43. From Clinical Practice to Biotech Pioneer with Dr. Joan Fallon
EPISODE 43
Dr. Joan Fallon shares her journey from clinical practice to founding Curemark, a biotech company developing novel therapies for Autism based on her discovery of enzyme deficiencies in children with the condition.
Her innovative approach challenges traditional pharmaceutical development by addressing the physiological root causes of Autism rather than just treating symptoms.
Catch the Conversation
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Dr. Joan Fallon shares her journey from clinical practice to founding Curemark, a biotech company developing novel therapies for Autism based on her discovery of enzyme deficiencies in children with the condition. Her innovative approach challenges traditional pharmaceutical development by addressing the physiological root causes of Autism rather than just treating symptoms.
Dr. Joan Fallon, Founder and CEO of Curemark, is a visionary scientist dedicated to improving the health and well-being of children globally. Under her leadership, Curemark has developed novel therapies for diseases with limited treatment options, including a Phase III clinical program for Autism and research on Parkinson’s Disease, schizophrenia, and addiction. The company’s first drug, CM-AT, targeting autism, has earned Fast Track status from the FDA. Dr. Fallon holds over 400 patents, has authored numerous scholarly articles, and is a sought-after lecturer. Recognized as one of Goldman Sachs' Top 100 Most Intriguing Entrepreneurs of 2020 and a recipient of the EY Entrepreneur Of The Year Award in 2017, she also published her first book, Goodbye, Status Quo: Reimagining the Landscape of Innovation, in 2022. A respected business leader, doctor, and academic, Joan is passionate about sharing her insights on entrepreneurship and innovation.You can connect with Dr. Joan Fallon on LinkedIn. You can also learn more about Curemark on their website.
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1:40
Meet Dr. Joan Fallon
5:10
The White Diet Discovery
10:08
From Practice to Patents
15:50
Women, Patents, and Entrepreneurship
20:12
Clinical Trials and Drug Development
27:40
Managing Risk in Biotech
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Julie: 0:04
Welcome to Figure 8, where we feature inspiring stories of women entrepreneurs who have grown their businesses to seven and eight figures revenue. If you're in the mix of growing a bigger business, these stories are for you. Join us as we explore where the tough spots are, how to overcome them and how to prepare yourself for the next portion of the climb. I'm your host, Julie Ellis. I'm an author, entrepreneur and a growth and leadership coach who co-founded, grew and exited an eight-figure business. This led me to exploring why some women achieve great things, and that led to my book Big Gorgeous Goals. Let's explore the systems, processes and people that help us grow our businesses to new heights. If you're interested in growing your business, this podcast will help. Now let's get going.
Julie: 1:04
Hello and welcome to this episode of Figure 8. Today, I'm in conversation with Dr Joan Fallon, who is the founder and CEO of Curemark. She's a visionary scientist dedicated to improving health and well-being of children all around the world, and Curemark is developing novel therapies for diseases and going through the whole process of fundraising and FDA approvals and all of the different things. They've got a fast track status on one of their drugs and we're going to talk about that today, and she has been widely recognized for her work, both as a scientist and as an entrepreneur, and I am very excited to talk to her today. Welcome, Joan.
Joan: 1:47
Thank you, Julie. I'm honored to be here today to have this conversation.
Julie: 1:51
Thank you so much. I'm delighted to have you and I'm so interested to hear, I mean, how you embarked on this journey, which is now coming into being a lot of years right. The path to having, you know, seeing a problem building a drug going through all the approvals, even with a fast track, is, is many, many years long, and so why don't you start with what you identified in the, in the research you were doing?
Joan: 2:20
Yeah, thank you so much. It's interesting because for many years drugs were developed by big pharma by looking at novel compounds and looking at their properties ones that you could patent and then looking at their properties and sort of retrofitting them into diseases, and some of them worked well and some of them didn't work well. This is a different pathway for discovery and it's really true translational medicine. So, being in practice late 80s, early 90s, I started to see children who had different symptomatology than I had been familiar with. So they had delayed speech and sometimes significantly delayed speech, expressive language, and they had no eye contact. A lot of them showed, you know, obsessive, compulsive, like behaviors, but they fit a pattern that was emerging, and so what it turns out to be is the beginning of all these cases of autism. And so it was intriguing to me because I had not seen them in the years prior to that. But as I started to see more and more children, what emerged was a pattern of symptoms that, while they're categorically the same, were not the same child to child. So if a child didn't have good expressive language, for example, some would not speak at all, some would recite whole I call them the soliloquies whole parts of movies, right like Toy Story, or they spoke a lot but didn't have any meaning to it. So it was a category, but it was different child to child, and that's true. It was true for all of their symptoms. So they had sensory issues. Some didn't like the loud noises, some didn't like the seams on their clothing.
