175 – Dr. Harsha Rajasimha, Founder of Jeeva Informatics, Lost A Child To Edwards Syndrome (AKA Trisomy 18) Shortly After Birth

Transcript:

Tom Couch: Special thanks to Horizon Therapeutics for sponsoring today’s Special Fathers Network Dad to Dad Podcast. Working tirelessly to research, develop and bring forward medicines for people living with rare and rheumatic diseases. Discover more about Horizon Therapeutics’ mission at horizontherapeutics.com.

Harsha Rajasimha: Being part of a network of other parents who are going through similar challenges will make a significant difference for your child, and you will feel like you have done your best to provide the best you could for the child.

Tom Couch: That’s our guest this week, Dr. Harsha Rajasimha, a father of three, and the founder of Jeeva Informatics, which helps medical professionals worldwide treat children with special needs. Harsha is the father of three daughters, including Kahushi, who sadly passed away shortly after birth due to Edwards Syndrome. We’ll hear the Rajasimha family story and about his superhuman quest to help other families with special needs children.

That’s all on this Special Fathers Network Dad to Dad Podcast. Say hello to David Hirsch.

David Hirsch: Hi, and thanks for listening to the Dad to Dad Podcast, fathers mentoring fathers of children with special needs, presented by the Special Fathers Network.

Tom Couch: The Special Fathers Network is a dad to dad mentoring program for fathers raising children with special needs. Through our personalized matching process, new fathers with special needs children connect with mentor fathers in a similar situation. It’s a great way for dads to support dads. To find out more, go to 21stcenturydads.org.

And if you’re a dad looking for help or would like to offer help, we’d be honored to have you join our closed Facebook group. Please go to facebook.com/groups and search Dad to Dad. And now, let’s hear this fascinating conversation between Harsha Rajasimha and David Hirsch.

David Hirsch: I’m thrilled to be talking today with Dr. Harsha Rajahsimha of Herndon, Virginia, who is a father of three, CEO and founder of Jeeva Informatics, a human-centric software as a service, also known as SaaS, enabling clinical research at scale.

He’s also founder of Indo-US Organization for Rare Diseases, a not-for-profit focused on accelerating therapies for rare diseases by building collaborative bridges between the USA and the Indian subcontinent for education, advocacy, and research. Harsha, thank you for taking the time to do a podcast interview for the Special Fathers Network.

Harsha Rajasimha: Thank you for having me, David.

David Hirsch: You and your wife Ashwini have been married for 16 years, and are the proud parents of three daughters: Amulya, 14, Mytri, 7, and middle daughter Kahushi, who sadly died in 2012 shortly after birth due to Edwards Syndrome, also known as Trisomy 18, which is a rare congenital disorder.

Let’s start with some background. Where did you grow up? Tell me something about your family.

Harsha Rajasimha: Yeah, I was born and raised in India, and mostly in the southern part of India, Bangalore, the first 22 years of my life, which is exactly halfway, given where I am today. I grew up mostly in Bangalore and neighboring cities, on and off. I did my high school and college before I immigrated to the United States for my graduate education and professional career.

David Hirsch: Okay. And what I remember is you were the middle of three boys.

Harsha Rajasimha: That’s exactly right.

David Hirsch: So any issues with being the middle child?

Harsha Rajasimha: Not any real issues. But often you feel like the older one gets some benefit of being the older one and the younger one gets the benefit of being younger. There is no such thing as benefit for being the middle one. So I did see that occasionally, but that’s probably just my feeling. I don’t think there was anything real there.

David Hirsch: Okay. Well, I was sort of curious to know what your brothers do and where do they live?

Harsha Rajasimha: My older brother also grew up with me in India. We grew up together in the same house until I was 22, and then I immigrated to the U.S. My older brother went to U.K. and got educated in Scotland, at University of Aberdeen, and then he moved back to Bangalore after eight years in London in his professional career. So he currently lives in Bangalore with my mother. Unfortunately, I lost my younger brother to juvenile diabetes. He was diabetic since age 17, and by age 33 he passed away due to multi-organ failure and cardiac arrest.

