"Biotech Vs. Depression" with Tomer Amit and Sonia Berrih-Aknin

Tomer Amit and Sonia Berrih-Aknin, PhD founded PreciseMent Health to target treatments for depression and bipolar disorder guided by protein markers associated with good outcomes. The work promises to address the great uncertainties that exist in current treatment practices. Truly a mind-expanding conversation with a compelling team.

Highlights:

  • Sal Daher Introduces Tomer Amit and Sonia Berrih-Aknin, PhD

  • What PreciseMent Health is Solving

  • "...Basically, you had a database of patient data, where the patient's response to treatment had been recorded. Then you took blood samples, and you analyzed to see if there were proteins that indicated certain treatments being more likely to lead to successful treatment than others..."

  • "... Really, for the first time, we can say that we are identifying dependable biosignatures in the peripheral blood..."

  • Dealing With Side Effects

  • "... We'll make it more accessible because of the copay. The $2,000 has a $300 copay with it, which makes it very difficult for a lot of people to pay. We can go in a lot lower because our costs of goods sold are going to be lower ... We want to really have a huge change in the way that mental health is treated and diagnosed..."

  • Intellectual Property Protection

  • "...We're targeting initially the psychiatry market. We'll be looking to provide them with a plasma card test, which will give them, in a sense, for the first time, the ability to test an individual at the point of care with a few drops of blood..."

  • Tomer and Sonia's Backstories

  • "... we are in the process of having biotechnology eat the world as software was eating the world for the last 11 years. We're seeing everything being turned over and reinterpreted in the light of these extremely powerful technologies that can discover patterns, where, before, it was just invisible for us..."

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Transcript of “Biotech Vs. Depression”

GuestS: Tomer Amit and Sonia Berrih-Aknin, PhD

Sal Daher: I'm really proud to say that the Angel Invest Boston podcast is sponsored by Purdue University Entrepreneurship and Peter Fasse, patent attorney at Fish & Richardson. Purdue is exceptional in its support of its faculty, faculty of its top five engineering school, in helping them get their technology from the lab out to the market, out to industry, out to the clinic. Peter Fasse is also a great support to entrepreneurs. He is a patent attorney specializing in microfluidics and has been tremendously helpful to some of the startups, which I'm involved, including a startup that came out of Purdue, Savran Technologies. I'm proud to have these two sponsors for my podcast.

Sal Daher Introduces Tomer Amit and Sonia Berrih-Aknin

Welcome to Angel Invest Boston, conversations with Boston's most interesting angels and founders. Today, we are very lucky to have two co-founders who are in Israel right now, but they have a very strong Boston connection. Welcome, Tomer Amit.

Tomer Amit: Hello.

Sal Daher: And Sonia Berrih-Aknin. Welcome.

Sonia Berrih-Aknin: Thank you. Very happy to be here.

Sal Daher: We're talking via Zencastr. I'm sitting in Cambridge, Massachusetts. They're both in Israel. I was connected to Tomer and Sonia by Luke Burns, who was at business school with Tomer and knows him very well. I'm very grateful to Luke for the connection. Thank you, Luke. The startup that Tomer and Sonia have is very interesting. They're doing something really powerful. It's called PreciseMent.Health. It really is an attempt to improve the care of depression; of people living with psychiatric disorders, but suppose you're working with depression.

I'll let you guys tell the problem that you're solving with PreciseMent.Health.

What PreciseMent Health is Solving

Tomer Amit: I can get started, and then Sonia can fill in the blank. Mental health, I think, as you know, is one of the only branches of medicine where diagnosis and treatment decisions rely exclusively on the clinical interview between a patient and a clinician. This is despite decades of scientific research psychiatry, until now, it's no closer to having any objective biological and diagnostic treatment decision tests. Until now, this is more or less eluded science. What this means is that today, the standard of care is trial and error.

If you bear with me for a minute, I want to share a personal story that illustrates what this means.

Sal Daher: Sure.

Tomer Amit: There's a friend of mine we'll call him, Brian, who's 15-year-old daughter had been diagnosed with depression. His daughter is in tremendous pain, and she's seeking help, and Brian would do anything to alleviate her suffering. His daughter's doctor can prescribe medication, but there are many kinds, and there's no way for her to know, which one would work. She knows that there's just an over 30% chance that the first line of treatment she would prescribe would actually work. She told Brian and his daughter that there is a genetic test that is supposed to help find the right treatment, but the results are not that dependable, and therefore, don't improve that much the odds of a successful treatment.