Joan: 4:32
But what was more similar child to child was what they ate and I thought, huh, that can't necessarily be by chance. Why would they all eat the same? And when I say the same, it's of course not every child, but the majority of them ate high levels of carbohydrates. Parents described it as white diets and tan diets. I say what did your child eat? And they say, oh, it's only white food.
Joan: 4:52
And as I looked at all of those numbers as they accumulated, it was, I called it the 10 thing diet. It was pastas without sauce, it was French fries, it was chips, it was bagels, it was all carbohydrate and very little protein. And if they had protein, a lot of it was very processed protein. It's like a hot dog or a chicken nugget. And so I kept thinking that cannot be by chance. So I worked with five children and their families and we did blood and urine and stool examination to see if there was anything protein related. And it turned out all five of those children had very low levels, like almost nascent levels, of a particular enzyme that digests protein. And we tested child after child. My colleagues tested children and we assembled a large number and you know if, let's say, depending on the lab, the levels were 10 or 11 or 12. These were like 0.5, 0.2, 1.0. So there was no mistaking this finding.
Julie: 6:08
So they didn't want to eat protein because when they did, it did not make them feel good, because they didn't process it.
Joan: 6:13
I think, if you can't, digest it, then it feels like a rancid piece of meat in your stomach. And so they were very and parents described them being like vehemently against eating those things. And children, you know, they go through cycles of food eating right when they're young. So they'll eat all of this, only want this one day and for like a month. That's all they eat, and then they don't want it anymore. They want something else, and that's pretty classic. This was the same over many years and that's pretty classic. This was the same over many years. And so that finding, which was a low level of chymotrypsin, which is a enzyme that digests a great deal of the protein, but it breaks off the most important amino acids and they're called essential amino acids, and that always takes people back to their high school biology class and in an essential amino acid, you can't make it in your body. There are other amino acids that you can make, but these you can't make, and there are important ones like tryptophan, which forms the basis of serotonin, and phenylalanine, which forms the basis of dopamine, and norepinephrine, epinephrine. So without that, you're theoretically at a lack of those neurotransmitters, because you need those things to make it. And so it was an interesting finding.
Joan: 7:43
I, uh, early in that journey I was um at a family dinner and my brother says to me so what's new? I said well, and I literally what I said was I found this funky thing in these children. He's like well, what does that mean? And I explained to him and he said well, do you think that replacing it could help? And I said I, I don't know, we could test it, I don't know. And he said well, look, if you think it can help the children with autism, you need to patent it so that it has a value, so people will ultimately use it. So I went down that road- which I had never thought I would, find myself patenting things.
Joan: 8:25
But then we saw, and then, when I've had that finding, there are a lot of related conditions, such as Parkinson's, which is a neurodegenerative condition, but it also has its origins in the gut, and so we tested people with that and, sure enough, mid to late stage Parkinson's had a similar finding and only, I think, earlier this week or last week there was this big breakthrough. We think Autism and Parkinson's are related. Well, I've known that for years that they're highly related, along with other conditions, right so, like Schizophrenia and other things. So I think that people pay attention to neurodegenerative conditions. So if you have a parent or a friend or someone who degenerates from their normal so Parkinson's, Alzheimer's, those things people get panicked over it. There's a lot of money thrown at research, but when there's a neuro-developmental condition, the thing is well that kid's never going to have the normal development. So therefore, why would we put all the money into researching?
