From PharmD to Pharmacogenomics Test Developer: Dr. Thierry Dervieux’s Story of Revolutionizing Healthcare Through Precision Medicine for Immune Modulated Inflammatory Diseases | PGx For Pharmacists

Becky Winslow, BS, PharmD Host and Pharmacogenomics Medical Science Liaison; Behnaz Sarrami, MS, PharmD, Host and Pharmacogenomics Medical Science Liaison; Thierry Dervieux, PharmD, PhD, Chief Scientific Officer at Prometheus Laboratories In this episode of the PGX for Pharmacists Podcast, Dr. Thierry Dervieux, Dr. Behnaz Sarrami, and I discuss Dr. Dervieux’s career as a PharmD, PhD, and chief scientific officer who has designed a pharmacogenomics test prescribers may use to optimize biosimilars for autoimmune gastrointestinal diseases. Dr. Dervieux will illustrate to our audience pharmacogenomics’ potential beyond Tier 1 and 2 genetic testing by describing the clinical validity and utility of his laboratory’s suite of tests in the autoimmune gastrointestinal disease diagnosis and treatment market. Behnaz and I hope this episode will inspire pharmacists interested in pharmacogenomics to think beyond the boxed PGx test most laboratories offer when they think about PGx and consider all the biological systems in which genetics impacts drugs’ efficacy and safety. Disclaimer: Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc. Becky Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of any other entity. Transcription: 1 00:00:06,190 --> 00:00:19,620 You're listening to the Pharmacy podcast Network in a world where one size fits all medications dominate the pharmaceutical industry. 2 00:00:20,079 --> 00:00:24,750 Precision medicine brings a ray of hope for those seeking customized health care. 3 00:00:25,350 --> 00:00:32,830 Pharmacists have a unique opportunity to help people in need of specialized testing to ensure medications work as intended. 4 00:00:33,540 --> 00:00:44,680 Welcome to PGX for pharmacists where we unravel the wonders of precision medicine and its potential to revolutionize the way we approach pharmacy care. 5 00:00:45,169 --> 00:00:52,790 Get ready to uncover the secrets behind pharmacogenomics and how it's transforming lives one genome at a time. 6 00:00:52,799 --> 00:00:53,189 Hello, 7 00:00:53,200 --> 00:00:53,950 everyone. 8 00:00:54,159 --> 00:00:55,080 I'm your host, 9 00:00:55,090 --> 00:00:56,389 Doctor Becky Winslow. 10 00:00:56,409 --> 00:01:09,860 And you're listening to the PGX for Pharmacist podcast that we magazine recognized in 2021 as the ninth most listened to genetics podcasts in the world on the PGX for Pharmacist podcast. 11 00:01:09,870 --> 00:01:16,690 We explore all things pharmacogenomics related and our mission is to educate and advocate for PGX. 12 00:01:16,769 --> 00:01:23,849 We accomplish this mission through exclusive interviews with highly qualified and well experienced pharmacogenomics. 13 00:01:23,860 --> 00:01:29,720 Industry leaders such as today's special guest and my name is Baas Sami, 14 00:01:29,730 --> 00:01:32,739 the co-host of PGX for Pharms podcast, 15 00:01:32,750 --> 00:01:33,860 Pharmacogenomics, 16 00:01:33,870 --> 00:01:36,819 medical science liaison and a mentor to pharmacist. 17 00:01:36,889 --> 00:01:40,239 Connect with us on linkedin and let's get a conversation going. 18 00:01:40,269 --> 00:01:46,720 We want to hear from you and how you're impacting pharmacogenomic stakeholders and what you have learned throughout your journey. 19 00:01:48,510 --> 00:01:49,010 Ok. 20 00:01:49,019 --> 00:01:50,819 So without any further ado, 21 00:01:50,839 --> 00:01:54,769 I'm extremely pleased to introduce to our audience. 22 00:01:54,919 --> 00:01:56,059 Doctor Theory Devo, 23 00:01:57,239 --> 00:02:01,129 the Chief Scientific Officer at Prometheus Laboratories, 24 00:02:01,139 --> 00:02:08,139 and Perme Prometheus Laboratories is a reference clinical laboratory that's focused on the diagnosis, 25 00:02:08,149 --> 00:02:13,330 prognosis and monitoring of immune mediated inflammatory diseases. 26 00:02:13,970 --> 00:02:14,229 So, 27 00:02:14,240 --> 00:02:14,649 thank you, 28 00:02:14,660 --> 00:02:17,759 Doctor De for joining us on the podcast. 29 00:02:17,770 --> 00:02:18,589 Today. 30 00:02:18,600 --> 00:02:23,190 I'm excited to share your and Prometheus's story with our audience. 31 00:02:23,649 --> 00:02:25,630 Um in particular, 32 00:02:25,639 --> 00:02:45,369 I'm excited about you sharing your career journey as a farm D phd and Chief scientific officer and designer of the Predictor PK AD A which is a precision guided dosing test for the optimization of Humira Remicade and their bio cylinders. 33 00:02:46,119 --> 00:02:46,449 So, 34 00:02:46,460 --> 00:03:04,220 one of Bana's and my main goals for this episode of the PGX for Pharmacist podcast is to expand our audience's notion of what a PGX test looks like and to inspire them to think bigger than the traditional box PGX test. 35 00:03:04,229 --> 00:03:08,020 Most of them or most of you are uh familiar with. 36 00:03:09,020 --> 00:03:09,429 So, 37 00:03:09,440 --> 00:03:22,179 Doctor D uh I'd like to start the podcast by having our guests um introduce themselves and elaborate on how you are a pharmacogenomics expert. 