What he told me, this I remember so well is it's like choosing between a toss of a coin or a roll of a die with my daughter's life on the line. Imagine in that situation where a physician would have a simple, dependable, accurate test that will tell her if the treatment is actually going to work. This is PreciseMent, this is what we do. Our goal in a sense is to help physicians shift tens of millions of decisions just like that from trial and error to biological objectivity for the first time.

Sonia Berrih-Aknin: I would say that the problem in mental health as in many other diseases, it is that the treatment is given to many patients while the patients have a very different biology. They may have the same symptoms, but very often they are different. They have a different genetics, they have a different biology, and so they get the same treatment. Some of them obviously will respond to the treatment and some others will not. With this theory, we believe that there are some biological biomarkers that should be different between responders and non-responders to treat it.

The question is, what kind of biomarkers could be the ones that could help to answer these questions? As just Tomer said, the genetics has been used a lot. The genetic has been used and has been very helpful for many diseases, but it's not enough because genetic stay stable all over your life. When you take a medication, it's not supposed to change the genetics. That's right. It is going to change the products of the genetics that are RNA proteins, and eventually metabolites. Genetics is probably not the good target. We believe that by using the products of the genetics, we can find very important biomarkers that can help to answer this question.

Sal Daher: What are the markers that you're looking at? RNA, and metabolites, and other byproducts of genetic expression, so to speak?

Sonia Berrih-Aknin: It's a good question because indeed, it's possible to use all kind of biomarkers, but what is important at this stage is the quality of the data that you can get. Transcriptomic is very interesting but the problem it is that analyzes transcriptome is still--

Sal Daher: Sonia, please unpack the term transcriptomics. Transcription, the process of taking information from a DNA and taking to the cell using RNA, please unpack that for the audience who may not be life science experts.

Sonia Berrih-Aknin: Okay. Note that from the DNA, to get to the proteins that are the effector molecules, they are in a damaged stage which is the RNA. RNA messenger. The DNA gives RNA that gives proteins.

Sal Daher: If I can just make it more accessible a little bit here, DNA works as a storage of long-term genetic information that is passed down through inheritance and so forth. The RNA, the various forms of RNA, but messenger RNA that we're talking about here, these are molecules that have genetic meaning and transcribe information, that store the DNA. They take them to the cells, and they act on certain parts of the cell, the ribosomes, to produce proteins, which is actually what does stuff in the bodies. Most things that are turning things on, turning things off, they're making stuff happen in the body, are proteins.

We have DNA storage, long-term, kind of like the master plan. The mRNA vaccines, it acts on the cell, and then we get proteins, we get other types of substances. Please continue.

Sonia Berrih-Aknin: Yes, sure. You're absolutely right.

Sal Daher: We want to make sure that that's accessible to a layperson.

Sonia Berrih-Aknin: Excellent. Excellent, thank you. What is important to understand is that the DNA is the same in all cells and tissues, and the RNA is very different from one cell to another, and one tissue to another. For example, in the pancreas, you will find a lot of insulin and other hormones, and that you will not find in other places, and you will find them at the level of the RNA and at the level of the proteins. If we have to choose between RNA and proteins, we choose to study proteins because the RNA are not very stable, and we know that it is a little bit dangerous to construct a test that we want robust with this kind of material.

We all know about the PCR test for the COVID that it's based on RNA, and we know that it's not always very stable. It's very difficult to use it. I think that all researchers know other problems using RNA. Sometimes it works, sometimes you lose it. It's very difficult to work with it, so we choose to work with proteins.

Sal Daher: Excellent.

Tomer Amit: I just want to add that since we'll be raising funds that will have availability for a biological researcher, and given your explanation, we're not sure how the investment is going [laughs] we would want you to join the team since you know quite a bit.

Sal Daher: [chuckles] No, no, it's just that I invest in this space. I have to have a layperson's understanding of what's going on because I'm a very curious person. I want to know how things work. Basically, I understand that you have some evidence the presence of certain proteins in serum have association with certain treatments being more successful than others. Would you care to elucidate that, to go into that?

"...Basically, you had a database of patient data, where the patient's response to treatment had been recorded. Then you took blood samples, and you analyzed to see if there were proteins that indicated certain treatments being more likely to lead to successful treatment than others..."

Sonia Berrih-Aknin: Yes, sure. Using platonic analyzers, we analyze patients that responded to treatment and patients that do not respond to treatment, so we get blood before they were treated. It was patient that comes from a clinical study, that means it was an historical cohort. That was a study that was done in a very famous laboratory, and we analyze the proteomics in these patients, and we had 60 patients altogether. 58 exactly. We found some molecules that are differently expressed between the responders and non-responders.