Joan: 9:41
And I've written a piece, I think it was in Fast Company, researching that. And I've written a piece, I think it was in Fast Company, talking about the disparity in the NIH monies that are directed to these conditions. And so you know, I made the bold jump to form a company and I founded the company when I had a couple of things. One was an okay from FDA to go forward. I hired an FDA expert and we met with them. I had two patents, right. So I had the two patents and I had all these tests that showed that these kids had this deficiency and again, it's not everyone and this is not a cure to treatment. But I embarked on looking to see if we can help these children. So I formed a company and then I had to raise money, right.
Joan: 10:42
Yes, and you had to raise a lot of money right, that's right and um, you know, fortunately the trials for something like this, which don't involve multiple blood tests and other things, are less expensive, but nonetheless I had to raise significant money. And so, um I, I met a woman through Springboard who now actually works for us, and she took me up and down Sand Hill Road in San Francisco, in Palo Alto, to meet with all the venture capital people and they were like look, we don't know what causes autism, we don't know what even the outcome measures that are the right ones. So therefore, we're not going to invest in autism. And they haven't, and they still haven't, invested in treatment. They invest in behavioral treatments. They buy all these centers. Now it's a big money-making business.
Joan: 11:40
But, in terms of drug, because there's been so much, so many failures, big, big companies have tried to crack that thing and they, they haven't. They haven't. Mostly, I think, because they think of it as a psychological and a mental issue, and I think it's more of a physiological issue. And so, as a result of that, we embarked on these trials. And so, as a result of that, we embarked on these trials and at first, when I went to the doctors who were the experts, I thought you know I'm looking at a gut brain mechanism. Are these psychiatrists? Are they going to understand that they were like yes, absolutely. We think there's other origins in the body for this, and so they enthusiastically went into the trials with us.
Julie: 12:25
Well, what's it like? I mean, here you are, you know you're a clinician with a practice and you know, suddenly you're patenting things and becoming an entrepreneur and raising a lot of capital. I mean, that's a really, really big shift. You know, just fundamentally in terms of, like, how you see something and it kind of becomes your life's work, and yet the role changes that that's brought.
Joan: 12:52
Right. So I had to. I took sort of a pragmatic view of that, and the thing about me is that I know what I don't know, and I think that was very helpful in this, because I, although I have a background in physiology as well, I didn't know how to do a clinical trial, and even though I wasn't going to be we have a CRO and all of those things I knew that if there were, you know, people that were not doing well in treatment in clinical trials for these children, I needed to know the ethics of clinical trials. I needed to know a lot of things. So Harvard mass general had a program that I went to.
Joan: 13:36
So at one point in my life I was practicing, I was writing patents and I was going to school in Boston two days a week and, uh, and using my retirement money, yeah, right, and to use my retirement money to do all of that, right, it was all in if I was going to go in. I was all in. And and then, uh, you know, one evening I was at friends, uh, who I've known for years. I was at their house and her husband got up and went to the drawer in the kitchen, took out a checkbook, wrote me a check for like $300,000 and said just leave practice and go for it.
Joan: 14:13
And I said okay and I did, and so, um, and it was daunting at times, right, it's like I didn't know how to do many things. But I had great mentors, people who saw what I did, who understood what it took to kind of leave what I was doing, what I loved, and start something new. And so I had terrific lawyers. And you know, I'm not from that business world or from that farmer world. So there are things that are done in those worlds that are not intuitive to me. They just weren't intuitive.
Joan: 14:51
Like the later you invest money, the more preferences you get with that money. And in my mind, the people who invested in the beginning took all the risk. Why don't they get the preference? So I did it backwards. I mean it's, it's really. They get the return of their money first and it's a small amount compared to what we sort of now have a valuation of. But I just felt like why would they get rewarded later when they didn't take the risk? And I had phenomenal lawyers and I would say to them is there any reason why I can't do that? Is there something like, uh, not kosher's, something not right about that? And they're like no, it's just how I. You know, convention doesn't mean anything to me If there's a better way to do something.
Julie: 15:37
Yeah Well, and that kind of speaks to what the research is and what it is you're doing. So let's talk about a little bit about patents. So in those early days you had that conversation with your brother who said patent that, and we talked about how lots of times women if you look at the number of women who are pursuing patents and think about patenting things, it can be quite low, right.