David Hirsch: I’m very sorry to hear that. It’s really just the two of you, you and your older brother, as far as your siblings. So I’m sort of curious to know, what did your dad do for a living?

Harsha Rajasimha: He was a banker. He was an officer in the largest nationalized bank in India. For 30 plus years he was in the same organization. He was very loyal to everything around him: his family, his friends, his work, his employer. So he stayed with the same employer ever since I knew him. And he passed away while he was still employed.

David Hirsch: So in what I remember, he died at a relatively early age.

Harsha Rajasimha: That’s right. He was just 56 when he passed away.

David Hirsch: So when you think about your relationship with your dad, I’m wondering what comes to mind.

Harsha Rajasimha: Caring affection and sacrifice. He would wear the same pair of shoes for a couple years just so he could educate and afford better shoes and uniforms for his sons, that kind of thing. When anybody fell sick in the family, he would be the most caring person there, nurturing them, and applying some balm and cream and medication, what have you.

So he was that kind of a caring, nurturing type person, but also someone with a high level of integrity. He was in the bank, and maintaining accounts to the last penny was important to him. And he was also a math prodigy. He would do six digit, seven digit multiplication and division in his head, like a calculator.

David Hirsch: That is crazy. I guess he worked in a bank, so maybe that served him well. He didn’t have to use a 10 key like everybody else who might work at the bank.

Harsha Rajasimha: Yeah, he had a master’s degree in mathematics, but it was not because of the degree or the profession. I think he was just gifted that way right from early childhood. He always believed mathematics was the bedrock of life and everything we do, and that was probably the reason he chose the banking profession.

David Hirsch: It sounds like he had a very high level of intellect, especially when it came to all things math, and a very caring person. And like you said, he had a very high level of integrity and loyalty for that matter.

And I remember in a prior conversation that one of the things that really stuck out when you were talking about your dad was that he emphasized that there’s always something you can learn from everybody you meet.

Harsha Rajasimha: That’s exactly right. He would always say, look, don’t belittle anyone. Whether you see a sweeper on the street or a janitor, irrespective of the profession and their educational level, there is something you can learn from every single person. So that has been my friend with me as well and served me well.

David Hirsch: Any other thoughts that come to mind when you think about your dad? Something that you’ve tried to emulate as a father yourself?  

Harsha Rajasimha: I’ve tried to live up to his level of caring affection. He would give up his entire night’s sleep, even though he had a full day of work ahead of him, if one of us were sick. He would not bother about getting his night’s sleep, and he would be there and be very careful, and even rush to the hospital or whatever was necessary. That kind of thing. So I’m still trying to live up to that level of commitment to family, and so on.

I feel like generationally it’s been decreasing somewhat, between how much our grandparents and parents really sacrificed and did for their kids, and how much I have done or am willing to do for my kids. I feel like there is an order of magnitude dilution in that level of effort. So I don’t think I can live up to the previous generation, but that’s the standard for me.

David Hirsch: Well, it’s great to have that as a measuring stick, and what a great role model it sounds like your dad was.

Harsha Rajasimha: Yeah, he definitely has been my role model for sure.

David Hirsch: I’m thinking about the schooling, and it seems like there was a high value placed on education. I don’t know if that’s all throughout India, or if that’s just in a certain sector of the population, but my recollection was you took an undergraduate degree in computer science from Bangalore University in India.

Harsha Rajasimha: That’s right.

David Hirsch: And then, like you referenced earlier, you came to the U.S. and you did your master’s and PhD at Virginia Tech in genetics, bioinformatics and computational biology. And when you were amassing this war chest of education, I’m wondering, what was it that you thought you were going to do with all this?

Harsha Rajasimha: So that was something very important to me: to connect the dots and see where I’m going to apply this and how it’s all going to matter. Although my choice of computer science was deeply influenced by my father. And to your question, it’s across India where education is considered the most important part of anybody’s success. There is strong belief even now, I think, that medicine and engineering are the most valued professions, and then lawyers, the law side, as well as some of the other professions. The teaching profession is considered very noble, but less paid, like everywhere else.

