Precision Health and PGx Podcast

Genetic Insight: Exploring MTHFR and Mental Health | Precision Health and PGx

Towny Robinson is the CEO of JayMac Pharmaceuticals and the inventor of EnLyte and EnBrace HR. He is a national expert on Methylation Biochemistry/Genetics and Psychiatric Disorders. Visit his website to learn more: www.enlyterx.com/about-enlytewww.enlyterx.com/about-enlyteBehnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.
 

Medical Science Liaison, A Career Path for Pharmacists with Dr. Samuel Dyer | PGX For Pharmacists

Special Episode: Travel with us in this journey through the fascinating world of Medical Science Liaison (MSL), new career path for pharmacists! Get firsthand knowledge from the CEO of The MSL Society and how to break into the amazing career path.We are giving away a signed copy of the book "The Medical Science Liaison Career Guide: How to Break Into Your First Role". To the one lucky aspiring MSL, please share our podcast link, tag Becky, Behnaz, and Samuel Dyer and make sure to use the hashtag PGx4Rx to be entered into the contest. The winners will be announced in the first week of January 2024. Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.
 

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 LaboratoriesDisclaimer: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: 
100:00:06,190 --> 00:00:19,620You're listening to the Pharmacy podcast Network in a world where one size fits all medications dominate the pharmaceutical industry.
200:00:20,079 --> 00:00:24,750Precision medicine brings a ray of hope for those seeking customized health care.
300:00:25,350 --> 00:00:32,830Pharmacists have a unique opportunity to help people in need of specialized testing to ensure medications work as intended.
400:00:33,540 --> 00:00:44,680Welcome to PGX for pharmacists where we unravel the wonders of precision medicine and its potential to revolutionize the way we approach pharmacy care.
500:00:45,169 --> 00:00:52,790Get ready to uncover the secrets behind pharmacogenomics and how it's transforming lives one genome at a time.
600:00:52,799 --> 00:00:53,189Hello,
700:00:53,200 --> 00:00:53,950everyone.
800:00:54,159 --> 00:00:55,080I'm your host,
900:00:55,090 --> 00:00:56,389Doctor Becky Winslow.
1000:00:56,409 --> 00:01:09,860And 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.
1100:01:09,870 --> 00:01:16,690We explore all things pharmacogenomics related and our mission is to educate and advocate for PGX.
1200:01:16,769 --> 00:01:23,849We accomplish this mission through exclusive interviews with highly qualified and well experienced pharmacogenomics.
1300:01:23,860 --> 00:01:29,720Industry leaders such as today's special guest and my name is Baas Sami,
1400:01:29,730 --> 00:01:32,739the co-host of PGX for Pharms podcast,
1500:01:32,750 --> 00:01:33,860Pharmacogenomics,
1600:01:33,870 --> 00:01:36,819medical science liaison and a mentor to pharmacist.
1700:01:36,889 --> 00:01:40,239Connect with us on linkedin and let's get a conversation going.
1800:01:40,269 --> 00:01:46,720We want to hear from you and how you're impacting pharmacogenomic stakeholders and what you have learned throughout your journey.
1900:01:48,510 --> 00:01:49,010Ok.
2000:01:49,019 --> 00:01:50,819So without any further ado,
2100:01:50,839 --> 00:01:54,769I'm extremely pleased to introduce to our audience.
2200:01:54,919 --> 00:01:56,059Doctor Theory Devo,
2300:01:57,239 --> 00:02:01,129the Chief Scientific Officer at Prometheus Laboratories,
2400:02:01,139 --> 00:02:08,139and Perme Prometheus Laboratories is a reference clinical laboratory that's focused on the diagnosis,
2500:02:08,149 --> 00:02:13,330prognosis and monitoring of immune mediated inflammatory diseases.
2600:02:13,970 --> 00:02:14,229So,
2700:02:14,240 --> 00:02:14,649thank you,
2800:02:14,660 --> 00:02:17,759Doctor De for joining us on the podcast.
2900:02:17,770 --> 00:02:18,589Today.
3000:02:18,600 --> 00:02:23,190I'm excited to share your and Prometheus's story with our audience.
3100:02:23,649 --> 00:02:25,630Um in particular,
3200:02:25,639 --> 00:02:45,369I'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.
3300:02:46,119 --> 00:02:46,449So,
3400:02:46,460 --> 00:03:04,220one 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.
3500:03:04,229 --> 00:03:08,020Most of them or most of you are uh familiar with.
3600:03:09,020 --> 00:03:09,429So,
3700:03:09,440 --> 00:03:22,179Doctor 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.
3800:03:23,619 --> 00:03:23,800Yeah,
3900:03:23,809 --> 00:03:24,250thank you,
4000:03:24,259 --> 00:03:25,759Becky for having me.
4100:03:25,770 --> 00:03:26,850Uh uh Yes.
4200:03:26,860 --> 00:03:27,289So I am a,
4300:03:27,300 --> 00:03:30,820I am a pharmacist uh with uh a family who is a,
4400:03:30,830 --> 00:03:33,039a doctorate in pharmacokinetics.
4500:03:33,539 --> 00:03:44,520Uh 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,
4600:03:44,929 --> 00:03:49,160uh primarily uh six Maturin as well as methotrexate.
4700:03:49,169 --> 00:03:50,550After my post doc,
4800:03:50,770 --> 00:03:52,960uh I moved uh in industry for promet.
4900:03:53,490 --> 00:04:01,429So I have a large experience in uh uh the implementation of pharmacogenetics testing in immune mediated inflammatory disease.
5000:04:01,509 --> 00:04:12,550Our 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.
5100:04:12,559 --> 00:04:13,029So,
5200:04:13,050 --> 00:04:21,989uh 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.
5300:04:23,660 --> 00:04:24,220All right.
5400:04:24,230 --> 00:04:27,359So thank you for qualifying yourself as an expert.
5500:04:27,369 --> 00:04:27,619So,
5600:04:27,630 --> 00:04:32,839let's jump right in and delve into your current PGX work.
