Hope in the Face of Cancer: Dr. Chris Apfel's Mission

[00:00:01] [SPEAKER_00]: Welcome to the Chalk Talk Jim podcast, where we explore insights into healthcare

[00:00:06] [SPEAKER_00]: that help uncover new opportunities for growth and success. I'm your host, Jim Jordan.

[00:00:18] [SPEAKER_00]: Welcome to Chalk Talk Jim. In today's episode, we are honored to have Dr. Chris

[00:00:23] [SPEAKER_00]: Apfel. He's a distinguished physician scientist whose personal experience with his parents'

[00:00:29] [SPEAKER_00]: battle against cancer has driven him to revolutionize cancer treatment. He's the

[00:00:34] [SPEAKER_00]: co-founder of Sage Medic Corporation, a pioneering company dedicated to developing precision

[00:00:40] [SPEAKER_00]: medicine oncology solutions. His innovative approach involves using a unique microtumor

[00:00:46] [SPEAKER_00]: model to predict the most effective cancer therapy to apply to the particular cancer,

[00:00:51] [SPEAKER_00]: offering hope to patients with even the most challenging cases. In this episode,

[00:00:55] [SPEAKER_00]: we delved into the intricacies of cancer treatment, the evolution of precision medicine,

[00:01:01] [SPEAKER_00]: and how Dr. Apfel's groundbreaking work is transforming patient care.

[00:01:06] [SPEAKER_00]: Doctor, tell me and the audience a little bit more about yourself and how this technology evolved.

[00:01:12] [SPEAKER_01]: It's my real pleasure to be with you on this podcast. I am Dr. Chris Apfel. I'm a physician

[00:01:20] [SPEAKER_01]: scientist whose parents actually have been affected by cancer. And when my father experienced cancer,

[00:01:30] [SPEAKER_01]: he refused therapy because when he took care of my mother who had ovarian cancer,

[00:01:35] [SPEAKER_01]: and the treatment didn't work in her last months of life, and it made her only more miserable,

[00:01:40] [SPEAKER_01]: he said to me, unless you can promise me that the treatment is going to work, I don't want it.

[00:01:49] [SPEAKER_01]: And I was, oh, wait a minute. I thought we are now in the era of precision medicine. I thought

[00:01:56] [SPEAKER_01]: we know what we are doing. We spent billions of dollars in cancer treatment, and it was only then

[00:02:00] [SPEAKER_01]: that I realized that cancer treatment even today is in layman's terms spoken a hit or miss. In a

[00:02:09] [SPEAKER_01]: late stage four lung cancer, tumor response rates are as low as 30%. And then it's often only

[00:02:16] [SPEAKER_01]: temporary. So it gives you only two or three more months on average, but you never know whether the

[00:02:23] [SPEAKER_01]: treatment is going to work. And I said, how can that be? So as a physician who has also been

[00:02:29] [SPEAKER_01]: active in the intensive care medicine space, we know that if a patient has an infection,

[00:02:36] [SPEAKER_01]: we usually cultivate the germs and we then put on antibiotics to understand which therapy is

[00:02:44] [SPEAKER_01]: likely to work best. And so I asked my oncologist, why are we not doing this for cancer? Can we not

[00:02:49] [SPEAKER_01]: try it out on the tumor itself instead of trying it out on the patient? And the response I got was

[00:02:57] [SPEAKER_01]: people have tried it before, but hasn't worked out yet. And that didn't make sense to me. So I

[00:03:02] [SPEAKER_01]: actually looked deeply into the literature, spent over a year actually to review what has been done

[00:03:09] [SPEAKER_01]: in the field and there have been honest efforts, but it was clear that there were some biological

[00:03:14] [SPEAKER_01]: misconceptions. There were also some other strategic limitations. There was often that it

[00:03:20] [SPEAKER_01]: took too long to grow the tumors. And so what we realized is somebody needs to step up to the plate

[00:03:28] [SPEAKER_01]: and really develop a method where we can know what's the most effective treatment for a cancer

[00:03:35] [SPEAKER_01]: patient. And I think we have now, with the support of my wife and I, we founded this together. She's

[00:03:41] [SPEAKER_01]: originally also a pulmonologist. She's now also a psychiatrist as well. And when she was a

[00:03:47] [SPEAKER_01]: pulmonologist, she actually has treated also a lot of lung cancer patients. So she has experienced

[00:03:53] [SPEAKER_01]: also firsthand how difficult it is to find the most effective treatment and that's what we set out to do.

[00:04:02] [SPEAKER_01]: So the company is called SageMedic?

[00:04:05] [SPEAKER_01]: Yes.

[00:04:05] [SPEAKER_01]: And when did you start it?