38 00:03:23,619 --> 00:03:23,800 Yeah, 39 00:03:23,809 --> 00:03:24,250 thank you, 40 00:03:24,259 --> 00:03:25,759 Becky for having me. 41 00:03:25,770 --> 00:03:26,850 Uh uh Yes. 42 00:03:26,860 --> 00:03:27,289 So I am a, 43 00:03:27,300 --> 00:03:30,820 I am a pharmacist uh with uh a family who is a, 44 00:03:30,830 --> 00:03:33,039 a doctorate in pharmacokinetics. 45 00:03:33,539 --> 00:03:44,520 Uh I completed my studies in France and I came as a postdoc uh fellow uh to work in the United States about 20 years ago to work on the pharmacogenomic of anti cancer agents, 46 00:03:44,929 --> 00:03:49,160 uh primarily uh six Maturin as well as methotrexate. 47 00:03:49,169 --> 00:03:50,550 After my post doc, 48 00:03:50,770 --> 00:03:52,960 uh I moved uh in industry for promet. 49 00:03:53,490 --> 00:04:01,429 So I have a large experience in uh uh the implementation of pharmacogenetics testing in immune mediated inflammatory disease. 50 00:04:01,509 --> 00:04:12,550 Our lab Rome was the first uh clinical laboratory in the United States to offer the fin uh metyl transfer genotyping as well as the thin metabolites. 51 00:04:12,559 --> 00:04:13,029 So, 52 00:04:13,050 --> 00:04:21,989 uh uh of uh of 70 publications in the field and uh I'm very uh very excited to have uh to be on the postcard with you uh uh today. 53 00:04:23,660 --> 00:04:24,220 All right. 54 00:04:24,230 --> 00:04:27,359 So thank you for qualifying yourself as an expert. 55 00:04:27,369 --> 00:04:27,619 So, 56 00:04:27,630 --> 00:04:32,839 let's jump right in and delve into your current PGX work. 57 00:04:32,850 --> 00:04:33,279 So, 58 00:04:33,489 --> 00:04:36,540 if you'll tell us um a little about Prometheus, 59 00:04:36,549 --> 00:04:38,000 specifically, 60 00:04:38,010 --> 00:04:40,350 what is Prometheus's mission? 61 00:04:40,359 --> 00:04:43,799 And how are you guys going about accomplishing your mission? 62 00:04:44,760 --> 00:04:44,980 Yeah, 63 00:04:44,989 --> 00:04:45,700 sure. 64 00:04:45,709 --> 00:04:47,459 Uh So Promet is a, 65 00:04:47,470 --> 00:04:52,790 is a reference uh clinical laboratory based in Southern California in San Diego. 66 00:04:53,230 --> 00:04:56,809 Uh The company has been there for uh over 25 years. 67 00:04:56,820 --> 00:05:03,950 We are uh specialize in the differential diagnosis of autoimmune G I disease uh disorders, 68 00:05:04,059 --> 00:05:06,019 uh gastrointestinal disorder, 69 00:05:06,230 --> 00:05:08,619 uh and inflammatory bowel disease. 70 00:05:08,980 --> 00:05:10,299 And over the years, 71 00:05:10,309 --> 00:05:16,600 we have developed a portfolio of a differentiated solution to facilitate the diagnosis, 72 00:05:16,609 --> 00:05:17,470 the prognosis, 73 00:05:17,480 --> 00:05:18,429 the monitoring, 74 00:05:18,660 --> 00:05:21,910 as well as therapy selection with pharmacogenetics testing, 75 00:05:21,920 --> 00:05:24,730 which we are offering to our clinical laboratory. 76 00:05:24,829 --> 00:05:26,350 And most importantly, 77 00:05:26,410 --> 00:05:27,299 uh recently, 78 00:05:27,309 --> 00:05:35,660 we are uh uh developing some uh uh testing solution with the credit topic care test to optimize treatment to uh biologics. 79 00:05:36,470 --> 00:05:37,130 Ok. 80 00:05:37,140 --> 00:05:37,329 Well, 81 00:05:37,339 --> 00:05:37,450 that, 82 00:05:37,459 --> 00:05:38,049 that's great. 83 00:05:38,059 --> 00:05:46,100 Can you also tell us uh about the Prois Library of Precision Medicine Tests for inflammatory bowel disease for patients? 84 00:05:46,109 --> 00:05:49,230 how they benefit medication therapy management. 85 00:05:49,239 --> 00:05:56,429 Stakeholders across the IB DS patients journey from diagnosis to treatment to disease, 86 00:05:56,440 --> 00:06:02,049 monitoring through remission and how they differ from other lab tests for IBD and his treatments. 87 00:06:02,709 --> 00:06:03,209 Yes. 88 00:06:03,220 --> 00:06:03,369 So, 89 00:06:03,380 --> 00:06:04,399 so we uh our, 90 00:06:04,410 --> 00:06:10,100 our clinical laboratory offers some uh highly specialized test to facilitate the, 91 00:06:10,109 --> 00:06:16,779 the diagnostic of uh to facilitate the differential diagnosis of uh uh inflammatory bowel disease. 92 00:06:16,790 --> 00:06:22,359 So we are following uh testing solution with uh serological testing, 93 00:06:22,529 --> 00:06:23,799 for example, 94 00:06:23,809 --> 00:06:38,410 uh uh piana as as as well as uh macro microbial uh uh antibodies that are present uh uh in Crohn's disease as well as uh over uh auto uh auto antibodies that are present in er colitis. 95 00:06:39,339 --> 00:06:43,684 These are conditions that are uh uh somewhat difficult to treat. 96 00:06:43,704 --> 00:06:49,994 Uh And uh we are uh uh offering those tests to uh help uh gastroenterologist. 