5700:04:32,850 --> 00:04:33,279So,
5800:04:33,489 --> 00:04:36,540if you'll tell us um a little about Prometheus,
5900:04:36,549 --> 00:04:38,000specifically,
6000:04:38,010 --> 00:04:40,350what is Prometheus's mission?
6100:04:40,359 --> 00:04:43,799And how are you guys going about accomplishing your mission?
6200:04:44,760 --> 00:04:44,980Yeah,
6300:04:44,989 --> 00:04:45,700sure.
6400:04:45,709 --> 00:04:47,459Uh So Promet is a,
6500:04:47,470 --> 00:04:52,790is a reference uh clinical laboratory based in Southern California in San Diego.
6600:04:53,230 --> 00:04:56,809Uh The company has been there for uh over 25 years.
6700:04:56,820 --> 00:05:03,950We are uh specialize in the differential diagnosis of autoimmune G I disease uh disorders,
6800:05:04,059 --> 00:05:06,019uh gastrointestinal disorder,
6900:05:06,230 --> 00:05:08,619uh and inflammatory bowel disease.
7000:05:08,980 --> 00:05:10,299And over the years,
7100:05:10,309 --> 00:05:16,600we have developed a portfolio of a differentiated solution to facilitate the diagnosis,
7200:05:16,609 --> 00:05:17,470the prognosis,
7300:05:17,480 --> 00:05:18,429the monitoring,
7400:05:18,660 --> 00:05:21,910as well as therapy selection with pharmacogenetics testing,
7500:05:21,920 --> 00:05:24,730which we are offering to our clinical laboratory.
7600:05:24,829 --> 00:05:26,350And most importantly,
7700:05:26,410 --> 00:05:27,299uh recently,
7800:05:27,309 --> 00:05:35,660we are uh uh developing some uh uh testing solution with the credit topic care test to optimize treatment to uh biologics.
7900:05:36,470 --> 00:05:37,130Ok.
8000:05:37,140 --> 00:05:37,329Well,
8100:05:37,339 --> 00:05:37,450that,
8200:05:37,459 --> 00:05:38,049that's great.
8300:05:38,059 --> 00:05:46,100Can you also tell us uh about the Prois Library of Precision Medicine Tests for inflammatory bowel disease for patients?
8400:05:46,109 --> 00:05:49,230how they benefit medication therapy management.
8500:05:49,239 --> 00:05:56,429Stakeholders across the IB DS patients journey from diagnosis to treatment to disease,
8600:05:56,440 --> 00:06:02,049monitoring through remission and how they differ from other lab tests for IBD and his treatments.
8700:06:02,709 --> 00:06:03,209Yes.
8800:06:03,220 --> 00:06:03,369So,
8900:06:03,380 --> 00:06:04,399so we uh our,
9000:06:04,410 --> 00:06:10,100our clinical laboratory offers some uh highly specialized test to facilitate the,
9100:06:10,109 --> 00:06:16,779the diagnostic of uh to facilitate the differential diagnosis of uh uh inflammatory bowel disease.
9200:06:16,790 --> 00:06:22,359So we are following uh testing solution with uh serological testing,
9300:06:22,529 --> 00:06:23,799for example,
9400:06:23,809 --> 00:06:38,410uh 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.
9500:06:39,339 --> 00:06:43,684These are conditions that are uh uh somewhat difficult to treat.
9600:06:43,704 --> 00:06:49,994Uh And uh we are uh uh offering those tests to uh help uh gastroenterologist.
9700:06:50,015 --> 00:06:51,114Uh uh first of all,
9800:06:51,125 --> 00:07:03,434to establish a differential diagnosis of IBD as compared to other uh condition typically uh uh irritable bowel syndrome as well as over gastrointestinal disorder.
9900:07:03,445 --> 00:07:05,635When the diagnostic is established,
10000:07:05,910 --> 00:07:31,839uh 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,
10100:07:31,850 --> 00:07:36,559establish de determining some genotyping with the fit transferal genotyping.
10200:07:36,570 --> 00:07:37,279For example,
10300:07:37,290 --> 00:07:40,250where we can uh indicate that the patient is,
10400:07:40,260 --> 00:07:45,079is likely uh to present with a side effect to those medication.
10500:07:45,399 --> 00:07:46,170And once you know,
10600:07:46,179 --> 00:07:47,799the the treatment is initiative,
10700:07:47,809 --> 00:08:16,089we 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.
10800:08:16,980 --> 00:08:24,040So we have a comprehensive portfolio to uh to surround the clinician with uh a variety of testing solution.
10900:08:24,049 --> 00:08:30,250With our goal being to improve the uh the outcome uh of patients with uh with diabetes.
11000:08:30,260 --> 00:08:34,520And I think that the pharmacist has a very important role to play from that perspective.
11100:08:35,179 --> 00:08:36,039So theory,
11200:08:36,049 --> 00:08:40,239could you elaborate for us more on the predictor test?
11300:08:40,249 --> 00:08:42,758Um especially since you designed that test,
11400:08:42,768 --> 00:08:44,218we'd really like to know,
11500:08:44,489 --> 00:08:45,039um you know,
11600:08:45,049 --> 00:08:49,638what did that take and what role does it play in your suite of testing?
11700:08:51,049 --> 00:08:51,270Yeah.
11800:08:51,280 --> 00:08:51,890Sure.
11900:08:51,900 --> 00:08:52,510So the,
12000:08:52,520 --> 00:08:52,570the,
12100:08:52,580 --> 00:08:52,989the,
12200:08:53,000 --> 00:08:53,229the,
12300:08:53,239 --> 00:08:59,960the predictor test is uh uh is uh is utilized when the patient is receiving treatment.
12400:09:00,280 --> 00:09:18,190It'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.
12500:09:18,200 --> 00:09:21,549This is what the test does is to you connect the blood specimen,
12600:09:22,229 --> 00:09:23,049uh you know,
12700:09:23,059 --> 00:09:24,750with dosing information.
12800:09:25,039 --> 00:09:41,989And 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.
12900:09:42,169 --> 00:09:43,729Typically a vast majority,
13000:09:43,739 --> 00:09:46,159about two third of a third to two third,
13100:09:46,169 --> 00:09:54,669a third of patient uh tend to be uh uh unresponsive uh to this uh very expensive medication.
13200:09:54,989 --> 00:09:57,960Uh Not because they don't have the uh you know,