But essentially engineering was the fastest route to success, especially computer science. Around the time I was growing up, the IT revolution had picked up and  was also providing an opportunity to immigrate to United States better than any other professions. There was a mass exodus, if you will, or a brain drain, where parents were very willing to make that sacrifice in exchange for the growth and opportunities that the U.S. offered.

So that influenced my choice of computer science. It was extremely competitive in India to get a computer science/engineering admission to an accredited university. It meant that you were at least in the top 5% or even top 1%. The population itself is so huge, so you had to really be at the top of the game to get in there.

But my deeper insight, I was very science driven, to life sciences and human social sciences. So those aspects were important to me. I was not all about machines. And so this human genome project in the year 2000, as I came to Virginia Tech, it was still a computer science master’s degree program that I came for.

And my father’s hope was that I would quickly finish my master’s program in a year and a half and get into Microsoft, where I did a summer internship that year. And as you know, Bill Gates is a role model for many, including me, and Microsoft is a household name in India. So that would have made him really proud.

He was already proud that I did a summer internship there. And I even got to meet Bill Gates and get a autograph from him personally at his house in Seattle. So that was an amazing experience. But my goal was to figure out how it all helps people. So my interest was in having a more direct impact that I could feel, and see that it’s helping people.

David Hirsch: Well, you’ve got a pretty amazing career too. I’ll just try to rattle through this. With SAIC, you were a senior software engineer. At NIH, you were involved with the NextGen Sequencing Project. You worked at Genomics as an executive consultant. You worked at Bioinformatics and Health IT as a senior director. You worked at a company called Strand as a VP of Global Strategy. Another company called NTT Data, where you led as managing consultant and the Organization for Rare Diseases, India, is the predecessor to, I believe, what is referred to now as Indo-US Organization for Rare Disease. And you founded this company, Jeeva Informatics Solutions eight years ago. So you’ve always had this constellation of projects, not doing one thing. So at some level, I think you have the adult version of Attention Deficit Disorder.

Harsha Rajasimha: Yes, it absolutely is, and it appears that way as well. But you know, it was the urge to do more, especially during the young years. My father used to do math tutorials while he was working at the bank, and my grandparents would always brag about it. Like he would wake up at 6:00 AM and do a couple classes before having a quick breakfast and rushing to the bank. Then he would come back late in the evening and do a couple more sessions with students. And even the chalk he would use to write on the blackboards—even the chalk powder affected some of his health. And stuff like that.

So there’s some bit of inspiration that my father and grandparents would brag about, that also kept me asking, “What am I going to do in the evenings?” I have a day job, I am able to deliver the expected value, and then I need to do more. And so I had these moonlighting consulting type engagements all along since my PhD days, and I never stopped.

David Hirsch: Well, thank you for sharing. We’ll talk a little bit more about both the organizations that you’re primarily focused on from a for-profit and not-for-profit standpoint in a few minutes.

I’m sort of curious to know, how did you and Ashwini meet? I know that when you told me the story the first time, you prefaced it by saying, “Oh, that’s a very funny story.” So if you can share that, I would appreciate it.

Harsha Rajasimha: Sure. Yeah, it’s probably interesting or funny for some who grew up entirely in the United States or in the western world, but for most people in India, the traditional way of getting married is arranged marriage. The families of the bride and the groom find each other and figure out a high level match. And then they make introductions between the potential bride and groom. And most times their decision is made in the first meeting. But in our case, we took three meetings before we decided we’ll tie the knot.

But interestingly, when I made the trip from Blacksburg, Virginia, to Bangalore, my parents had literally advertised my profile for matrimony. And if you look at Indian newspapers, you will see a dedicated section for matrimonials. So if someone is looking to get married, they would essentially make a very small investment in buying newspapers, and they would find all the matrimonial ads right there.

But there are thousands of years of history of these paternal lineages in India, where you are supposed to marry someone from a paternal lineage that is different from your own. So everyone belonging to the same paternal lineage is considered a brother or a sister, even though it’s cousins. Hence it’s never recommended to marry within the same paternal lineage, what’s called gotra.

