Bringing Practical Applications of Endogenous Biomarkers for Drug Transporters a Step Closer: Current Status and Future Perspectives | An ISSX 2024 Virtual Workshop Event

Bringing Practical Applications of Endogenous Biomarkers for Drug Transporters a Step Closer: Current Status and Future Perspectives | An ISSX 2024 Virtual Workshop Event

  • Register
    • Non-member - $400
    • Member - $300
    • Student - $125
    • Premier - Free!

This workshop is organized through the efforts of the ISSX Transporters Focus Group and is organized by Drs. Aleksandra Galetin, Xinning Yang, Bhagwat Prasad, Xiaoyan Chu, Hong Shen, Pei Feng Shawn Tan (student member), Mitesh Patel, Eva Gil Berglund, and Chitra Saran.

This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years. 

The three-day workshop will cover several important topics in these areas: 

-application of transporter biomarker in drug development,
-understanding transporter function changes in specific populations facilitated by biomarker assessment, 
-methods to identify transporter biomarkers, and 
-emerging biomarkers of efflux transporters.  

Each session of the workshop consists of presentations from several expert speakers followed by roundtable discussions, with case study presentations incorporated into one session to showcase the experience and advances in using transporter endogenous biomarkers during drug development. In addition, there will be an interactive virtual poster session, which will be selected from the pool of abstracts from trainees and industry attendees.

Your workshop registration includes access to all presentation slides and recordings.

  • Contains 10 Component(s)

    This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years.

    Co-Chairs: Xiaoyan Chu, Merck, Rahway, New Jersey, USA & Hong Shen, Bristol Myers Squibb, Princeton, New Jersey, USA

    Why Drug Metabolites Can be Important; Examples of Active and Toxic Metabolites 

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    Kenta Yoshida, Genentech, South San Francisco, California, USA


    Update from IQ OATP1B Biomarker Working Group

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    Bridget L. Morse, Eli Lilly, Indianapolis, Indiana, USA



    Case Studies: Applying Transporter Biomarker Data to Support Mechanistic Understanding of DDIs and Drive DDI Strategy and Decision-Making in Drug Development

         Utilizing Endogenous Biomarkers to Streamline Assessment of Transporter-Mediated Drug-Drug Interactions: Case Studies

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    Fenglei Huang, Boehringer Ingelheim, Ridgefield, Connecticut, USA



         Evaluation of the Impact of Ritlecitinib on Organic Cation Transporters Using Sumatriptan and Biomarkers as Probes

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    Xiaoxing Wang, Pfizer, Vienna, Virginia, USA




         Ticagrelor Increases Exposure to the Breast Cancer Resistance Protein Substrate Rosuvastatin

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    Mikko Niemi, University of Helenski, Helenski, Finland


         

         Pharmacokinetic Drug-drug Interaction Study Using Cimetidine and Dolutegravir to Elucidate Predictive Performance of the Endogenous Biomarkers for OCT2 and MATEs in Healthy Volunteers

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    Tomoki Koishikawa, University of Tokyo, Tokyo, Japan



    Regulatory Perspectives on Transporter Biomarkers

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    Xinning Yang, US FDA, Silver Spring, Maryland, USA




    Roundtable Discussion with Speakers








  • Contains 12 Component(s)

    This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years.

    Co-Chairs: Aleksandra Galetin, University of Manchester, Manchester, UK & Xinning Yang, US FDA, Silver Spring, Maryland, USA

    Coproporhyrin I in Different Patient Populations – Implications on DDI Assessment 

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    Manthena Varma, Pfizer, Groton, Connecticut, USA




    Endogenous Biomarkers for Renal Drug Transporters in Patients with Impaired Renal Function 

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     Aleksandra Galetin, University of Manchester, Manchester, UK



    Selected Abstract Talks

         P1. GADOXETIC ACID-ENHANCED HEPATIC MAGNETIC RESONANCE IMAGING AND CIRCULATING COPROPORPHYRIN I IN THE ASSESSMENT OF DRUG TRANSPORTER ACTIVITY IN NONALCOHOLIC FATTY LIVER DISEASE       Rommel G Tirona, Departments of Physiology & Pharmacology and Medicine, University of Western Ontario, London, Ontario, Canada