97 00:06:50,015 --> 00:06:51,114 Uh uh first of all, 98 00:06:51,125 --> 00:07:03,434 to establish a differential diagnosis of IBD as compared to other uh condition typically uh uh irritable bowel syndrome as well as over gastrointestinal disorder. 99 00:07:03,445 --> 00:07:05,635 When the diagnostic is established, 100 00:07:05,910 --> 00:07:31,839 uh we offer uh testing to uh establish a prognosis where we're gonna in inform the clinician that the patient has a more aggressive uh disease that will require more aggressive treatment where uh we can uh provide the testing solution to initiate uh uh the most appropriate therapy for uh for the patient uh with uh a testing where we are uh basically uh you know, 101 00:07:31,850 --> 00:07:36,559 establish de determining some genotyping with the fit transferal genotyping. 102 00:07:36,570 --> 00:07:37,279 For example, 103 00:07:37,290 --> 00:07:40,250 where we can uh indicate that the patient is, 104 00:07:40,260 --> 00:07:45,079 is likely uh to present with a side effect to those medication. 105 00:07:45,399 --> 00:07:46,170 And once you know, 106 00:07:46,179 --> 00:07:47,799 the the treatment is initiative, 107 00:07:47,809 --> 00:08:16,089 we have a portfolio of solution uh to facilitate the monitoring of the disease of the inflammatory bowel disease as well as the dosing optimization with uh uh the answer test which uh measure blood level uh for uh uh monoclonal antibodies that are indicated in the treatment of IB start with starting with Infliximab Adalimumab as well as uh Tein and vidal. 108 00:08:16,980 --> 00:08:24,040 So we have a comprehensive portfolio to uh to surround the clinician with uh a variety of testing solution. 109 00:08:24,049 --> 00:08:30,250 With our goal being to improve the uh the outcome uh of patients with uh with diabetes. 110 00:08:30,260 --> 00:08:34,520 And I think that the pharmacist has a very important role to play from that perspective. 111 00:08:35,179 --> 00:08:36,039 So theory, 112 00:08:36,049 --> 00:08:40,239 could you elaborate for us more on the predictor test? 113 00:08:40,249 --> 00:08:42,758 Um especially since you designed that test, 114 00:08:42,768 --> 00:08:44,218 we'd really like to know, 115 00:08:44,489 --> 00:08:45,039 um you know, 116 00:08:45,049 --> 00:08:49,638 what did that take and what role does it play in your suite of testing? 117 00:08:51,049 --> 00:08:51,270 Yeah. 118 00:08:51,280 --> 00:08:51,890 Sure. 119 00:08:51,900 --> 00:08:52,510 So the, 120 00:08:52,520 --> 00:08:52,570 the, 121 00:08:52,580 --> 00:08:52,989 the, 122 00:08:53,000 --> 00:08:53,229 the, 123 00:08:53,239 --> 00:08:59,960 the predictor test is uh uh is uh is utilized when the patient is receiving treatment. 124 00:09:00,280 --> 00:09:18,190 It's been speci specifically designed to optimize uh biological uh uh disease modifiers such as Infliximab adalimumab that are co therapies in the treatment of inflammatory bowel disease as well as other immune uh mediated inflammatory. 125 00:09:18,200 --> 00:09:21,549 This is what the test does is to you connect the blood specimen, 126 00:09:22,229 --> 00:09:23,049 uh you know, 127 00:09:23,059 --> 00:09:24,750 with dosing information. 128 00:09:25,039 --> 00:09:41,989 And what we do is to uh uh provide guidance uh to clinician with uh respect of the best dose to give in order to achieve the best the level which is the most consistent with uh uh the disease control that needs to be achieved for the patient. 129 00:09:42,169 --> 00:09:43,729 Typically a vast majority, 130 00:09:43,739 --> 00:09:46,159 about two third of a third to two third, 131 00:09:46,169 --> 00:09:54,669 a third of patient uh tend to be uh uh unresponsive uh to this uh very expensive medication. 132 00:09:54,989 --> 00:09:57,960 Uh Not because they don't have the uh you know, 133 00:09:57,969 --> 00:09:59,289 typically because they have a, 134 00:09:59,299 --> 00:09:59,590 you know, 135 00:09:59,599 --> 00:10:05,599 pharmacokinetic uh suboptimal pharmacokinetic uh that makes them uh you know, 136 00:10:05,609 --> 00:10:09,440 unresponsive because uh not enough drug has been given. 137 00:10:09,450 --> 00:10:18,469 So what we do with a predictor test is to basically estimate the pa the pharmacokinetic uh parameter for the patient. 138 00:10:18,750 --> 00:10:24,729 And from then uh re report the best dose uh to give in order to achieve the, 139 00:10:24,760 --> 00:10:31,570 the level which is consistent with the uh the most uh uh effective disease control to be achieved for the patient. 140 00:10:32,169 --> 00:10:33,059 So we are offering, 141 00:10:33,070 --> 00:10:38,049 we have developed a test for the Infliximab as well as Adalimumab which is Humira, 142 00:10:38,909 --> 00:10:41,309 but these are antimony causes factor. 143 00:10:41,460 --> 00:10:49,549 And we are also developing the test for vidur as well as uh is that are widely used also in the treatment of, 144 00:10:49,559 --> 00:10:51,969 of uh inflammatory bubble disease. 