So anyway, all those types of complex, traditional, ancestral, historical concepts of how to find a match and get married—those were all taken care of by my parents. I of course was way too focused on my career to have any time dating and spending the time thinking about that part as well.

In some sense, it worked out. And like I said, my father wanted to see me married and settle as quickly as he could. And in hindsight I’m glad I did, because he probably had the foresight that he wasn’t not going to live too much longer. So just a couple years after that arranged wedding in Bangalore, the next time I visited India, my father had passed away. That was the reason I had to visit India.

David Hirsch: Well, my recollection was that your mom or your parents ran an ad in the local newspaper. They had your picture, and the description said, “He is a vegetarian,” and some other things about their son, sort of like a profile. And by the time you traveled back to India for your older brother’s wedding, they had narrowed it down from dozens and dozens and dozens of inquiries to just three. And why don’t you take the story from there.

Harsha Rajasimha: Yeah, absolutely. So the day I landed, I met three, although there were ten on the short list. And Ashwini was the first person I met in that visit. I continued to meet the rest of the shortlisted candidates, and then my brother’s wedding came. And after that we had not had made any decision about whether I’m going to get married to any of the ten ladies that I had met.

And out of that Ashwini had a good feel in the conversation, so I chose to meet her second time and a third time. It’s the transparency and exchange of information and openness and all that, and the laughter we had was all good. It gave me a good feeling to move forward with that.

And my mother’s judgment also is something I care a lot about. So my mother also found Ashwini to be a good match, so we went ahead with that. I had to extend my paid time off by a couple weeks, and in those couple weeks the wedding was arranged. So essentially we got engaged and ten days from the engagement day was the wedding date.

David Hirsch: That’s amazing. So I’m just trying to picture this. You’re telling your work colleagues that you’re going home for your brother’s wedding. And then you call back and say, “I’m gonna stay a little bit longer. I’m getting married too.” That’s a great story. Thank you for sharing.

And you’ve been married for 16 years. Interestingly, you were part of the conference earlier this year, and I think 80% of the hundreds of dads who attended indicated that they are married. And then just a handful of them, no more than five or six, indicated that they were happily married.

I think it is remarkable. Certainly by U.S. standards, that’s way out of bounds. But like you were saying, in Indian culture this has been going on for hundreds, if not a thousand or more, years. This sort practice is more typical.

Harsha Rajasimha: Yes, absolutely.

David Hirsch: Well, God bless you. I’m hoping that you and Ashwini enjoy a long and healthy and happy marriage.

So let’s talk about special needs, first on a personal basis, and then what you do occupationally and as a volunteer. So I’m sort of curious to know, what is Edwards Syndrome? How was it diagnosed? I know it all happened very quickly after Kahushi’s birth.

Harsha Rajasimha: Right. So Edwards Syndrome is essentially a congenital condition, so it’s not a inherited genetic disease. And what congenital means is it’s a random event that occurs some time during the fertilization of the egg and beyond. So it’s something that happens after the fact. It’s not something inherited from the mother, the father, or the family’s genetics. The way it’s usually diagnosed is through amniocentesis or some sort of diagnostic method.

In our case, I was still in my thirties and Ashwini was in her late twenties. So we were a very low risk couple. We had a first child who was normal without any condition. So all we were told is that there was fluid detected in the heart and that there’s a possibility of open heart surgery soon after birth. We needed to be prepared for such a event, and it would have to be done at the children’s hospital in Washington, DC.

So we were mentally prepared for that. We had packed our bags and everything for potentially having to go through that ordeal. But it was even more fatal than that.

David Hirsch: Well, I’m very sorry to hear about the situation that developed. And you knew right after the birth that it was pretty cataclysmic situation you were both facing. And without going into a lot of detail, what transpired after the birth?

Harsha Rajasimha: It was obviously a crisis and a lot of confusion, with multiple emotions all happening at once. And I obviously had to put up a brave face for my wife and give her the assurance that it was not her fault, and that kind of thing. And so there was guilt, there were miserable feelings and all that.

