The goal of TIP — the Tolerance Induction Program at the Food Allergy Institute (FAI) — is to achieve not only tolerance to allergens but also full remission, allowing the patient to eat freely without avoidance.
We often receive questions about TIP from our readers, so we went straight to the source and invited Dr Inderpal Randhawa, founder of FAI and the creator of TIP, for an interview. He answers some of your most frequently asked questions, including how the protocol works, how it was developed, the safety profile during treatment, the cost, and insurance reimbursement, among others.
Here is the interview in its entirety, followed by a transcript of the session:
If you have questions or would like to learn more about TIP and the Food Allergy Institute, visit their website at foodallergyinstitute.com
Transcript
Dave Bloom, CEO SnackSafely.com: Hi, I’m Dave Bloom, CEO of SnackSafely.com. If you follow our blog, you know we do a lot of reporting on food allergy therapies, and one therapy that’s getting a lot of attention nowadays is called TIP which stands for the Tolerance Induction Program. It’s offered exclusively by the Food Allergy Institute, and we get tons of questions about TIP every month.
So I thought it’d be a good idea to invite doctor Inderpal Randhawa, who is the founder of the Food Allergy Institute and the creator of TIP, to come on and answer some questions you might have. So here’s that interview. I hope you find it informative.
Good morning, Doctor Randhawa. How are you? I’m doing great. Thank you for having me. Terrific. Well, thanks so much for joining us. We’d like to find out much more about the Food Allergy Institute and TIP but let’s first talk about you. Could you introduce yourself? Tell us how you founded the Food Allergy Institute and, maybe tell us a little bit more about your background?
Dr Inderpal Randhawa, Founder Food Allergy Institute: Yeah, absolutely. I’ve been a physician for over 25 years, and it’s been a, you know, a long road for what I initially was looking to do. I’m board certified in five fields. So both in adult and pediatric pulmonary. So most of my life was in the ICU. I’m a transplant immunologists. So think about solid organ transplant.
So that’s most of my world. And you know, I did that for the first, you know, ten years of my career still do some of that work today. But really, things kind of took a left turn in 2005 when I first started seeing anaphylaxis in the ICU. And that’s where I, by interest, started in the field.
Dave: So tell us, tell us about the Food Allergy Institute. Tell us about TIP, what it is, how it works. And for those at home, TIP stands for the the Tolerance Induction Program., and it’s very unique to the way that the Food Allergy Institute operates. So tell us a little bit more about that.
Dr Randhawa: Absolutely. So it really does stem from my, my, early career as a transplant immunologist.
So my goal when I first started looking at this condition of anaphylaxis was to find a way to take an immune system that looks at a food like peanut or milk or any other primary allergen, and find a way to make sure it down regulates itself very aggressively before we ever give that person peanut or milk or any primary allergen.
So it’s a very different model, but it’s actually a very similar model to what we do in the transplant space. So if you think about an organ we’re going to transplant a lung for example. We don’t just give somebody a lung. We actually have to take the recipient and pretreat and condition the immune system so that when the lung actually is given to that individual, that the chance for rejection is limited significantly.
So when I started this work a long time ago, my goal was to study all of these different proteins that are out there in different plants, different animal proteins, and see how they’re related to primary allergens like peanut milk, eggs, tree nuts, and so forth. That started in 2005. You fast forward to, you know, 2015, when we actually built our complete databases and started conducting our work through artificial intelligence and machine learning.
And now the Tolerance Induction Program essentially is a very unique form of treatment that utilizes this type of technology. So patients will come in, we’ll draw their blood, we’ll run about 400 parameters, 400 different tests on every single patient. And we will then forecast for them whatever their primary allergens are, how to cross match, down, regulate those allergens.
And before they know it, they’re consuming openly foods like peanuts, tree nuts, milk, eggs, all the top allergens without restriction. So I’d say the one singular difference between TIP and any other form of therapy out there is that we are the only non-avoidance treatment out there. So the end of the program for us is that they actually eat like a non-allergic person.
You no longer avoid food, you actually eat freely without restriction. And of course from our standpoint we do this where the immune system continues to stay in a very calm, down-regulated state of remission, and that remission gets deeper and deeper year after year.
Dave: So it sounds like there was a lot of work, a lot of groundwork that was laid before, TIP came into existence. Can you tell me a little bit about the research that you did in preparation for creating this program?