Sal Daher: Ah, okay. Basically, you had a database of patient data, where the patient's response to treatment had been recorded. Then you took blood samples, and you analyzed to see if there were proteins that indicated certain treatments being more likely to lead to successful treatment than others.

Sonia Berrih-Aknin: Yes.

Sal Daher: It's an ex post facto analysis, based on historical outcomes.

Sonia Berrih-Aknin: Absolutely.

Sal Daher: You went back and you figured out what proteins likely are associated with those types of outcomes?

Sonia Berrih-Aknin: Absolutely.

Sal Daher: Very interesting. Can you tell me a little bit the sample size?

Sonia Berrih-Aknin: Yes. We had 58 patients, 29 responding to the treatment, and 29 did not respond to the treatment. I can give you an example. We found that in the responder patients, we have low level of some neurotrophic factors, for examples, which we don't see in the responder patients. When we analyzed what happens after 10 weeks, we found that the levels of this molecule were increased.

Sal Daher: Neurotrophic factors, is this something having to do with growth of nerves, neuro trophos?

Sonia Berrih-Aknin: Yes, it's factors that are neurotrophic. That means that factors that has the survival and growth of nervous cells. Those patients have a lack of these factors, but when they took a treatment that increased the level of this molecule, and we can explain why these patients really are responding. The story for the non-responders is very different. We have some explanations, I don't how much we want to talk about, but we just found some explanation that we need to confirm, let's say. It's maybe too early to speak about it.

Sal Daher: Were the blood tests taken prior to the therapies or after the therapies?

Sonia Berrih-Aknin: Yes, prior to the therapies. All the analyzes were done prior to the therapies, but we also took a point after the therapies, just to check what the treatment was doing.

Sal Daher: In this sample size, you found it to be significant?

Sonia Berrih-Aknin: I can tell you we know that it is a small part, but we found clear, significant, and very scientifically meaningful results. We know that we need to confirm, and we need to have bigger cohorts. Let's say that we think that the results that we have are solid. I really believe that they are solid because I think they were indeed better than I thought they will be. The results are very coherent with what we know of the pathophysiology of the disease and what we know about that. It's just that it seems that no one thought to do that before, and also, no one thought that we can find something in the blood.

Tomer Amit: It's also some skill set and technology. Sonia has, she's modest, which we try to work on.

Sal Daher: Scientists are like that. They're very careful, very guarded.

"... Really, for the first time, we can say that we are identifying dependable biosignatures in the peripheral blood..."

Tomer Amit: Yes, but it's over 30 years of investigating complex diseases in a lot of different methodologies and technologies, and the ability to take the latest and greatest technologies and adopt that to mental health is what Sonia brought to the table. I think the breakthrough thought is to view mental health in the lens of biology in the way that hasn't been done before. Sonia and her team built this platform based on these technologies, which again are used in other complex diseases, but only very recently, and to adopt that to mental health. This is why we're really seeing the signals that we're seeing. Really, for the first time, we can say that we are identifying dependable biosignatures in the peripheral blood.

Sal Daher: This is very exciting because not a huge sample, but the signal seems to be strong enough that it's scientifically significant.

Tomer Amit: Yes, and keep in mind that we also looked at the side effects as well. We also found very significant signals, and all of these are also explained biologically by what we're seeing. These signals are completely different than the signals that we found for responsive or unresponsive. We have a lot of different orthogonal evidence within this cohort, that indicate that what we have is quite real. Granted, we have to do validations, and this is going to be very scientific company. One of the things I tell people, both investors and people who come in, our goal is not just to create successful diagnostic companies, we want to change the standard of care.

To do that, you will need to do in-depth clinical studies to build this product, improve their reports. It's going to take a little bit more time. We just want to do a quick CLIA test to market. There's more work to do, but given the clarity of the signals that we have, the results are very, very promising for things to come.

Sal Daher: Okay. If I can summarize a little bit here, the problem that you're addressing is the fact that selection of therapy for major depression is now very difficult. It's mostly trial and error.

Tomer Amit: Yes.

Sal Daher: There is a genetic test existing, but looking at the DNA, at the genetics of the patient, doesn't predict very well. The reason is that sometimes that genetic trait is expressed, sometimes it is not in the way that it's expressed. It's not looking at the DNA, doesn't give you much information. Even looking at the RNA, which is closer to the action, doesn't give you much information. You look for protein markers, which is ultimately the stuff that's where the rubber hits the road, so to speak, biologically, and you found certain markers that predict strongly, whether or not a therapy will work. Also, what type of side effects that therapy is likely to have quite distinctly?