But essentially the issue was we needed to make up our minds to remove the ventilators and life support on the baby. So, “How many more days do you want to prolong this, is the decision you need to make.” And that was a very, very difficult decision to make.

We consulted our family Hindu priest for the religious perspective on this type of situation. We sought the Bhagavad Gita, which has some guidance in general, but nothing was specific to a situation like this. Some references in the mythologies and the stories around that are the great epics of India, the Ramayana and Mahabharata. Those were some of the guides and references we had.

And the scientific medicine, they were helpless. The doctors were the ones who told us there was nothing that could be done and she was not a viable baby. So we consulted all possible references and made the best choice at the time. On the fourth day, we had to lay the baby to rest, and that was very difficult. We were literally holding the baby in our arms and had to take the plug off, and then go through the funeral process and all that.

David Hirsch: Yikes. It sounds like it was a very dark period of time in your relationship and your family. Because here you’re having your second child, and there’s all this energy and excitement, right? Most people’s expectations are at a very high level. And then it’s like you do a 180. You’re going in the opposite direction, and it just sounds brutal.

Harsha Rajasimha: Yeah. Yeah. It was definitely a low point in our lives.

David Hirsch: From what I remember, this is the pivot point, right? It really impacted you, not just on a personal and family basis, but it inspired you to do something from a career standpoint that perhaps you weren’t as focused on or committed to.

Harsha Rajasimha: That’s correct.

David Hirsch: So all the work that you’ve been doing subsequent to Kahushi’s passing is part of her legacy.

Harsha Rajasimha: Yeah.

David Hirsch: And you know, the impact that you’re having on other families as a result, at some level there’s a purpose in the pain that you’ve experienced, the pain that Ashwini has experienced. And I’m hoping that as time goes by, you can put the experience in perspective and say, “Hey, it wasn’t something we had a lot of control over, but we didn’t just move on as if it didn’t happen.”

It’s had a profound impact on your lives and the work that you’ve been doing for others. Let’s use that as a turning point and talk about Jeeva, what it is that Jeeva does and who it serves..

Harsha Rajasimha: So coming out of that crisis started me focusing on accelerating diagnostics and therapies. If we had the option of knowing it was not a viable baby in the first trimester, that would have helped save a good bit of trauma and a lot of time and emotion.

So I started focusing on how long it takes to diagnose patients with rare diseases. In our case, it was still at birth, so it was not that terrible. I learned afterwards that some rare disease patients have waited 33 years, 37 years, before they were diagnosed with Ehlers-Danlos syndrome or some other types of complex genetic diseases.

Many of the thousands of those diseases can be diagnosed very quickly, even before birth now, with the type of genetic testing available, like the maternity test or panorama test, and so on. But they come with their own ethical issues on whether early diagnosis and prenatal diagnosis is right, and what action can or cannot be taken as a result of diagnosing a disease. Knowing that nothing is 100%, there may be a 95% chance that test result is true, but there is still a small chance that the test may not be true, and even if it is true, is it appropriate to terminate the baby?

Or is it a religious, moral, ethical question, which nobody has figured out. And even if some people have figured it out for themselves, it’s something very hard for everybody to agree on the right thing to do. So it’s very personal to the mother and maybe the family to make that decision for what’s appropriate for them.

Jeeva came about when I moved from my focus on diagnosis and faster diagnosis through next generation sequencing based clinical diagnostic tests, where I spent about four or five years. I then moved into healthcare, life science consulting, where I was focused more on why it takes 10 to 15 years to bring a therapy to market, and why the cost had surpassed two and a half billion dollars to bring one treatment to market.

So out of the 7,000 plus known rare diseases, only 5% of them have any approved treatments—about 600 of them. And at that rate, the NIH NCATS director, Dr. Christopher Austin, predicted that it would take 2000 years before all the 7,000 diseases would have at least one treatment. So that’s many, many generations that would not live without having any treatment options for them.

