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 l...
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
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:
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You're listening to the Pharmacy podcast Network in a world where one size fits all medications dominate the pharmaceutical industry.
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Precision medicine brings a ray of hope for those seeking customized health care.
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Pharmacists have a unique opportunity to help people in need of specialized testing to ensure medications work as intended.
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Welcome to PGX for pharmacists where we unravel the wonders of precision medicine and its potential to revolutionize the way we approach pharmacy care.
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Get ready to uncover the secrets behind pharmacogenomics and how it's transforming lives one genome at a time.
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Hello,
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everyone.
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I'm your host,
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Doctor Becky Winslow.
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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.
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We explore all things pharmacogenomics related and our mission is to educate and advocate for PGX.
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We accomplish this mission through exclusive interviews with highly qualified and well experienced pharmacogenomics.
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Industry leaders such as today's special guest and my name is Baas Sami,
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the co-host of PGX for Pharms podcast,
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Pharmacogenomics,
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medical science liaison and a mentor to pharmacist.
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Connect with us on linkedin and let's get a conversation going.
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We want to hear from you and how you're impacting pharmacogenomic stakeholders and what you have learned throughout your journey.
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Ok.
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So without any further ado,
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I'm extremely pleased to introduce to our audience.
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Doctor Theory Devo,
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the Chief Scientific Officer at Prometheus Laboratories,
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and Perme Prometheus Laboratories is a reference clinical laboratory that's focused on the diagnosis,
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prognosis and monitoring of immune mediated inflammatory diseases.
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So,
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thank you,
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Doctor De for joining us on the podcast.
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Today.
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I'm excited to share your and Prometheus's story with our audience.
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Um in particular,
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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.
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So,
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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.
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Most of them or most of you are uh familiar with.
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So,
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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.
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Yeah,
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thank you,
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Becky for having me.
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Uh uh Yes.
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So I am a,
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I am a pharmacist uh with uh a family who is a,
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a doctorate in pharmacokinetics.
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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,
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uh primarily uh six Maturin as well as methotrexate.
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After my post doc,
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uh I moved uh in industry for promet.
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So I have a large experience in uh uh the implementation of pharmacogenetics testing in immune mediated inflammatory disease.
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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.
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So,
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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.
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All right.
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So thank you for qualifying yourself as an expert.
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So,
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let's jump right in and delve into your current PGX work.
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So,
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if you'll tell us um a little about Prometheus,
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specifically,
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what is Prometheus's mission?
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And how are you guys going about accomplishing your mission?
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Yeah,
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sure.
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Uh So Promet is a,
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is a reference uh clinical laboratory based in Southern California in San Diego.
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Uh The company has been there for uh over 25 years.
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We are uh specialize in the differential diagnosis of autoimmune G I disease uh disorders,
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uh gastrointestinal disorder,
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uh and inflammatory bowel disease.
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And over the years,
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we have developed a portfolio of a differentiated solution to facilitate the diagnosis,
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the prognosis,
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the monitoring,
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as well as therapy selection with pharmacogenetics testing,
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which we are offering to our clinical laboratory.
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And most importantly,
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uh recently,
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we are uh uh developing some uh uh testing solution with the credit topic care test to optimize treatment to uh biologics.
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Ok.
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Well,
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that,
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that's great.
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Can you also tell us uh about the Prois Library of Precision Medicine Tests for inflammatory bowel disease for patients?
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how they benefit medication therapy management.
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Stakeholders across the IB DS patients journey from diagnosis to treatment to disease,
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monitoring through remission and how they differ from other lab tests for IBD and his treatments.
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Yes.
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So,
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so we uh our,
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our clinical laboratory offers some uh highly specialized test to facilitate the,
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the diagnostic of uh to facilitate the differential diagnosis of uh uh inflammatory bowel disease.
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So we are following uh testing solution with uh serological testing,
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for example,
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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.
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These are conditions that are uh uh somewhat difficult to treat.
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Uh And uh we are uh uh offering those tests to uh help uh gastroenterologist.
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Uh uh first of all,
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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.
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When the diagnostic is established,
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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,
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establish de determining some genotyping with the fit transferal genotyping.
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For example,
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where we can uh indicate that the patient is,
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is likely uh to present with a side effect to those medication.
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And once you know,
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the the treatment is initiative,
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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.
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So we have a comprehensive portfolio to uh to surround the clinician with uh a variety of testing solution.