Tomer Amit: Correct.

Dealing With Side Effects

Sal Daher: This is very powerful because one of the problems with treating depression is that there are a lot of side effects. If you can find the optimal treatment, and avoid someone who's susceptible to certain side effects for that person, it's like winning on two playing fields.

Tomer Amit: This is exactly what the Scientific Advisory Board told us, they want this information to have a dialogue with an individuals to know, "Hey, this has a good chance of working, but keep in mind, these are the side effects are you going to have? Are you going to keep taking the medication?" I also want to add that the treatment decision is the first solution. Since we're building a platform, we're looking at precision medicine in mental health. We're also looking in diagnostics, we're looking at three specific problems, which we identify both having as a clinical and a business liability, which is depression, PTSD, and bipolar.

We're also looking to help in clinical trials. This is in selecting the right population for clinical trial, and of course, we also want to bring this to novel therapeutic targets. Because in a sense, since everybody is different, once you're creating this, we're creating millions of new biological data points that have never been seen before. With that sort of platform, one of the main part of our vision is to bring that back and see what specific therapeutic targets we can find.

Sal Daher: Okay, so with these incredibly rich options of possibilities that you have, what have you identified as a low-hanging fruit that a startup can develop into something that is akin to a product?

Tomer Amit: The first one is the treatment decision, and the reason is that it's not just a need, it's a market. This is something that is already reimbursed for the pharmaco genetic tests, we're looking to bring something that's going to be two to three times more accurate and cost probably a fourth as much. The cost is significant because even if you can get it reimbursed for a higher price, the copay is a huge issue. If you lower the costs, you have a much larger market access than you would when the cost is significantly higher. In that case, there's a lot of research that says untreated people with depression costs about $7,000 more per year than people who are treated well.

Beyond that, health funds have already proven to want to reimburse something like this, so the work has been done. Actuary work has been done to say, hey, this is something that's worth about $2,000 per year to pay. You take that, and you say, "I'm going to do something that's going to be more accurate, clinically proven, and cheaper. That's the initial market that we're going to go after.

Sal Daher: This is quite consonant with a fact that listeners to the podcast are already familiar, with which they're already familiar, and that is that mental health patients, I think they're something like 5% of the population, but they consume two-thirds of the resources in the United States.

Tomer Amit: Yes.

Sal Daher: There is a startup in which I'm invested, it's been on the podcast, called Connected Health. What they do is nothing more than bring together data to enrich the electronic health record of patients, so that they know to what extent a patient is a mental health patient, to what extent that person is taking medication that's been prescribed, what other providers they've seen, and so forth. Just that data, bringing that data together and putting it in front of the primary care physician has already shown to be extremely valuable in proving the care, changing the care, that that patient receives.

It does nothing to increase the-- There's a lot to be done also, just on the coordination of care because mental health patients frequently don't comply with prescriptions. There are lots of problems. They may not even show up for appointments with physicians, and so there's a lot to be done in terms of helping coordinate their care. What this is doing is providing a more powerful tool for diagnosis and for selection of therapy.

Tomer Amit: Correct. We're taking the biological approach. What we're saying is the body is telling us a lot of different things, and we developed a way to see what they are and determine what they mean.

"... We'll make it more accessible because of the copay. The $2,000 has a $300 copay with it, which makes it very difficult for a lot of people to pay. We can go in a lot lower because our costs of goods sold are going to be lower ... We want to really have a huge change in the way that mental health is treated and diagnosed..."

Sal Daher: Yes, but these are patients who are very, very costly to the medical system.

Tomer Amit: Yes.

Sal Daher: $2,000 a year expenditure on testing and so forth is going to pay off massively. Massively.

Tomer Amit: Yes, that's what it's reimbursed. We are going to go probably one-fourth the price of that.

Sal Daher: Oh, wow. Wow.

Tomer Amit: We'll make it more accessible because of the copay. The $2,000 has a $300 copay with it, which makes it very difficult for a lot of people to pay. We can go in a lot lower because our costs of goods sold are going to be lower and going to have a bigger access again because our goal is not to have a small piece of population that can pay. We want to really have a huge change in the way that mental health is treated and diagnosed.

Sal Daher: That cost advantage, is that because of the technology? What brings it about? Is it because you're looking at proteins instead of DNA? You're not doing sequencing?

