Source: Medium
In recent years, Big Tech has gotten a bad rep. But of course many tech companies are doing important work making monumental positive changes to society, health, and the environment.
To highlight these, we started a new interview series about “Technology Making An Important Positive Social Impact”.
We are interviewing leaders of tech companies who are creating or have created a tech product that is helping to make a positive change in people’s lives or the environment.
As a part of this series, I had the pleasure of interviewing Harsha K. Rajasimha.
Dr. Rajasimha is the founder and CEO of the decentralized clinical trials software company, Jeeva Clinical Trials Inc. based in Virginia.
He is a precision medicine data scientist-turned social entrepreneur on a mission to accelerate human-centric clinical research through technology innovation and global advocacy.
He is the founder and chairman of the humanitarian non-profit Indo US Organization for Rare Diseases. Earlier, he served as cofounder and co-chair of the Organization for Rare Diseases in India from 2013–2019.
He is academically affiliated as a faculty in the School of Systems Biology at George Mason University in Fairfax, VA since 2012.
Prior to founding Jeeva, Harsha was leading the healthcare and life science R&D practice at NTTDATA Services, a global top 7 consulting company.
He was Vice President of business development at Strand Life Sciences where he led the commercial launch of next-generation sequencing based genetic testing panels for rare diseases and Cancer.
Earlier, he was a Sr. Director of Bioinformatics and Translational Research at Dovel Technologies, a Virginia based health IT company, where he covered academic and US Federal Government contracts, advised FDA on the STARLIMS implementation program at their office of regulatory affairs.
Dr. Rajasimha has over a decade of experience working on various interdisciplinary projects involving genomics and big data as a consultant for clients including National Cancer Institute, National Eye Institute, Georgetown University, and Genome International Corporation.
His research has focused on the genomics and systems biology of diseases including cancer, infectious diseases, neuro-muscular diseases, and retinal degenerative diseases.
He completed his M.S. in Computer Science and Ph.D. in Genetics, Bioinformatics and Computational Biology at Virginia Tech, where he developed and applied reusable simulation models of mitochondrial DNA heteroplasmy dynamics to study various diseases.”
Thank you so much for joining us in this interview series. Before we dive in, our readers would love to learn a bit more about you. Can you tell us a bit about your childhood backstory and how you grew up?
I had an introverted childhood growing up in an orthodox Hindu family with my caring parents, two brothers, and paternal grandparents.
My father was a bank officer all his life and has been my major inspiration. He had his master’s in mathematics and was a child prodigy at it. He could do 6-digit multiplication and division faster than I could crunch the numbers in a calculator.
My mother was a homemaker and was a pillar of support for the entire extended family. I was an average student until sometime in the middle of high school when I suddenly realized the only way to command respect from peers and teachers was to be among top performers. That determination carried me through fierce competition, getting me into the top-rated, state government-backed Bangalore University College of Engineering in Bengaluru, India.
Soon after graduating, I pursued graduate education in computer science at Virginia Tech. Even now, the biggest and proudest smile I have ever seen was the one on my father’s face when I received a US student visa.
Just 2 years into my life as an expat scholar, I entered into the prestigious summer internship program at Microsoft in 2002 where I met my professional inspiration, Mr. Bill Gates, at his home at Seattle, WA.
Meanwhile, my curiosity towards science was amplified by the completion of the Human Genome Project and the promise of curing all genetic diseases in our lifetime.
There was a newly established Virginia Bioinformatics Institute (now renamed to Virginia Biocomplexity Institute) at Blacksburg, VA. They were a highly qualified research faculty with exciting, funded projects to work on including analysis of genome sequencing data of bacteria and viruses (including coronaviruses).
As I graduated my MS program in computer science, I decided to take up a full-time role as a research associate and pursued doctoral research in the interdisciplinary program of Genetics, Bioinformatics, and Computational Biology.
I got married during this time and had my first baby daughter before my graduation in 2007, marking the moment when I fully “grew up.”
Can you share the most interesting story that happened to you since you began your career?
Soon after graduation, I started my post-doctoral career as a Bioinformatics consultant at the National Institutes of Health and moved to the DMV area. The work at the Cancer Institute and Eye Institute was so exciting that I never felt like I had a job.
Within 4 years, I had contributed to numerous publications involving analysis of next generation sequencing data from mouse and human photoreceptor cells.
In 2012, I moved into my new role as a technical advisor at the FDA on their automated laboratory management (ALM) program involving the development of cloud-based validated system for distributed laboratory information management systems.
My life turned upside down that year when our second baby diagnosed at birth with a rare congenital disorder that was incompatible with life. We were told that our baby would not live.
As we recovered from the crisis as a family, I had learned a good bit about the plight of over 300 million people world-wide affected by one of 7000+ rare diseases. Although the Orphan Drug Act of 1983 had ground-breaking impact on accelerating orphan therapies for rare diseases, much work remained to be done in this space.
Only 5% of rare diseases have any FDA approved therapies and the average time to diagnose a rare disease was 5–7 years.