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With our goal being to improve the uh the outcome uh of patients with uh with diabetes.
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And I think that the pharmacist has a very important role to play from that perspective.
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So theory,
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could you elaborate for us more on the predictor test?
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Um especially since you designed that test,
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we'd really like to know,
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um you know,
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what did that take and what role does it play in your suite of testing?
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Yeah.
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Sure.
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So the,
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the,
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the,
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the,
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the predictor test is uh uh is uh is utilized when the patient is receiving treatment.
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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.
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This is what the test does is to you connect the blood specimen,
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uh you know,
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with dosing information.
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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.
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Typically a vast majority,
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about two third of a third to two third,
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a third of patient uh tend to be uh uh unresponsive uh to this uh very expensive medication.
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Uh Not because they don't have the uh you know,
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typically because they have a,
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you know,
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pharmacokinetic uh suboptimal pharmacokinetic uh that makes them uh you know,
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unresponsive because uh not enough drug has been given.
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So what we do with a predictor test is to basically estimate the pa the pharmacokinetic uh parameter for the patient.
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And from then uh re report the best dose uh to give in order to achieve the,
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the level which is consistent with the uh the most uh uh effective disease control to be achieved for the patient.
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So we are offering,
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we have developed a test for the Infliximab as well as Adalimumab which is Humira,
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but these are antimony causes factor.
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And we are also developing the test for vidur as well as uh is that are widely used also in the treatment of,
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of uh inflammatory bubble disease.
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Wow,
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uh for MET is a suite of tests.
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Goes well beyond um the PGX testing that our audience is most familiar with,
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uh which typically only includes snips for cyp genes and some pharmacodynamic genes.
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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,
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it was developed by a larger laboratory for maybe smaller laboratories use.
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So my understanding,
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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.
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So,
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could you elaborate for our audience on the difficulties that are associated with immunology,
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research and developing tests uh for immunology versus say oncology?
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Yeah,
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sure.
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So in uh in immunology,
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as compared to oncology,
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there is no such a thing such as a somatic mutation where for example,
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you're gonna have a behalf,
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you know,
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that indicates that the patient,
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you know,
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is likely to benefit or not from some treatment in immunology.
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This is far more complicated,
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complicated for the reason,
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starting with uh the fact that,
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you know,
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the response to this uh medication uh are multifactorial.
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And the fact that uh you know,
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the mutation that uh the,
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the,
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the single nucleotide polymorphism in the GM line which uh uh you know,
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can potentially associate with uh with outcome uh uh uh uh a lo in advance,
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meaning that uh they're gonna have a weak association uh with a response to those medications.
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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,
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the,
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the,
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the,
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the clinician uh you know,
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uh order the test and most importantly,
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the,
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the,
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the payer to pay for the test.
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So this field has been uh you know,
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is,
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is moving for,
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you know,
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there are some tests that are being developed right now.
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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.
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I couldn't agree with you more.
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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,
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even with those,
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it's sometimes difficult uh to get payers um to see the value.
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So I absolutely agree with you.
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Um The fact that you guys are,
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are uh investing in producing the data necessary says a lot about your laboratory.
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Um you know,
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and how committed you are to this testing and,
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and how you believe in the testing.
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So I just want to make sure that our audience recognizes that,
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you know,
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Prometheus doesn't simply provide tests to determine if drugs for IBD will be effective and safe.
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Um And maybe what the dose of the drug should be for the patient,
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but you have that whole suite of tests.
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Um the diagnostic test for the differential diagnosis all the way through remission.
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So can you elaborate you elaborated on it some in the previous question?
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But um can you tell us the difference between how you had to actually develop the test?
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Um You didn't,
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in other words,
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purchase a test from another manufacturer with the biomarkers that you include in your testing.
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Can you elaborate on how much more difficult it is to to develop a test from scratch?
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Yeah,
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sure.
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I mean,
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this is this is challenging for multiple and first of all,
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you need to have the,
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you need to have a clinical data set available with specimen available.
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Uh you know,
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in front,
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obviously,
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available.
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Uh So we are leveraging a pro meters a large bi bank of specimen.
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Uh as I said,
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Prometheus has been founded 25 years ago.
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So over the,
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the past two decades,
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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.
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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.
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Then we are entering validation phase where we are uh you know,
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using validation cohorts where we are again,
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combining multiple modalities together uh patient demographic as well as genetic marker together with theological marker.
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Actually,
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to come up with some Multivariate models that are uh again,
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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.