145 00:10:51,979 --> 00:10:52,669 Wow, 146 00:10:52,679 --> 00:10:55,450 uh for MET is a suite of tests. 147 00:10:55,460 --> 00:11:00,940 Goes well beyond um the PGX testing that our audience is most familiar with, 148 00:11:01,299 --> 00:11:08,679 uh which typically only includes snips for cyp genes and some pharmacodynamic genes. 149 00:11:08,690 --> 00:11:31,424 This is really exciting um genes and biomarkers related to immunology are not commonly found in what I call the box PGX tests such as those uh made by large uh laboratory manufacturing companies um where the panel has a set number of genes and uh you know, 150 00:11:31,434 --> 00:11:36,054 it was developed by a larger laboratory for maybe smaller laboratories use. 151 00:11:36,729 --> 00:11:39,010 So my understanding, 152 00:11:39,020 --> 00:11:53,729 having talked with you extensively theory is that immunology has fewer PGX test available because it's actually more difficult say than oncology to research and develop tests. 153 00:11:53,739 --> 00:11:54,119 So, 154 00:11:54,130 --> 00:12:00,729 could you elaborate for our audience on the difficulties that are associated with immunology, 155 00:12:00,739 --> 00:12:05,830 research and developing tests uh for immunology versus say oncology? 156 00:12:06,330 --> 00:12:06,530 Yeah, 157 00:12:06,539 --> 00:12:07,049 sure. 158 00:12:07,059 --> 00:12:09,969 So in uh in immunology, 159 00:12:09,979 --> 00:12:11,590 as compared to oncology, 160 00:12:11,599 --> 00:12:17,169 there is no such a thing such as a somatic mutation where for example, 161 00:12:17,179 --> 00:12:18,429 you're gonna have a behalf, 162 00:12:18,440 --> 00:12:18,659 you know, 163 00:12:18,669 --> 00:12:20,349 that indicates that the patient, 164 00:12:20,679 --> 00:12:20,919 you know, 165 00:12:20,929 --> 00:12:25,239 is likely to benefit or not from some treatment in immunology. 166 00:12:25,250 --> 00:12:26,750 This is far more complicated, 167 00:12:26,760 --> 00:12:28,830 complicated for the reason, 168 00:12:29,239 --> 00:12:31,020 starting with uh the fact that, 169 00:12:31,030 --> 00:12:31,179 you know, 170 00:12:31,190 --> 00:12:36,219 the response to this uh medication uh are multifactorial. 171 00:12:36,260 --> 00:12:37,820 And the fact that uh you know, 172 00:12:37,830 --> 00:12:39,380 the mutation that uh the, 173 00:12:39,390 --> 00:12:39,619 the, 174 00:12:39,630 --> 00:12:45,190 the single nucleotide polymorphism in the GM line which uh uh you know, 175 00:12:45,200 --> 00:12:52,429 can potentially associate with uh with outcome uh uh uh uh a lo in advance, 176 00:12:52,440 --> 00:12:58,359 meaning that uh they're gonna have a weak association uh with a response to those medications. 177 00:12:58,369 --> 00:13:09,609 So there is a necessity in immunology to combine multiple genetic polymorphism together in order to achieve uh some uh performances characteristics that will make uh you know, 178 00:13:09,619 --> 00:13:09,859 the, 179 00:13:09,869 --> 00:13:10,380 the, 180 00:13:10,390 --> 00:13:10,520 the, 181 00:13:10,530 --> 00:13:13,219 the clinician uh you know, 182 00:13:13,419 --> 00:13:15,619 uh order the test and most importantly, 183 00:13:15,630 --> 00:13:15,840 the, 184 00:13:15,849 --> 00:13:16,179 the, 185 00:13:16,190 --> 00:13:17,739 the payer to pay for the test. 186 00:13:17,750 --> 00:13:20,469 So this field has been uh you know, 187 00:13:20,479 --> 00:13:20,679 is, 188 00:13:20,690 --> 00:13:21,705 is moving for, 189 00:13:21,715 --> 00:13:21,994 you know, 190 00:13:22,005 --> 00:13:24,575 there are some tests that are being developed right now. 191 00:13:24,924 --> 00:13:39,034 But the biggest challenge is to be able to achieve again the the threshold of uh of performance that makes the test is variable enough uh to be uh again ordered by the clinician and the utilize uh to the benefit of the patient. 192 00:13:39,659 --> 00:13:41,200 I couldn't agree with you more. 193 00:13:41,210 --> 00:13:53,489 Um I've worked on the payer side or market access side of pharmacogenomics and even uh with a box test for which there's um a lot of research data available, 194 00:13:53,500 --> 00:13:55,119 even with those, 195 00:13:55,130 --> 00:13:59,760 it's sometimes difficult uh to get payers um to see the value. 196 00:13:59,770 --> 00:14:01,640 So I absolutely agree with you. 197 00:14:01,940 --> 00:14:03,679 Um The fact that you guys are, 198 00:14:03,690 --> 00:14:11,789 are uh investing in producing the data necessary says a lot about your laboratory. 199 00:14:11,979 --> 00:14:12,559 Um you know, 200 00:14:12,570 --> 00:14:15,380 and how committed you are to this testing and, 201 00:14:15,390 --> 00:14:17,320 and how you believe in the testing. 