So I thought, that’s the type of goal where I could put all my strength and energy, working towards accelerating them through technology, innovation, science and advocacy. So, as I spoke and listened to many more patient families and looked at some inspiring fathers like John Crowley and others who actually made a treatment happen in one lifetime, we know it is quite possible if we really make it more industrialized rather than a one-off success story here and there. So how do we industrialize them, and where are the missing links to industrialize?

And that’s where Jeeva was born, with the idea that the clinical trial process is one of the most complex endeavors undertaken by mankind. There are a lot of moving parts, a lot of risks at various levels. The therapy has to work, and the patients have to try them and give it a fair try. Whether it’s a drug that is followed or a gene therapy. It might be a one-time shot, or a long-term, permanent cure though therapy, or a biologic which is administered every couple weeks as a infusion. Whichever modalities or medical devices, in all these instances some patients have to go through that process first to demonstrate that it works.

Then once it is approved, the rest of the patients can potentially afford them. But if it is going to take 10 to 15 years and cost two and half billion dollars, in many cases, that’s not even a practical option—unless it’s a huge medical need and the companies investing can recover the investment, let alone make profits. And so I thought that has to be accelerated, as well as the cost being reduced, for any of these to be industrialized.

And that’s where Jeeva was born. Where we can really help is when the patients are willing to participate, and they’re eligible, and they’re interested, but they are not able to travel to Boston three times a year, or 12 times a year, from North Dakota, or even from India, for that matter.

So that’s where the technology can help reduce that logistical burden. When we asked hundreds of patients, “Would you be more willing to travel if it was once a year versus 12 times a year?” the answer was an emphatic yes. “Would you consider participating if that was reduced by even three out of ten times?” The answer was yeah, maybe. “By seven out of ten times?” Sure. That would make a big difference in my choice.”

It’s not just because the patient has to travel, because the caregiver may also have to travel with the patient. So historically most of these clinical trials have occurred and recruited patients who live within a 50 mile radius of the clinical trial sites, which often happen to be metro cities with major academic medical centers. And patients obviously live all over the country and all over the world, and in the case of rare diseases, that’s even more sparsely distributed nationally and internationally.

So it was clear that there was a definite opportunity to make a difference, but that was not happening. And it was not a novel idea that we can solve this problem using technology through telemedicine and remote informed consent and enrollment, social media enrollment, and so on. So overcoming all these barriers is the innovation that was needed, rather than the building a new piece of technology which never existed before.

So that is where I got really fascinated and have spoken with more than 2000 stakeholders by now in the last more than two years of existence of Jeeva. And we have learned a lot from the regulatory perspective, the sponsors, CRO sites, patients, advocates, and multiple stakeholder perspectives. And we have now launched a commercial product that can flexibly address the patient burden as well as the study burden remotely, by reducing the need to travel wherever possible.   

David Hirsch: Well, what I took away from what you just described to address these problems, because it’s pretty high level thinking, is that you want to accelerate the amount of time it takes to do the research and bring these diagnoses to bear, and then you want to reduce the cost.

Harsha Rajasimha: Of diagnosis and treatments. Yes.

David Hirsch: And is there something that our listeners that might be impacted by rare disease should know about Jeeva?

Harsha Rajasimha: Absolutely. So obviously the entire work that I have been doing, like you said earlier, is Kahushi’s legacy, and it was inspired by what families go through. They’re already going through so much that they should not have to take on additional logistical burdens to get what they could get to perform at their best.

It could be quality of life, it could be a life or a death situation, but in any case, accessing innovative new medicines is very important for patients with rare diseases because the majority of them don’t have any. And although our technology is not specific to rare diseases, that remains a very important motivating factor for us to make sure that it addresses the needs of rare disease patients in particular. That’s what I would say.

But in general chronic diseases, and some of the other less severe diseases, but more long-lasting, chronic conditions would benefit greatly from this type of technology as well. Just because patients with rare diseases said, “We are willing to travel the globe to get access to treatment if we can afford it.”

And in many cases, the biotech company conducting these clinical trials pays for travel. So it’s a matter of whether they have the time and energy and the resources to take time off from work to participate in this clinical trial and get this therapy. So in some sense, the travel burden is not going to stop patients from rare diseases for most part, but it’ll really help them.