[00:04:07] [SPEAKER_01]: The SageMedic Corp was incorporated in 2017 and we started this on our own dime. It was clear that

[00:04:14] [SPEAKER_01]: we would be unlikely to get NIH funding and so we needed to develop a technology that is robust,

[00:04:22] [SPEAKER_01]: that is IP protected, and where we can actually know this can reliably predict the most effective

[00:04:28] [SPEAKER_01]: therapy for cancer patients.

[00:04:30] [SPEAKER_01]: So how many cancers does your test cover?

[00:04:34] [SPEAKER_01]: So the advantage of the Sage OncoTest is that we can cover a very wide range of tumors because

[00:04:44] [SPEAKER_01]: basically all solid tumors and we actually have also done some multiple myeloma and some lymphoma

[00:04:50] [SPEAKER_01]: patients. The advantage of our technology is that we take a fresh biopsy and we divide up the tumor

[00:04:57] [SPEAKER_01]: into fragments, re-aggregate them within a day and then we have hundreds of these micro tumors

[00:05:05] [SPEAKER_01]: that are similar to your original tumor and therefore can then test them within three to five

[00:05:13] [SPEAKER_01]: days, understand which therapy is likely to be most effective and read that information back to

[00:05:20] [SPEAKER_01]: you and your oncologist. And so a wide range of tumors, all solid tumors, we're talking about

[00:05:25] [SPEAKER_01]: ovarian, we're talking about glioblastoma. We also can take, and that's a great interest,

[00:05:31] [SPEAKER_01]: tumors of unknown origin, rare diseases, rare cancers because there is often,

[00:05:36] [SPEAKER_01]: there aren't enough studies that guide which therapy might be effective. And so we can test

[00:05:42] [SPEAKER_01]: a wide range of tumors, all solid tumors. It's basically our platform is tumor type agnostic.

[00:05:49] [SPEAKER_00]: Okay. So when you take the biopsy, one of the challenges out there is hitting the exact tumor.

[00:05:58] [SPEAKER_00]: What's the margin of error on the selection of the sample size? How does that influence

[00:06:03] [SPEAKER_00]: the ability for you to detect what cancer is there or what isn't there?

[00:06:08] [SPEAKER_01]: So there are two questions in here, right? So how much tissue do you need? And then the other

[00:06:13] [SPEAKER_01]: question is how accurate is the prediction, right? So how much tissue we need. If you get,

[00:06:19] [SPEAKER_01]: if you are scheduled for surgery, let's say ovarian cancer or glioblastoma, there is usually a lot of

[00:06:26] [SPEAKER_01]: tissue that otherwise would go into the bin, into the trash. And that's fresh, valuable tissue

[00:06:32] [SPEAKER_01]: before it's thrown into formalin that actually needs to be prearranged to get to us. Then there

[00:06:40] [SPEAKER_01]: is usually a ton of tissue available. Anything above a gram is enough to test dozens of drugs.

[00:06:48] [SPEAKER_01]: If you already have been diagnosed, if you already had your standard of care treatment and

[00:06:55] [SPEAKER_01]: the treatment doesn't work for you, then a fresh biopsy makes sense. That could be from a lymph node.

[00:07:02] [SPEAKER_01]: The lymph node could be resected on the neck or elsewhere when it's easily accessible.

[00:07:07] [SPEAKER_01]: It could also be a core needle biopsy. So we have received a liver biopsy from breast cancer

[00:07:14] [SPEAKER_01]: patients. That's a possibility. Those core needle biopsies provide limited tissue, but because our

[00:07:21] [SPEAKER_01]: technology is so advanced, we can test with those at least six to 12 drugs. And so either a core

[00:07:27] [SPEAKER_01]: needle biopsy or a surgical biopsy is sufficient to test the most important drug.

[00:07:34] [SPEAKER_00]: So we, you and I had nerded out about a month ago on a conversation. And I think I told you

[00:07:38] [SPEAKER_00]: of this company I knew in the early days and the data was, went something like this. If you treated

[00:07:44] [SPEAKER_00]: the right chemotherapy to a right cancer, you got a certain result. If you use the wrong chemotherapy

[00:07:50] [SPEAKER_00]: to that cancer and then use the right one secondarily, the results were very different.

[00:07:56] [SPEAKER_00]: Can you explain that concept to the audience?

[00:07:59] [SPEAKER_01]: So we have actually looked into the literature, have done our own meta-analysis. In principle,

[00:08:05] [SPEAKER_01]: what we do know is if you get the best possible treatment, you basically double your chance that

[00:08:12] [SPEAKER_01]: your tumor will respond to the treatment. That's clear. To what degree it translates into surviving,

[00:08:19] [SPEAKER_01]: that's probably not doubling the chance, it's probably increasing it by 40%. But 40% in the

[00:08:26] [SPEAKER_01]: field of oncology is a big deal. And that's often not obtained by any new drugs that's in

[00:08:33] [SPEAKER_01]: development. In terms of accuracy that you were asking ahead of time, in the previous question,

[00:08:40] [SPEAKER_01]: the advantage of our assay is we have an extreme drug resistance assay. We dose those microtumors