202 00:14:18,039 --> 00:14:23,640 So I just want to make sure that our audience recognizes that, 203 00:14:24,359 --> 00:14:24,619 you know, 204 00:14:24,630 --> 00:14:31,820 Prometheus doesn't simply provide tests to determine if drugs for IBD will be effective and safe. 205 00:14:32,190 --> 00:14:36,900 Um And maybe what the dose of the drug should be for the patient, 206 00:14:36,909 --> 00:14:40,219 but you have that whole suite of tests. 207 00:14:40,229 --> 00:14:47,380 Um the diagnostic test for the differential diagnosis all the way through remission. 208 00:14:48,030 --> 00:14:53,390 So can you elaborate you elaborated on it some in the previous question? 209 00:14:53,400 --> 00:15:01,229 But um can you tell us the difference between how you had to actually develop the test? 210 00:15:01,520 --> 00:15:02,530 Um You didn't, 211 00:15:02,539 --> 00:15:03,059 in other words, 212 00:15:03,070 --> 00:15:10,659 purchase a test from another manufacturer with the biomarkers that you include in your testing. 213 00:15:10,669 --> 00:15:16,830 Can you elaborate on how much more difficult it is to to develop a test from scratch? 214 00:15:18,169 --> 00:15:18,320 Yeah, 215 00:15:18,330 --> 00:15:18,659 sure. 216 00:15:18,669 --> 00:15:18,809 I mean, 217 00:15:18,820 --> 00:15:22,070 this is this is challenging for multiple and first of all, 218 00:15:22,080 --> 00:15:23,130 you need to have the, 219 00:15:23,419 --> 00:15:27,450 you need to have a clinical data set available with specimen available. 220 00:15:27,460 --> 00:15:28,159 Uh you know, 221 00:15:28,169 --> 00:15:28,780 in front, 222 00:15:28,859 --> 00:15:29,770 obviously, 223 00:15:29,859 --> 00:15:30,890 available. 224 00:15:31,200 --> 00:15:35,890 Uh So we are leveraging a pro meters a large bi bank of specimen. 225 00:15:36,299 --> 00:15:37,190 Uh as I said, 226 00:15:37,200 --> 00:15:39,719 Prometheus has been founded 25 years ago. 227 00:15:39,729 --> 00:15:40,599 So over the, 228 00:15:40,760 --> 00:15:41,919 the past two decades, 229 00:15:41,929 --> 00:15:54,849 we have been able to assemble a large uh substrate of data and specimen which we are uh uh using to uh uh establish our proof of concept if you will. 230 00:15:54,859 --> 00:16:07,559 And then when we have uh identify some genetic polymorphism that are uh adequately uh associated with uh uh disease outcome and disease progression as well as uh toxicity. 231 00:16:07,969 --> 00:16:11,469 Then we are entering validation phase where we are uh you know, 232 00:16:11,570 --> 00:16:14,789 using validation cohorts where we are again, 233 00:16:14,969 --> 00:16:22,630 combining multiple modalities together uh patient demographic as well as genetic marker together with theological marker. 234 00:16:22,640 --> 00:16:23,190 Actually, 235 00:16:23,500 --> 00:16:27,419 to come up with some Multivariate models that are uh again, 236 00:16:27,429 --> 00:16:39,250 bringing the performances characteristics of the pharmacogenomic test or its combination with our marker to the level where it's supposed to be in the first place to meet uh uh payer. 237 00:16:39,650 --> 00:16:41,190 And uh obviously, 238 00:16:41,200 --> 00:16:41,760 again, 239 00:16:41,770 --> 00:16:45,320 the patient uh to the benefit of the patient and to, 240 00:16:45,330 --> 00:16:46,619 to improve its outcome, 241 00:16:46,739 --> 00:16:47,429 the outcome. 242 00:16:48,340 --> 00:16:53,380 I think what you're describing really is the future of pharmacogenomics. 243 00:16:53,390 --> 00:16:54,599 Um In other words, 244 00:16:54,609 --> 00:17:03,419 not singing out pharmacogenomics as you know the end all and be all in the treatment paradigm. 245 00:17:03,559 --> 00:17:08,040 But using a PGX test in combination with, 246 00:17:08,050 --> 00:17:09,069 like you mentioned, 247 00:17:09,250 --> 00:17:11,160 other serological tests, 248 00:17:11,170 --> 00:17:12,959 maybe other genetic tests. 249 00:17:13,290 --> 00:17:14,890 Um But you know, 250 00:17:14,900 --> 00:17:25,869 I think what we want our audience to really wrap their heads around is that PGX is just a piece of that larger puzzle um from diagnosis to treatment to, 251 00:17:25,880 --> 00:17:26,910 to remission. 252 00:17:27,239 --> 00:17:29,880 So I think you guys are absolutely, 253 00:17:29,890 --> 00:17:31,579 you're already in the future. 254 00:17:31,589 --> 00:17:32,849 In other words, 255 00:17:32,859 --> 00:17:33,130 you know, 256 00:17:33,140 --> 00:17:39,689 you're already providing all these different uh tests um like you mentioned to, 257 00:17:39,699 --> 00:17:44,310 to facilitate from diagnosis to remission to remission. 258 00:17:44,660 --> 00:17:45,520 That's correct. 259 00:17:45,530 --> 00:17:45,829 Yeah. 260 00:17:46,349 --> 00:17:55,089 So um you've given us so much great information about uh the tests that that you guys offer. 261 00:17:55,329 --> 00:18:02,060 Can you explain to our audience um your newest test? 262 00:18:02,069 --> 00:18:03,859 Uh the responder test. 263 00:18:04,150 --> 00:18:12,979 And um what role it will play in the paradigm from the diagnosis of IBD to remission? 