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And uh obviously,
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again,
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the patient uh to the benefit of the patient and to,
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to improve its outcome,
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the outcome.
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I think what you're describing really is the future of pharmacogenomics.
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Um In other words,
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not singing out pharmacogenomics as you know the end all and be all in the treatment paradigm.
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But using a PGX test in combination with,
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like you mentioned,
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other serological tests,
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maybe other genetic tests.
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Um But you know,
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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,
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to remission.
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So I think you guys are absolutely,
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you're already in the future.
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In other words,
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you know,
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you're already providing all these different uh tests um like you mentioned to,
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to facilitate from diagnosis to remission to remission.
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That's correct.
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Yeah.
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So um you've given us so much great information about uh the tests that that you guys offer.
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Can you explain to our audience um your newest test?
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Uh the responder test.
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And um what role it will play in the paradigm from the diagnosis of IBD to remission?
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Yeah,
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sure.
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So we,
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we are doing things a little bit different than other.
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We do believe that uh you know,
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the it has to be simple.
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Uh uh We can obviously construct some very,
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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,
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you know,
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those sorts of things.
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But we have taken on a different approach where with the responder test,
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we are basically,
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we are taking an approach which is very simple to address the first and foremost.
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Most important aspect of responding uh predicting response to uh to medication is the pharmacokinetics.
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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.
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And this is what we are doing with the responder test.
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We are addressing some uh uh you know,
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fundamental issues with those uh biologist,
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for example,
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uh the anti tumor necrosis factors.
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So,
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such as uh Infliximab and Adalimumab,
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it is well known uh that uh uh those drugs,
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first of all are prone to immunization.
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Uh Meaning that uh uh the drug itself uh is recognized by the immune system uh and digested by the antigen presenting cells.
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If you will uh where you gonna have uh uh an immune uh uh response,
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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.
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So,
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we are with the risk conductors,
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we are combining two things together.
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First of all is the genetic test itself which uh predicts the risk of immun immunization.
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The name of the test is on HL A uh DQ A 105 ali uh that uh uh promotes the presentation of the,
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of the,
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of Infliximab,
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for example,
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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,
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which is as important.
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Uh One of the key issue is the,
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the,
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the monoclonal antibodies and uh such as Infliximab or Adalimumab.
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But in fact,
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a neon antibodies that those drugs are uh you know,
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cleared and consumed uh from the,
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from the central compartment if you will,
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since we are doing a little bit of uh uh pharmacokinetics here.
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And uh uh you know,
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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,
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in the presence again of the HL AD Q A 105 genetic marker that uh associate with uh immunization.
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So I but this is a combination of both,
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these are the predictive factors of pharmacokinetic,
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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,
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you know,
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will clear the drug very,
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very fast.
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For example,
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due to the inefficient uh recirculation of the drug itself with the new,
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the,
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the the in the reticular on the system.
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Together,
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those patients presenting with uh uh together these uh poor prognostic factor of pharmacokinetic origin will tend to be severely underdose,
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will not be responding to the drug uh adequately as and they,
325
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and they probably should in the first place if you are able to address uh you know,
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the the the exposure.
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So what we do with this test,
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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.
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So that the the the proper uh exposure is achieved uh during induction to again to,
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to,
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to,
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to achieve a better outcome.
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And I think the pharmacist will have a very important role to play here in terms of absolutely,
335
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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
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And if I may add in our previous conversation,
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uh before the recording of podcast,
339
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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
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can you please uh briefly detail how Prometheus has proactively worked with payers to solve the problem.
342
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Um the population health problem by building the evidence payers want,
343
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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.
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So briefly I can,
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I'm,
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I'm probably not the right person to answer that question.
348
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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.
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But uh uh uh what I can tell you that we have an evidence uh uh development plan in place where we,
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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
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and the impact of our technology on the,
353
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on physician behavior.
354
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Uh We have uh uh already uh you know,
355
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commercialized uh two of those tests for which we have initiated,
356
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initiated the Power studies uh that uh uh you know,
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already provide uh you know,
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differentiated and the value to,
359
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to the payer where we are,
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00:24:35,925 --> 00:24:36,025
the,
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the clinicians are basically using our technology to make treatment decision uh as well as uh some prospective clinicality study which we are initiating,
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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,
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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 for Rx dot com.
441
00:28:39,569 --> 00:28:43,380
That's PGX for Rx dot com.