         P2. IDENTIFICATION OF ENDOGENOUS SUBSTRATES OF RENAL ORGANIC CATION TRANSPORTERS AS POTENTIAL BIOMARKERS BY UNTARGETED METABOLOMICS ANALYSIS OF CIMETIDINE-TREATED RAT BLOOD AND         URINE SAMPLES
         
    Anoud Ailbouni,Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington, USA

         P3. DE NOVO IDENTIFICATION AND VALIDATION OF HUMAN ENDOGENOUS BIOMARKERS OF RENAL ORGANIC ANION TRANSPORTERS FOR PREDICTING INTERINDIVIDUAL VARIABILITY
         A
    arzoo Thakur, Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington, USA

         P4. PBPK MODELING OF COPROPORPHYRIN I: EVALUATION OF THE IMPACT OF SLCO1B1 GENOTYPE, ETHNICITY AND OATP1B-MEDIATED DDIS
         Yuki Ujihira, Centre for Applied Pharmacokinetic Research, School of Health Sciences, The University of Manchester, UK and Laboratory for Safety Assessment and ADME, Pharmaceuticals Research Center, Asahi             Kasei Pharma Corporation, Shizuoka, Japan

         P5. INVESTIGATING INTRINSIC, EXTRINSIC, AND DISEASE STATE IMPACT ON ENDOGENOUS BIOMARKERS IN RENAL-TRANSPORTER-MEDIATED DRUG DRUG INTERACTIONS
         
    HeeJae Choi, Boehringer Ingelheim, Ridgefield, Connecticut, USA

         P6. ELUCIDATING ELIMINATION PATHWAYS OF ENDOGENOUS BIOMARKERS FOR ORGANIC ANION TRANSPORTER 1/3 (OAT1/3) INHIBITION IN CYNOMOLGUS MONKEYS 
         
    Renmeng Liu, Drug Metabolism, Gilead Sciences Inc., Foster City, California, USA

         P7. INCEPTION & DEVELOPMENT OF A LC-MS/MS ASSAY FOR THE MULTIPLEXED QUANTITATION OF NINE HUMAN DRUG TRANSPORTER BIOMARKERS
         Eugene P. Kadar, Bioanalytical Group, Medicine Design, Pfizer Worldwide Research & Development, Pfizer Inc., Groton, Connecticut, USA


    Drug Transporters in Pediatrics: Ontogeny, Variability, and Clinical Significance 

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    Bhagwat Prasad, Washington State University, Spokane, Washington, USA





    Roundtable Discussion with Speakers

  • Contains 7 Component(s)

    This virtual workshop will bring together scientists from academia, industry, and regulatory agencies to share their research findings, experience, and expert views on endogenous biomarkers for drug transporters, an active research area with rapid advances in recent years.

    Co-Chairs: Bhagwat Prasad, Washington State University, Spokane, Washington, USA & Pei Feng Shawn Tan, University of Manchester, Manchester, UK

    Use of Metabolomics for Biomarker Identification and Validation

    image  Martin Fromm, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlagen, Germany



    Isolation of Exosomes/extracellular Vesicles as Biomarkers of Transporter Expression/activity: Challenges, Methodology and Promise

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    Brahim Achour, University of Rhode Island, Kingston, Rhode Island, USA




    An Update to Existing SLC Biomarkers: Evaluation of the Selectivity of Several OATP1B Biomarkers Using a Relative Activity Factor Method

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    Xiaoyan Chu, Merck, Rahway, New Jersey, USA





    Discovery and Validation of Riboflavin as A Surrogate Marker of Breast Cancer Resistance Protein (BCRP)

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    Hong Shen, Bristol Myers Squibb, Princeton, New Jersey, USA




    Identification and Evaluation of Biomarkers for BCRP

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    Kathleen Giacomini, University of California San Francisco, San Francisco, California, USA



    Roundtable Discussion with Speakers