[00:08:48] [SPEAKER_01]: in different concentrations. And if the microtumors are not responding to very high dosages

[00:08:57] [SPEAKER_01]: in vitro, so in our lab, they are very unlikely, more than in the high 90s of percentage,

[00:09:06] [SPEAKER_01]: very unlikely to respond to a patient in the patient. So if you cannot kill it in the lab,

[00:09:14] [SPEAKER_01]: it will certainly not work. Most certainly not work in a patient. And that's a very important

[00:09:20] [SPEAKER_01]: information because most, more than often, more than 50, 60, 70% of drugs are actually not effective

[00:09:29] [SPEAKER_01]: for that particular type of tumor. And you want to know that ahead of time. Just knowing that can

[00:09:34] [SPEAKER_01]: already double your chance. And then we have a graded response where we are also looking at what

[00:09:41] [SPEAKER_01]: are the most promising options that are looking most promising and that will be played back to the

[00:09:47] [SPEAKER_00]: oncologist. I guess before we continue, we should probably get some definition. So one of the things

[00:09:52] [SPEAKER_00]: in the diagnostic world is this concept of sensitivity and specificity. Can you explain

[00:09:58] [SPEAKER_00]: that? Because not everyone in our audience is from the diagnostic world. Yeah. So the sensitivity is

[00:10:04] [SPEAKER_01]: how many patients that actually will respond to the treatment are correctly identified to respond

[00:10:11] [SPEAKER_01]: to that treatment. And the specificity is how many patients who do not respond to the treatment

[00:10:18] [SPEAKER_01]: will be correctly identified not responding to their treatment. Okay. And so for your test compared

[00:10:24] [SPEAKER_00]: to other attempts in the past to do this, what's the difference? The huge advantage of the SAGE

[00:10:31] [SPEAKER_01]: OncoTest is number one, it's a 3D microtumor model. So it has the tumor microenvironment and

[00:10:37] [SPEAKER_01]: tumor heterogeneity of the patient's biopsy and therefore is really a step ahead of what has been

[00:10:44] [SPEAKER_01]: done before in the past. And because we are culturing the tumor, so we don't need to grow it,

[00:10:51] [SPEAKER_01]: we have a result within 7 to 10 days. And it's not only the speed, it's also the test results,

[00:10:58] [SPEAKER_01]: the likelihood to get a test result. In the past when people have tried to grow tumors,

[00:11:03] [SPEAKER_01]: the so-called clonogenic assay or the tumor stem cell assay, very often if you don't have a very

[00:11:11] [SPEAKER_01]: aggressive tumor, those don't grow and then you don't have a result. And even if they grow,

[00:11:16] [SPEAKER_01]: it may sometimes take three weeks, four weeks, six weeks, two months, three months. And the advantage

[00:11:23] [SPEAKER_01]: of the SAGE OncoTest is that we almost always have a reliable result for you. That's amazing.

[00:11:29] [SPEAKER_00]: So this brings about the concept of fitting into the bigger healthcare concept of precision

[00:11:34] [SPEAKER_01]: medicine, correct? That's right. And it's really an important step forward and brings it to the

[00:11:40] [SPEAKER_01]: next level. In the last 10 to 20 years, there have been enormous advances in terms of genomic testing,

[00:11:50] [SPEAKER_01]: next generation sequencing to identify certain mutations that are relevant driver of the tumor

[00:11:59] [SPEAKER_01]: behavior. And if a patient has that mutation or if the tumor harbors that mutation, then big pharma

[00:12:08] [SPEAKER_01]: have been able to develop targeted therapy that can really target that particular mutation and

[00:12:15] [SPEAKER_01]: often keep the tumor at bay. That is really a great success in terms of instead of 30%,

[00:12:22] [SPEAKER_01]: response rates can be as high as 60, 70 or 80%. Not 100%, but much, much higher than

[00:12:29] [SPEAKER_01]: unspecifically with chemotherapy. However, so far only one out of four patients have mutations that

[00:12:39] [SPEAKER_01]: are actionable, which means in three quarter of the patients, roughly 75%, there are no actionable

[00:12:47] [SPEAKER_01]: mutations. And then there is no information as to which therapy is most likely to work best.

[00:12:54] [SPEAKER_01]: And that's where Sage Medic comes in because we are independent of any mutations, of any

[00:13:01] [SPEAKER_01]: potential pathways. We actually see what works best in a more holistic sense

[00:13:09] [SPEAKER_01]: because we take the tumor as a live tumor because the sum is much more than,

[00:13:13] [SPEAKER_01]: I'd say, oh, it is much more than the sum of its parts. And therefore we can actually see

[00:13:20] [SPEAKER_01]: whether a drug is working irrespective of which pathway might be affected. Being able to provide

[00:13:27] [SPEAKER_01]: information for the majority of patients where genomic testing does not provide information,

[00:13:33] [SPEAKER_01]: that's a big deal for many patients.