Dr Randhawa: Absolutely. Again, I’ve been in the research space for 20 plus years. I’ve published over 100 plus now, well over 100 plus, you know, peer reviewed publications, abstracts and so forth. I always have been involved in research, so I’ve had a research laboratory essentially under my belt since really since 2004.
And so my initial work in this space required me to go ahead and actually sequence protein. So that means taking something like peanut and sequencing it down to RNA, DNA and protein level and doing the same thing for every biosimilar protein that was present. So that included, you know, other tree nuts that also included legumes, things of this nature.
Believe it or not, this is something that had not been done significantly prior to that. I then took that information and actually built it into databases. So now I had these class databases. So databases that told me how much protein sequence was similar between this, you know, particular food and this particular food. I then built another database of evolutionary protein, classes, which is basically something that has been in existence previously.
We just simply hastened to something that was more usable. And now I had two mathematical models. I then added a third mathematical model, which was the human immune system. So I started testing and building better tests for the human immune system. So this included cytokine assays, basophil assays, histamine assays, as well as very specific protein sequence assays to actual allergens themselves.
In fact, many of that, those that I was working on way back then are actually now available as commercial tests like the one test for Sesame. It came out of my work in what I was doing with Thermo Fisher. So we took all of these big databases. And the great thing about AI technology is now there’s these large databases can be built into machine learning systems.
And now when we draw someone’s blood, we simply feed that blood into this very deep learning system. And it will read and analyze all of that information and match it accordingly to drive that patient to remission.
Dave: We know that folks nowadays, kids have two, three, four or five, sometimes 20 different allergies. And it’s frightening. But how does TIP handle multiple allergies? Do you handle them sequentially? Do you handle them at the same time? How does that all work?
Dr Randhawa: Yeah. So it’s all handled simultaneously. We will do it all at the same time. You know, back in 2009, 2008, 2009, I have already treated, you know, hundreds of hundreds of patients at that time.
And all of a sudden, I patients coming from Texas and Colorado and places far away from Southern California, where we’re where we are based. And I quickly realized, well, if this is the case, I can’t expect these families to come back every six weeks. So I needed to find a different way. So we changed our entire, again, applied mathematic models and, you know, the vector models that we have and said, all right, let’s find a way to actually treat multiple foods simultaneously.
So indeed, when patients start this program, they’re going to actually be treating all of their food allergens simultaneously going through a pre-treatment conditioning induction and remission. And they will all kind of hit the finish line not exactly the same time. So essentially they’re finishing some foods earlier than others. But by the time they hit their final visit with us, all foods will be in remission.
Dave: Can you talk about sort of your typical course of treatment? Someone comes in from the time they come in to, you know, for their initial visit. What is the progression? How does that all work? Please explain that to our folks.
Dr Randhawa: Absolutely. So our primary goal is that we are a system that wants to make sure our patients hit the finish line on time. So the beauty of what we do as a technology company is we’re able to forecast. And just a quick example I always give to folks. Imagine if you had something simple like high blood pressure and you could go to your doctor and they’d say, yes, I’m going to do some measurements. I’m going to know that your particular system will respond to these cocktail of medications.
Your blood pressure is in remission within seven months and five days. Unfortunately, that doesn’t happen to that, right?
Dave: By the way, I need that. So…
Dr Randhawa: Perfect. But but for us we will actually forecast, you know, literally at their launch visit, their total number of visits that they’ll be in the program and estimated timeline of when they will finish the program.
And we are accurate to that point, roughly in this kind of low 90% range. So patients know, hey, when I start this program, I will be done at this time. I will complete these foods at a specific time. And this all starts when they come into the enrollment process. So again, we have hundreds of employees literally hundreds of employees, 125,000ft² of space supporting our 16,000 plus patients who are most of whom are already in remission.
When somebody enrolls in our process, we will walk them through every single step that it takes to get moving. They will come in for an initial visit where we draw their blood. We have our own diagnostics laboratory that will make sure everything is accurate, and then that will be fed into our machine learning system by the time they hit their launch visit, which is roughly about ten weeks later, we will already start conducting food challenges and we will start the treatment process.
So very quickly it’s moving. And next thing you know, most patients are in the program for roughly two and a half years. Again, it depends. You know, if you have just one allergen, it won’t take that long. Often it’s about a year. If you have, you know, 20 allergens as you described, it may be a 4 or 5 year program, depending on what’s going on, based on severity.