Tomer Amit: That's a good question, and I honestly don't know to give you an exact answer. Can the other test be cheaper? Probably, but the way sometimes the market work is sometimes companies maximize short-term gain, and we've seen that before.

Sal Daher: We can translate it as "we don't sell a $500 product, we sell a $2,000 product. Costs the same, but we don't do $500 products. We do $2,000 products", yes.

Tomer Amit: I think both from a business ethical and cultural perspective, a lower price point makes more sense. It's going to reach more people, it's going to reach more psychiatrists. Market education is going to be larger so you may be less profitable in the beginning, but you're going to reach far higher people, which are going to make up for, and it's still very good margin. Our strategy is different, even though we know that the costs are higher. Keep in mind the $2,000, the $1,800 without copay was calculated based on 2017 numbers.

They only proved 0.03 QALY, which is quality-adjusted life years. We'll believe we'll prove more, and obviously, 2022, '23 numbers are higher, so we can prove actually much higher justification. All that will say, it will make reimbursement easier to achieve and make the test more accessible.

Sal Daher: Tomer, would you please unpack QALY, the QALYs to the listener who may not be familiar?

Tomer Amit: The quality-adjusted life year is what the health plan, in a sense, puts a number on what an individual costs, what it's worth. In 2017, that was I think $70,000 per person, so if you have a diagnosing test that improves it by x, in this case, 0.03, it's 2 weeks. The math then, then it's worth about $2,000 per patient. That's just the way that the plants are doing the math. It's really important to know these numbers when you're bringing any new tests because, at the end of the day, you don't just need to prove the clinical quality. You have to show that you're improving their overall outcomes and the cost as well. It's important to understand how the plans work and calculate to know how you price a test, what outcomes you need, and what you can price them at.

Sal Daher: Okay, so it's very promising in that direction.

Sonia Berrih-Aknin: I think that to add some comments about that, is that indeed today, there are some other companies that sell the pharmacogenetics at a lower price. Because one of the company was the first one, and probably because they did a lot of research to get the results, the price was much higher. They keep it high, but now obviously, it should be a little bit lower.

Sal Daher: This proteomic process, which is the basis of your biological analysis, is studying the proteins. Is that scalable? Is that something that can be done at scale? I imagine it's highly developed already there.

Sonia Berrih-Aknin: Yes, it is, but I think that we are not going to do proteomics to each patients. That's not the idea. The idea is to select the interesting proteins, the one that have a meaningful explanation for us, for each of the drug, and each of the side effect, everything that we can think interesting and important. Then we'll have a test with 40 to 50 proteins, so it'll be multianalyte test. We will not need to do multi-proteomics because, as you may imagine, 80% or 90% of the proteins are not relevant for the question we ask, so there's no need to study them.

Sal Daher: You're targeting a subset of the proteins that are relevant for making the decision and that process you think can be scalable?

Sonia Berrih-Aknin: Yes, absolutely, because don't forget that we do that from the blood, and so it will be a blood test, so it will be a quite a smooth translation.

Sal Daher: Okay. It's a minimal to multiplexing once you have the process in place, these 96 well machine that you can build?

Sonia Berrih-Aknin: Yes. It's a very specific question and that's a very specific technology. What Tomer has just said before, it's true that I have more than 30 years of research behind me. I have tested many, many of the technologies, and I do believe that some technologies are better than other ones. The one that I have chosen here is one that I think it's really very strong, and robust, and reputable. It will be possible to have a multianalyte, a multiplex with 50 proteins with very good results without any loss of specificity.

Sal Daher: Give me an idea, a little bit here, of the intellectual property protection that you have in terms of patents or know-how, which is your own that no one else has. Because you're talking about these papers that you published and this is public information, can you explain a little bit what the moat is to keep competitors out so you can create value in your company?

Intellectual Property Protection

Sonia Berrih-Aknin: Yes, we have used a pipeline of analysis that is very specific to our company. We have property algorithm, we use soft machine learning to get the combinations that are the best with the best accuracy, so we have a very specific analysis. It's not a simple analysis as I did in my academic career before that. It's quite different, and at the end, we got molecules, combinations of molecules that give good results for prediction, and that's the pattern that we have already submitted.

Sal Daher: Oh, very good.

Tomer Amit: The IP is a combination of the analytes, the method of treatment, the algorithms. A combination of all of that goes into the IP, and, of course, it continues to grow as our research grows.

Sal Daher: Okay. This is good to know. You have IP protection on the proteins, but also, in the algorithm, and as you have more data points, your algorithm gets more powerful, and it's proprietary. It's your own.