264 00:18:14,050 --> 00:18:14,260 Yeah, 265 00:18:14,270 --> 00:18:14,760 sure. 266 00:18:14,770 --> 00:18:15,569 So we, 267 00:18:15,579 --> 00:18:18,069 we are doing things a little bit different than other. 268 00:18:18,079 --> 00:18:19,489 We do believe that uh you know, 269 00:18:19,500 --> 00:18:21,449 the it has to be simple. 270 00:18:21,459 --> 00:18:24,189 Uh uh We can obviously construct some very, 271 00:18:24,199 --> 00:18:33,530 very complex algorithm and there are some tests that do that with a very sophisticated machine learning based tools that are available using neural networks, 272 00:18:33,540 --> 00:18:33,729 you know, 273 00:18:33,739 --> 00:18:34,790 those sorts of things. 274 00:18:34,800 --> 00:18:39,729 But we have taken on a different approach where with the responder test, 275 00:18:39,739 --> 00:18:40,329 we are basically, 276 00:18:40,339 --> 00:18:45,160 we are taking an approach which is very simple to address the first and foremost. 277 00:18:45,170 --> 00:18:53,020 Most important aspect of responding uh predicting response to uh to medication is the pharmacokinetics. 278 00:18:53,280 --> 00:19:03,250 Uh You cannot be responding to a drug if the drug is not given and you obviously cannot respond to a drug if the drug is not metabolized adequately. 279 00:19:03,359 --> 00:19:06,349 And this is what we are doing with the responder test. 280 00:19:06,579 --> 00:19:09,010 We are addressing some uh uh you know, 281 00:19:09,020 --> 00:19:11,630 fundamental issues with those uh biologist, 282 00:19:11,640 --> 00:19:12,410 for example, 283 00:19:12,660 --> 00:19:15,170 uh the anti tumor necrosis factors. 284 00:19:15,180 --> 00:19:15,650 So, 285 00:19:15,750 --> 00:19:19,199 such as uh Infliximab and Adalimumab, 286 00:19:19,209 --> 00:19:23,050 it is well known uh that uh uh those drugs, 287 00:19:23,060 --> 00:19:25,689 first of all are prone to immunization. 288 00:19:25,989 --> 00:19:36,949 Uh Meaning that uh uh the drug itself uh is recognized by the immune system uh and digested by the antigen presenting cells. 289 00:19:36,959 --> 00:19:42,209 If you will uh where you gonna have uh uh an immune uh uh response, 290 00:19:42,380 --> 00:19:56,979 uh mounted a cancer drug to produce uh immunogen that will severely impact its pharmacokinetics where the labels will be inadequate to produce uh the desired uh anti-inflammatory effects. 291 00:19:56,989 --> 00:19:57,150 So, 292 00:19:57,160 --> 00:19:58,890 we are with the risk conductors, 293 00:19:58,900 --> 00:20:01,040 we are combining two things together. 294 00:20:01,189 --> 00:20:07,959 First of all is the genetic test itself which uh predicts the risk of immun immunization. 295 00:20:07,969 --> 00:20:18,010 The name of the test is on HL A uh DQ A 105 ali uh that uh uh promotes the presentation of the, 296 00:20:18,020 --> 00:20:19,130 of the, 297 00:20:19,140 --> 00:20:19,910 of Infliximab, 298 00:20:20,010 --> 00:20:20,750 for example, 299 00:20:20,760 --> 00:20:32,130 to the T cell repertoire in order to uh promote the Ronon expansion and the formation of the anti antibodies together with uh another dimension which is the clearance, 300 00:20:32,140 --> 00:20:33,670 which is as important. 301 00:20:33,949 --> 00:20:36,209 Uh One of the key issue is the, 302 00:20:36,219 --> 00:20:36,770 the, 303 00:20:36,780 --> 00:20:41,239 the monoclonal antibodies and uh such as Infliximab or Adalimumab. 304 00:20:41,329 --> 00:20:42,280 But in fact, 305 00:20:42,290 --> 00:20:45,890 a neon antibodies that those drugs are uh you know, 306 00:20:45,900 --> 00:20:49,010 cleared and consumed uh from the, 307 00:20:49,020 --> 00:20:50,949 from the central compartment if you will, 308 00:20:50,959 --> 00:20:54,520 since we are doing a little bit of uh uh pharmacokinetics here. 309 00:20:54,530 --> 00:20:56,020 And uh uh you know, 310 00:20:56,030 --> 00:21:06,670 if the patient present who is uh a high degree of inflammatory burden is gonna have uh the patient will have a high clearance and that's gonna worsen uh in the, 311 00:21:06,680 --> 00:21:13,939 in the presence again of the HL AD Q A 105 genetic marker that uh associate with uh immunization. 312 00:21:13,949 --> 00:21:16,859 So I but this is a combination of both, 313 00:21:17,199 --> 00:21:19,359 these are the predictive factors of pharmacokinetic, 314 00:21:20,359 --> 00:21:38,209 which we combine together where the patient presenting with a risk of immunization as well as accelerated clearance due to the fact that the patient has high inflammation or due to the fact that they are so intrinsic pharmacokinetic properties that makes that the patient, 315 00:21:38,219 --> 00:21:38,300 you know, 316 00:21:38,310 --> 00:21:39,479 will clear the drug very, 317 00:21:39,489 --> 00:21:40,260 very fast. 318 00:21:40,560 --> 00:21:41,670 For example, 319 00:21:41,680 --> 00:21:46,819 due to the inefficient uh recirculation of the drug itself with the new, 320 00:21:46,869 --> 00:21:46,930 the, 321 00:21:46,939 --> 00:21:50,599 the the in the reticular on the system. 