Joan: 16:04
That's right. So just before the pandemic I actually testified in front of Congress about this and I believe that that there is a issue with women ownership of their own things and there's lots of. You know there's lots of anecdotes out there about, for example, Watson and Crick being not the ones who actually saw the double helix. You know it was the woman who ran the microscope, who identified and wrote about it first, so and didn't get part of the patent or part of the Nobel Prize. So there's a lot of that out there. But I think, just even on a on a regular note, women don't own their own ideas, inventions, those kinds of things, and I think it's historical.
Joan: 16:56
So while patents are one of the most egalitarian processes in this country and it's in the Constitution, right, so you can invent something, you will forever be the inventor. But there's also a person who was the assignee who basically owns it. And when women patented early on and it was only a couple of years after the first patent was done in this country that a woman did a patent, she couldn't own it. She couldn't get any of the money from the invention. Some male person had to do that in her family and that lasted until the mid-1800s, and then they could own their invention as well and reap the benefits financially from it.
Joan: 17:51
But if that's our historical legacy, if that's what's in our past and our mother's past and their past and their past, ownership of that kind of thing is not intuitive. It wasn't intuitive to me and I have a brother that's, you know, invented something very young and then retired and you know and did other things. So I feel like I was exposed to it and yet it wasn't something that I could own. So I think it's very important and also when women and entrepreneurs in general, it's a very expensive process, so oftentimes they leave it to the last, to the end. But when I went out to raise money, it was very important that I had two patents.
Julie: 18:36
Yeah, I believe that, because then they know that you're building a moat around what it is, you're protecting what it is you've discovered.
Joan: 18:44
Yes, exactly, and even more basic than that. Some other regulatory body recognize that it's unique.
Julie: 19:00
Yes, it's not just unique in your own view and in you know what you in the research you've done, it has also been there. But how did that organization really help you, in terms of both the IP piece but the fundraising piece, especially right?
Joan: 19:18
So the the IP piece, you know my brother was he. He works for me now and he keeps track of all of that, which is great. Keeps track of all of that, which is great. But Springboard was founded by a woman named Kay Koplovitz, and Kay was one of the very successful women entrepreneurs who she herself had trouble raising money. She started the Madison Square Garden Network and the USA Network and has served on the board from everything from you know, from HBO to Liz Claiborne, so she's been a very prominent woman, now investor and board member. But she started this to expose women to sort of the right way to raise money for your company, to help with your pitch deck and all of those things. And one of the most valuable parts of Springboard that I have found is that the same thing and going through the same struggles and you know it was a very it's been a you find yourself in that space. You really should go through the springboard training and go to their events. You'll learn a tremendous amount.
Julie: 20:57
Yeah, and you really do need to build that network, because I think, also, you know it's harder to get funding all of the things that you talked about. Get funding all of the things that you talked about. It's also like when you're a woman with a business, you're still wearing all the other hats that we wear in our lives, right, whether it's with your parents or your kids, or you know family obligations of other kinds, and you know you're the CEO of many things, not just your business.
Joan: 21:24
Right, that's absolutely true and I think that the, the camaraderie that comes from that is very helpful. And you know, like I have one, one person who say I have this great investor who just made an investment. I think he'd be perfect for you or she'd be perfect for you. Let me make an intro. And you know, and always looking out for the other one which I think is really really important, yeah, well, and the other thing you know, and always looking out for the other one which I think is really really important.
Julie: 21:50
Yeah, well, and the other thing of course that happens is you know. You have, then an awareness of who's coming up behind you, and when do you get to a point where you can start investing in the people that are coming up? To right, I mean there's a cycle that starts to be able to develop.
Joan: 22:04
Yeah, and that's a very important thing. And so people ask me all the time to invest in their companies, which I'm able to do in little bits. I'm like I'm still an entrepreneur. I get it, I got this big thing going on, but it's, I'm still an entrepreneur.
Julie: 22:21
So yeah, and so take us back now to you. Started with clinical trials and you've been jumping through all of the many hoops on your way to an approval, but it is. It's a very long road that is very expensive.
Joan: 22:36
Right, it's very expensive, it's very long, and the the thing that you need to keep in mind is that entrepreneurship is full of ups and downs, constantly, right, and so if you're on the down, you know the up is coming, and I've learned to ride that kind of wave because it's happened over and over and over again for me, and you need to have a lot of tenacity. I mean people. I've heard in the last two weeks more people say to me you have perseverance like I haven't seen. I said, well, I have a mission, right, I see that this is. I've done the clinical trial, I see that it's helpful and now we have to get it approved and we have to get it out to the kids.
