The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr Harsha Rajasimha to apply his years of training to accelerate therapies for rare and common conditions. His steadfast commitment to listening to the rare disease community and learning exactly what the unmet need is, is at the heart of all his endeavours

RARE entrepreneur series: meeting the beating hearts behind the RARE brands

By digitising and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70 per cent, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over three times faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrolment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. 

1.

What was the driving force is starting your own business in the rare disease space? Was there an unmet need you were responding to?

I trained as a precision medicine data scientist at Virginia Tech, NIH, FDA, and in industry between 2000 – 2012, and loved my work. In 2012, my wife and I had a baby born with a rare congenital disorder called Edwards’ syndrome. The diagnosis was missed during the first trimester and the baby went to full term, receiving a diagnosis at birth. The OB-GYN and neonatologist told us “the baby is not compatible with life” and that she was not a “viable baby”. We were devastated and in crisis. As we healed, we learned a lot about this untreatable rare disease and that 95 per cent of all rare diseases have no approved treatment options.

I visited Dr Stephen Groft’s office of rare disease research at the NIH, attended the World Orphan Drug Congress and attended events organised by NORD and Global Genes. I visited India for the BangaloreIndiaBio conference in 2013 as there was no organisation focused on rare diseases in India then. Before I knew it, I had become an advocate and brought together a group of kindred spirits to lead a review article on the challenges and opportunities for rare diseases in India. This lead to the formation of a humanitarian non-profit organisation in India. I had become a social entrepreneur.

I later founded the Indo US Organization for Rare diseases to build collaborative bridges between stakeholders in the US and Indian subcontinent. During this journey, I identified key challenges facing the RARE community. In 2017, I lost my younger brother, who was in his 30s, to juvenile diabetes and related complications in India. I wish I could have done more for him remotely from the US where I was pursuing my career. Within months I quit my full-time job, became a full-time entrepreneur and founded Jeeva Informatics Solutions Inc.

3.

What advice, if any, did you get when setting up your business? Has there been anyone in particular who has been pivotal in supporting your business?

The best advice I have is that the number one reason most product companies fail is “building something nobody wants”. This was so timely in 2018 when I was planning to build a product that I thought patients needed to connect with clinical trials remotely. I was introduced to Bob Smith, director of the Innovation Commercialization Assistance Program (ICAP) at George Mason University, Fairfax, Virginia. Bob challenged my business plan and assumptions. He encouraged me to find evidence to support (or reject) critical assumptions by interviewing more than 100 key stakeholders of rare disease clinical research.

By now (Jan 2022), my team and I at Jeeva have interviewed over 2000 stakeholders asking why clinical research is slow? Why the process of developing innovative treatments (for rare diseases) takes 10+ years? Why does it cost over $2.5 Billion? And digging deeper and deeper into understanding the real-world challenges at every step of the process. My team spent a good part of the first year in customer discovery, validating the business model canvas, and gathering evidence for product-market fit. This is a never-ending process which became part of the company culture. Bob continues to guide us on our formal advisory board along with six other life science industry leaders. 

4.

How do you manage the demands of running a business with your own health needs, those of someone you care for, or those of your employees?

I don’t think I manage my own health very well at the moment. One of my new year’s resolutions is to address that. With 16-hour workdays, seven days a week, it is hard to make the necessary time for yourself, your health and family. But of course, it is important and the only way is to be highly disciplined in allocating time. For 2022 I have blocked the full lunch hour on my calendar so I have a break at midday.

5.

What advice do you have for someone starting their own business?

DO NOT build something nobody wants. Be sure to validate your idea before building the product by asking the right questions to your target customers, decision makers, influencers and end users. Consult with at least a few hundred of these stakeholders before making an informed GO or NO-GO decision based on real world evidence.

You are lucky if you have a supporting family (particularly a spouse) before venturing on your own. I don’t think any entrepreneur can succeed without family, friends, and community support.

6.

What are the most rewarding aspects of establishing and running your own business?

You are never bored, you are on your toes every single day, you are motivated to bring your ‘A’ game to work daily, and you feel alive every single moment. It is even more rewarding when you are primarily focused on addressing the unmet needs of people suffering from hopeless diseases.

7.

What would you consider to be the greatest achievements of your business thus far?

Journeying on the right path to enabling equitable access to clinical trials globally is what I celebrate every day. And yes, we celebrate milestones along the way. The business invested early on in research and development to learn about the perspectives of the stakeholders in the ecosystem: customers, end-users, regulators, other technology solutions providers, CROs, and patient organisations. We interviewed over 2000 stakeholders without trying to sell to them. Our sole intent was to understand their problems with existing solutions and what is most important to them. This focus on patients and stakeholders of clinical research has led to the development of an eClinical platform that incorporates many of the learnings.

Raising capital to progress the mission has not been easy but we have been fortunate to have the support of over 20 healthcare and life science investors. The business quickly learned that the eClinical solutions market is not a mass market. We identified numerous niche segments such as rare diseases, patient registries, natural history studies, phase 0 and phase 4 studies, early phase development studies such as Phase 1 and 2, paediatric research studies, gene therapy clinical trials and many more categories. Each one has its own unique requirements in addition to several common operational requirements across all types of studies. So, there is no one-size fits all. We developed an organisation that is aware of this and is nimble and agile to be responsive to the needs of each market segment.

8.

What advice would you give someone considering working in the rare disease space?

Discover with empathy. That’s my advice. I think most professions will find it very gratifying and rewarding to work in this space. But start by listening to patients, researchers, industry, advocates, policy makers, innovators and key opinion leaders, and attend prominent conferences. Invest your time to learn and understand the various stakeholder perspectives. You will find that the rare disease space is filled with passionate and compassionate people driven to address the societal problems for which human ingenuity and collaborations are critical components of all solutions.

9.

What are your hopes for the future of your business?

As someone who grew up in India with 5000 year old cultural and traditional nuances, I know there is no one size fits all solution to the challenges facing rare disease patients. I have a dream to educate, and connect a large portion of the 350+ million patients living with rare diseases globally to clinical trials irrespective of their geographical location, age, gender, race, or any other parameter (with the obvious exception of matching the inclusion/exclusion criteria of a clinical trial protocol). We have a long way to go on this journey. We need to support numerous languages and continuous remote patient monitoring with wearable sensors, build cultural humility in our technology solutions, and continuously learn the commonalities in the complex requirements of 7000+ rare diseases.

10.

If you hadn’t founded Jeeva Informatics, what was Plan B?  What did your 10-year-old self want to be?

I had a plan B until I held the fear of failure in my mind. In 2018, I overcame that fear. I disconnected the boat from the harbour so I know I have no option of going back to my Plan B. I don’t worry about results or destination. It’s the purposeful journey that matters. I am fortunate to have a supporting wife and two daughters with me in my journey and literally thousands of people to be thankful to for guiding the journey in ways they will never know.