322 00:21:50,920 --> 00:21:51,619 Together, 323 00:21:51,630 --> 00:22:02,109 those patients presenting with uh uh together these uh poor prognostic factor of pharmacokinetic origin will tend to be severely underdose, 324 00:22:02,380 --> 00:22:06,719 will not be responding to the drug uh adequately as and they, 325 00:22:06,729 --> 00:22:10,719 and they probably should in the first place if you are able to address uh you know, 326 00:22:10,729 --> 00:22:12,270 the the the exposure. 327 00:22:12,439 --> 00:22:14,079 So what we do with this test, 328 00:22:14,089 --> 00:22:21,640 we will be able to inform uh the clinic that the patient is at risk of achieving, 329 00:22:21,650 --> 00:22:30,829 of achieving suboptimal pharmacokinetics and therefore being able to adjust the dose uh uh to start with more adequately. 330 00:22:30,839 --> 00:22:38,650 So that the the the proper uh exposure is achieved uh during induction to again to, 331 00:22:38,660 --> 00:22:39,040 to, 332 00:22:39,050 --> 00:22:39,380 to, 333 00:22:39,390 --> 00:22:40,890 to achieve a better outcome. 334 00:22:41,040 --> 00:22:47,270 And I think the pharmacist will have a very important role to play here in terms of absolutely, 335 00:22:47,280 --> 00:22:51,239 that information is priceless in the management of these medications. 336 00:22:51,250 --> 00:22:54,930 So thanks for elaborating on that. 337 00:22:56,010 --> 00:22:59,040 And if I may add in our previous conversation, 338 00:22:59,050 --> 00:23:00,810 uh before the recording of podcast, 339 00:23:00,819 --> 00:23:08,869 we had discussed um you guys' robust platform for collaborating with payers to obtain market access and reimbursements for the test. 340 00:23:09,109 --> 00:23:14,109 But without stealing the Thunder from uh Prometheus market access and reimbursement team, 341 00:23:14,199 --> 00:23:22,619 can you please uh briefly detail how Prometheus has proactively worked with payers to solve the problem. 342 00:23:22,920 --> 00:23:27,349 Um the population health problem by building the evidence payers want, 343 00:23:27,359 --> 00:23:41,170 want to see um about your test before you go to the market and then build the test and then hope the payers will see the value and the result and then that will improve the market access and reimbursement for your um precision medicine test. 344 00:23:42,160 --> 00:23:42,339 Yeah. 345 00:23:42,349 --> 00:23:43,180 So briefly I can, 346 00:23:43,189 --> 00:23:43,579 I'm, 347 00:23:43,589 --> 00:23:46,619 I'm probably not the right person to answer that question. 348 00:23:46,630 --> 00:23:47,369 We have a very, 349 00:23:47,380 --> 00:23:52,400 very efficient market access group uh uh pro meters that does a splendid job. 350 00:23:52,410 --> 00:23:59,780 But uh uh uh what I can tell you that we have an evidence uh uh development plan in place where we, 351 00:23:59,790 --> 00:24:14,000 we are establishing the clinical utility of our testing solution by demonstrating uh the payer value uh with respect of uh patient management and uh uh and the, 352 00:24:14,010 --> 00:24:16,630 and the impact of our technology on the, 353 00:24:16,640 --> 00:24:18,119 on physician behavior. 354 00:24:18,430 --> 00:24:21,319 Uh We have uh uh already uh you know, 355 00:24:21,329 --> 00:24:25,160 commercialized uh two of those tests for which we have initiated, 356 00:24:25,170 --> 00:24:29,040 initiated the Power studies uh that uh uh you know, 357 00:24:29,050 --> 00:24:32,000 already provide uh you know, 358 00:24:32,104 --> 00:24:34,484 differentiated and the value to, 359 00:24:34,494 --> 00:24:35,915 to the payer where we are, 360 00:24:35,925 --> 00:24:36,025 the, 361 00:24:36,035 --> 00:24:46,005 the clinicians are basically using our technology to make treatment decision uh as well as uh some prospective clinicality study which we are initiating, 362 00:24:46,145 --> 00:24:47,555 initiating to. 363 00:24:47,564 --> 00:24:48,574 Um uh again, 364 00:24:48,584 --> 00:24:49,425 demonstrate the, 365 00:24:49,435 --> 00:24:49,915 the, 366 00:24:49,925 --> 00:24:50,244 the, 367 00:24:50,255 --> 00:24:53,594 the payer value you uh uh we can certainly follow up with, 368 00:24:53,604 --> 00:24:58,755 uh you can certainly follow up with our market access group uh uh as appropriate there. 369 00:24:58,765 --> 00:25:00,765 Uh They can fill you with more information. 370 00:25:01,349 --> 00:25:01,589 No, 371 00:25:01,599 --> 00:25:02,520 that totally makes sense. 372 00:25:02,530 --> 00:25:03,310 That totally makes sense. 373 00:25:03,319 --> 00:25:10,890 But um we're excited that you're also farm d So how did you get to this role of outside the box path? 374 00:25:10,900 --> 00:25:11,550 There? 375 00:25:11,640 --> 00:25:17,530 There may be a pharmacist student or pharmacist wanting to switch or transition into a role such as yours, 376 00:25:17,540 --> 00:25:19,609 which is a Chief Scientific Officer. 