Tomer Amit: Yes.

Sal Daher: Very good.

Tomer Amit: The data as well.

Sal Daher: Yes, and the data is yours. Very good. Where do you stand right now in terms of, are you actively looking to sign up practitioners to use your analysis, or do you need some kind of regulatory clearance before you do that?

Tomer Amit: Right now we're in the development phase of the product. We're probably about a year and a half out before we can bring it to clinicians. We'll probably be about a 6-month approval for CLIA, and then probably a year afterwards to receive FDA. Right now we are raising funding to build a product that we mentioned and continue to develop the IP on the other diagnostic indications.

Sal Daher: Okay, yes, let's unpack that a little bit. CLIA is a lab that--

Sonia Berrih-Aknin: Certification.

Sal Daher: Yes, it's a certified lab, and that lab can do analyses for other people.

Tomer Amit: Yes. I'll try to unpack this from a market access perspective. As I mentioned before, the company is going to be as clinical as possible, and we will pursue an FDA path, even though likely we won't have to. The way that the strategy work is you pursue a CLIA test first. What that does, it gives you market access fairly early. The plan is, with the right publications and evidence, is to go to market with early adopters with a CLIA. In parallel, we will go through prospective studies to receive the FDA, and in parallel, after that, we'll also do the studies to receive the reimbursement. All that is happening while we're gaining both market access and market credibility that our test actually work. CLIA, simply for us, a way to get into the market early and prove what we have actually works.

Sal Daher: Yes, that's well established. Before you're doing it on a commercial scale, you have a CLIA lab that takes orders. The one site is actually doing the analysis. It's not like done at an industrial scale, but it allows you to gather data, allows you to learn more about the process, and improve your process.

Tomer Amit: Yes.

"...We're targeting initially the psychiatry market. We'll be looking to provide them with a plasma card test, which will give them, in a sense, for the first time, the ability to test an individual at the point of care with a few drops of blood..."

Sal Daher: It costs less money because you don't require this broad clearance from the FDA.

Tomer Amit: Correct, to get a CLIA test up and running is about six months, and that will get us ready to provide services to physician. We're targeting initially the psychiatry market. We'll be looking to provide them with a plasma card test, which will give them, in a sense, for the first time, the ability to test an individual at the point of care with a few drops of blood. That card will be mailed to our lab, and the results will be provided electronically to the physician.

Sal Daher: Okay. I'm sorry, the card? Would you explain that again?

Sonia Berrih-Aknin: Because the psychiatrist are not used to do any blood tests, we thought that to send the patients to collect the blood is maybe not a very good idea, and the best would be to take the blood sample on a card

Tomer Amit: At the point of care.

Sonia Berrih-Aknin: Yes, at the point of care, or at home, but at the point of care. The idea is to use a plasma card because we want to use plasma. This plasma card, you collect some blood, and the cells are separated from the plasma. You can get the plasma, and you can do the analysis in the plasma.

Sal Daher: It's a way of having the patient provide the sample herself or himself. It's a lower-burden way of getting the blood cells.

Tomer Amit: Precisely. You don't want to have psychiatrists deal with lab works, and laboratories, and having samples shipped and frozen. This way, something that psychiatrists can have in their office, they can have these kits, they can do couple of drops of blood at the point of care from the patient, or the patient can do it at home, and then they mail it to us. The process is very simple, but from a company perspective, in a way, it's almost a full-stack solution since we'll be providing the full-service end-to-end.

Sal Daher: Right, so instead of having a full blood draw, it requires a phlebotomist, it's just like diabetics do. They measure blood sugar, a little finger prick, and they get a drop of blood.

Tomer Amit: Precisely.

Sonia Berrih-Aknin: Absolutely. It is very important for us to have it as simple as possible. If you want it to work, it needs to be very simple. Because we don't need too much material to do the test this way, this technology fits very well to our needs.

Sal Daher: Yes, it all points in the direction of low friction, low burden workflow, and also low cost so that you can be doing this massively. It could become the standard of care for patients with depression that they go, they get their little finger stick, send it in to be analyzed.

Tomer Amit: That is our goal, absolutely.

Sal Daher: At this point, what would you like to highlight about your company? Do you want to talk about the business model? Do you want to talk about, perhaps it's early, about the resources that you need, the kind of help that you need? What direction would you like to go in?