13300:09:57,969 --> 00:09:59,289typically because they have a,
13400:09:59,299 --> 00:09:59,590you know,
13500:09:59,599 --> 00:10:05,599pharmacokinetic uh suboptimal pharmacokinetic uh that makes them uh you know,
13600:10:05,609 --> 00:10:09,440unresponsive because uh not enough drug has been given.
13700:10:09,450 --> 00:10:18,469So what we do with a predictor test is to basically estimate the pa the pharmacokinetic uh parameter for the patient.
13800:10:18,750 --> 00:10:24,729And from then uh re report the best dose uh to give in order to achieve the,
13900:10:24,760 --> 00:10:31,570the level which is consistent with the uh the most uh uh effective disease control to be achieved for the patient.
14000:10:32,169 --> 00:10:33,059So we are offering,
14100:10:33,070 --> 00:10:38,049we have developed a test for the Infliximab as well as Adalimumab which is Humira,
14200:10:38,909 --> 00:10:41,309but these are antimony causes factor.
14300:10:41,460 --> 00:10:49,549And we are also developing the test for vidur as well as uh is that are widely used also in the treatment of,
14400:10:49,559 --> 00:10:51,969of uh inflammatory bubble disease.
14500:10:51,979 --> 00:10:52,669Wow,
14600:10:52,679 --> 00:10:55,450uh for MET is a suite of tests.
14700:10:55,460 --> 00:11:00,940Goes well beyond um the PGX testing that our audience is most familiar with,
14800:11:01,299 --> 00:11:08,679uh which typically only includes snips for cyp genes and some pharmacodynamic genes.
14900:11:08,690 --> 00:11:31,424This 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,
15000:11:31,434 --> 00:11:36,054it was developed by a larger laboratory for maybe smaller laboratories use.
15100:11:36,729 --> 00:11:39,010So my understanding,
15200:11:39,020 --> 00:11:53,729having 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.
15300:11:53,739 --> 00:11:54,119So,
15400:11:54,130 --> 00:12:00,729could you elaborate for our audience on the difficulties that are associated with immunology,
15500:12:00,739 --> 00:12:05,830research and developing tests uh for immunology versus say oncology?
15600:12:06,330 --> 00:12:06,530Yeah,
15700:12:06,539 --> 00:12:07,049sure.
15800:12:07,059 --> 00:12:09,969So in uh in immunology,
15900:12:09,979 --> 00:12:11,590as compared to oncology,
16000:12:11,599 --> 00:12:17,169there is no such a thing such as a somatic mutation where for example,
16100:12:17,179 --> 00:12:18,429you're gonna have a behalf,
16200:12:18,440 --> 00:12:18,659you know,
16300:12:18,669 --> 00:12:20,349that indicates that the patient,
16400:12:20,679 --> 00:12:20,919you know,
16500:12:20,929 --> 00:12:25,239is likely to benefit or not from some treatment in immunology.
16600:12:25,250 --> 00:12:26,750This is far more complicated,
16700:12:26,760 --> 00:12:28,830complicated for the reason,
16800:12:29,239 --> 00:12:31,020starting with uh the fact that,
16900:12:31,030 --> 00:12:31,179you know,
17000:12:31,190 --> 00:12:36,219the response to this uh medication uh are multifactorial.
17100:12:36,260 --> 00:12:37,820And the fact that uh you know,
17200:12:37,830 --> 00:12:39,380the mutation that uh the,
17300:12:39,390 --> 00:12:39,619the,
17400:12:39,630 --> 00:12:45,190the single nucleotide polymorphism in the GM line which uh uh you know,
17500:12:45,200 --> 00:12:52,429can potentially associate with uh with outcome uh uh uh uh a lo in advance,
17600:12:52,440 --> 00:12:58,359meaning that uh they're gonna have a weak association uh with a response to those medications.
17700:12:58,369 --> 00:13:09,609So 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,
17800:13:09,619 --> 00:13:09,859the,
17900:13:09,869 --> 00:13:10,380the,
18000:13:10,390 --> 00:13:10,520the,
18100:13:10,530 --> 00:13:13,219the clinician uh you know,
18200:13:13,419 --> 00:13:15,619uh order the test and most importantly,
18300:13:15,630 --> 00:13:15,840the,
18400:13:15,849 --> 00:13:16,179the,
18500:13:16,190 --> 00:13:17,739the payer to pay for the test.
18600:13:17,750 --> 00:13:20,469So this field has been uh you know,
18700:13:20,479 --> 00:13:20,679is,
18800:13:20,690 --> 00:13:21,705is moving for,
18900:13:21,715 --> 00:13:21,994you know,
19000:13:22,005 --> 00:13:24,575there are some tests that are being developed right now.
19100:13:24,924 --> 00:13:39,034But 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.
19200:13:39,659 --> 00:13:41,200I couldn't agree with you more.
19300:13:41,210 --> 00:13:53,489Um 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,
19400:13:53,500 --> 00:13:55,119even with those,
19500:13:55,130 --> 00:13:59,760it's sometimes difficult uh to get payers um to see the value.
19600:13:59,770 --> 00:14:01,640So I absolutely agree with you.
19700:14:01,940 --> 00:14:03,679Um The fact that you guys are,
19800:14:03,690 --> 00:14:11,789are uh investing in producing the data necessary says a lot about your laboratory.
19900:14:11,979 --> 00:14:12,559Um you know,
20000:14:12,570 --> 00:14:15,380and how committed you are to this testing and,
20100:14:15,390 --> 00:14:17,320and how you believe in the testing.
20200:14:18,039 --> 00:14:23,640So I just want to make sure that our audience recognizes that,
20300:14:24,359 --> 00:14:24,619you know,
20400:14:24,630 --> 00:14:31,820Prometheus doesn't simply provide tests to determine if drugs for IBD will be effective and safe.
20500:14:32,190 --> 00:14:36,900Um And maybe what the dose of the drug should be for the patient,
20600:14:36,909 --> 00:14:40,219but you have that whole suite of tests.
20700:14:40,229 --> 00:14:47,380Um the diagnostic test for the differential diagnosis all the way through remission.
20800:14:48,030 --> 00:14:53,390So can you elaborate you elaborated on it some in the previous question?
20900:14:53,400 --> 00:15:01,229But um can you tell us the difference between how you had to actually develop the test?