377 00:25:19,619 --> 00:25:20,609 I want to learn more. 378 00:25:20,619 --> 00:25:23,920 So how would you um can you talk a little bit about that? 379 00:25:24,560 --> 00:25:24,780 Well, 380 00:25:24,790 --> 00:25:26,270 we are clinical laboratories. 381 00:25:26,280 --> 00:25:29,400 So in order to uh uh to be in my role, 382 00:25:29,410 --> 00:25:34,020 you need to have uh uh you need to have expertise in clinical laboratory science. 383 00:25:34,030 --> 00:25:36,140 So for the students is basically, 384 00:25:36,150 --> 00:25:36,300 you know, 385 00:25:36,310 --> 00:25:40,770 to do the family degree and then complete the family degree with uh a doctorate, 386 00:25:40,780 --> 00:25:40,930 you know, 387 00:25:40,939 --> 00:25:44,260 which is uh focus on clinical laboratory science. 388 00:25:44,270 --> 00:25:46,079 So you can achieve uh uh you know, 389 00:25:46,089 --> 00:25:47,640 the all the elements you need to be, 390 00:25:47,650 --> 00:25:48,219 for example, 391 00:25:48,229 --> 00:25:53,189 board certified uh as uh as as medical laboratory director. 392 00:25:53,199 --> 00:25:55,160 So you can uh uh so, 393 00:25:55,170 --> 00:25:55,589 uh yeah, 394 00:25:55,599 --> 00:25:56,030 this is, 395 00:25:56,040 --> 00:25:56,400 this is, 396 00:25:56,410 --> 00:25:57,209 this is uh you know, 397 00:25:57,219 --> 00:25:59,160 a great opportunity I think for pharmacies, 398 00:25:59,170 --> 00:26:10,800 there is an absolute need to uh have the clinical pharmacist provide uh uh drug information to healthcare professional as well as uh assist patient with the monitoring of their disease, 399 00:26:10,810 --> 00:26:15,229 the effectiveness of the therapy and um and uh you know, 400 00:26:15,239 --> 00:26:16,060 monitoring the, 401 00:26:16,069 --> 00:26:20,969 the side effect and the toxicity from uh from those uh those medication. 402 00:26:24,650 --> 00:26:24,959 Well, 403 00:26:24,969 --> 00:26:32,119 the I know our audience is going to have uh additional questions for you. 404 00:26:32,130 --> 00:26:32,540 I mean, 405 00:26:32,989 --> 00:26:35,609 you've provided them with so much great information, 406 00:26:35,619 --> 00:26:44,959 but it's only the beginning of what they could possibly learn um about um the testing that you do for IBD and, 407 00:26:44,969 --> 00:26:46,729 and even your career path. 408 00:26:47,050 --> 00:26:47,530 So, 409 00:26:47,540 --> 00:26:49,300 if you wouldn't mind telling us, 410 00:26:49,310 --> 00:26:51,359 um because we have to wrap up, 411 00:26:51,369 --> 00:26:52,670 unfortunately, 412 00:26:53,150 --> 00:26:55,810 this episode of the podcast, 413 00:26:55,819 --> 00:27:00,250 uh could you tell us how our audience members might be able to contact you directly. 414 00:27:01,260 --> 00:27:01,449 Yeah, 415 00:27:01,459 --> 00:27:07,079 I can be contacted on my uh on my email at TT W at como slab dot com. 416 00:27:07,949 --> 00:27:08,810 All right. 417 00:27:09,069 --> 00:27:09,300 Well, 418 00:27:09,310 --> 00:27:14,290 thank you again so much uh for joining us on this episode. 419 00:27:14,300 --> 00:27:15,290 We really, 420 00:27:15,300 --> 00:27:29,530 really hope that our listeners um ideas of not only what PGX can be but how PGX can be utilized in a comprehensive testing suite. 421 00:27:29,709 --> 00:27:35,670 We really hope that our a our audience will um listen in and learn this information. 422 00:27:36,280 --> 00:27:37,869 Um And to our audience, 423 00:27:37,880 --> 00:27:39,439 thank you for tuning in. 424 00:27:39,449 --> 00:27:42,619 We really hope that you've learned from this episode. 425 00:27:43,130 --> 00:27:46,339 Uh We do a whole lot of PG Xing here on this podcast. 426 00:27:46,349 --> 00:27:48,380 We talk about PGX Science, 427 00:27:48,390 --> 00:27:52,030 clinical application and the business of PGX. 428 00:27:52,260 --> 00:27:54,880 So we'd love to hear about from you. 429 00:27:55,099 --> 00:27:56,479 I love to hear from you. 430 00:27:56,489 --> 00:27:58,439 Um What can we teach you? 431 00:27:58,449 --> 00:28:00,920 What more can we teach you through our podcast? 432 00:28:00,930 --> 00:28:12,349 So please drop us a message on linkedin and let us know and please share this link to this podcast link episode with everyone so they can tune in and listen to the PGX for promises podcast. 433 00:28:12,520 --> 00:28:15,369 Leave us a review on Apple podcast or Spotify. 434 00:28:15,459 --> 00:28:18,130 And you can also visit us on PGX four, 435 00:28:18,140 --> 00:28:22,989 the number four Rx dot com to listen to all our other episodes. 436 00:28:23,000 --> 00:28:23,079 Well, 437 00:28:23,089 --> 00:28:23,790 thank you. 438 00:28:24,199 --> 00:28:28,750 Thanks for your interest in PGX and for spending some time with us. 439 00:28:28,760 --> 00:28:35,670 Please share this podcast and leave us a review on Apple podcasts or Spotify for all of our episodes. 440 00:28:35,680 --> 00:28:39,390 Please visit PGX four Rx dot com. 441 00:28:39,569 --> 00:28:43,380 That's PGX four Rx dot com.