[00:13:37] [SPEAKER_00]: It's actually quite interesting. So maybe trying to figure out an example here for the audience,

[00:13:41] [SPEAKER_00]: but I think of PD-L1, I think of BRCA1 and 2. I think of different ways that people have

[00:13:49] [SPEAKER_00]: said if you have this, then you can use this product. In your case, you could ironically

[00:13:56] [SPEAKER_00]: discover that something that might be used for one of those areas actually works on a particular

[00:14:01] [SPEAKER_00]: tumor. And without this technology, we might have dismissed the ability to use that drug.

[00:14:08] [SPEAKER_01]: That's right. So there is actually a potential for discovering that certain targeted therapies

[00:14:15] [SPEAKER_01]: that would normally not be considered for your tumor type because there haven't been studies

[00:14:20] [SPEAKER_01]: done on this tumor type, that they actually may be beneficial for you. And the advantage is that

[00:14:28] [SPEAKER_01]: we are not, because we are looking in a holistic sense, in a very integrative sense on the

[00:14:34] [SPEAKER_01]: totality of the tumor and not at a single mutation, there may actually be a tumor type that

[00:14:41] [SPEAKER_01]: is actually does not harbor the mutation but would still respond to that targeted therapy.

[00:14:48] [SPEAKER_00]: That is actually quite profound. Is the pharmaceutical industry discovered this

[00:14:52] [SPEAKER_00]: with you to try to quantify this or understand it? Or is it still early in the cycle of development?

[00:14:57] [SPEAKER_01]: We have been approached by a couple of companies. We are now working with two companies

[00:15:03] [SPEAKER_01]: specifically that have a drug in development. It's currently pre-phase one. So it's too early

[00:15:11] [SPEAKER_01]: for a patient to have access to that, but it can also help drug developers for their label extension

[00:15:17] [SPEAKER_01]: and identify, ah, there may be a specific other type of tumor that are more likely to be responsive

[00:15:24] [SPEAKER_00]: that we didn't have on our radar before. So that's a little deviation here for our

[00:15:28] [SPEAKER_00]: startup people. You can create this test and you can do what you're doing.

[00:15:32] [SPEAKER_00]: But if you step back and you think about it ahead of time in how you collect data and how

[00:15:37] [SPEAKER_00]: you present data, you could actually have a data set and samples that would create another business

[00:15:42] [SPEAKER_00]: model for the pharmaceutical industry for future targets. It could be useful for future targets

[00:15:47] [SPEAKER_01]: in drug development, in lead compound generation. It could be used in phase one to demonstrate the

[00:15:54] [SPEAKER_01]: correlation with the patient outcomes. And then it could be used to de-risk the phase two and phase

[00:16:00] [SPEAKER_01]: three studies. And so that you can have a statistically significant result with a lower

[00:16:06] [SPEAKER_01]: number of patients in a shorter period of time when you can use this as a companion diagnostic,

[00:16:15] [SPEAKER_01]: but that's in the future. What we are very focused on is how can we help a patient today?

[00:16:22] [SPEAKER_01]: If a patient gets diagnosed with a serious disease, often standard of care will only

[00:16:28] [SPEAKER_01]: provide average results. I mentioned ovarian, I mentioned glioblastoma, brain cancer. Those

[00:16:36] [SPEAKER_01]: patients would be best advised to contact us well ahead of time of the surgery because otherwise

[00:16:41] [SPEAKER_01]: the tissue goes into the formalin and then it's dead and can't be used because ours is a real

[00:16:46] [SPEAKER_01]: functional profiling test. And then those patients where the therapy is failing when first line

[00:16:54] [SPEAKER_01]: therapy may have worked perhaps initially, but then the patient's tumor has developed resistance.

[00:17:00] [SPEAKER_01]: Those patients shouldn't wait too long contacting us to see whether we can get a biopsy and a sample

[00:17:08] [SPEAKER_01]: from them to understand which one is the most effective treatment. So in a treatment world now

[00:17:14] [SPEAKER_00]: that's moving from monotherapies to combination therapies, how do you dial that in in your

[00:17:20] [SPEAKER_01]: approach? First of all, what's really important is to be to try to stay within standard of care

[00:17:28] [SPEAKER_01]: because even within standard of care there are a couple of options. And so the SAGE oncotest can

[00:17:34] [SPEAKER_01]: help the oncologist to provide as I like to say superior care within standard of care. This can

[00:17:40] [SPEAKER_01]: be completely MCC and guideline compliant and if you look at the guidelines very often combination

[00:17:46] [SPEAKER_01]: therapies are also part of the standard regimen and we can look into what do the individual drugs

[00:17:53] [SPEAKER_01]: do and what do the combinations do. If we think about colorectal cancer, if we think about

[00:18:00] [SPEAKER_01]: pancreatic cancer, if we think about Folfox or Folfirinox, these are combination treatments

[00:18:06] [SPEAKER_01]: that have 5-FU, they have oxalipatin, they have irenotecin and we can look into what are

[00:18:13] [SPEAKER_01]: the individual components that contribute to the tumor responding to the therapy.