21000:15:01,520 --> 00:15:02,530Um You didn't,
21100:15:02,539 --> 00:15:03,059in other words,
21200:15:03,070 --> 00:15:10,659purchase a test from another manufacturer with the biomarkers that you include in your testing.
21300:15:10,669 --> 00:15:16,830Can you elaborate on how much more difficult it is to to develop a test from scratch?
21400:15:18,169 --> 00:15:18,320Yeah,
21500:15:18,330 --> 00:15:18,659sure.
21600:15:18,669 --> 00:15:18,809I mean,
21700:15:18,820 --> 00:15:22,070this is this is challenging for multiple and first of all,
21800:15:22,080 --> 00:15:23,130you need to have the,
21900:15:23,419 --> 00:15:27,450you need to have a clinical data set available with specimen available.
22000:15:27,460 --> 00:15:28,159Uh you know,
22100:15:28,169 --> 00:15:28,780in front,
22200:15:28,859 --> 00:15:29,770obviously,
22300:15:29,859 --> 00:15:30,890available.
22400:15:31,200 --> 00:15:35,890Uh So we are leveraging a pro meters a large bi bank of specimen.
22500:15:36,299 --> 00:15:37,190Uh as I said,
22600:15:37,200 --> 00:15:39,719Prometheus has been founded 25 years ago.
22700:15:39,729 --> 00:15:40,599So over the,
22800:15:40,760 --> 00:15:41,919the past two decades,
22900:15:41,929 --> 00:15:54,849we 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.
23000:15:54,859 --> 00:16:07,559And 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.
23100:16:07,969 --> 00:16:11,469Then we are entering validation phase where we are uh you know,
23200:16:11,570 --> 00:16:14,789using validation cohorts where we are again,
23300:16:14,969 --> 00:16:22,630combining multiple modalities together uh patient demographic as well as genetic marker together with theological marker.
23400:16:22,640 --> 00:16:23,190Actually,
23500:16:23,500 --> 00:16:27,419to come up with some Multivariate models that are uh again,
23600:16:27,429 --> 00:16:39,250bringing 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.
23700:16:39,650 --> 00:16:41,190And uh obviously,
23800:16:41,200 --> 00:16:41,760again,
23900:16:41,770 --> 00:16:45,320the patient uh to the benefit of the patient and to,
24000:16:45,330 --> 00:16:46,619to improve its outcome,
24100:16:46,739 --> 00:16:47,429the outcome.
24200:16:48,340 --> 00:16:53,380I think what you're describing really is the future of pharmacogenomics.
24300:16:53,390 --> 00:16:54,599Um In other words,
24400:16:54,609 --> 00:17:03,419not singing out pharmacogenomics as you know the end all and be all in the treatment paradigm.
24500:17:03,559 --> 00:17:08,040But using a PGX test in combination with,
24600:17:08,050 --> 00:17:09,069like you mentioned,
24700:17:09,250 --> 00:17:11,160other serological tests,
24800:17:11,170 --> 00:17:12,959maybe other genetic tests.
24900:17:13,290 --> 00:17:14,890Um But you know,
25000:17:14,900 --> 00:17:25,869I 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,
25100:17:25,880 --> 00:17:26,910to remission.
25200:17:27,239 --> 00:17:29,880So I think you guys are absolutely,
25300:17:29,890 --> 00:17:31,579you're already in the future.
25400:17:31,589 --> 00:17:32,849In other words,
25500:17:32,859 --> 00:17:33,130you know,
25600:17:33,140 --> 00:17:39,689you're already providing all these different uh tests um like you mentioned to,
25700:17:39,699 --> 00:17:44,310to facilitate from diagnosis to remission to remission.
25800:17:44,660 --> 00:17:45,520That's correct.
25900:17:45,530 --> 00:17:45,829Yeah.
26000:17:46,349 --> 00:17:55,089So um you've given us so much great information about uh the tests that that you guys offer.
26100:17:55,329 --> 00:18:02,060Can you explain to our audience um your newest test?
26200:18:02,069 --> 00:18:03,859Uh the responder test.
26300:18:04,150 --> 00:18:12,979And um what role it will play in the paradigm from the diagnosis of IBD to remission?
26400:18:14,050 --> 00:18:14,260Yeah,
26500:18:14,270 --> 00:18:14,760sure.
26600:18:14,770 --> 00:18:15,569So we,
26700:18:15,579 --> 00:18:18,069we are doing things a little bit different than other.
26800:18:18,079 --> 00:18:19,489We do believe that uh you know,
26900:18:19,500 --> 00:18:21,449the it has to be simple.
27000:18:21,459 --> 00:18:24,189Uh uh We can obviously construct some very,
27100:18:24,199 --> 00:18:33,530very complex algorithm and there are some tests that do that with a very sophisticated machine learning based tools that are available using neural networks,
27200:18:33,540 --> 00:18:33,729you know,
27300:18:33,739 --> 00:18:34,790those sorts of things.
27400:18:34,800 --> 00:18:39,729But we have taken on a different approach where with the responder test,
27500:18:39,739 --> 00:18:40,329we are basically,
27600:18:40,339 --> 00:18:45,160we are taking an approach which is very simple to address the first and foremost.
27700:18:45,170 --> 00:18:53,020Most important aspect of responding uh predicting response to uh to medication is the pharmacokinetics.
27800:18:53,280 --> 00:19:03,250Uh 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.
27900:19:03,359 --> 00:19:06,349And this is what we are doing with the responder test.
28000:19:06,579 --> 00:19:09,010We are addressing some uh uh you know,
28100:19:09,020 --> 00:19:11,630fundamental issues with those uh biologist,
28200:19:11,640 --> 00:19:12,410for example,
28300:19:12,660 --> 00:19:15,170uh the anti tumor necrosis factors.
28400:19:15,180 --> 00:19:15,650So,
28500:19:15,750 --> 00:19:19,199such as uh Infliximab and Adalimumab,
28600:19:19,209 --> 00:19:23,050it is well known uh that uh uh those drugs,
28700:19:23,060 --> 00:19:25,689first of all are prone to immunization.
28800:19:25,989 --> 00:19:36,949Uh Meaning that uh uh the drug itself uh is recognized by the immune system uh and digested by the antigen presenting cells.