But if most patients are here for two and a half years, they’re coming back roughly every 8 to 10 weeks and every 8 to 10 weeks, we are doing these large challenges, clearing significant numbers of foods. And before you know it, you’re hitting remission. And the greatest thing when patients hit the remission visit is all of that maintenance.
All of those food proteins that you’re consuming will be moved to a weekly or biweekly basis. And once they’re in remission again, there’s no no restrictions on what they can eat. They can literally eat like a normal allergic person.
Dave: So but after treatment, you do recommend that people continue to eat those foods that they were allergic to originally to keep up their their tolerance.
Dr Randhawa: To maintain their tolerance, or what we say is to maintain remission and the scientific term being sustained unresponsiveness, we do want them to consume a specific amount of protein roughly every week or two weeks for the first year by year three of remission, that often is moved to once a month. So it’s really not a heavy lift at that stage.
Dave: So, let’s talk about the allergens that you treat. I presume you treat the top nine, obviously. But let’s say someone comes in with, you know, with, let’s pick a mustard allergy. How many allergens can you accommodate? Is that something that your database is growing over time? How are you? How are you addressing those issues?
Dr Randhawa: It’s a great question. So we take all comers. Like I always tell people, you know, we the only exclusion criteria we have is that you are not anaphylactic, right?
So if somebody comes in and they don’t have anaphylaxis, we don’t treat them. Obviously that’s not what we do. We are here to only treat anaphylaxis. And so when patients come in, you know, I’ve been in this space now we are the largest, you know, food allergy treatment center globally at this stage. So we’ve seen a lot of complex cases.
And so, we are an ongoing research and development organization as well. So we have a nonprofit arm. We continue. We have multiple scientists. We continue to publish, continue to do research. So in that space, if someone has something atypical, so maybe a pumpkin seed allergy or maybe it’s a very atypical profilin allergy which can actually be with vegetables and very severe, examples of that.
We have no issue because we actually have that built into our database. I will say occasionally we will get like a really atypical thing, like a mushroom anaphylaxis case, which that’s a little difficult. But even there, we started collecting that data. We also have a biobank. So we can actually collect the blood of individuals that consent for that process.
It’s all de-identified, and we use that to actually generate more and more research activities so that we can treat these kinds of patients effectively. So basically, as you progress, you are building up that database of foods and then doing the work behind that to, to create a treatment for it. That’s correct. It gets better and better year after year.
Dave: Terrific! So, tell me a little bit about the safety profile for TIP. I presume there must be some issues at times, so if you could talk about that.
Dr Randhawa: Sure, absolutely. So the Tolerance Induction Program is a high-risk program in that sense, where we’re taking patients who are very anaphylactic. They have other kind of medical conditions as well.
And remember, what really makes us unique is that we are conducting food challenges when you come back for your visits. But 99% of this program is done at home. And that’s really unheard of. Like if you look at any other treatment out there, you know, to say you’re going to be doing dosing and up dosing and hitting pretty high amounts of protein at home is unheard of.
Right. But again, with our technology, we know that’s a safe and effective way to do things. We are continuously getting better with our safety profile. It’s already very good. If you actually look at our numbers we’re at well under 1% side effect profile. And again, that’s that’s a great number because if 99% of people are doing great, that means our data science is working, right.
It’s going to continue to get better. But let’s talk about the 1%. What happens to those patients and what’s the typical. So roughly speaking, we actually look at, I’ll start maybe with the worst first, like EpiPen use, right. How often are EpiPens being deployed in our program? During the summer months. Keep in mind that you’re looking at millions and millions of doses of food proteins being dosed on a weekly basis.
We will usually go maybe one whole month and have one EpiPen deployed. In the winter time, that number will tick up to sometimes 3 to 4 EpiPens per month. Now, what are those reactions? Those reactions are often not severe. I mean, again, remember a lot of times parents or patients themselves are going to say, look, my threshold to using epi is different. So no problem.
So most often we’re looking at oral itch maybe some hives or stomach symptoms. We have never had a patient end up in the ICU. We never had a patient require hospitalization. And to that to this day that number still holds true. We’re very proud of that. I’m also very proud to say that our numbers get better year after year.
So with more and more patients being treated, the reaction rates are decreasing, which means that our process is actually getting better., kind of, just with time itself. And I’d say one last point is we are we are a highly regulated organization. And in fact, we publish publicly what our reaction rates are on our website in, in real time.
Dave: And that kind of transparency is really needed across the whole realm.
Dr Randhawa: I would agree.