Tomer Amit: I think maybe we can talk a little bit about the operating plan. What we plan to do, what we plan to achieve, if that makes sense to you. What the world will look like when you can finally bring dependable objective tests to physicians all over the world in mental health. As I mentioned, we're raising seed round. The seed is to develop the treatment decision test. We will be doing a similar type of analysis as we did with our original cohort with probably about 1,200 patients or so. We will build a large data pool from that, we expect to have a product within 18 months or so. Probably we will be developing the IP for the diagnosis for PTSD, depression, and bipolar. By then, we'll also believe we have some indications for novel targets for depression.

Sonia Berrih-Aknin: For each drug, we need to do analysis on about 200 patients. As we mentioned before, we had already very interesting result with 60, but we need to increase it to 200 to be sure that what we have seen is really clear. It's very important that it is robust because we are going to do a test for patients here. We are going to test several types of treatments because here we have just tested one of them, which is an SSRI, and we are going to test the other groups of treatments as well.

Sal Daher: Okay, and each one, about 200 patients, so half a dozen treatments, maybe something like 1,200 patients.

Sonia Berrih-Aknin: Absolutely.

Tomer Amit: It's also important to note that we already established partnership with healthcare organizations. We have ethical committee approvals for three drugs, So we're planning to do these studies immediately.

Sal Daher: Excellent.

Sonia Berrih-Aknin: We have also the pipeline of analysis is ready also, so it will be quite rapid to get results.

Tomer Amit: Exciting times. We're ready to run, and as you can imagine, we're looking for people to join us.

Sal Daher: You need people to provide money as investors, and also, what else can help you?

Tomer Amit: I want to build foundations from the get-go. I think people with access to healthcare if you think about it, we're looking to do market adoption. The first things we'll do is we'll try to implement this at a major healthcare institution like Kaiser Permanente, Cleveland Clinic. We're certainly looking for people with knowledge on how the healthcare system works in mental health, who would be the ideal users. We're actually speaking with a couple of people who ran large mental health organizations, who will really help us to structure it from the get-go because, for us, if you think about it, what we do now, what studies we're doing now is going to matter down the road for FDA, what sort of reimbursement we will need.

We want to bring as much knowledge as we can right now to make sure that we plan accordingly and run the right tests.

Sal Daher: Very good. I find this really, really fascinating, the idea of using biological markers to help psychiatry, it's just like--

Sonia Berrih-Aknin: It is just needed.

Sal Daher: It is amazing. Before we go into your journeys here, that got you to this point, I just want to ask listeners who are enjoying this interview to take a moment and to highlight the really important conversations we have here. These conversations are created as learning vehicles. They're created to help people learn about the new things that are going on, the really new and exciting things that are going on in the world of biotech startups, technology startups. You can support us by going to Apple Podcasts and leaving a written review.

A brief written review is tremendously powerful. Not just a star rating, but also a written review explaining why you found the podcast compelling. This will help the algorithm, which Apple Podcasts or Google, they all use, to say this is an episode of a podcast that is really valuable and other people should listen to it. It's surprising, one or two reviews sends the downloads, the listenership way up, skyrockets because it means that people care enough to go and leave a review. If you have enjoyed this, if you found it valuable, if this has opened your eyes or something, gotten you excited, if you learned something here, please take that step, and do that.

Anyway, so now, I'd like to get a little bit more biographical. Just tell us your journeys to where you are right now. Tomer, I know that you went to business school, you're a business person. Sonia, you're a scientist. Please fill this in a little bit for me.

Tomer and Sonia's Backstories

Sonia Berrih-Aknin: I have a doctorate, a PhD immunology. I have been in academic position for more than 35 years in France, and I was also visiting professor at the Weizmann Institute, and the Technion here in Israel. I was always very much interested by deciphering diseases. I used a lot of technology in my life, and when there was a new technology I start to use it to see how it can help us to learn more and to require more knowledge. When Omix technology, there's technology that can then use a lot of different molecules started to be in the market, I try them.

It was genomics, methylomics, that analyzed your methylome. Proteomics for the protein, transcriptomics for the RNA, as we just said, et cetera, et cetera. I use all of them, and that's the way we could discover many molecules involved in diseases. I have a PhD immunology, as I said, and I work in the field of autoimmune diseases, so I was interested by understanding the pathology of this disease. We discover a lot of new molecules. That's the way we have been working. I published more than 200 articles, and I retired four years ago.

What happens, it was a tragedy around me. One of my friend and neighbor died. He committed suicide. He was bipolar, and I started to understand what is bipolar, what is mental health. I started to read. I was surprised to read that more than 30% of patients that has bipolar disease commit suicide. 30%. Why? Because they don't get a good treatment at the good time, and the doctors don't know which kind of treatment they can give them. They don't have an idea, and they give a treatment with a lot of side effects. The patient don't want to take them anymore, and that could happen, this kind of thing.