28900:19:36,959 --> 00:19:42,209If you will uh where you gonna have uh uh an immune uh uh response,
29000:19:42,380 --> 00:19:56,979uh 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.
29100:19:56,989 --> 00:19:57,150So,
29200:19:57,160 --> 00:19:58,890we are with the risk conductors,
29300:19:58,900 --> 00:20:01,040we are combining two things together.
29400:20:01,189 --> 00:20:07,959First of all is the genetic test itself which uh predicts the risk of immun immunization.
29500:20:07,969 --> 00:20:18,010The name of the test is on HL A uh DQ A 105 ali uh that uh uh promotes the presentation of the,
29600:20:18,020 --> 00:20:19,130of the,
29700:20:19,140 --> 00:20:19,910of Infliximab,
29800:20:20,010 --> 00:20:20,750for example,
29900:20:20,760 --> 00:20:32,130to 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,
30000:20:32,140 --> 00:20:33,670which is as important.
30100:20:33,949 --> 00:20:36,209Uh One of the key issue is the,
30200:20:36,219 --> 00:20:36,770the,
30300:20:36,780 --> 00:20:41,239the monoclonal antibodies and uh such as Infliximab or Adalimumab.
30400:20:41,329 --> 00:20:42,280But in fact,
30500:20:42,290 --> 00:20:45,890a neon antibodies that those drugs are uh you know,
30600:20:45,900 --> 00:20:49,010cleared and consumed uh from the,
30700:20:49,020 --> 00:20:50,949from the central compartment if you will,
30800:20:50,959 --> 00:20:54,520since we are doing a little bit of uh uh pharmacokinetics here.
30900:20:54,530 --> 00:20:56,020And uh uh you know,
31000:20:56,030 --> 00:21:06,670if 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,
31100:21:06,680 --> 00:21:13,939in the presence again of the HL AD Q A 105 genetic marker that uh associate with uh immunization.
31200:21:13,949 --> 00:21:16,859So I but this is a combination of both,
31300:21:17,199 --> 00:21:19,359these are the predictive factors of pharmacokinetic,
31400:21:20,359 --> 00:21:38,209which 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,
31500:21:38,219 --> 00:21:38,300you know,
31600:21:38,310 --> 00:21:39,479will clear the drug very,
31700:21:39,489 --> 00:21:40,260very fast.
31800:21:40,560 --> 00:21:41,670For example,
31900:21:41,680 --> 00:21:46,819due to the inefficient uh recirculation of the drug itself with the new,
32000:21:46,869 --> 00:21:46,930the,
32100:21:46,939 --> 00:21:50,599the the in the reticular on the system.
32200:21:50,920 --> 00:21:51,619Together,
32300:21:51,630 --> 00:22:02,109those patients presenting with uh uh together these uh poor prognostic factor of pharmacokinetic origin will tend to be severely underdose,
32400:22:02,380 --> 00:22:06,719will not be responding to the drug uh adequately as and they,
32500:22:06,729 --> 00:22:10,719and they probably should in the first place if you are able to address uh you know,
32600:22:10,729 --> 00:22:12,270the the the exposure.
32700:22:12,439 --> 00:22:14,079So what we do with this test,
32800:22:14,089 --> 00:22:21,640we will be able to inform uh the clinic that the patient is at risk of achieving,
32900:22:21,650 --> 00:22:30,829of achieving suboptimal pharmacokinetics and therefore being able to adjust the dose uh uh to start with more adequately.
33000:22:30,839 --> 00:22:38,650So that the the the proper uh exposure is achieved uh during induction to again to,
33100:22:38,660 --> 00:22:39,040to,
33200:22:39,050 --> 00:22:39,380to,
33300:22:39,390 --> 00:22:40,890to achieve a better outcome.
33400:22:41,040 --> 00:22:47,270And I think the pharmacist will have a very important role to play here in terms of absolutely,
33500:22:47,280 --> 00:22:51,239that information is priceless in the management of these medications.
33600:22:51,250 --> 00:22:54,930So thanks for elaborating on that.
33700:22:56,010 --> 00:22:59,040And if I may add in our previous conversation,
33800:22:59,050 --> 00:23:00,810uh before the recording of podcast,
33900:23:00,819 --> 00:23:08,869we had discussed um you guys' robust platform for collaborating with payers to obtain market access and reimbursements for the test.
34000:23:09,109 --> 00:23:14,109But without stealing the Thunder from uh Prometheus market access and reimbursement team,
34100:23:14,199 --> 00:23:22,619can you please uh briefly detail how Prometheus has proactively worked with payers to solve the problem.
34200:23:22,920 --> 00:23:27,349Um the population health problem by building the evidence payers want,
34300:23:27,359 --> 00:23:41,170want 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.
34400:23:42,160 --> 00:23:42,339Yeah.
34500:23:42,349 --> 00:23:43,180So briefly I can,
34600:23:43,189 --> 00:23:43,579I'm,
34700:23:43,589 --> 00:23:46,619I'm probably not the right person to answer that question.
34800:23:46,630 --> 00:23:47,369We have a very,
34900:23:47,380 --> 00:23:52,400very efficient market access group uh uh pro meters that does a splendid job.
35000:23:52,410 --> 00:23:59,780But uh uh uh what I can tell you that we have an evidence uh uh development plan in place where we,
35100:23:59,790 --> 00:24:14,000we 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,
35200:24:14,010 --> 00:24:16,630and the impact of our technology on the,
35300:24:16,640 --> 00:24:18,119on physician behavior.
35400:24:18,430 --> 00:24:21,319Uh We have uh uh already uh you know,
35500:24:21,329 --> 00:24:25,160commercialized uh two of those tests for which we have initiated,
35600:24:25,170 --> 00:24:29,040initiated the Power studies uh that uh uh you know,
35700:24:29,050 --> 00:24:32,000already provide uh you know,
35800:24:32,104 --> 00:24:34,484differentiated and the value to,
35900:24:34,494 --> 00:24:35,915to the payer where we are,
36000:24:35,925 --> 00:24:36,025the,