I decided to turn into a social entrepreneur focused on accelerating diagnostics and therapies for rare and neglected diseases. I co-founded the Organization for Rare Diseases India in 2013 and led a coalition to chart a vision and roadmap for awareness, advocacy, education, & research in India between 2013–2019 in the first peer-reviewed review article on the topic.
My efforts to resolve outstanding patient health issues has been inspired by my personal life’s crises, and the organizations that I have started because of these losses are memorials to their humanity.
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story about that?
My biggest realization along my entrepreneurial journey was that self-reliance is a myth. Without leveraging the wisdom, experience, coaching, and resources of the right people in large numbers, no entrepreneur can be truly successful.
I am someone who recounts the lessons learned from every teacher, friend, and colleague I had the good fortune of working with. It truly takes a village to solve even the smallest of human problems. Accelerating clinical trials is a complex endeavor and it is impossible to recount all the persons who have helped me get this far.
My approach to building a world-class company was influenced by Bob Smith, who introduced me to the NSF I-Corps program and Steve Blank’s methodology.
I am also grateful to Mr. Gulab Bhawnani, who watched my presentation at a WHEELS Foundation event in 2018 and became the first angel investor to trust me. He wrote a check before Jeeva Clinical Trials Inc. was incorporated.
I am also thankful for the difficult people in my life, who Dr. Anand Swaroop at the National Eye Institute had trained me to manage and withstand.
I would be doing a gross disservice if I did not mention our 20+ investors, hundreds of friends, family, and advisors, and the thousands of customer stakeholders who generously shared their sincere stories and pain points with us to develop our proprietary technology.
Newest on my thank you list is the Governor of Virginia Dr. Ralph Northam and the creators of the Commonwealth Commercialization Fund (CCF) for bestowing Jeeva with their inaugural grant. As always, I am grateful to the fertile ecosystem in the DMV area.
Can you please give us your favorite “Life Lesson Quote”?
Our family priest very well summarizes the essence of all religions & humanity in one line “Do your duty with honesty and devotion without ego”.
Can you share how that was relevant to you in your life?
The quote says it all. I look at life as a journey and not a destination. As hard as it is, I try not to worry about the results and focus on the present and doing my best every single day.
You are a successful business leader. Which three character traits do you think were most instrumental to your success? Can you please share a story or example for each?
The three-character traits are mentioned in the life lesson quote above. Mastering these traits is a journey requiring continuous effort daily. Without an honest interest in solving a real problem that affects millions of people, it is not practical to sustain the ups and downs of an entrepreneur’s journey. My persistence is an example common to most social entrepreneurs that are driven by their passion to solve problems.
The next trait is to develop love and devotion for the vision or people you are trying to help. Without devotion, it is a stressful job. With devotion, it becomes a journey that attracts more like-minded people to join forces. This is something we see a lot in people who are willing to help a greater cause than themselves.
Lastly, all humans are selfish to an extent. If you are driven primarily by a selfish interest, it is unlikely you can solve complex human problems. Deep empathy for the people you are trying to help is crucial to lasting success.
You have to be able to visualize a day in the life of your customer or end-user. What problems are they facing? How are they trying to solve them today? What solution can help them an order of magnitude better than current solutions? This means, you must rise above your own ego and see the other persons where they are.
Ok super. Let’s now shift to the main part of our discussion about the tech tools that you are helping to create that can make a positive impact on our wellness. To begin, which particular problems are you aiming to solve?
Clinical trials provide the evidence for bringing lifesaving therapies to patients in need, but they are highly complex and completely dependent on participation from the public. However, low patient recruitment delays about 85% of clinical trials and causes 30% of trials to be terminated altogether, these are categorically big losses for drug sponsors as well as patients.
Every day delayed during clinical trials causes Biopharmaceutical sponsors a revenue loss of $600K to $8M. After patient enrollment, about 30% of patients drop out during the trials, which leads to incomplete data and reduced evidence quality.
There is also a significant lack of diversity, equity, and inclusion of participants in clinical trials with most studies being performed with middle-aged Caucasian male participants. This can bias clinical evidence and lead to insufficient understanding of drug safety and effectiveness on the general public.
Furthermore, according to the data from clinicaltrials.gov, over 80% of the clinical trials are conducted on 10% of the world’s population residing mostly in the western world. Unless we address the speed of patient enrollment and the intersectional diversity of patients, the costs and timelines of developing new therapies for thousands of diseases will not improve.
How do you think your technology can address this?
Jeeva’s scalable eClinical Software as a Service (SaaS) platform helps our customers (academics conducting investigator-initiated trials (IITs), sites, Contract Research Organizations (CROs), and biopharmaceutical sponsors of Phase I-IV clinical trials) to accelerate patient recruitment timelines by 3x while reducing logistical burdens of clinical trial operations by >70%.
Unlike other tools, the Jeeva™ platform is the premium modular, easy-to-use site- and patient-facing cloud solution that is available on any browser-enabled device from a single log-in.