[00:18:18] [SPEAKER_00]: It seems to me that if I were a patient and I was trying to get information on this whole approach,

[00:18:25] [SPEAKER_00]: where would I go to find that? Do you have a website that's more oriented and one that's

[00:18:29] [SPEAKER_01]: physician oriented? So exactly, so we have a website sagemedic.com, SAGE like the plant or

[00:18:37] [SPEAKER_01]: the SAGE person you're talking to, medic not medical, so one word sagemedic.com and you can

[00:18:43] [SPEAKER_01]: search there, there's information for patients and there is information for physicians and you

[00:18:48] [SPEAKER_01]: can then on the patient's page you can register and request more information about the SAGE oncotest.

[00:18:56] [SPEAKER_01]: You can then also once you have your information you can also speak with your oncologist. The

[00:19:03] [SPEAKER_01]: important thing is that you educate yourself first, you need to understand what's the prognosis,

[00:19:09] [SPEAKER_01]: what are the options that I have. If you for example search the web there is this

[00:19:13] [SPEAKER_01]: target cancer podcast where I have presented with Dr. Csuneha and that gives you a good background

[00:19:21] [SPEAKER_01]: on what SAGE Medic is doing and why a number of oncologists are very excited about what we do.

[00:19:28] [SPEAKER_01]: But most likely is because this is very new, most oncologists have not heard of us and you need to

[00:19:35] [SPEAKER_01]: actually also be able to provide the oncologist with some of information. Perhaps the website is

[00:19:40] [SPEAKER_01]: one part but the part that's important for oncologists is to say this can be within standard

[00:19:46] [SPEAKER_01]: of care and it can be an additional tool in their armamentarium to identify the most effective

[00:19:54] [SPEAKER_01]: treatment that goes beyond genomic testing and may provide additional options we might not have

[00:20:00] [SPEAKER_00]: considered. So how much is this covered by insurance today if I were to do this? We are

[00:20:06] [SPEAKER_01]: now fully accredited by the Centers for Medicare and Medicaid Services to commercialize the assay

[00:20:12] [SPEAKER_01]: to provide this information for patients and oncologists but it's currently not covered by

[00:20:18] [SPEAKER_01]: insurance. Insurance coverage often lags well behind the innovation and so you would actually

[00:20:25] [SPEAKER_01]: need to speak with us what this would cost. It depends on what type of test your oncologist

[00:20:32] [SPEAKER_01]: would like to have. There's a standard panel that's NCCN guideline compliant. NCCN stands

[00:20:39] [SPEAKER_01]: for the National Comprehensive Cancer Network. So those are the main universities in this country,

[00:20:44] [SPEAKER_01]: the main cancer centers and we can stay within that framework and then some patients actually opt

[00:20:52] [SPEAKER_01]: for having and physicians order additional testing. So for example, Lovastatin or Desulfiram

[00:21:02] [SPEAKER_01]: or other drugs that are FDA approved for other indications have actually shown

[00:21:10] [SPEAKER_01]: effectiveness against cancer and they can be used in combination with it. If those are to be tested

[00:21:17] [SPEAKER_01]: in addition that would of course be an another different pricing than if you are just limiting

[00:21:23] [SPEAKER_00]: yourself to the standard stage oncotest. Now in the medical world, the doctor always has the right

[00:21:31] [SPEAKER_00]: to use their judgment on these things and something is off label or not but I would imagine to me that

[00:21:36] [SPEAKER_00]: I would be even comforted more to have evidence in addition to my judgment that it works. So I

[00:21:42] [SPEAKER_00]: could imagine more and more people would love to have this in their arsenal. And you're touching

[00:21:46] [SPEAKER_01]: on a point of evidence and the question is how much evidence is needed? As we are launching and

[00:21:53] [SPEAKER_01]: are new to the field, we are starting with cohort studies and then subsequently with randomized

[00:22:01] [SPEAKER_01]: controlled trials. But what we are also doing is we are giving patients a discount if they are

[00:22:07] [SPEAKER_01]: willing to participate in our, I would like to say, registry trial. The patients get a 25% discount

[00:22:14] [SPEAKER_01]: if they are okay with us using this information for our own R&D and quality control purposes

[00:22:22] [SPEAKER_01]: and that way the patients have a cost reduction and we collect data that demonstrates the

[00:22:29] [SPEAKER_01]: correlation with the patient outcome. What a nice way to do that. You've been in business

[00:22:34] [SPEAKER_01]: with FDA approval for how many years now? It's been... So we just launched effectively this year

[00:22:42] [SPEAKER_01]: and to be clear, this is a laboratory developed test so it's not FDA approved and the regulatory