36100:24:36,035 --> 00:24:46,005the clinicians are basically using our technology to make treatment decision uh as well as uh some prospective clinicality study which we are initiating,
36200:24:46,145 --> 00:24:47,555initiating to.
36300:24:47,564 --> 00:24:48,574Um uh again,
36400:24:48,584 --> 00:24:49,425demonstrate the,
36500:24:49,435 --> 00:24:49,915the,
36600:24:49,925 --> 00:24:50,244the,
36700:24:50,255 --> 00:24:53,594the payer value you uh uh we can certainly follow up with,
36800:24:53,604 --> 00:24:58,755uh you can certainly follow up with our market access group uh uh as appropriate there.
36900:24:58,765 --> 00:25:00,765Uh They can fill you with more information.
37000:25:01,349 --> 00:25:01,589No,
37100:25:01,599 --> 00:25:02,520that totally makes sense.
37200:25:02,530 --> 00:25:03,310That totally makes sense.
37300:25:03,319 --> 00:25:10,890But um we're excited that you're also farm d So how did you get to this role of outside the box path?
37400:25:10,900 --> 00:25:11,550There?
37500:25:11,640 --> 00:25:17,530There may be a pharmacist student or pharmacist wanting to switch or transition into a role such as yours,
37600:25:17,540 --> 00:25:19,609which is a Chief Scientific Officer.
37700:25:19,619 --> 00:25:20,609I want to learn more.
37800:25:20,619 --> 00:25:23,920So how would you um can you talk a little bit about that?
37900:25:24,560 --> 00:25:24,780Well,
38000:25:24,790 --> 00:25:26,270we are clinical laboratories.
38100:25:26,280 --> 00:25:29,400So in order to uh uh to be in my role,
38200:25:29,410 --> 00:25:34,020you need to have uh uh you need to have expertise in clinical laboratory science.
38300:25:34,030 --> 00:25:36,140So for the students is basically,
38400:25:36,150 --> 00:25:36,300you know,
38500:25:36,310 --> 00:25:40,770to do the family degree and then complete the family degree with uh a doctorate,
38600:25:40,780 --> 00:25:40,930you know,
38700:25:40,939 --> 00:25:44,260which is uh focus on clinical laboratory science.
38800:25:44,270 --> 00:25:46,079So you can achieve uh uh you know,
38900:25:46,089 --> 00:25:47,640the all the elements you need to be,
39000:25:47,650 --> 00:25:48,219for example,
39100:25:48,229 --> 00:25:53,189board certified uh as uh as as medical laboratory director.
39200:25:53,199 --> 00:25:55,160So you can uh uh so,
39300:25:55,170 --> 00:25:55,589uh yeah,
39400:25:55,599 --> 00:25:56,030this is,
39500:25:56,040 --> 00:25:56,400this is,
39600:25:56,410 --> 00:25:57,209this is uh you know,
39700:25:57,219 --> 00:25:59,160a great opportunity I think for pharmacies,
39800:25:59,170 --> 00:26:10,800there 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,
39900:26:10,810 --> 00:26:15,229the effectiveness of the therapy and um and uh you know,
40000:26:15,239 --> 00:26:16,060monitoring the,
40100:26:16,069 --> 00:26:20,969the side effect and the toxicity from uh from those uh those medication.
40200:26:24,650 --> 00:26:24,959Well,
40300:26:24,969 --> 00:26:32,119the I know our audience is going to have uh additional questions for you.
40400:26:32,130 --> 00:26:32,540I mean,
40500:26:32,989 --> 00:26:35,609you've provided them with so much great information,
40600:26:35,619 --> 00:26:44,959but it's only the beginning of what they could possibly learn um about um the testing that you do for IBD and,
40700:26:44,969 --> 00:26:46,729and even your career path.
40800:26:47,050 --> 00:26:47,530So,
40900:26:47,540 --> 00:26:49,300if you wouldn't mind telling us,
41000:26:49,310 --> 00:26:51,359um because we have to wrap up,
41100:26:51,369 --> 00:26:52,670unfortunately,
41200:26:53,150 --> 00:26:55,810this episode of the podcast,
41300:26:55,819 --> 00:27:00,250uh could you tell us how our audience members might be able to contact you directly.
41400:27:01,260 --> 00:27:01,449Yeah,
41500:27:01,459 --> 00:27:07,079I can be contacted on my uh on my email at TT W at como slab dot com.
41600:27:07,949 --> 00:27:08,810All right.
41700:27:09,069 --> 00:27:09,300Well,
41800:27:09,310 --> 00:27:14,290thank you again so much uh for joining us on this episode.
41900:27:14,300 --> 00:27:15,290We really,
42000:27:15,300 --> 00:27:29,530really hope that our listeners um ideas of not only what PGX can be but how PGX can be utilized in a comprehensive testing suite.
42100:27:29,709 --> 00:27:35,670We really hope that our a our audience will um listen in and learn this information.
42200:27:36,280 --> 00:27:37,869Um And to our audience,
42300:27:37,880 --> 00:27:39,439thank you for tuning in.
42400:27:39,449 --> 00:27:42,619We really hope that you've learned from this episode.
42500:27:43,130 --> 00:27:46,339Uh We do a whole lot of PG Xing here on this podcast.
42600:27:46,349 --> 00:27:48,380We talk about PGX Science,
42700:27:48,390 --> 00:27:52,030clinical application and the business of PGX.
42800:27:52,260 --> 00:27:54,880So we'd love to hear about from you.
42900:27:55,099 --> 00:27:56,479I love to hear from you.
43000:27:56,489 --> 00:27:58,439Um What can we teach you?
43100:27:58,449 --> 00:28:00,920What more can we teach you through our podcast?
43200:28:00,930 --> 00:28:12,349So 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.
43300:28:12,520 --> 00:28:15,369Leave us a review on Apple podcast or Spotify.
43400:28:15,459 --> 00:28:18,130And you can also visit us on PGX four,
43500:28:18,140 --> 00:28:22,989the number four Rx dot com to listen to all our other episodes.
43600:28:23,000 --> 00:28:23,079Well,
43700:28:23,089 --> 00:28:23,790thank you.
43800:28:24,199 --> 00:28:28,750Thanks for your interest in PGX and for spending some time with us.
43900:28:28,760 --> 00:28:35,670Please share this podcast and leave us a review on Apple podcasts or Spotify for all of our episodes.
44000:28:35,680 --> 00:28:39,390Please visit PGX for Rx dot com.
44100:28:39,569 --> 00:28:43,380That's PGX for Rx dot com.
 

