from University of Maryland. Prior to academia, she worked at PricewaterhouseCoopers in Management Consulting.