[00:22:50] [SPEAKER_01]: pathway here is the so-called CLIA approved accreditation and CLIA stands for Clinical

[00:22:56] [SPEAKER_01]: Laboratory Improvement Act and this act was put into law in the 80s, 1980s, in order to make sure

[00:23:06] [SPEAKER_01]: that if you get your blood tested, if you get your hemoglobin or your electrolytes tested in any lab

[00:23:13] [SPEAKER_01]: that these values are reliable. And so what we, we fulfill all those criteria, we fall under that

[00:23:21] [SPEAKER_01]: regulatory category and we have hundreds of pages on SOPs to be 100% compliant so we are

[00:23:31] [SPEAKER_01]: a California registered CLIA accredited lab. And so that's the regulatory approval that we have

[00:23:38] [SPEAKER_01]: in order to be able to provide this information for patients. What challenges is your organization

[00:23:44] [SPEAKER_00]: facing now as you look to expand this? You've moved from the science now to getting into the

[00:23:50] [SPEAKER_00]: scaling and the business. What sort of activities do you have going on and challenges that you have

[00:23:56] [SPEAKER_00]: going on as the healthcare system is changing? For example, I believe this summer there's been

[00:24:03] [SPEAKER_00]: some changes from CLIA standards to at the FDA and the FDA was trying to implement something

[00:24:10] [SPEAKER_00]: early this summer but I believe there's a lot of lawsuits going on so you have regulatory things

[00:24:14] [SPEAKER_00]: changing on you. But just what sort of give the audience a sense of what it takes to commercialize

[00:24:19] [SPEAKER_01]: this? Yeah, so the regulatory issue is we are not troubled by that. Individual labs are exempt,

[00:24:27] [SPEAKER_01]: academic labs are exempt. So I'm not concerned about that. I think we have said well under

[00:24:32] [SPEAKER_01]: control. And the other part is if there is a requirement for FDA approval, which usually

[00:24:39] [SPEAKER_01]: requires outcome studies, which are important not only for regulators but also important for us.

[00:24:48] [SPEAKER_01]: We want outcome studies. So at the end of the day, whatever is needed for an FDA approval,

[00:24:55] [SPEAKER_01]: if we ever need that, we will generate this evidence anyway. And so from a regulatory perspective,

[00:25:03] [SPEAKER_01]: we are not concerned at all. In terms of market penetration, most oncologists, especially in

[00:25:12] [SPEAKER_01]: larger centers, feel very much locked into what is standard of care and that has to do with A,

[00:25:21] [SPEAKER_01]: what's described in the NCCN guidelines. And most oncologists are trying to stay within those walls

[00:25:31] [SPEAKER_01]: to be covered and to have so that they're not open up for liability is one part. But the other part

[00:25:38] [SPEAKER_01]: is actually reimbursement. Even if they stay within the NCCN guidelines, there is sometimes

[00:25:45] [SPEAKER_01]: pushback from insurers because healthcare costs have actually spiraled out of control. And

[00:25:52] [SPEAKER_01]: therefore oncologists are always reluctant in going the extra mile. Many oncologists are reluctant

[00:26:00] [SPEAKER_01]: in going the extra mile if it's not covered by insurance. And so if you want to have superior

[00:26:07] [SPEAKER_01]: care, you actually need to have an oncologist who is on your side and is willing to go the extra

[00:26:12] [SPEAKER_00]: mile. So in one of the first clear companies that I worked with, we raised up to 5 million in revenue

[00:26:20] [SPEAKER_00]: at no problem. And then we just paused. And there were two issues that caused that pause. One of it

[00:26:26] [SPEAKER_00]: is not having enough data to get the reimbursement studies in. But the second issue was we did not

[00:26:32] [SPEAKER_00]: realize that the sample process in a typical hospital has one pathway or one flow. And we

[00:26:40] [SPEAKER_00]: needed it to take a different flow. And so for our audience, when you're implementing something new

[00:26:45] [SPEAKER_00]: like this, it ended up being that we switched to a FedEx box because whatever the company was using

[00:26:51] [SPEAKER_00]: had one process flow and we were losing samples because they didn't follow the normal supply chain,

[00:26:58] [SPEAKER_00]: quote unquote. And so in addition to going through all that, science ends up being little details

[00:27:02] [SPEAKER_00]: that have to certainly be attended to.

[00:27:05] [SPEAKER_01]: And we address this by providing a shipment kit, briefs this to the patient. And this is actually

[00:27:10] [SPEAKER_01]: a box that actually keeps it cool for up to 72 hours, which brings actually up another interesting

[00:27:17] [SPEAKER_01]: point because it's live tissue. It needs to be processed right away and it needs to be fresh.