Using Technology to Decrease Barriers to the Clinical Implementation of Pharmacogenomics: LetsGetChecked’s PGx Story | PGx For Pharmacists

On this episode, Dr. Avni Santani, Chief Genomics Officer of Let's Get Checked, Dr. Behnaz Sarrami, and I discuss how Let's Get Checked solves several major barriers that have held pharmacogenomics back from becoming the standard of care in medication therapy management, pharmacists' critical and unique role in PGX at Let's Get Checked, and how nontraditional PGx payers are championing for PGx testing to decrease adverse drug events, increase therapeutic medication outcomes, and improve patient adherence to their medications.  https://www.letsgetchecked.com/mypgx/Becky Winslow, BS, PharmD and Behnaz Sarrami, MS, PharmD (Hosts) Avni A. Santani, PhD, FACMG, Chief Genomics Officer at LetsGetChecked
New boost

PGx Roundtable: The Patient’s Perspective | PGx For Pharmacists

Explore the realm of pharmacogenomic testing as patients open up about their experiences, sharing stories of both success and tragedy. These courageous guests provide insights into the power of personalized medicine and the crucial lessons learned along the way.
A journey from medication struggles to success through pharmacogenomics. A heartbreaking tale of genetic-based medication complications. Navigating emotions while uncovering genetic insights.
Triumphs of Personalization: Guests share uplifting accounts of renewed health and life improvements due to pharmacogenomic testing.
Learning from Tragedy: Stories underscore the consequences of neglecting genetic factors, advocating for greater awareness.
Emotional Resilience: Discussing the psychological challenges in the context of chronic conditions and medication adjustments.
Empowering Patients and Providers: Guests stress education and dialogue between patients and medical professionals for informed decisions.
Join us as we unravel narratives of strength, hope, and knowledge in pharmacogenomic testing. This episode provides a valuable perspective on the fusion of genetics and healthcare, whether you're a patient, healthcare provider, or simply intrigued by personalized medicine's evolution.
Special interviews with Christina Delsoldato, Karen Merrit, Christine Von Raesfeld, and Joanne McIntyre.
Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.