Joan: 23:22
My thing is has always been cause I would never want to see myself as a pharma person or a biotech. I would never want to see myself as a pharma person or a biotech. I always said I went kicking and screaming into biotech and so. But now I've traveled the globe and I was, you know, in the last eight weeks I was in Qatar and China, where the problem is the same, and so they need that help as well. So our tagline in the company is it's all about the kids and it's about getting this to them. Yeah.
Julie: 23:56
And how does it work in terms of like? Obviously the FDA is regulating the drug within the United States, but it's also a world known body. Is it like the gateway for drug approvals or like how does that part work for you?
Joan: 24:12
That's a great question. In some countries it's the gateway. In other countries they require you to do some level of trial there, depending on the on where you're going, and so I think that getting this approved here will be helpful in many countries and some. We need to help them go through the approval. So there's some countries, like China, where we can't go in and do clinical trials. We need a Chinese pharma company to do that and we would have a partner and and and uh, and we're in the process of doing that now and is meeting with the companies and selecting a partner and picking up, yeah yeah, picking a partner who can get it to their children.
Joan: 24:58
I've met with the physicians there. I met with physicians in the middle east, where there's a very high number of kids with Autism and um, they understand this and they, they want this more than anything for their kids.
Julie: 25:13
Well, and I think I have some notes of those Autism rates, from 1 in 500, down to 1 in 350, to now 1 in 31. I mean, that's pretty startling really.
Joan: 25:26
It is. It is, and I think that many of the other countries that report lower rates actually are catching up and they recognize that.
Julie: 25:37
Yeah, and so now, how do drugs go to market? I mean, obviously, once you, once you get that approval, somebody's got to make the drug, right. So is that another partnership for you.
Joan: 25:52
Well, it's a partnership now in any case. So we don't make the drug right. We, we outsource this manufacturing. We had a lot of challenges in the beginning because of the kids. The kids have lots of sensory issues, right. So they're, you know, so sort of the thickness of the drug it's a sprinkle on food, it's a little packet you sprinkle on the food so they can't swallow a pill. So when you're giving it to a three-year-old that they can sprinkle on their food, the sizing of the particles had to be such that they couldn't detect it on their tongue.
Joan: 26:29
We had to have it tasteless and we had to have it delivered in a part of the gut that prior there's been no drug to do that right. So we had it because we were targeting protein digestion. It had to be done very early in the GI tract and so it had to get through stomach acid and then be able to be released. So it had to get through stomach acid and then be able to be released. So we had to kind of scour the globe to find a coating that would work. But the other thing is that we don't have any extraneous with the enzyme and we have this lipid coating, so it's a oil coating and when it's spun at high speeds and high temperatures becomes a solid around the enzyme.
Joan: 27:13
And so we solved a lot of problems in the very early time because I didn't want a drug that had like dyes and extenders and all those things that are in every drug, not ours. And we have given, in these clinical trials and the extension of the clinical trial, which still goes on today, over 1.2 million doses of the drug and with you know, we had no, no related serious adverse events at all in over 12 years of giving this drug. So it's safe. I mean, I couldn't sleep the whole time we were doing trials because I was always worried, you don't know. You know we believed it was safe, we believe that we had, but you don't know.
Julie: 27:56
Yeah, and now you talk about so do you have participants who have actually been involved over a lot of years at that point? That must be really interesting to track them. I mean, you're not into longitudinal studies yet, but like you will get there.
Joan: 28:14
Right, yeah, so as you bring that up, we did what they call a delayed start analysis, and so what that does is look at long-term results. So very often you go through the double blind and you get efficacy, but if you go out a little further it reverts back, and that's true with a lot of drugs that they found. So this particular analysis, which tracks the drug over time, delineates between symptom modifying and disease, or we call disorder modifying. So if you have a double blind where the drug has more efficacy and then you give the placebos the drug, sometimes they then look exactly like the drug-treated children. That's a symptom modifying. But if you have a result where the continuation of the improvement is there but the placebo lags behind the drug-treated children from the earlier part of the study, then you know you have a disease modifying, and we published those results in JAMA at the end of 2023.