The Jeeva™ eClinical SaaS platform enables remote and hybrid clinical research including FDA-regulated clinical trials by providing the following benefits and features:
Quick & Easy Set Up: Rapid configuration of study database from unstructured protocol documents and enrollment workflow builder.
Remote Recruitment: Remote eligibility screening, electronic informed consent (eIC), and support for protocol amendments & reconsenting;
Evidence Collection: Enabling entry of electronic clinical outcomes assessments (eCOA) by investigators and electronic patient reported outcomes (ePRO) by participants via configured forms an
Long-term Participation: Personalized digital engagement for better patient retention in long-term studies; and
Real Time Intelligence: Built-in AI/machine learning for continuous real-time monitoring with dashboards that display recommended actions for study team and patients at-a-glance.
Disease- and Device-Agnostic: The secure modular platform enables the flexible selection of modules on a per-study fit basis and works in a bring your own device (BYOD) model for use anywhere the internet is available.
Because of the growing number of people who regularly use the internet, our technology will give more patients from diverse populations greater access to life saving therapies during the clinical trial process as well as the commercial stage once outcomes data represents everyone and not just the privileged few.
Can you tell us the backstory about what inspired you to originally feel passionate about this cause?
A second crisis occurred in my life after the untimely loss of my younger brother to a chronic condition that should have been cured in his lifetime considering the common therapeutic area knowledge and resource allocation toward research for the disease.
I had closely seen the challenges associated with engaging patients in clinical care, research, and therapy development process. That’s when I called it enough. I decided to channel my technology expertise into building solutions that make therapies available faster.
Now, launch human-centric technology innovations based on insights based on clinical trial stakeholders who share our mission to accelerate therapy development processes for many diseases.
How do you think this might change the world?
Over 3.7 Billion people who have internet access can potentially be engaged online for participating in clinical research. By comparison, this is orders of magnitude greater than the amount of people living within a 50-mile radius of the hundreds of clinical trial sites, the segment of people who currently have access to clinical trials.
Keeping “Black Mirror” and the “Law of Unintended Consequences” in mind, can you see any potential drawbacks about this technology that people should think more deeply about?
While the Jeeva™ solution may be very convenient for a large number of people, it may make it difficult for some who may not be comfortable using technology. That’s why we designed our technology to be simple for patients and clinical staff to operate and long term.
Another drawback is that countries may not have the proper regulations for conducting decentralized or digital clinical trials yet.
Unfortunately, the last countries to adopt will have less experience implementing site-less clinical trial processes and their patients will have been given the least amount of time being at the center of study design.
That’s why I embrace the international clinical research community in thought leadership and information exchange in anticipation of regulatory changes that are likely to improve return on investment for participants, researchers, and sponsors. With these efforts, I hope at least that the late adopters can benefit from wealth of knowledge gained over time.
Here is the main question for our discussion. Based on your experience and success, can you please share “Five things you need to know to successfully create technology that can make a positive social impact”? (Please share a story or an example, for each.)
- Take the time to listen to your target customer stakeholders and end users with deep empathy. After all, you should be able to literally feel the pain by imagining yourself in the shoes of those you are trying to help.
- Do not first build the product hoping that customers will come. This is a recipe for failure.
- Human-centered design means thinking from the ground up and balancing the right amount of technology, humanity, and processes that complete the user experience.
- In this information economy, you need to figure out the value of data, privacy, sharing, and regulations thoroughly.
- Consider all perspectives before developing the product so as to not leave any resources on the table. The business model should drive the technology, not the other way round.
If you could tell other young people one thing about why they should consider making a positive impact on our environment or society, like you, what would you tell them?
If you work for yourself, it’s a job. If you work to make a social or environmental impact, it’s no longer a job but a purpose. The earlier in your career you realize this, the better off you will be.
Is there a person in the world, or in the US with whom you would like to have a private breakfast or lunch, and why? He or she might just see this, especially if we tag them. 🙂
I would like to meet Mr. Satya Nadella, current CEO and chairman of Microsoft. I have come to admire his journey and his empathetic leadership style. Mr. Nadella has a child with special needs who seems to have inspired and positively impacted his career.
His rise to the helm of the global corporation is awe-inspiring, which would have taken all 3 success traits I mentioned here and many more at the highest level. I am sure a private meeting with him could be energizing and insightful for my own journey. So, a breakfast with Mr. Nadella would be ideal.
Dr. Vas Narasimhan of Novartis also holds equal respect in my opinion. His on the field work on public health issues in Africa leading him to the top position at the global biopharmaceutical powerhouse and his bold approach to an otherwise risk-averse industry is quite remarkable.
I am trying to follow his intermittent fasting approach to maintain energy levels through the day. So, a late lunch with Dr. Narasimhan would be great!
How can our readers further follow your work online?
You can also learn more about my venture at www.jeevatrials.com and @jeevatrials on Twitter, LinkedIn, Facebook, YouTube, and Instagram. I am also easy to find on most social channels @harsharajasimha.
Thank you so much for joining us. This was very inspirational, and we wish you continued success in your important work.