PGx Education History & Future Projection with Dave Kisor | PGX For Pharmacists

Dr. Dave Kisor, a professor and director of pharmacogenomics at Manchester University. He graduated from The Ohio State University College of Pharmacy in 1986 and completed a two-year fellowship in therapeutic drug monitoring/pharmacokinetics at OSU. Before he joined Manchester, Dave was professor of pharmaceutical sciences at Ohio Northern University after being a research scientist at Burroughs Wellcome Co/GlaxoWellcome. Dave has over 80 peer-reviewed publications including being the lead author on two pharmacogenomics textbooks. He is a past chair of the American Association of Colleges of Pharmacy (AACP) Pharmacogenomics Special Interest Group. Dave was named a Fellow of the American College of Clinical Pharmacology in 2017, and in 2021, along with Dr. Tom Smith, he received an AACP Innovations in PGx Teaching Award. His current research is related to PGx and opioid use disorder. Dave currently serves as co-chair of the Pharmacogenomics Global Research Network (PGRN) Education Committee and is Editor-In-Chief of Pharmacogenomics: Foundations, Competencies, and the Pharmacists’ Patient Care Process.
 
Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.

Desperation to Discovery Empowered by PGx | PGX For Pharmacists

Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences on topics ranging from clinical trial recruitment to data & digital rights, from a true patient perspective. She serves as an e-patient scholar with Stanford MedicineX and a Technical Expert Panelist with CMS among other roles. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and has become a thought leader worldwide, stimulating dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program and the NIH All of Us Research Program and serves as a board member/advisor to multiple organizations and startups. For her many contributions to the field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future50, and one of Medika Life's 50 most influential voices in healthcare among other distinctions. www.peoplewithempathy.org/
Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.

Maternal Medication Management Through Pharmacogenomics | PGX For Pharmacists

Hyperemesis Gravidarum (HG) is a potentially life-threatening pregnancy disease that may cause weight loss, malnutrition, dehydration, and debility due to severe nausea and/or vomiting, and may cause long-term health issues for mother and baby(ies). It occurs in up to 3% of pregnant women and may last the entire pregnancy, which can lead to malnourished. Dr. Danielle Plummer has unfortunately been a three-time survivor of HG and she is the founder and CEO of HG clinical solutions (www.hgclinicalsolutions.com). Please visit that website and learn more. She offers personalized medication planning and patient advocacy in addition to educating providers on HG disease state. She has women around the world reaching out to her for advice and support, and she is looking forward to the day that PGx is utilized in all the countries that she is supporting. www.HGPharmacist.com is a link to Danielle's free ebook called "Dear ER doctor, Believe Us" There is also a FaceBook support group: www.facebook.com/groups/hgsolutions.
"Coming Soon" is the course called "Preparing for a Hyperemesis Pregnancy". Connect with Danielle to sign up.
 
Behnaz Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.

The Human Cost of Ignoring DPD Deficiency | PGX For Pharmacists

DYPD is a gene that provides instructions for making an enzyme called dihydropyrimidine dehydrogenase (DPD). This enzyme plays very important in breaking down a substance called uracil, which is found in our DNA and RNA. Mutations in the DYPD gene can lead to decreased or absent DPD activity, which if you think about it can cause a buildup of uracil in the body. If someone is DPD deficiency it can make it difficult for the body to process certain chemotherapy drugs and can lead to severe side effects, such as nerve damage, GI problems, and even death. Genetic testing before being placed on a chemo agent, to see if there is a DPD deficiency is vital. According to Advocates for Universal DPD/DPYD Testing (AUDT), Europe is becoming the standard of care for testing for this gene and only in some selected institutions in the US the testing it being done. AUDT is made up of a group of patient advocates and medical professionals who are seeking to improve treatment outcomes for patients that are preparing to receive chemotherapy based on fluoropyrimidine drugs. One of the founders of this non-profit organization, AUDT, Karen Merritt is our guest today. She lost her mother in 2014 due to being DPD deficient and after getting her first infusion of 5FU. Karen dedicated herself to advocating and raising awareness about pre-testing for DPD deficiency before fluoropyrimidine chemotherapy administration to reduce unnecessary suffering.
Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.Resources: https://test4dpd.org/about-us/

Beyond the PGx Certificate: Real World PGx Experiences in the Business of Pharmacogenomics | PGx For Pharmacists

Pharmacogenomics consulting isn't the glamorous and highly lucrative career path some voices in the pharmacogenomics industry portray it to be... In this episode, Behnaz and Becky dispel the "get rich quick" myth about PGx and discuss what pharmacists need to know “beyond the PGX certificate” to be successful creating a career in pharmacogenomics as they have. So, don't quit your full time pharmacist job to become a pharmacogenomics consultant until you listen to this enlightening episode of the PGx for Pharmacists Podcast! https://cpicpgx.org/
Disclaimer: These are my personal views and opinions, and I am not speaking on behalf of Castle Biosciences, Inc.