And many mothers. I have had many letters of support endorsing why the work that Jeeva is doing is so important. Where a single mom says, “I can’t take time off from my work to go to a clinic for one of my two daughters, because I still have to earn money to make ends meet, and I can’t take too much paid time off.” And stuff like that.

So there is a lot of complexity and reasons why patients with rare diseases really appreciate this. Although the sponsors may or may not make an effort to apply this technology, especially if it’s going to increase the cost. So we are figuring out a way where we can help patients by making this more affordable, and deploy it in a manner that doesn’t burden the sponsors and at the same time reduces the burden on patients significantly.

David Hirsch: Well, what my grandmother used to say, “From your lips to God’s ears.” I’m hoping that you’re able to shorten the amount of time and reduce the cost like you had indicated.

So let’s spend a moment talking about the Indo-US Rare, which is a not-for-profit organization. What’s the vision, the mission, and who does that organization serve?

Harsha Rajasimha: The vision is exactly the same as the vision for Jeeva, which is accelerating therapies for all patients affected by rare diseases. The approach, or the way we achieve that goal, is different. It’s through global advocacy and engaging the Indian subcontinent in global clinical trials and research.

Historically, almost all of the drugs that are the rare disease treatments approved by FDA were developed in the Western world, in the US and Europe. Most of the clinical trials were conducted here, mostly on Caucasian populations. And now we have come to a point where gene therapy is very promising to address many of the genetic diseases, and they have the potential to even cure many of the genetic diseases if diagnosed and treated very early on before the damage occurs.

So what that means is the patient population available in the U.S. and Europe is already very small, and many times there is competition. A number of companies trying to make a treatment for muscular dystrophy, or lysosomal storage diseases like Batten disease and mucopolysaccharidosis, et cetera.

Sponsors are unable to find patients in the US and EU alone anymore. So there is a need to go global to be able to even complete the clinical trials and generate the evidence necessary to get approvals. India and rest of the world, outside of US and EU, and maybe to some degree Australia and Japan—most other countries have not really engaged in this process, or very superficially so far. So I personally believe that engaging Indian subcontinent in this process is a critical catalyst in accelerating drug development.

David Hirsch: Excellent. Well, maybe we should do a follow up, a year, a couple years down the road, and see how this is all transpired.

Harsha Rajasimha: That would be exciting.

David Hirsch: I’m thinking about advice now. I’m wondering, based on your own personal and more recently professional experience, if there’s any advice you can offer a dad who’s raising a child with special needs or perhaps a rare disease, for that matter.  

Harsha Rajasimha: Yeah, I think most dads are probably doing the best they can already. But some things to consider would be, are you actively involved and engaged in the care for your child?

Many times there may be a clinical trial that you may not even be aware of. You can go to the clinicaltrials.gov portal that’s maintained by the US government and look for clinical trials that may be ongoing. Set some alerts, and be engaged to see, not just what the best treatment option is available as of today, but clinical trial as a care option. That would be one.

The second is, be more actively involved and advocate for your child, if you’re not already doing that. It’s usually the mothers who take on that role of advocating for the child and caring for the child on a day-to-day basis. If that’s not possible to do on a daily basis, I strongly urge the father to be more involved in finding a patient organization that advocates for that particular medical condition that the child may have. Whether it’s a common condition or a rare condition is secondary.

I think being part of a network of other parents who are going through similar challenges will make a significant difference for your child. And you will feel like you have done your best to provide for whatever best you could for the child.

David Hirsch: Yeah. Well, what I hear you say, if I can paraphrase, is to be intentional. Air on the side of engaging, and you don’t want to look back with any regrets, regardless of how your situation transpires. So pearls of wisdom. Thank you.

Harsha Rajasimha: Absolutely.

David Hirsch: I’m sort of curious to know, why is it that you’ve agreed to be a mentor father as part of the Special Fathers Network?

