Clinical trials patient recruitment

Launch easy to access HIPAA-compliant clinical trial patient recruitment solution that brings diverse users & healthcare orgs. to Cardano

We are building on already existing successful clinical trial AI-enabled analytics business to respond to our current Big Pharma clients’ unmet needs. Our team is composed of senior leaders (Pharma & IT) who wish to impact patients' lives, find cures and grow Cardano's ecosystem.

[IMPACT]

Main components:

1. Portal (desktop and mobile) that interacts with patients
2. Blockchain solution that interacts with patient data, EMRs and clinical trials data
3. NLPs/ML that match patient data to clinical trials
4. APIs that integrate into CTMS of clients for automated data hand-over

Key definitions:

• NLP: Natural Language Processing
• ML: Machine Learning
• CTMS: Clinical Trial Management System

Key features vs. current solutions on market

1. Coin distribution program:
2. incentivize patients to sign up, qualify for trials and refer our solution
3. help pay for costs incurred while in the clinical trial
4. incentivize Pharma clients to participate in our solution by earning coins via ADA staking. We will have a separate program for onboarding client's Treasury departments.
5. Direct access/partnership to top pharma clients working on developing next-gen medicines/therapies (currently working with them) and access to patient records
6. Key focus on under-represented people from diverse backgrounds to join clinical trials to advance health equity
7. First clinical trial solution to be built on blockchain ensuring data safety and integrity

Market: We are listening to our current Pharma clients and aim to deliver this requested & much anticipated patient recruitment solution. At any time, there are ~1,500 ongoing oncology (cancer) clinical trials consistently looking for looking for 250k patients. Based solely on these figures and attractive patient recruitment fees ($Ks per referral), this is a growing multi-billion dollar market/opportunity. Furthermore and more importantly, our pharma clients along with the FDA have embarked on a journey to ensure more people from diverse backgrounds join clinical trials as a way to advance health equity. Participants in clinical trials should represent the patients that will use the medical products. This is often not the case - as people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products. Via our SEO/Social Media and various patient acquisition strategies, we will be paying special attention to this important matter to ensure that more people from diverse backgrounds join clinical trials as a way to advance health equity.

Product: Our solution will increase drug trials approval success, reduce delays, accelerate launch of live-saving medical treatments and ensure that people from diverse backgrounds are adequately represented. Building this HIPAA-compliant project leveraging Cardano blockchain will ensure that patients’ data is secure & trusted, and patients have full control of how their data is shared with various parties involved. The superior security and control over data will ensure that more patients will feel comfortable to share their health data as they come onboard.

Acquisition: We intend to leverage currently existing relationships with our clients (7 Big Pharma clients) and have line of sight to 250k potential candidates identified with access to thousands of add'l EMRs

Achieve full HIPAA-compliance and successful integration of DIDS, however, we feel confident in achieving successful outcome. Our IT/Blockchain dev. team has relevant experience in the traditional IT environment and has deployed relevant solutions on competing blockchain. We are looking in Cardano ecosystem for relevant best-practices and will be looking to learn from them (possibly partner) and share any of our finding/solutions with the community.

[FEASIBILITY]

Key Steps and Deliverables for Phase 1 (thru Month 6)

Month 1

Commercial:

• Company registration

Scientific:

• Adaptive Questionnaire ready for 1 cancer indication
• Hire 2 SA Analysts

IT/Technical:

• Web front end and Mobile App POC strawman developed
• Token design
• White paper

Month 3

Commercial:

• Agreements with 1 Pharma client and Advocacy Groups are secured
• Produce marketing collateral (web portal and rationale for blockchain)

Scientific:

• Adaptive Questionnaire ready for 10 cancers indication

IT/Technical:

• Solution Architecture and Side Chain in testing
• POC ready with Web/Mobile and blockchain
• Role-based login for Individuals and Corporates

Month 6

Commercial:

• “Why run patient recruitment on Cardano blockchain vs. legacy database” & “Why run patient recruitment on public chain vs. private chain” marketing collaterals finalized (print and electronic version)
• Agreements with Pharma clients and Advocacy Groups are signed

Scientific:

• Hire remaining 2 SA Analysts

IT/Technical:

• Process integration with Pharma and their CTMS
• Ready to pilot with one pharma client
• Using a few clinical trials, build integrated solution
• Launch token

Few key notes:

• Remaining activity to be scheduled: Scheduling meeting with Charles Hoskinson, and his father and brother, who are doctors and have a clinic. We received an invitation from Charles to schedule a meeting after presenting our business solution at one of Charles' Twitter Space sessions. Charles has always openly expressed his interest in moving Cardano further into healthcare space, so we look forward to discussing how we can help with his vision and further collaborate to make a blockchain industry-leading solution and reach as many people as possible around the world.
• For Phase 1, Go-Live is planned for Month 9 (if not sooner). For activities post-Month 6, we will be submitting subsequent new Project Catalyst proposal

We’re seeking to request equiv. of $200k for the initial 6 months. Blockchain & IT development costs will be assumed by the co-founders team for this phase of the project. Please note that total project's budget is higher than requested amount for first 6 months of Phase 1; we're looking to cover portion of our 3rd party expenses to help us avoid relying on external and/or VC funding

Funds will be used to:

• hire 4 Scientific Affairs associates (all four associates will be based out Northeast region in US)
• @150k Fully-loaded annual salary. 2 associates for 4.5 months $113k and remaining 2 associates for 3 months $75k. ($188k total)
• work with marketing agency to develop first set of marketing collateral material, i.e. 1) “Why run patient recruitment on Cardano blockchain vs. legacy database” 2) “Why run patient recruitment on public chain vs. private chain” marketing collaterals finalized (print, online and electronic version). ($12k total)

The key contributors/team members are: (no order of importance)

Balazs Kontes, Co-Founder, Focus: operations, strategy and finance

https://www.linkedin.com/in/balazskontes/

• 13 years working in Pharma/Healthcare industry in Finance
• 5 years of management consulting experience at Deloitte

Aqil Ahsan, Co-Founder, Focus: sales, strategy and scientific affairs

https://www.linkedin.com/in/aahsan/

• 7 years founding and managing his own AI-enabled clinical trials data analytics company
• 15 years of engineering and application engineering/development experience

Shyam Mamidi, Co-Founder, Focus: IT and blockchain dev. team management

https://www.linkedin.com/in/shyam-mamidi-a841412/

• Founder and CEO at Natsoft Asia Pte. Ltd. Advisor at WandX Co-Founder at Chainflux (Blockchain Innovations)

[AUDITABILITY]

From a program level perspective, we will be tracking the the timelines and deliverables of each functional work-stream.

From a solution perspective, we will be tracking the following:

• Portal visits/activity
• Portal patient sign-up rate
• % of patients of diverse background signed up
• Number of questions answered by patients
• Patient trial enrollment rate
• % of patients of diverse background enrolled in trials
• Type of tumor being accessed/searched
• Number of pharma clients signed up
• Number of Scientific Affairs (SA) associates hired
• System availability of 99.95%
• Response times of web sessions within 5 seconds
• Data privacy and encryption for HIPAA and GDPR

Critical success goals: 1) Building critical healthcare HIPAA-compliant solution that integrates DIDS on Cardano to prove blockchain’s superior robustness and reliability, 2) help as many people as possible easily find and sign up for clinical trials in their area giving them better chance to find a cure, and 3) play an active role in being part of the journey that our pharma clients along with the FDA have embarked on to ensure that more people from diverse backgrounds join clinical trials as a way to advance health equity.

Furthermore, in Phase 1 our Therapeutic Area is limited to Oncology (cancer) and Geographical area is limited to North America (HIPAA). In Phase 2, we'll add Europe to the Geographical area scope and will then tackle GDPR compliance. In Phase 3, we foresee to branch into other Therapeutic Areas, namely CV, CNS, Nephrology & Infectious Diseases. As Cardano continues to grow, we will look to expand into Africa and Asia. Our ultimate goal is to reach as many patients as possible and give them an opportunity to find a cure for their disease, and further advance health equity

This is entirely new project, however, we anticipate to follow up with subsequent Catalyst funding proposals.

SDG Rating

"Good Health and Well-Being": Our solution will increase drug trials approval success, reduce delays, accelerate launch of live-saving medical treatments. Our intent is to help as many people as possible easily find and sign up for clinical trials in their area giving them better chance to find a cure.

"Reduced Inequalities": our pharma clients along with the FDA have embarked on a journey to ensure more people from diverse backgrounds join clinical trials as a way advance health equity. Participants in clinical trials should represent the patients that will use the medical products. This is often not the case - as people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products. Via our SEO/Social Media and various patient acquisition strategies, we will be paying special attention to this important matter to ensure that more people from diverse backgrounds join clinical trials as a way to advance health equity.