Dave: Tell us about the success rate. So we understand., we understand it’s a safe protocol. How many people… how successful is your protocol? Someone comes in, has a plethora of food allergies. How often do they… can they expect to be completely in remission?
Dr Randhawa: So again, a great question. So we are bringing in roughly 100 to 150 new patients a month, right? That’s just our typical number. And, you know, we already have patients who are in our system. And then, of course, we have lots of patients in remission. If you look at patients now who start the program over the last five years, roughly speaking, 80 to 85% of them will never communicate with us a single time into our command center that they’ve ever had a symptom start to finish. That’s pretty remarkable. Literally 80 to 85% will go start to end. These are, you know, severe cases milk, egg. Yeah. You name it. And they’re going straight through the program and it’s smooth sailing. The 15%, you know, who we tend to have symptoms often will only have one symptom.
So it’s like, you know, hives once or itch once. And again, I think we do a really good job walking our patients through the process. We have 24/7 support, 365 days a year with a full team to manage anything that pops up. So we get them right back on track quickly. Then we’re going to kind of go down to this very small percentage of individuals who have more than one set of symptoms.
And, you know, we call those patients our “less than 1%,” you know, the ones that are just more complex. You know, I’d say there’s no particular pattern to them. I would say one pattern to them is that they often have tried OIT [Oral Immunotherapy] in the past. And I believe that kind of having OIT [Oral Immunotherapy] immune kind of fingerprints sometimes makes our data science approach a little bit murkier.
But again, we also treat a lot of OIT patients. They do just fine. You know, so regardless of that or less than 1% of cases, we will still do our best to get them to the finish line. And I’ll tell you, we put a lot of effort into that small group of patients. I am directly involved with those patients on an ongoing basis.
And I’m most proud of those cases because they have a lot of complexity. And as long as the family doesn’t want to stop, we’re going to find a way to support them and get them to the finish line. So ultimately, what is our true, you know, kind of failure rate? That’s the that’s the question I often get asked.
I would say in a given year, we may only have 2 to 4 patients drop out because we haven’t hit remission on time. But it’s a very, very small number of patients, most of them because we’re willing to work with them. They’re like, look, we’ve gotten so many wins in this program. If you if you’re not if you want to support us, let’s find a way to get to the finish line.
Dave: That’s wonderful. And for some, the finish line may not even be remission. They’re just looking to be able to go out and have a meal where they couldn’t before. So I presume that’s calculated in.
Dr Randhawa: Yeah. And you know, again Dave, the great thing is that we do have data and data science. So if we ever have a patient who’s in that very small group that we have to work harder with, we will continue to run their data in real time and make adjustments accordingly.
So we’re not blindly trying to guess on any case, we can almost always find a solution.
Dave: So of the people that do drop out, are we talking about mainly… cost prohibition? Or are we talking about maybe the travel involved? So, describe the people who do drop out. What are their big concerns generally?
Dr Randhawa: So right now we have a dropout rate just under 2%. You know, and again, that I was giving percentage numbers like that because again, it depends on kind of when they started and when they decide to drop out. But we always give the most kind of, I’d say aggressive numbers, you know, but that’s where our numbers are at.
If you look at most of them, the vast majority, are very, very young children, to be honest, you know, you’re looking at like seven, eight, ten month old, 12 month olds who’s trying to start the program. We often tell them, look, you know, you’re your infant, you’re young, young baby has to be a good eater to do any program like this.
And, you know, that makes it difficult. So sometimes, you know, they’re like, look, he’s just not eating. Well, we will tell them, listen, why don’t you take six months? Why don’t you take nine months? We’ll bring you right back in. And so you already have your data once. It’s going to be very, you know, helpful to kind of proceed.
So that is still the largest category. The second category that falls is what we call life events. You know, parents, you know, they they change jobs, they move to different cities or different countries. That ends up being one of the big factors. And I’d say the third factor is, potentially financial, where, I wouldn’t say it’s the travel as much as, you know, jobs, that change and things of that nature.
Dave: So now that we’re talking about costs, tell us a little bit about — and I know it probably runs the gamut because it must be different for someone who’s coming in with a peanut allergy versus someone who’s coming in with 20 allergies — but can you give us a general idea of the cost involved and whether insurances will pick up for that?
Dr Randhawa: Yeah, absolutely. You know, when I first started this program, my goal was to have the cost of tip roughly reflect the cost of orthodontics. I know it sounds kind of strange, but I felt like that was just a good example. You know, you’re willing to put in a few years of hard work. You want to, you know, do all this, you know, and twisting a metal in the mouth to get this beautiful smile.