[00:27:22] [SPEAKER_01]: It's usually shipped overnight. But we have and we have also Saturday delivery acceptance. So

[00:27:28] [SPEAKER_01]: we process on Saturday, but there are situations where FedEx doesn't deliver it and you can only

[00:27:34] [SPEAKER_01]: pick it up on Monday. Interestingly, our assay is so robust that and we have shown this repeatedly

[00:27:40] [SPEAKER_01]: that even if there is a three day delay, we still get basically the identical results. And that's

[00:27:45] [SPEAKER_01]: another thing where from a logistics perspective, we are very proud of that our assay will always

[00:27:51] [SPEAKER_01]: come up with a useful result.

[00:27:53] [SPEAKER_00]: And that's it. I brought that up just for that perfect story because it tells the audience you

[00:27:59] [SPEAKER_00]: can get the science right and then there's all these little operational details to get the

[00:28:03] [SPEAKER_00]: business model to work and scale to support that patient. And so that's fantastic. So what's the

[00:28:08] [SPEAKER_00]: biggest lesson you've learned on your journey so far with this?

[00:28:11] [SPEAKER_01]: The biggest lesson is if you want to make a difference in people's lives, you need to step

[00:28:18] [SPEAKER_01]: up to the plate and you have to do it. You have to overcome all those little hurdles, but it can be

[00:28:27] [SPEAKER_01]: done. And what I think what I learned is that if you want to move the world, you need to be bold

[00:28:34] [SPEAKER_01]: and you need to be systematic. You need to be rational. You need to listen to people

[00:28:40] [SPEAKER_01]: and you need to have the patient's needs. You have to put that first, put first things first,

[00:28:47] [SPEAKER_01]: like in the book of seven habits of highly effective people. And if you follow your true

[00:28:53] [SPEAKER_01]: north in helping patients, you will find a way to make that happen.

[00:28:58] [SPEAKER_00]: I imagine there's a mental aspect for the patient too that having the benefit of knowing that

[00:29:03] [SPEAKER_00]: something's been tested and had a result. I have to imagine that has some sort of psychological

[00:29:10] [SPEAKER_00]: effect. Have you any data on that other than probably the experiences you've had with your

[00:29:15] [SPEAKER_00]: customers so far?

[00:29:16] [SPEAKER_01]: We have not systematically explored that. And there are different type of people. There are

[00:29:22] [SPEAKER_01]: people who would prefer not to rock the boat. And in a way, if you think about there is, let's say

[00:29:30] [SPEAKER_01]: there is a small melanoma, say one melanoma that needs to be cut out in total. It's way too small

[00:29:37] [SPEAKER_01]: for us to look at it. The pathologist has to have the whole specimen to demonstrate that there's a

[00:29:43] [SPEAKER_01]: free margin. That's your cure rate is 90 in the high 90s. Right? So it's not necessary. The same

[00:29:51] [SPEAKER_01]: applies for many very early, let's say DCIS, ductal carcinoma in situ of breast cancer patients.

[00:29:59] [SPEAKER_01]: There's a little lump can be removed surgically needs to be removed in total. There is no need

[00:30:04] [SPEAKER_01]: for the say, truncal test. And then there is the other side. When you have an aggressive tumor,

[00:30:09] [SPEAKER_01]: you want this to have a peace of mind. And so there are patients who really are comfortable if

[00:30:16] [SPEAKER_01]: they have an early stage disease to leave it to the standard of care because standard of care provides

[00:30:21] [SPEAKER_01]: good outcomes. But there are patients, they know that the outcome is likely not very favorable.

[00:30:29] [SPEAKER_01]: And there is, if they want to have a real fighting chance to overcome this, then they take action

[00:30:37] [SPEAKER_01]: into their own hand. And for them, it's very reassuring to have additional information,

[00:30:42] [SPEAKER_01]: what can be done. And then there are these other situations where the side effects of the therapy

[00:30:49] [SPEAKER_01]: is extreme. One doesn't really think this, the tumor is responding. And then there's a big

[00:30:54] [SPEAKER_01]: question, should we continue with the treatment, especially when you have failed first and second

[00:30:57] [SPEAKER_01]: line treatment? And here comes another part. And that is, there are, the more often you are getting

[00:31:05] [SPEAKER_01]: treated and the tumor doesn't respond, the lower becomes the probability that it will respond to

[00:31:10] [SPEAKER_01]: the next treatment. And the next treatment would usually also be with side effects. So the question

[00:31:15] [SPEAKER_01]: on going on to treat or not to treat is important. And that's where the sage-onco test comes in as

[00:31:21] [SPEAKER_01]: an extreme drug resistance assay. So we can actually rule out ahead of time and say, no,

[00:31:26] [SPEAKER_01]: these other treatment options that we might consider, they actually show multidrug resistance.