Julie: 29:30
Oh, that's so interesting, so we know that it's a lasting effect.
Joan: 29:34
And again, these kids are all different, right, and they all started different kinds of. Some are very severe, some had less severe, but they all had Autism. We had to triple screen them to get them in, so we paid a lot of attention to who they were and what they had to not take during the trial. So, for example, we counted 37 off-label prescription drugs that these kids were taking when they showed up for the trial. And then they come off of them because we couldn't a lot of ADHD drugs and other things, so they had to wash out and then they can come into the trial.
Julie: 30:12
So right, because otherwise your results are modified potentially right. So fascinating, so fascinating and so I think, world changing really. I mean getting into this final. You know you're in the final stretch now and I think it's going to be really interesting to see how this can change and improve lives for people.
Joan: 30:37
And it's a different paradigm and I think that that paradigm not only will help these children but will help other biotechs and other pharmas to look at things a little bit differently. Because you know, traditionally psychiatric drugs are like one molecule, one receptor. They go in there and that's it With a lot of off. You know off target side effects, right, and so this is a improving a lack or a missing part of the biology, the physiology of the child. So looking at that in a different way, I think is really important.
Julie: 31:16
Yeah, and I mean, and I don't know, is it you know? Is it that as women, we look at the world a little differently? And and your curiosity about you know that connection that was different than how other people would have looked at it. I mean, it started a great journey, that's for sure, but it is that interesting piece right. Of what does it take for someone to have that different viewpoint.
Joan: 31:40
So I think there are two things. One is that I looked at it from a deductive viewpoint rather than an inductive. So allopathic medicine is all inductive. You have symptoms, you put them together, you have a diagnosis, you get a treatment. But here were these kids who had deficits or differences. Why did they have those differences is a deductive model, so we took a deductive finding and put it through a very inductive clinical trial process, and so that's different. And the other thing is that very often entrepreneurs are afraid of risk. We're all afraid of risk, period right, and so I think it's something that guides all of our behaviors. But both of my parents someone asked me a long time ago why are you and your brother both entrepreneurs? How did that happen? Him very early and me very late? And I said, you know, my parents were both. My mother was an actuary and my father was a big lines underwriter for like Lloyds of London and AIG, and so risk was something you managed. It wasn't something you were afraid of In those professions.
Joan: 32:54
You are managing risk.
Joan: 32:57
So they were never afraid of risk, right? They just knew that you had to manage it correctly.
Julie: 33:03
That's so interesting.
Joan: 33:04
It's very important.
Joan: 33:05
I try to teach people other entrepreneurs about risk.
Julie: 33:08
Yes, well, and I mean certainly you know the risk of not taking the risk Right Like there is that you know that it never can happen, right Like if you had not been able to, you know take that investment and leave clinical practice if you had not like that. Just that risk of you know it's taken you out with a very full time effort this long to get this far.
Julie: 33:35
You know you would have not made that progress if you hadn't taken those calculated risks.
Joan: 33:40
Yeah, right, and you know I, as I said, I went kicking and screaming into biotech but I had to do it because if I didn't do it I would never know right, you would never know if it could have helped these children no and I'm sure, it's changed your life also oh, completely, yeah, completely.
Joan: 34:00
And and I think that the journey, you know, doors open all the time. Like you're thinking, I'm on the down cycle, what happens? And the next thing, you know, I get a call or an email from someone saying, hey, I would really like to meet you. I heard about what you're doing or I'm somewhere, so it just it's in a bit. It's been an amazing journey and and the people I have met throughout this time have been have taught me something all the time.
Julie: 34:26
So good, so good. Well, it's been really great talking to you and I can't wait to hear when the drug gets approved and how you are making a difference for even more people in this world. It's a great story and thank you for sharing. Thank you.
Joan: 34:42
Yeah, I'll come back on here after it's approved.
Julie: 34:43
I would love that very much.
Julie: 34:46
All right.
Julie: 34:47
Thanks, Joan.
Joan: 34:48
Great. Thank you so much. I appreciate it.
Julie: 34:52
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