Harsha Rajasimha: My father and my grandfather played a very important role in my life, and I believe fathers need to play an important role in their child’s life. And as I said during the conference, it’s impossible to repay the debt of a mother, at least I believe so, in our culture. But it is possible to repay the debt of a father, and we should do that if we can.

And so if you borrow something from someone, you do make an effort to return it back. So the way to do that, and this is coming from our cultural heritage, I can say proudly, is by fathering your own child and providing for them at the same level or better than what you received from your father. By doing so, you would’ve repaid the debt of your father.

I knew it was important to me personally. I was not aware of Special Fathers Network until we were recently connected by Effie Parks, our mutual friend, who also did a podcast with me recently, and so I really appreciate the work you do, David and everybody at Special Fathers Network, in many communities, let alone the level of awareness about repaying debt of your father, et cetera.

If the fathers are not even present, the children are left on their own, either as orphans or with mother only. So it’s very important that fathers recognize the important impact they received from their fathers. And whether or not they received it from their father, it is important to pass it to the child, for sure.

David Hirsch: Well, we’re thrilled to have you. Thank you for being part of the network. Very enlightening about the different cultural aspects of being a father of Indian descent. And yes, let’s give a special shout out to Effie Parks who hosts the Once Upon a Gene podcast for helping connect us that.

Is there anything else you’d like to say before we wrap up?

Harsha Rajasimha: No, thank you for having me, David. It’s an honor and pleasure to be on your podcast and amazing interviews over the past. I’m looking forward to catching up with some of those that resonate with me in particular, and all of them hopefully someday.

It’s really good work that you’re doing, and I admire that you make a real effort to understand the cultural, professional and personal human aspects of each person you interview. That truly makes it very valuable to those who are listening. So thank you for this.

David Hirsch: Well, thank you. So if somebody wants to learn more about Jeeva Informatics or the Indo-US Organization for Rare Disease, or contact you, what’s the best way to do that?

Harsha Rajasimha: I’m easy to find on LinkedIn, and through that you can get to the website. For Jeeva, it’s jeevatrials.com. Jeeva literally stands for “life” in Sanskrit. And indousrare.org is the website for the nonprofit foundation.

David Hirsch: I’ll be sure to include those in the show notes so it’ll make it as easy as possible for people to follow up.

Harsha, I just want to say thank you for your time and many insights. As a reminder, Harsha is just one of the individuals who’s part of the Special Fathers Network, a mentoring program for fathers raising children with special needs. If you’d like to be a mentor father, or are seeking advice from a mentor father with a similar situation to your own, please go to 21stcenturydads.org.

Thank you for listening to the latest episode of the Special Fathers Network Dad to Dad Podcast. I hope you enjoyed the conversation as much as I did. As you probably know, the 21st Century Dads Foundation is a 501(c)3 not-for-profit organization, which means we need your help to keep our content free to all concerned. Would you please consider making a tax deductible contribution? I would really appreciate your support.

Harsha. Thanks again.

Harsha Rajasimha: Thank you again.

Tom Couch: And thank you for listening to the Dad to Dad Podcast presented by the Special Fathers Network. The Special Fathers Network is a dad to dad mentoring program for fathers raising children with special needs. Through our personalized matching process, new fathers with special needs children connect with mentor fathers in a similar situation. It’s a great way for fathers to support fathers. Go to 21stcenturydads.org.

David Hirsch: And if you’re a dad looking for help or would like to offer help, we would be honored to have you join our closed Facebook group. Please go to facebook.com/groups and search dad to dad. Also, please be sure to register for the Special Fathers Network biweekly Zoom calls held on the first and third Tuesdays of every month.

Lastly, we’re always looking to share interesting stories. If you’d like to share your story, or know of a compelling story, please send an email to David@21stcenturydads.org.

Tom Couch: The Dad to Dad podcast was produced by Couch Audio for the Special Fathers Network. Thanks again to Horizon Therapeutics who believe that science and compassion must work together to transform lives. That’s why they work tirelessly to research, develop, and bring forward medicines for people living with rare and rheumatic diseases. Discover more about Horizon Therapeutics at horizontherapeutics.com.