[00:31:32] [SPEAKER_01]: So don't go for it. And it's actually useful that a patient knows the truth. Some patients

[00:31:40] [SPEAKER_01]: want to know it. They want to know ahead of time, is this going to work? And there are other

[00:31:46] [SPEAKER_01]: patients who say, I want to see that everything else is tried and that's fine. But then we can

[00:31:51] [SPEAKER_01]: actually rule out those that don't look effective and just focus on those that might have a fighting

[00:31:58] [SPEAKER_00]: chance. But I think to the point, the example you just gave that a lot of patients that have that

[00:32:04] [SPEAKER_00]: attitude don't realize that being treated with the wrong one first could reduce the overall

[00:32:10] [SPEAKER_00]: probability. Right. The importance, I think, of what you're doing. It's another important point

[00:32:17] [SPEAKER_01]: approaching us ahead of time and not to wait until it's too late. So as you look into the future,

[00:32:23] [SPEAKER_00]: if you're been in business 10 years from now, what have you brought or changed to the treatment

[00:32:28] [SPEAKER_01]: of cancer? What we see it in five to in years to come is that this will evolve, become part

[00:32:36] [SPEAKER_01]: of the new standard, would bring precision medicine to the next level so that we have a

[00:32:42] [SPEAKER_01]: higher rate of cure. Currently, when a patient, let's say, comes with a late stage cancer,

[00:32:48] [SPEAKER_01]: the chance to real cure may still be fairly low and the difference we can make in terms of long-term

[00:32:55] [SPEAKER_01]: cure may be limited. But we may, the patient may actually by getting the right treatment have

[00:33:01] [SPEAKER_01]: another year. And that's a big deal already. Now, as we become more established and we will have

[00:33:08] [SPEAKER_01]: publications that demonstrate the benefit, oncologists would be more comfortable to use it at

[00:33:13] [SPEAKER_01]: an earlier stage. And when used as an earlier stage, when you have minimal residual disease,

[00:33:20] [SPEAKER_01]: we expect that we can also increase the cure rate so that, let's say, a mother with a stage

[00:33:26] [SPEAKER_01]: three breast cancer can actually be there for her family and not, and effectively survive

[00:33:34] [SPEAKER_01]: and have a good life. That's great. Is there anything else you'd like to share with the

[00:33:39] [SPEAKER_01]: I appreciate the conversation. And I think the important part is spread the word. If you are,

[00:33:46] [SPEAKER_01]: or one of your loved ones is affected, check out SageMedic.com. I do think that Sage is very blessed

[00:33:53] [SPEAKER_01]: also with having recently assembled a very strong scientific advisory board. For example, Dr. Kanz,

[00:34:01] [SPEAKER_01]: Dr. William Kanz has joined us, our board as the chair of our scientific and medical advisory board.

[00:34:08] [SPEAKER_01]: He was the past president of the Society of Surgical Oncologists, and he is, has also

[00:34:16] [SPEAKER_01]: been the chief medical and chief scientific officer of the American Cancer Society. And so

[00:34:21] [SPEAKER_01]: slowly but surely, the establishment realizes that we are addressing a really important need

[00:34:28] [SPEAKER_01]: and that this is not a incremental benefit, but this can be really transformational for the field

[00:34:34] [SPEAKER_00]: in years to come. In addition for the patient, bringing down the overall cost of cancer care,

[00:34:41] [SPEAKER_00]: it, the last, those last treatments, those last years of treatment become very expensive.

[00:34:46] [SPEAKER_01]: And that's right. And I think that's also where the SAGE oncotest can help to have more effective

[00:34:52] [SPEAKER_01]: and rational decisions. Sometimes a inexpensive generic therapy could be equally effective or

[00:35:00] [SPEAKER_01]: better than a $200,000 drug. And that's all what SAGE is about to make sure patients get the

[00:35:08] [SPEAKER_01]: most effective treatment and the most cost-effective treatment.

[00:35:12] [SPEAKER_00]: I'm going to maybe talk out of order of our podcast here as we're wrapping up, but to me,

[00:35:16] [SPEAKER_00]: that would be a great peace of mind because sometimes you, when you are offered something

[00:35:21] [SPEAKER_00]: that's more generic, you sometimes think this is a pharmacy benefit play and there's the narrowing

[00:35:28] [SPEAKER_00]: cost savings and it would be incredibly comforting to me personally to know that I have evidence

[00:35:33] [SPEAKER_00]: supporting that selection. I would bring such a peace of mind. Yeah, yeah, I agree. Thank you.

[00:35:40] [SPEAKER_00]: Thank you so much for sharing this. I'm going to actually not only have your SAGE medic website in

[00:35:45] [SPEAKER_00]: the notes, but for the audience, I'll also put the Target Cancer podcast in there because I thought

[00:35:51] [SPEAKER_01]: that was beautifully done. Thank you very much. I appreciate our conversation and I'm looking

[00:35:55] [SPEAKER_01]: forward to connecting with you also in the future on other levels.

[00:36:01] [SPEAKER_00]: Thank you. Thanks for tuning into the Chalk Talk Gym podcast. For resources,

[00:36:08] [SPEAKER_00]: show notes and ways to get in touch, visit us at chalktalkgym.com.