And, you know, if Insurance doesn’t pay that money that at least for the rest of your life, you’re going to have a great smile. Hopefully you wear your retainer.
So when I started this process, I was, really hoping that, you know, insurance coverage would be relatively quick. And so clinical coverage would be easy. It took a long time, but we are now generally clinically covered by every major payer out there for clinical activity. It is not easy to get that accomplished. But we’ve gotten that accomplished now for the last 5 or 6 years. The second aspect of cost is laboratory and laboratories, because we run our own diagnostics, it’s a very complex and highly regulated process, that aspect can be covered by some insurance companies. Some are totally out of network.
We continue to push that forward to this day. And we’ve been getting more and more contracts even in that space. And then the last cost is really the out-of-pocket cost, you know, which is essentially, the 24/7 support that individuals get, the AI analytics, plus remember all of our food proteins, the high risk proteins are given to our patients in the form of gummies and tarts.
We have our own food manufacturing facility and we give all of our patients that. So you add all that up. For an average patient, it’s roughly $1,000 a month, about a thousand bucks a month. That’s out of pocket for the time you’re in treatment. So that may only be two, two and a half years. Once you’re done with that, that number drops drastically because once you’re in remission, we only do a once a year checkup.
Dave: Got it. Understood. Now, the question that that I certainly would love to have an answer to. I’m on the East Coast. Southern California’s a long way away. What about the folks who live elsewhere in the country? They can’t make the trip in. Do you have plans on expanding elsewhere in the United States or, maybe having satellite offices? Can you talk a little bit about your plans for the future?
Dr Randhawa: Sure. Look, it’s always been my goal. It’s always been my goal to make this accessible and as affordable as possible for anybody who wants to reach a life of food freedom. I think had the pandemic not happened, I believe we would have already expanded, certainly to the East Coast.
The pandemic obviously was tough for everybody. We, I think did a great job and made made it through. And I think we we’re a great example of what technology can look like as far as making it through a calamity like the pandemic. So now we’re in a position where we are looking at how to expand.
And so again, we have already expanded from our initial satellite. We actually have another site in San Diego that’s already been open for several years. It was very important for us to test how that would operate and make sure that our safety never was sacrificed for the work that we do. And so I can’t give you a hard timeline.
But I will tell you, we are very close to looking at satellite sites, starting next year, essentially, the question is, what will that satellite site look like? What will be the, size and scope of it? And these are some of the dynamics that we’re trying to figure out. Right now we have roughly 1500 active patients from the greater New York, you know, all the way up to Boston area.
And, you know, of course, if we can just put something that’s centrally located, staffed accordingly, and just get that travel aspect at least reduced significantly, it’d be a huge win. So, it is top of mind. We were taking it very seriously. And I anticipate next year you’re going to see some, big announcements.
Dave: That’s terrific. And by next year, you mean 2025.
Dr Randhawa: That’s correct.
Dave: Well, I think you’ve answered all my questions. Can you tell us, is there anything else that we should know about the Food Allergy Institute that we haven’t covered? Anything else you want to say in sort of summing up?
Dr Randhawa: Yeah. You know, look, I’m not only proud of the work that we’re doing at, Food Allergy Institute through TIP, but I’m also really proud of the community that we’ve really started to build support for.
And I’m not talking about people who are coming in for treatment. I’m talking about the general food allergy community. I really feel, I mean, I’ve been in the space now for several decades that, you know, with the technology and social media that the kind of direct person to person contact that makes communities so strong, that part’s kind of gone away, you know, like it was 20 years ago
it was very easy to find these groups of support. At least I could say, in California, not as easy to find. Online support is perfect, but we want folks to not only, you know, support each other, but have hope. You know, we are a great example of an organization that is taking the idea of hope, transcribed it into real therapy and now putting patients into remission.
We’re, frankly, the next 4 to 5 years. If our research pans out accordingly, we will probably get to a point where we can even get rid of an EpiPen, because it really turns the disease state off. So we will continue to do our great work. But I encourage everyone in the food allergy community to kind of, you know, bond together, support each other, and, continue to look for the best innovations possible.
Dave: We’re very excited and looking forward to the progress that you make. Thank you so much for joining us today. Appreciate it, Doctor Randhawa.
Dr Randhawa: Thank you.