I just read more and more and go deeper and deeper in the biography of mental health and the geography of mental health. I understood that, I don't know why, but all the technology that I said that are very new, and they bring a lot of informations are not so much used in this world. Not so much. There are some, we can find some publications, but the numbers is very small. That's how I thought that I can translate the work that I have done in immunology to mental health by using the technologies that I have used before, and the one that I know that are good. That's how we have created PreciseMent.

"... we are in the process of having biotechnology eat the world as software was eating the world for the last 11 years. We're seeing everything being turned over and reinterpreted in the light of these extremely powerful technologies that can discover patterns, where, before, it was just invisible for us..."

Sal Daher: This is interesting. It's another example of a biotechnology eating the world. Marc Andreessen, the venture capitalist and founder has this thought about software eating the world back in 2011, and how everything was going to be modified because of these advancements in the world of software that made all these things possible. Here we have the counterpart which is the genomics revolution. When they sequenced the genome, they discovered that knowing what the genes are wasn't enough. You needed to understand gene expression.

You need to understand the proteins, the sugars, all these different levels. The complexity just is fractal. It just exploded. The complexity exploded, but the technology is also developed. Now, decades later, we have all these tools, and we are in the process of having biotechnology eat the world as software was eating the world for the last 11 years. We're seeing everything being turned over and reinterpreted in the light of these extremely powerful technologies that can discover patterns, where, before, it was just invisible for us. This is one of these applications of this. It's biotechnology eating psychiatry.

Sonia Berrih-Aknin: I agree. I agree. There is a lot of progress in some of the technology, not all of them yet, but that will happen in the future.

Tomer Amit: What we've seen is, and this is something it's got even its own brand, it's called bio convergence, which is, you're looking at biotechnology that's creating new data, and then you're looking computer science that's created the relatively recent AI/ML capabilities, and you combine those. All of a sudden, you're finding amazing things, which is exactly what we're doing.

Sal Daher: Yes, this is tremendous. Give us a little bit of a biography Tomer. What's the journey that brought you to PreciseMent?

Tomer Amit: It's, they say if you're in Rome be like the Romans, so if you're in Israel, probably good idea to be in ventures. For the past 40 years or so, this is what I've been doing. I've been looking and finding for phenomenal people with brilliant ideas. I'm an entrepreneur. I founded three companies, raised probably $50 million or so. Last round was actually closed a few months ago by Amazon. I've been fortunate to work in a number of different areas from software built for human persuasion attire with an alternative geometry, now a technology to make dialysis more efficient, and even robots that climb shelves.

Past 10 years have been in healthcare, and as you mentioned, I was more on the business side, so I was able to bring solutions to both payers and providers, which are, of course, entirely, entirely different markets. Also, was fortunate about to get exposed to the operational side, helping change healthcare, build an innovation center here. Also, on the B2C side, doing some consulting work for DarioHealth, which is a digital therapeutic. Most of our roles have always been commercial building sales and marketing infrastructure, some MNA sourcing, and, of course, founder and CEO.

Engineer by training, MBA from MIT, where, of course, I met Luke. Grew up in both US and Israel. Israeli is apple pie.

Sal Daher: Okay, Israeli is apple pie. [laughs] Very good. Is there particularly delicious apple pie in Israel?

Tomer Amit: No. For delicious apple pie, probably you want to go to Austria for a nice strudel.

Sal Daher: Oh yes, okay. Oh, there's strudel.

Tomer Amit: I could think of some pretty cool desserts here, yes.

Sal Daher: I can imagine. I can imagine, very good. I'm very grateful, Sonia Berrih-Aknin and Tomer Amit for making time to be on the Angel Invest Boston podcast, and to tell us about your startup, PreciseMent Health, and the really exciting thing that you're doing, of trying to figure out how to look at the proteins of people's bloods, and help that be a clue to what type of treatment for depression might best work for that population. This is extremely exciting, I thank you for making the time.

Tomer Amit: Thank you for having us very much.

Sonia Berrih-Aknin: Thank you. Thank you very much. It was a pleasure.

Sal Daher: Outstanding. This is Angel Invest Boston, I'm Sal Daher, thanks for listening.

[music]

Sal Daher: I'm glad you were able to join us. Our engineer is Raul Rosa. Our theme was composed by John McKusick. Our graphic design is by Katharine Woodman-Maynard. Our host is coached by Grace Daher.